Pharma Reviews: Govt sets up council to boost local manufacturing, export of medical devices

In a major fillip to medical devices industry, the Indian government has decided to set up a National Medical Devices Promotion Council under the ...
Read more: Govt sets up council to boost local manufacturing, export of medical devices

Pharma Reviews: Indian pharma market growth likely to be in double digits in 2019

Healthcare sector may see further consolidation in 2019 with tightening of regulatory environment set to make it difficult for small players to stay afloat ...
Read more: Indian pharma market growth likely to be in double digits in 2019

Pharma Reviews: Healthcare sector may see further consolidation in 2019

"We expect a good recovery for the pharma sector in the domestic market. The Indian pharma market growth is likely to be in double digits and we will ...
Read more: Healthcare sector may see further consolidation in 2019

Pharma Reviews: Top 19 for 2019: Stocks that could give double-digit returns in a year

We expect Ashok Leyland to benefit as the Indian MHCV industry is .... of the biggest integrated pharma companies in India with a strong presence in ...
Read more: Top 19 for 2019: Stocks that could give double-digit returns in a year

Pharma Reviews: Now Indian stents represent more than 50% of the market : Gurmeet Singh Chugh

The creation of every new drug diluting stent is almost equivalent to creating a new pharma molecule. Now within Indian companies, we face two ...
Read more: Now Indian stents represent more than 50% of the market : Gurmeet Singh Chugh

Pharma Reviews: From Zinetac to Calpol, top 10 drugs drive India revenue for big firms

A few thousand brand launches happen in the Rs 1.2-trillion domestic pharmaceuticals industry every year. Almost all major drugmakers market a few ...
Read more: From Zinetac to Calpol, top 10 drugs drive India revenue for big firms

Product Recall Alerts: FDA issues alert, voluntary recall on cardiovascular medication

Recalls of prescription drugs used to treat cardiovascular conditions continue with the Food and Drug Administration issuing a Dec. 20 alert on certain ...
Read more: FDA issues alert, voluntary recall on cardiovascular medication

Pharma Reviews: Outlook 2019: Pharma looks medically fit for double-digit growth after years of suffering

Indian pharma companies have been going through a tough phase for the past couple of years due to significant competitive intensity and pricing ...
Read more: Outlook 2019: Pharma looks medically fit for double-digit growth after years of suffering

Pharma Reviews: Indian Pharma, Sugar and Agri Industry should invest in Sudan, says Indian Ambassador to Sudan

Hyderabad, Dec 28 (UNI) Mr Ravindra P Jaiswal, IFS, Ambassador of India to Sudan invited investors from the Agri, Food Processing, Sugar ...
Read more: Indian Pharma, Sugar and Agri Industry should invest in Sudan, says Indian Ambassador to Sudan

Pharma Reviews: 'NMDPC' was long-standing need of Indian medical devices industry: CII

National Medical Devices Promotion Council, set up under the Department of Industrial Promotion and Policy, will help promote growth of the sector ...
Read more: 'NMDPC' was long-standing need of Indian medical devices industry: CII

Pharma Reviews: National Medical Devices Promotion Council to fuel growth of domestic industry: CII

The industry chamber said that it was a long-standing need of the medical devices industry in India. "Time has come for the medical technology sector ...
Read more: National Medical Devices Promotion Council to fuel growth of domestic industry: CII

Pharma Reviews: Rising shipments to US help Indian pharma exports rebound in H1FY19

Indian pharmaceutical exports grew 12.2 percent to $10.8 billion year-on-year (YoY) in the first half of FY19, riding on generic drug launches, easing of ...
Read more: Rising shipments to US help Indian pharma exports rebound in H1FY19

Pharma Reviews: ICRA assigns stable outlook for Indian Pharma companies

ICRA has given a stable outlook on the Indian pharmaceutical industry. The headwinds from pricing pressure in large regulated markets, especially ...
Read more: ICRA assigns stable outlook for Indian Pharma companies

Pharma Reviews: Sun Pharma: Global Is Local

Sun was one of first Indian pharma companies to invest in these areas. “We are meticulously nurturing the specialty business and have built a portfolio ...
Read more: Sun Pharma: Global Is Local

Pharma Reviews: Closing bell: Sensex up 157 points, Nifty fails to hold 10800 as banking stocks drag

Mumbai: Indian shares extended gains for a second straight session on .... The company on Wednesday said its arm DUSA Pharmaceuticals has ...
Read more: Closing bell: Sensex up 157 points, Nifty fails to hold 10800 as banking stocks drag

Pharma Reviews: Motilal Oswal's 10 stocks to bet on in 2019

Indian hospitality industry is set to enter an upcycle, led by favourable ... the biggest integrated pharma companies in India with strong presence in US, ...
Read more: Motilal Oswal's 10 stocks to bet on in 2019

Pharma Reviews: Share market update: Pharma shares slip; Sun Pharma down nearly 3%

Shares of Sun Pharmaceutical Industries (down 2.69 per cent), Piramal ... Shares of YES Bank, Indian Oil Corp, Bank of Baroda, Tata Motors, SAIL, ...
Read more: Share market update: Pharma shares slip; Sun Pharma down nearly 3%

Pharma Reviews: Holistic quality enhancement is the need of the hour: 70th Indian Pharmaceutical Congress

Whereas the Indian diagnostics market was a $ 9.6 million industry, just under 20% of Indians have ever given their blood for testing while Tier III & IV ...
Read more: Holistic quality enhancement is the need of the hour: 70th Indian Pharmaceutical Congress

Pharma Reviews: Biocon Says Won't Play The Bloodbath Game In Indian Market For Now

Biocon Ltd.—India's second-best performing pharmaceutical stock this year—will continue to focus on Europe and the U.S. in 2019. That's according ...
Read more: Biocon Says Won't Play The Bloodbath Game In Indian Market For Now

Pharma Reviews: Make India global capital for generic medicines: Naidu

Vice President M. Venkaiah Naidu on Friday called up on the pharmaceutical industry to work towards making India an international capital of generic ...
Read more: Make India global capital for generic medicines: Naidu

Pharma Reviews: India wants China to allow import of drugs cleared by US, Europe

Almost 1,500 Indian products have obtained clearances from the food and pharmaceutical regulators of the US, EU and Japan, but only 535 are ...
Read more: India wants China to allow import of drugs cleared by US, Europe

Pharma Reviews: Cost of HIV/AIDS treatment down globally due to Indian firms: VP Naidu

Noida (UP): Due to the ability of the Indian pharma companies to produce drugs at economical rates, the cost of HIV/AIDS treatment has gone down to ...
Read more: Cost of HIV/AIDS treatment down globally due to Indian firms: VP Naidu

Pharma Reviews: 70th Indian Pharmaceutical Congress commences in NCR

With the theme Pharma Vision 2030 aimed at establishing India as the global industry leader, the 70th edition of the Indian Pharmaceutical Congress ...
Read more: 70th Indian Pharmaceutical Congress commences in NCR

Pharma Reviews: Pharma sector: Earnings downgrade is yet to bottom out

A large chunk of incremental investments by Indian pharmaceutical companies have been in complex and specialty. The sector's R&D spends have ...
Read more: Pharma sector: Earnings downgrade is yet to bottom out

US FDA News: FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.
Read more: FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

Pharma Reviews: Cost of HIV/AIDS treatment down globally due to Indian firms: Venkaiah Naidu

Due to the ability of the Indian pharma companies to produce drugs at economical rates, the cost of HIV/AIDS treatment has gone down to $400 per ...
Read more: Cost of HIV/AIDS treatment down globally due to Indian firms: Venkaiah Naidu

Pharma Reviews: Cost of HIV/AIDS treatment down globally due to Indian firms: VP Naidu

Due to the ability of the Indian pharma companies to produce drugs at economical rates, the cost of HIV/AIDS treatment has gone down to USD 400 ...
Read more: Cost of HIV/AIDS treatment down globally due to Indian firms: VP Naidu

Pharma Reviews: Business Top 5: TCS, UPL, Torrrent Pharma, Sun Pharma, stock market wrap

Business Top 5: TCS, UPL, Torrrent Pharma, Sun Pharma, stock market wrap ... He also stated that India as a Pharma market will continue to grow in ...
Read more: Business Top 5: TCS, UPL, Torrrent Pharma, Sun Pharma, stock market wrap

Pharma Reviews: VP Naidu addresses 70th Indian Pharmaceutical Congress at Amity University

The Vice President of India, Shri M. Venkaiah Naidu has called upon the pharmaceutical industry to work towards making India an International ...
Read more: VP Naidu addresses 70th Indian Pharmaceutical Congress at Amity University

Pharma Reviews: Indian Pharma industry projected to grow 55 Million USD by 2020

Noida – Addressing the 70th Indian Pharmaceutical Congress at Amity University, Noida , Vice President Naidu said that India becoming the largest ...
Read more: Indian Pharma industry projected to grow 55 Million USD by 2020

US FDA News: FDA approves new treatment for adult patients with rare, life-threatening blood disease

The FDA approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.
Read more: FDA approves new treatment for adult patients with rare, life-threatening blood disease

US FDA News: FDA approves first treatment for rare blood disease

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.
Read more: FDA approves first treatment for rare blood disease

Pharma Reviews: Naidu says make India an international capital of generic medicines

Addressing the 70th Indian Pharmaceutical Congress at Amity University in Noida, Mr Naidu said that apart from being the world leader in generic ...
Read more: Naidu says make India an international capital of generic medicines

Pharma Reviews: Make India the international capital for Generic Medicines, says Vice President

Vice President of India, Shri M. Venkaiah Naidu has called up on the pharmaceutical industry to work towards making India an International Capital of ...
Read more: Make India the international capital for Generic Medicines, says Vice President

Pharma Reviews: Over 150 volunteers from IPCA initiate Swachh Bharat Drive within Amity Campus

Cleanliness drive was organized on the run-up to the 70th Indian Pharmaceutical Congress (IPC) which will be held from December 21 to 23 at Amity ...
Read more: Over 150 volunteers from IPCA initiate Swachh Bharat Drive within Amity Campus

Pharma Reviews: India provides access to life-saving medicines at affordable prices: Vice President

Addressing Indian Pharmaceutical Congress in Noida on Friday, Mr Naidu said, rural health programmes, lifesaving drugs and preventive vaccines ...
Read more: India provides access to life-saving medicines at affordable prices: Vice President

Pharma Reviews: 5 lessons Dalal Street taught us in 2018 & 5 themes to bet on for 2019

Indian pharma companies, which are focusing on building complex and specialty products pipeline, would be able to sustain better profitability ...
Read more: 5 lessons Dalal Street taught us in 2018 & 5 themes to bet on for 2019

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Pharma Reviews: Industry to discuss various critical issues during pharma event

The pharmaceutical industry would deliberate on various issues related to generic drugs and medical devices at 70th edition of Indian Pharmaceutical ...
Read more: Industry to discuss various critical issues during pharma event

Pharma Reviews: All You Need To Know Going Into Trade On Dec. 20

Coal India seeks to buy coking coal mines in Australia and Canada. ... This film is mainly used in dairy industry for flavored milk, pharma industry and ...
Read more: All You Need To Know Going Into Trade On Dec. 20

US FDA News: Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.
Read more: Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

US FDA News: FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

FDA alerted parents, caregivers and health care providers to the safety risks that jewelry used for relieving teething pain pose for children.
Read more: FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

US FDA News: FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.
Read more: FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

Pharma Reviews: Stocks To Watch: Coal India, GSK, Religare Enterprises, Tata Consultancy Services

Uflex launched three packaging foil solutions for pharma companies. Executive Director Amitava Ray said that the 'fast tear strip' foil will prove to be a ...
Read more: Stocks To Watch: Coal India, GSK, Religare Enterprises, Tata Consultancy Services

Pharma Reviews: Pharma's tough year concludes; hopes up for a better 2019

The calendar year, just concluding, has arguably been a tough year for most of the Indian pharmaceutical companies. Most of them, especially the ...
Read more: Pharma's tough year concludes; hopes up for a better 2019

Pharma Reviews: Quality can't be ensured without stringent regulations

Even as Indian generics share the lion's share of the global market, closer home, they have missed the paramount objective of 'alleviating diseases by ...
Read more: Quality can't be ensured without stringent regulations

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

FDA announces steps being taken on two medical device programs: finalizing guidance on the Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on new steps to promote innovations in medical devices that help advance patient safety

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

FDA’s 2017 report of sales/distribution data for antimicrobial drugs for food animals showed a continued decline in sales, a reflection of improved antimicrobial stewardship
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

US FDA News: Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Saranac Brand Foods, Inc. specialized in a variety of 35 different ready-to-eat foods, including prepared salads, dips, and sauces.
Read more: Michigan-based food manufacturer agrees to stop operations after repeated food safety violations

Pharma Reviews: China emerging as big opportunity for Indian pharma: Pharmexcil

Hyderabad: With China easing regulations in the pharma sector, many Indian players are now showing interest in foraying into that market, Pharmexcil ...
Read more: China emerging as big opportunity for Indian pharma: Pharmexcil

Pharma Reviews: The way forward for Healthcare sector in India

Indian pharma companies have proven time and again that they are good at manufacturing low cost generic drugs that can benefit the patient, and ...
Read more: The way forward for Healthcare sector in India

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation

Pharma Reviews: Closing bell: Sensex up 150 points, Nifty ends at 10791, Yes Bank shares fall 6%

Mumbai: Indian benchmark indices BSE Sensex and NSE's Nifty 50 continued .... complaint against Dilip Shanghvi-led Sun Pharmaceutical Industries.
Read more: Closing bell: Sensex up 150 points, Nifty ends at 10791, Yes Bank shares fall 6%

Pharma Reviews: The 12th Edition of CPhI P-MEC India Expo Witnessed a Spectacular Opening in its Debut in Delhi ...

The reputed CPhI Global Pharma Index ranks India no. 1 in terms of pharma market growth potential, and within the top 3 countries on the parameter ...
Read more: The 12th Edition of CPhI P-MEC India Expo Witnessed a Spectacular Opening in its Debut in Delhi ...

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development

FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development

Pharma Reviews: The 12th Edition of CPhI & P-MEC India Expo Witnessed a Spectacular Opening in its Debut in ...

1 in terms of pharma market growth potential, and within the top 3 countries on the parameter of competitiveness. India has also taken giant strides to ...
Read more: The 12th Edition of CPhI & P-MEC India Expo Witnessed a Spectacular Opening in its Debut in ...

Pharma Reviews: The Tiger Finds Its Way Into The Dragon Cave: Aurobindo Pharma's Subsidiary To Form Joint ...

Indian pharmaceutical major, Aurobindo Pharma's subsidiary, Helix Healthcare BV, will form a Joint Venture (JV) with the Chinese pharma company, ...
Read more: The Tiger Finds Its Way Into The Dragon Cave: Aurobindo Pharma's Subsidiary To Form Joint ...

Pharma Reviews: Indian pharmaceutical meet: Impact of e-pharma on agenda

New Delhi, Dec 11 (IANS) The upcoming “Indian Pharmaceutical Congress 2018” would discuss various aspects of the industry including the impact ...
Read more: Indian pharmaceutical meet: Impact of e-pharma on agenda

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

Pharma Reviews: Industry welcomes TRS victory

This could be followed up by setting up mega industrial townships on ... not have much impact on pharma exports as Indian pharmaceutical industry is ...
Read more: Industry welcomes TRS victory

US FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Read more: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

Pharma Reviews: Indian pharmaceutical meet: Impact of e-pharma on agenda

The upcoming "Indian Pharmaceutical Congress 2018" would discuss various aspects of the industry including the impact of e-pharmacy players on ...
Read more: Indian pharmaceutical meet: Impact of e-pharma on agenda

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

FDA announces new actions advancing the agency’s biosimilars policy framework
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework

Product Recall Alerts: Recall Alert: 3 Brands of Infants' Ibuprofen Recalled for Higher Concentrations of Medicine

Three brands of Infants' Ibuprofen Concentrated Oral Suspension are being voluntarily recalled by Tris Pharma, Inc. for potentially higher ...
Read more: Recall Alert: 3 Brands of Infants' Ibuprofen Recalled for Higher Concentrations of Medicine

US FDA News: Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
Read more: Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

Pharma Reviews: Acute therapy segments pull down domestic pharma sales growth to 6% in Nov

While Indian companies grew 6.2 per cent for the month, multinational firms grew slightly faster at 6.8 per cent for the same period. Amongst the top 60 ...
Read more: Acute therapy segments pull down domestic pharma sales growth to 6% in Nov

Pharma Reviews: India pharma market slows due to lower offtake of anti-infective, respiratory drugs

The Indian pharmaceutical market (IPM) grew 6.3 percent in November, much slower than the previous month, due to lower offtake of anti-infective ...
Read more: India pharma market slows due to lower offtake of anti-infective, respiratory drugs

Pharma Reviews: Over 8000 to participate in 70th Indian Pharma Congress

Indian Pharmaceutical Congress (IPC) is held every year in the country under the aegis of Indian Pharmaceutical Congress Association (IPCA) which ...
Read more: Over 8000 to participate in 70th Indian Pharma Congress

US FDA News: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder
Read more: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Pharma Reviews: 70th Indian Pharmaceutical Congress to begin on Dec 21

The 70th Indian Pharmaceutical Congress (IPC) is all set to be inaugurated by Vice President of India, Venkaiah Naidu on December 21. Around ...
Read more: 70th Indian Pharmaceutical Congress to begin on Dec 21

Pharma Reviews: Pharma torch bearers congregate to select industry's best in class in Mumbai

Members of the jury overseeing the presentation by nominated pharma firms at the second and final jury selection round at the India Pharma Awards.
Read more: Pharma torch bearers congregate to select industry's best in class in Mumbai

Pharma Reviews: The Murky Affairs Of Sun Pharma

Among the large corporates in India, Sun Pharmaceuticals Ltd., India's biggest pharma company, stood out as a relatively clean organisation, whose ...
Read more: The Murky Affairs Of Sun Pharma

Product Recall Alerts: Childrens' Pain Reliever Recalled Due to Potentially Higher Potency Level

Tris Pharma announced a voluntary nationwide recall of 3 lots of Infants' Ibuprofen Concentrated Oral Suspension, 50mg/1.25mL as the products may ...
Read more: Childrens' Pain Reliever Recalled Due to Potentially Higher Potency Level

Product Recall Alerts: Parents Beware: Infant Ibuprofen Recalled Over Dosage Problem

Ibuprofen is one of the most common over-the-counter medications given to young kids, but a huge new recall on the drug has parents on high alert.
Read more: Parents Beware: Infant Ibuprofen Recalled Over Dosage Problem

Product Recall Alerts: HEALTH ALERT: Retailers nationwide recalling infants' ibuprofen

HEALTH ALERT: Retailers nationwide recalling infants' ibuprofen .... That manufacturer, New Jersey-based Tris Pharma Inc., says the recall affects ... received no reports of infants injured as a result of taking the recalled ibuprofen.
Read more: HEALTH ALERT: Retailers nationwide recalling infants' ibuprofen

Product Recall Alerts: Recall Alert! Baby Ibuprofen From Walmart, CVS, and Family Dollar Has Been Recalled

A press release from Tris Pharma - a company based in New Jersey - just recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension, USP ...
Read more: Recall Alert! Baby Ibuprofen From Walmart, CVS, and Family Dollar Has Been Recalled

Product Recall Alerts: Recall Alert: Pharma Company Pulls Infant Ibuprofen From CVS, Walmart, Family Dollar

Tris Pharma, Inc. has voluntarily recalled a popular infant's Ibuprofen product that is being sold at Walmart, CVS and Family Dollar. The recalled lots ...
Read more: Recall Alert: Pharma Company Pulls Infant Ibuprofen From CVS, Walmart, Family Dollar

Product Recall Alerts: RECALL ALERT: Infant ibuprofen products

NBC – A New Jersey pharmaceutical company has recalled three lots of infant ibuprofen product over concerns that there may be a higher ...
Read more: RECALL ALERT: Infant ibuprofen products

Product Recall Alerts: Recall alert: Infant ibuprofen sold at Walmart, CVS, Family Dollar

Tris Pharma, Inc., has recalled three lots of infant ibuprofen because of a formulation error creating a potency that could cause babies to develop ...
Read more: Recall alert: Infant ibuprofen sold at Walmart, CVS, Family Dollar

Product Recall Alerts: RECALL ALERT: Infant ibuprofen sold at CVS, Family Dollar and Walmart

Tris Pharma, Inc. is recalling three lots of infants' liquid Ibuprofen because they may contain higher concentrations of ibuprofen than advertised.
Read more: RECALL ALERT: Infant ibuprofen sold at CVS, Family Dollar and Walmart

Product Recall Alerts: Infant ibuprofen sold at CVS, Walmart, Family Dollar recalled

Tris Pharma Inc. issued the recall Wednesday, affecting lots sold at Walmart, CVS, and Family Dollar. The products were labeled to contain 50 mg of ...
Read more: Infant ibuprofen sold at CVS, Walmart, Family Dollar recalled

Product Recall Alerts: CONSUMER ALERT: Infant ibuprofen recalled sold at Walmart, CVS, Family Dollar

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants' Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the ...
Read more: CONSUMER ALERT: Infant ibuprofen recalled sold at Walmart, CVS, Family Dollar

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products

Pharma Reviews: Forthcoming challenges and changing skill sets for Indian pharmaceutical industry in next decade

What was noticeable was major Indian pharma companies initiating their defined and conscious journey in this direction. In fact the status of this ...
Read more: Forthcoming challenges and changing skill sets for Indian pharmaceutical industry in next decade

Product Recall Alerts: Infants' ibuprofen sold at Walmart, CVS, Family Dollar recalled

The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed here. Tris Pharma, Inc. sold the ...
Read more: Infants' ibuprofen sold at Walmart, CVS, Family Dollar recalled

Product Recall Alerts: Voluntary nationwide recall issued for infant ibuprofen sold at Walmart, CVS, Family Dollar

(WFLA) – A voluntary nationwide recall has been issued for three lots of infant ibuprofen. The recalled lots of the product have been found to ...
Read more: Voluntary nationwide recall issued for infant ibuprofen sold at Walmart, CVS, Family Dollar

Product Recall Alerts: Infant liquid ibuprofen sold at Walmart, CVS and Family Dollar recalled

Recall Alert. Infant liquid ibuprofen sold at Walmart, CVS and Family Dollar recalled ... Several brands of infant liquid ibuprofen are being recalled as they might contain higher and ... (NSAID) 50 mg per 1.25 mL" product sold and packaged in 0.5 oz. bottles at CVS Pharmacy, Family Dollar and Walmart.
Read more: Infant liquid ibuprofen sold at Walmart, CVS and Family Dollar recalled

Pharma Reviews: Do we need powerful Law on Medical devices in India?

Though India's medical devices market has become the hub of global majors like Medtronic, Stryker, Abbott, Bayer and Johnson & Johnson, ...
Read more: Do we need powerful Law on Medical devices in India?

Pharma Reviews: India registers 10% growth in containerised trade in Q3 2018, says report

The demand for India-made goods such as vehicles and mechanical ... The report said the Indian pharma sector witnessed high export growth to ...
Read more: India registers 10% growth in containerised trade in Q3 2018, says report

Pharma Reviews: Sun Pharma shares fall 7.5% after whistleblower email to Sebi

According to the whistleblower, acquisitions by Sun Pharma Group of overseas pharmaceutical companies and many Indian brokerage firms were ...
Read more: Sun Pharma shares fall 7.5% after whistleblower email to Sebi

Pharma Reviews: Closing Bell: Sensex ends flat, Nifty fails to close above 10900; Sun Pharma down 8%

Pharmaceuticals were the big losers, with the Nifty Pharma ending over 2 ... Further India's GDP and fiscal deficit data disappointed the market. Hence ...
Read more: Closing Bell: Sensex ends flat, Nifty fails to close above 10900; Sun Pharma down 8%

Pharma Reviews: Market Live: Selling in all sectors drags Nifty below 10900; Sensex marginally lower; RIL, Sun ...

Global research firm believes that the Indian tyre industry is witnessing a .... Sun Pharma cracks Shares of Sun Pharmaceuticals are down around 9 ...
Read more: Market Live: Selling in all sectors drags Nifty below 10900; Sensex marginally lower; RIL, Sun ...

US FDA News: FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
Read more: FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

Pharma Reviews: Top stocks to watch out for on December 3: Sun Pharma, Maruti Suzuki, Tata Motors, SBI

The Indian market is set for a positive start on Monday, taking cues from its Asian peers after the top economic leaders US and China brokered a truce ...
Read more: Top stocks to watch out for on December 3: Sun Pharma, Maruti Suzuki, Tata Motors, SBI

Pharma Reviews: #ImplantFiles: Law on medical devices has waited 12 years

Successive governments in India have neglected the medical devices sector. For over 12 years, a proposed legislation, the Medical Device ...
Read more: #ImplantFiles: Law on medical devices has waited 12 years

Pharma Reviews: #ImplantFiles: Pharma majors gave freebies to doctors, claimed tax benefits

Records accessed by The Indian Express show that several pharmaceutical and medical devices manufacturers have claimed tax benefits on crores ...
Read more: #ImplantFiles: Pharma majors gave freebies to doctors, claimed tax benefits

US FDA News: FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
Read more: FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

Pharma Reviews: Pinched in the US, Indian pharma feels the pain. And the markets are wincing too.

The year 2018 has been one of the worst for India's pharma sector. The share of sales in the US, the biggest market for Indian pharma companies, ...
Read more: Pinched in the US, Indian pharma feels the pain. And the markets are wincing too.

US FDA News: FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.
Read more: FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

Pharma Reviews: Decoding the ban on irrational fixed-dose combination drugs in India

The ban must be viewed not as an obstacle for the pharmaceutical industry, but as a pillar for a stronger Indian healthcare system.
Read more: Decoding the ban on irrational fixed-dose combination drugs in India

Pharma Reviews: PharmaHopers Explains the Expectations From Third Party Pharma Manufacturing Companies

Indian Pharmaceutical industry has gained prominence since the 1970s but back then, not much attention was given on the manufacturing standards.
Read more: PharmaHopers Explains the Expectations From Third Party Pharma Manufacturing Companies

Pharma Reviews: Unilever emerges as leading bidder for GSK's Indian Horlicks business: Sources

... to Indian pharmaceuticals and consumer company Zydus Wellness for 45.95 ... Horlicks comfortably dominates the health-drinks market in India and a big ... A spokesman for Nestle India said the company would not comment on ...
Read more: Unilever emerges as leading bidder for GSK's Indian Horlicks business: Sources

US FDA News: FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.
Read more: FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

Pharma Reviews: Ras Al Khaimah Economic Zone woos more Indian investors

Pharmaceutical is an area, where Indian companies are yet to make their mark at RAKEZ, but which holds immense potential. “We recently had a ...
Read more: Ras Al Khaimah Economic Zone woos more Indian investors

Pharma Reviews: Healing Lupin

Sales in North America, the US in particular, contribute heavily to Lupin's revenue (as they do for all leading Indian pharma companies). In 2017/18 ...
Read more: Healing Lupin

Pharma Reviews: Exclusive interview: Ecosystem that fosters innovation key, says A Vaidheesh, President of ...

Indian pharma industry has to maintain uniform baseline quality standards of the World Health Organisation (WHO) along with good manufacturing ...
Read more: Exclusive interview: Ecosystem that fosters innovation key, says A Vaidheesh, President of ...

Pharma Reviews: Fitch says access to service key for growth of Indian pharma market

MUMBAI – Indian pharmaceutical market's growth going ahead depends on the expansion of the access to healthcare services, global rating agency ...
Read more: Fitch says access to service key for growth of Indian pharma market

Pharma Reviews: Lupin CFO quits, to pursue opportunities outside pharma

Lupin, one of India's leading generic drug maker, has been on a turbulent times in recent years as the company battled regulatory challenges from the ...
Read more: Lupin CFO quits, to pursue opportunities outside pharma

US FDA News: FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Read more: FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

US FDA News: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
Read more: FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

US FDA News: FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health
Read more: FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

Pharma Reviews: #ImplantFiles: Exploring India's thriving medical device bazaar

According to industry estimates cited on the Make in India website, the industry in India is currently valued at $5.2 billion and is expected to grow to ...
Read more: #ImplantFiles: Exploring India's thriving medical device bazaar

Pharma Reviews: Cipla CEO Umang Vohra on why Indian drugmakers must diversify

The Indian pharmaceutical industry has for long depended on generic drugs for expansion. But it's now time for the industry to go beyond the generics ...
Read more: Cipla CEO Umang Vohra on why Indian drugmakers must diversify

Pharma Reviews: 2nd National Biotechnology Conclave: Driving inclusive growth for India Bio-economy Vision-2025

While pharma companies are easily billion dollar plus, the ecosystem for ... A CII-Sathguru Report titled “Roadmap on Indian Biosimilars Industry: ...
Read more: 2nd National Biotechnology Conclave: Driving inclusive growth for India Bio-economy Vision-2025

Pharma Reviews: The 3rd Edition of the India Pharma Week Gears up for a Grand Debut in Delhi-NCR

Apart from the business, and the medley of captivating events, key discussion areas will include 'Growth of Indian Pharmaceutical industry: Vision ...
Read more: The 3rd Edition of the India Pharma Week Gears up for a Grand Debut in Delhi-NCR

Pharma Reviews: Closing bell: Sensex rises 159 points led by Infosys, TCS; Nifty ends at 10685

Sun Pharmaceutical Industries Ltd on Monday said it has bought Japanese ... recent underperformance, these risks remain for Indian equity market.
Read more: Closing bell: Sensex rises 159 points led by Infosys, TCS; Nifty ends at 10685

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

US FDA News: FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).
Read more: FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

Pharma Reviews: Lupin plans expansion, eyes product purchase in chronic and acute therapy

The fifth-largest Indian pharma company also plans to grow its product portfolio on the back of investment in research and development (R&D) for ...
Read more: Lupin plans expansion, eyes product purchase in chronic and acute therapy

Pharma Reviews: Indian Pharma Giant Lupin Launches Chatbot To Dispense Medical Information

Noted Indian pharmaceutical company Lupin launched a new chatbot called ANYA on Friday. It provides medical information and addresses queries ...
Read more: Indian Pharma Giant Lupin Launches Chatbot To Dispense Medical Information

Pharma Reviews: Alpha Moguls: Next Wealth-Creation Cycle Won't Start Soon, Says Ravi Dharamshi

The correction in Indian equities is mostly done but the wealth creation cycle won't start soon, according to Ravi Dharamshi, chief investment officer of ...
Read more: Alpha Moguls: Next Wealth-Creation Cycle Won't Start Soon, Says Ravi Dharamshi

Pharma Reviews: Indian pharma's window of opportunity

Call it opportunistic volume gain at better margins or seeking new growth options under adverse market conditions. Either way, some of the leading ...
Read more: Indian pharma's window of opportunity

US FDA News: FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.
Read more: FDA approves new treatment for patients with acute myeloid leukemia

Pharma Reviews: PharmaHopers (Pharma Franchise Portal) Explains the Indian Future of Pharma Franchise & PCD ...

Indian Pharmaceutical Industry is growing with the CAGR of 15% and is expected to touch USD 250 billion by 2020. Investing in Pharma Franchise is ...
Read more: PharmaHopers (Pharma Franchise Portal) Explains the Indian Future of Pharma Franchise & PCD ...

Pharma Reviews: Conundrum! India Inc's RCEP fear is not unwarranted

The fear is that it may limit access to affordable drugs and have serious implications for the domestic pharma industry. Moreover, India's experience ...
Read more: Conundrum! India Inc's RCEP fear is not unwarranted

US FDA News: Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.
Read more: Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine

US FDA News: FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.
Read more: FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

US FDA News: FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.
Read more: FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

Pharma Reviews: Kovind calls for cooperation with Vietnam in agriculture, pharma, textiles and IT

The President also said that the Indian pharmaceuticals industry, the third largest in terms of volume and the world's largest provider of generic drugs, ...
Read more: Kovind calls for cooperation with Vietnam in agriculture, pharma, textiles and IT

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

US FDA News: Declaración del Dr. Scott Gottlieb, comisionado de la FDA, sobre las nuevas medidas propuestas para proteger a los jóvenes impidiendo el acceso a los productos de tabaco de sabores y prohibiendo el uso del mentol en los cigarrillos

El día de hoy, procuro adoptar medidas encaminadas a enfrentar la preocupante tendencia del consumo de nicotina entre los jóvenes y a continuar impulsando las reducciones históricas alcanzadas en los últimos años en las tasas de consumo de cigarrillos combustibles entre los niños.
Read more: Declaración del Dr. Scott Gottlieb, comisionado de la FDA, sobre las nuevas medidas propuestas para proteger a los jóvenes impidiendo el acceso a los productos de tabaco de sabores y prohibiendo el uso del mentol en los cigarrillos

Product Recall Alerts: Another Tainted 'Sartan' Recalled for Impurity

The saga of contaminated sartans reaching the US market continues, with the US Food and Drug Administration (FDA) and Sandoz Inc announcing a ...
Read more: Another Tainted 'Sartan' Recalled for Impurity

Pharma Reviews: Pharmacy gets shot in arm

Viranchi Shah, chairman of the Gujarat State Board, Indian Drug Manufacturers' Association (IDMA), said that there would be a greater demand for ...
Read more: Pharmacy gets shot in arm

Pharma Reviews: Food, pharma and e-commerce driving demand for packaging: Saha

Indian packaging industry is growing at 13 per cent in India. Its growth reflects a growing consumption in the economy. The segment has over 22,000 ...
Read more: Food, pharma and e-commerce driving demand for packaging: Saha

US FDA News: FDA approves new drug to treat travelers’ diarrhea

FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Read more: FDA approves new drug to treat travelers’ diarrhea

US FDA News: Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.
Read more: Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

US FDA News: FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
Read more: FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

US FDA News: Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.
Read more: Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Pharma Reviews: LEAP India is a leading foldable large containers rental provider across India

Tell us about your company and the concept of palletisation? ... while corporates from automobile and Pharma industry use Foldable Large Containers ...
Read more: LEAP India is a leading foldable large containers rental provider across India

Pharma Reviews: Cipla doesn't want to be Amazoned: how Indian pharma's quintessential do-gooder is rebuilding itself

Back in 2000, Cipla's charismatic boss, Yusuf Hamied, had changed the complexion of the pharma industry and put generic drugs in the forefront by ...
Read more: Cipla doesn't want to be Amazoned: how Indian pharma's quintessential do-gooder is rebuilding itself

Pharma Reviews: Activists irked by RCEP talks over pharma patents

By resisting constant pressure in the past and safeguarding its generic industry, India — often referred to as 'a pharmacy of the developing world', has ...
Read more: Activists irked by RCEP talks over pharma patents

Pharma Reviews: SEBI Watch: Pharma companies must raise the curtain of opaqueness

Indian listed pharmaceutical companies have made a significant mark for themselves in global markets, but of late they have been more in the news ...
Read more: SEBI Watch: Pharma companies must raise the curtain of opaqueness

US FDA News: Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.
Read more: Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

US FDA News: FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.
Read more: FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

Product Recall Alerts: Drug recall for Mitomycin-C Kyowa 10mg Powder for solution for injection

MHRA has issued a company-led drug alert for the recall of Mitomycin-C ... The batch is being recalled because an out of specification result for sub ...
Read more: Drug recall for Mitomycin-C Kyowa 10mg Powder for solution for injection

Pharma Reviews: Sun Pharma falls to 4-month low

Shares of Sun Pharmaceutical Industries, India's largest drugmaker by ... moving average of around 4.6 million shares ($1 = 72.0900 Indian rupees).
Read more: Sun Pharma falls to 4-month low

Pharma Reviews: Markets Live: Sensex trading flat; HUL, Maruti jump over 3%

Shares of Sun Pharmaceutical Industries, India's largest drugmaker by market capitalisation, fell as much as 4.1 per cent to Rs 538.65, their lowest ...
Read more: Markets Live: Sensex trading flat; HUL, Maruti jump over 3%

Pharma Reviews: Health activists raise concerns over IP provisions at RCEP

By "resisting pressure" in the past, and safeguarding its generic industry, India —often referred as 'a pharmacy of the developing world,' has become a ...
Read more: Health activists raise concerns over IP provisions at RCEP

Pharma Reviews: How US mid-term poll outcome will impact Indian IT and pharma sectors

How India's export-led sectors IT and pharma would be impacted with Democrats taking control of the House, following the midterm elections in the US ...
Read more: How US mid-term poll outcome will impact Indian IT and pharma sectors

Pharma Reviews: Sun Pharma posts Q2 loss at ₹219 crore on one-time charge

Indian pharmaceutical companies have been hit by US regulatory bans and warnings over quality control violations at production plants, which have ...
Read more: Sun Pharma posts Q2 loss at ₹219 crore on one-time charge

Pharma Reviews: Sun Pharma swings to surprise quarterly loss

(Reuters) - Sun Pharmaceutical Industries was sent to an unexpected ... Indian pharmaceutical companies have been hit by U.S. regulatory bans and ...
Read more: Sun Pharma swings to surprise quarterly loss

US FDA News: FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
Read more: FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

Pharma Reviews: Pharma lobby for hiking cost of drugs under govt price control

The Indian pharma industry, particularly small drug makers, has been hurt by a shutdown of API manufacturing units in China because of ...
Read more: Pharma lobby for hiking cost of drugs under govt price control

Pharma Reviews: Need for India to evolve as an SRA

India, being a large contributor to the pharma industry, needs to have regulations imposed upon the pharmaceutical activities. They are crucial not ...
Read more: Need for India to evolve as an SRA

Pharma Reviews: Offline versus online in Indian pharmacies is past the use-by date. Omnichannel is what the doctor ...

Discounts and chronic diseases behind the e-pharmacy surgeThe Indian pharmacy market comprises more than 850,000 outlets, of which around ...
Read more: Offline versus online in Indian pharmacies is past the use-by date. Omnichannel is what the doctor ...

Pharma Reviews: India is not just a premier vaccine manufacturer, it can develop new vaccines too

The Organisation of Pharmaceutical Producers of India (OPPI) has come out with a new publication, In Science We Trust. The book, available online, ...
Read more: India is not just a premier vaccine manufacturer, it can develop new vaccines too

Product Recall Alerts: Hypertension drug recall by USFDA shot in the arm for some drug majors

According to the USFDA's list of products under recall, four companies - Teva, ... primary Chinese supplier Zhejiang Huahai Pharmaceutical on import alert. ... The companies, whose drugs were recalled, have to change the source of ...
Read more: Hypertension drug recall by USFDA shot in the arm for some drug majors

US FDA News: FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

U.S. Marshals Service has conducted a mass seizure of FDA-regulated products that were being held in an Arkansas grocery warehouse under insanitary conditions
Read more: FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

FDA is taking steps to modernize the agency’s inspections program
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

US FDA News: FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader
Read more: FDA authorizes emergency use of first Ebola fingerstick test with portable reader

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

The FDA is committed to the expanded access program which provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma

FDA approves new version of OTC Primatene Mist inhaler to treat mild, intermittent asthma for people who have been diagnosed with asthma by their physician
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma

Pharma Reviews: Animal healthcare yields rich dividends for Sequent

ET Intelligence Group: In 2013, when Indian pharma companies came under increasing scrutiny of the US Food and Drug Administration (USFDA), ...
Read more: Animal healthcare yields rich dividends for Sequent

Pharma Reviews: India to boost food, pharma, IT, tourism exports in China's first import only show

India exported pharmaceutical products worth $15.6 billion in 2017-18 but exports to China was only $41 million, a share of 0.2%. In marine products ...
Read more: India to boost food, pharma, IT, tourism exports in China's first import only show

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market

Product Recall Alerts: Irbesartan, IABP, INR test strips recalled

According to one alert, Aurobindo Pharma Limited recalled 22 batches of irbesartan, an angiotensin receptor blocker, due to detection of an impurity, ...
Read more: Irbesartan, IABP, INR test strips recalled

Product Recall Alerts: FDA Issues Alert on Irbesartan Due to Contamination

SciGen Pharmaceuticals has voluntary recalled certain lots of the angiotensin II receptor blocker (ARB) irbesartan, owing to the presence of ...
Read more: FDA Issues Alert on Irbesartan Due to Contamination

Pharma Reviews: Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman ...

Indian drug makers are now more aware and appreciative of compliance issues in global markets, Frances Zipp, CEO at Lachman Consultants, one of ...
Read more: Indian pharma companies maintaining good compliance standards: Frances Zipp, CEO, Lachman ...

Pharma Reviews: “There is need to nurture and mentor innovation & disruption in Indian management education”

India continues to be the world leader in generic pharmaceutical products despite recent export concerns and problems in availability of APIs.
Read more: “There is need to nurture and mentor innovation & disruption in Indian management education”

Pharma Reviews: Weak rupee likely to help pharma companies post double-digit growth

MUMBAI: The persistent slide of the Indian rupee has come as a shot in the arm for Indian pharmaceutical companies which are expected to post ...
Read more: Weak rupee likely to help pharma companies post double-digit growth

US FDA News: FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
Read more: FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

US FDA News: FDA and DoD formalize collaboration to advance medical products in support of American military personnel

FDA and DoD formalize collaboration to advance medical products in support of American military personnel. New Memorandum of Understanding aligns agency efforts to foster the development and use of safe and effective medical products for members of the U.S. military.
Read more: FDA and DoD formalize collaboration to advance medical products in support of American military personnel

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

FDA announces approval of Dsuvia and new steps the agency may be taking to evaluate opioids.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Product Recall Alerts: Tainted Blood Pressure Drugs Causes FDA to Issue Recall Alert

The U.S. Food and Drug Administration (FDA) issued a voluntary recall of a medication to treat high blood pressure due to trace amounts of a ...
Read more: Tainted Blood Pressure Drugs Causes FDA to Issue Recall Alert

US FDA News: FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.
Read more: FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

Pharma Reviews: How Global Fake Medicine Industry is Putting Your Life at Risk

Yet India's pharmaceutical sector is indifferently regulated, and Indian pharmaceutical companies have been pulled up by foreign trading partners for ...
Read more: How Global Fake Medicine Industry is Putting Your Life at Risk

US FDA News: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure

Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program report release on radiofrequency energy exposure
Read more: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure

US FDA News: Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications

FDA warns consumers about concerns with pharmacogenetic tests whose claims have not been reviewed by FDA
Read more: Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications

US FDA News: FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
Read more: FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use