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