US FDA News: FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain

FDA issues drug supply chain guidances to alert industry of changes to pharmaceutical product identification and tracing procedures.
Read more: FDA In Brief: FDA advances policies related to bolstering security of drug products in the U.S. supply chain

Pharma Reviews: Sales at home are sluggish. US rivals are pinning it down. Can Dilip Shanghvi revive Sun Pharma?

The Indian road is bumpy As with peers of similar size, Sun Pharma's strongest domain is the home market, netting 26% of its overall revenue.
Read more: Sales at home are sluggish. US rivals are pinning it down. Can Dilip Shanghvi revive Sun Pharma?

US FDA News: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

FDA warns patients and providers that certain Medtronic MiniMed insulin pumps are recalled due to potential cybersecurity risks and recommends patients switch to models better equipped to protect against these potential risks.
Read more: FDA warns patients and health care providers about potential cybersecurity concerns with certain Medtronic insulin pumps

US FDA News: FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Read more: FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

US FDA News: FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

This press release highlights an update on the FDA’s investigation into a potential connection between certain diets and cases of canine heart disease
Read more: FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease

US FDA News: FDA approves first treatment for chronic rhinosinusitis with nasal polyps

FDA approves Dupixent to treat adults with nasal polyps accompanied by chronic rhinosinusitis or prolonged inflammation of the sinuses and nasal cavity.
Read more: FDA approves first treatment for chronic rhinosinusitis with nasal polyps

Pharma Reviews: Will Glenmark's attempts to unlock value of API, R&D units prove beneficial?

While Indian pharma companies increased their average R&D spend from 5.3 per cent in FY12 to 8.5 per cent in FY19, Glenmark's R&D expenditure ...
Read more: Will Glenmark's attempts to unlock value of API, R&D units prove beneficial?

Pharma Reviews: FDI Drying Up

The pharma sector is no longer a priority sector for foreign direct investment (FDI) in India. FDI in the sector witnessed a sharp fall of 73 per cent during ...
Read more: FDI Drying Up

Pharma Reviews: Closing Bell: Nifty ends around 11850, Sensex up 157 points; metal stocks gain

Market Close: Indian indices ended higher for the second consecutive ... Power Grid Corp, Sun Pharma and Hindalco Industries were among major ...
Read more: Closing Bell: Nifty ends around 11850, Sensex up 157 points; metal stocks gain

Pharma Reviews: PD Hinduja Hospital, MRC hosts a conclave called 'Skilling India'

P.D. Hinduja Hospital, MRC hosts a conclave called 'Skilling India' ... On the occasion, Healthcare Sector Skill Council (HSSC) also the launched Western ... and private sector like pharma companies, medical device companies etc.
Read more: PD Hinduja Hospital, MRC hosts a conclave called 'Skilling India'

Pharma Reviews: Mylan, Dr Reddy's, Aurobindo, and Torrent Pharma can't sell generic Gilenya that is patented by ...

The court verdict has come a day after an Indian broking house, India Infoline ... The unit, which manufactures active pharmaceutical ingredients, was ...
Read more: Mylan, Dr Reddy's, Aurobindo, and Torrent Pharma can't sell generic Gilenya that is patented by ...

Pharma Reviews: Heart drug set to cause investor palpitation

MUMBAI – Aurobindo Pharma Ltd has become the latest entrant in a ... Aurobindo Pharma, one of the biggest manufacturers of active ingredients such as ... Indian companies like Aurobindo Pharma, Torrent Pharmaceuticals and ...
Read more: Heart drug set to cause investor palpitation

Pharma Reviews: FOCUS:Aurobindo Pharma heart drug set to cause investors palpitation

Aurobindo Pharma, one of the biggest manufacturers of active ingredients such as ... of Valsartan started product recalls including Indian companies like Aurobindo Pharma, Torrent Pharmaceuticals and McLeods Pharma Ltd.
Read more: FOCUS:Aurobindo Pharma heart drug set to cause investors palpitation

Pharma Reviews: Drug marketers to be held liable for quality churned out by third parties

At present a drug manufacturer is responsible for product quality and ... added Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance.
Read more: Drug marketers to be held liable for quality churned out by third parties

US FDA News: Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products
Read more: Statement on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

US FDA News: FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC– for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms.
Read more: FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

Pharma Reviews: Why India needs to reform its trade policy

The US is keen on getting reasonable access to Indian markets primarily for its three industries—pharmaceuticals, telecom and the dairy industry.
Read more: Why India needs to reform its trade policy

Pharma Reviews: Lupin revamps quality governance; showcases Nagpur unit as face of things to come

The risks associated with any slippage in maintaining high quality while manufacturing medicines can be too high. Leading Indian pharmaceutical ...
Read more: Lupin revamps quality governance; showcases Nagpur unit as face of things to come

Pharma Reviews: Roadshow in Mumbai to promote Pharma Pro

Messe Muenchen India, Indian Pharma Machinery Manufacturers Association (IPMMA) and Indian Analytical Instruments Association (IAIA) hosted a ...
Read more: Roadshow in Mumbai to promote Pharma Pro

Pharma Reviews: MAHE ventures into new drug discovery, pharma researches

While the pharma industry is booming globally, Manipal Academy of Higher Education (MAHE) started researching new drugs and repurposing old ...
Read more: MAHE ventures into new drug discovery, pharma researches

Pharma Reviews: India calls for clear roadmap from China to ramp up Indian pharmaceutical exports

Beijing, Jun 21 (PTI) India has called for a “clear roadmap” from China to meet its long-standing demand to open up Chinese pharmaceuticals market ...
Read more: India calls for clear roadmap from China to ramp up Indian pharmaceutical exports

Pharma Reviews: Sudip Bandyopadhyay says, stay off auto, realty and YES Bank; buy Auro Pharma

If you look at the domestic status, the unusual delay in monsoons is definitely not a good news for the Indian market and economy. All the economic ...
Read more: Sudip Bandyopadhyay says, stay off auto, realty and YES Bank; buy Auro Pharma

Pharma Reviews: To ramp up Pharma exports, India calls for clear roadmap from China

New Delhi, June 22: India has called for a "clear roadmap" from China to meet its long-standing demand to open up Chinese pharmaceuticals market ...
Read more: To ramp up Pharma exports, India calls for clear roadmap from China

US FDA News: FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

FDA approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Read more: FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

Pharma Reviews: India seeks "clear roadmap" from China to ramp up export of pharma products

Beijing: In an unusual move, India on Friday used a hugely popular Chinese movie to seek enhanced market access for Indian medicines in China as ...
Read more: India seeks "clear roadmap" from China to ramp up export of pharma products

Pharma Reviews: India Calls for Clear Roadmap from China to Ramp Up Indian Pharmaceutical Exports

Beijing: India has called for a "clear roadmap" from China to meet its long-standing demand to open up Chinese pharmaceuticals market for Indian ...
Read more: India Calls for Clear Roadmap from China to Ramp Up Indian Pharmaceutical Exports

Pharma Reviews: MPI begins supplying animal tissue to SCTIMST

Indian medical device and equipment market is estimated to be $4 billion of which 70 per cent is imported. This endeavour is another attempt by ...
Read more: MPI begins supplying animal tissue to SCTIMST

US FDA News: FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

FDA expanded the indication for Symdeko for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.
Read more: FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

Pharma Reviews: India seeks 'clear roadmap' from China to ramp up export of pharma products

In an unusual move, India on Friday used a hugely popular Chinese movie to seek enhanced market access for Indian medicines in China as the drug ...
Read more: India seeks 'clear roadmap' from China to ramp up export of pharma products

Pharma Reviews: India calls for clear roadmap from China to ramp up Indian pharmaceutical exports

India has called for a "clear roadmap" from China to meet its long-standing demand to open up Chinese pharmaceuticals market for Indian exports as ...
Read more: India calls for clear roadmap from China to ramp up Indian pharmaceutical exports

US FDA News: Statement on agency’s efforts to increase transparency in medical device reporting

The FDA is taking a number of important steps to update its Medical Device Reporting Program.
Read more: Statement on agency’s efforts to increase transparency in medical device reporting

Pharma Reviews: Dr Reddy's sale of proprietary drug brands underscores R&D challenges

Three years hence, the company is shrinking the drug discovery unit. ... But for investors tracking the Indian pharma industry trajectory, the whole ...
Read more: Dr Reddy's sale of proprietary drug brands underscores R&D challenges

Pharma Reviews: Indian pharma aims to corner 7% of global market by 2030: Report

The Indian pharmaceutical industry aspires to have a 7 percent share in the global drug market by 2030, a joint report by the Indian Pharmaceutical ...
Read more: Indian pharma aims to corner 7% of global market by 2030: Report

US FDA News: Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

FDA issues a new draft guidance on the application of the benefit-risk assessment framework for evaluating applications for opioids.
Read more: Statement on the FDA’s benefit-risk framework for evaluating opioid analgesics

Pharma Reviews: Nifty closes above 11800 mark

Gains in pharma, metal and banks stocks contributed to the rally. ... The Indian pharmaceutical industry is aspiring to touch $120-130 billion by 2030 ...
Read more: Nifty closes above 11800 mark

Pharma Reviews: MARKET LIVE: Banks, Sun Pharma take Sensex higher; Nifty above 11700

India, which has upset companies such as Mastercard and irked the US government with stringent new rules on data storage, is the largest recipient of ...
Read more: MARKET LIVE: Banks, Sun Pharma take Sensex higher; Nifty above 11700

Pharma Reviews: The Indian pharma industry can do better than conspiracy theories and ad-hominem attacks

These attacks against Eban's work is in keeping with a playbook of the Indian pharmaceutical industry to deal with its critics. This playbook includes ...
Read more: The Indian pharma industry can do better than conspiracy theories and ad-hominem attacks

Pharma Reviews: Slow growth weighs on defensive tag of pharmaceutical stocks

Since these segments contribute considerably to the fortunes of the Indian pharmaceutical market, the decline in volumes is worrying. In fact, domestic ...
Read more: Slow growth weighs on defensive tag of pharmaceutical stocks

Pharma Reviews: Indian Pharma industry aspiring to grow to $120-130 billion by 2030: IPA

NEW DELHI: The Indian pharmaceutical industry is aspiring to touch USD 120-130 billion by 2030 from the current USD 38 billion, industry body ...
Read more: Indian Pharma industry aspiring to grow to $120-130 billion by 2030: IPA

Pharma Reviews: Indian Pharma industry aspiring to grow to USD 120-130 bn by 2030: IPA

The Indian pharmaceutical industry is aspiring to touch USD 120-130 billion by 2030 from the current USD 38 billion, industry body Indian ...
Read more: Indian Pharma industry aspiring to grow to USD 120-130 bn by 2030: IPA

Pharma Reviews: Ashok Leyland to close Pantnagar plant for 6 days to adjust production

The report, tiltled 'Indian Pharmaceutical Industry: The Way Forward - Vision 2030', is based on a research collaboration with McKinsey & Co and ...
Read more: Ashok Leyland to close Pantnagar plant for 6 days to adjust production

Pharma Reviews: I am not comfortable at all with this tag of “the richest Indian” and all the attention that follows: Dilip ...

As the news spread like wildfire, Indians beyond the finance world, doctors, and the pharmaceuticals industry woke up to a surname—Shanghvi, and ...
Read more: I am not comfortable at all with this tag of “the richest Indian” and all the attention that follows: Dilip ...

Pharma Reviews: Generics vs Branded Generics, matters more now than ever : Dr. Krupal J Joshi & Dr. Dhwani J Patel

In the year 2017-2018, the Indian pharmaceutical industry exported drugs worth USD 17.3 billion. However, despite India's generic drug ...
Read more: Generics vs Branded Generics, matters more now than ever : Dr. Krupal J Joshi & Dr. Dhwani J Patel

US FDA News: Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

FDA is enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity).
Read more: Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

Pharma Reviews: India may lose out on potential bulk drug boom for lack of policy sops

The government, in its Draft Pharmaceutical Policy – 2017, had proposed several incentives to encourage local industries to take up the manufacture ...
Read more: India may lose out on potential bulk drug boom for lack of policy sops

US FDA News: Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.
Read more: Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

US FDA News: Statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

This is a statement regarding the FDA’s new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products.
Read more: Statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

Pharma Reviews: Aditya Birla Sun Life Mutual Fund launches Pharma & Healthcare Fund

The fund house also said that the main reason for it to come up with a pharma and healthcare fund is that the Indian pharma industry is projected to ...
Read more: Aditya Birla Sun Life Mutual Fund launches Pharma & Healthcare Fund

Pharma Reviews: Innovation in pharmaceutical supply chain

Indian pharmaceutical sector is expected to reach US$ 55 billion by 2020. As a largest provider of generic drugs globally and with a unique business ...
Read more: Innovation in pharmaceutical supply chain

US FDA News: FDA approves new treatment for pediatric patients with type 2 diabetes

: FDA approves Victoza (liraglutide) injection for pediatric patients with type 2 diabetes. Victoza creates the same effect as GLP-1 receptor protein and is the first non-insulin drug approved since metformin in 2000.
Read more: FDA approves new treatment for pediatric patients with type 2 diabetes

Pharma Reviews: Nimesh Shah on two trends to look for in the next 10 years

There are two long term trends in India; one, the private sector banks with a good liability franchisee and the pharma trend, the healthcare segment of ...
Read more: Nimesh Shah on two trends to look for in the next 10 years

Pharma Reviews: USFDA completes inspection at Divi's Laboratories' Unit-II facility in Chippada

The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical ...
Read more: USFDA completes inspection at Divi's Laboratories' Unit-II facility in Chippada

Pharma Reviews: 25 batches of drugs of 18 pharma companies found substandard since Jan 2018 by BPPI

While 17 out of the 18 companies are private, one is a public sector unit (PSU) -- Indian Drugs and Pharmaceuticals Limited (IDPL), according to the ...
Read more: 25 batches of drugs of 18 pharma companies found substandard since Jan 2018 by BPPI

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 latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices

FDA takes more steps toward strengthening 510(k) program for premarket review of medical devices
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 latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices

US FDA News: FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues
Read more: FDA Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

Pharma Reviews: Novartis India appoints Sanjay Murdeshwar as vice chairman and managing director

Pharma firm Novartis India Saturday announced the appointment of Sanjay Murdeshwar as vice chairman and managing director of the company.
Read more: Novartis India appoints Sanjay Murdeshwar as vice chairman and managing director

US FDA News: Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices
Read more: Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

US FDA News: Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

FDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
Read more: Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

Pharma Reviews: Indian pharmaceutical market growth slows to 7% in May

The Indian pharmaceutical market (IPM) growth slipped to 7 percent in May after growing at an average 10 percent in the last four consecutive ...
Read more: Indian pharmaceutical market growth slows to 7% in May

Pharma Reviews: 'Expedite solution to cases of overcharging for essential medicines'

Groups like the Indian Drug Manufacturers Association (IDMA), which represent several pharma firms, had responded to the proposal arguing that the ...
Read more: 'Expedite solution to cases of overcharging for essential medicines'

Pharma Reviews: Indian pharma industry likely to grow by 11% to $41.9 bn in FY20: Report

Helped by the growth in domestic and export markets, India's pharma industry is set to rise by 9-11 per cent over the previous fiscal and it is likely to ...
Read more: Indian pharma industry likely to grow by 11% to $41.9 bn in FY20: Report

Pharma Reviews: HP offers huge potential for investment in various sectors: CM tells German investors

He said that with 300 pharma companies and over 700 Pharma formulation manufacturing units are functioning in Himachal Pradesh and the state is ...
Read more: HP offers huge potential for investment in various sectors: CM tells German investors

Pharma Reviews: HP signs MoU with German company to explore Ayurgenomics

He said that India has more than 1600 Indo-German collaborations and over ... "I personally feel that Tourism, AYUSH, Pharmaceutical, Agri & Food ...
Read more: HP signs MoU with German company to explore Ayurgenomics

Pharma Reviews: Himachal Rolls Out Red Carpet For German Industry At Frankfurt

He also highlighted that there were over 300 pharmaceutical companies ... in India and I personally feel that Tourism, AYUSH, Pharmaceutical, Agri ...
Read more: Himachal Rolls Out Red Carpet For German Industry At Frankfurt

Pharma Reviews: Health systems in the BIMSTEC and East Africa: Current and future engagements

India's export of pharmaceutical products to Africa increased from US$247.64 million in 2000 to US$3.5 billion in 2014. Its Foreign Direct Investment ...
Read more: Health systems in the BIMSTEC and East Africa: Current and future engagements

Pharma Reviews: Sameer Baisiwala of Morgan Stanley speaks on trends in the pharmaceutical space

... Baisiwala speaks on the trends in the pharmacy sector and how U.S generics market is panning out for export-oriented Indian pharma companies.
Read more: Sameer Baisiwala of Morgan Stanley speaks on trends in the pharmaceutical space

Pharma Reviews: The Sweet Pill

Drug regulatory reforms in China have turned the heat on the Indian pharmaceutical industry and raised the cost of bulk drugs. But some firms have ...
Read more: The Sweet Pill

Pharma Reviews: Selling Wellness

Pharma companies the world over, as also in India, are not far behind. Most are diversifying from chemical-based medicines into nutraceutical and ...
Read more: Selling Wellness

Pharma Reviews: INR14 crore for a single drug shot: the unfair price of living with a deadly rare disease in India

But it is the reluctance of drug companies to even launch these treatments in India — a stance that the government has also failed to change — that ...
Read more: INR14 crore for a single drug shot: the unfair price of living with a deadly rare disease in India

Pharma Reviews: Goldman downgrades Sun Pharma to 'sell', also cuts its target price

Mumbai: Goldman Sachs downgraded shares of India's largest pharmaceutical company Sun Pharmaceutical Industries to 'sell' from 'neutral' and cut ...
Read more: Goldman downgrades Sun Pharma to 'sell', also cuts its target price

Pharma Reviews: DNA Money Edit: Indian pharma faces pricing troubles in US

It isn't a great time for the pharma sector. While the March quarter has been a mixed bag in terms of earnings for Indian pharma companies, the recent ...
Read more: DNA Money Edit: Indian pharma faces pricing troubles in US

Pharma Reviews: India: Pharma Giants' Tussle Over Weight Loss Medicine: Analysis Of EISAI v. Dr. Reddy's

Plaintiff no.1, a Japanese Pharmaceutical company which is an exclusive licensee of Indian patent no. 215528 and Plaintiff no. 2, is the patentee in ...
Read more: India: Pharma Giants' Tussle Over Weight Loss Medicine: Analysis Of EISAI v. Dr. Reddy's

US FDA News: Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys
Read more: Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

US FDA News: FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”
Read more: FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Pharma Reviews: Pharma conundrums & “bottle of lies”

The knowledge base, strength and capabilities of the Indian pharma have not been appreciated and image of Indian pharma industry is constantly ...
Read more: Pharma conundrums & “bottle of lies”

Pharma Reviews: After IT & pharma, chemicals likely to score big on exports

While most Indian industries are facing a slowdown, the chemical industry is bucking the trend, posting strong growth every quarter. The top 10 ...
Read more: After IT & pharma, chemicals likely to score big on exports

US FDA News: FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
Read more: FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Pharma Reviews: Wake-up call for watchdogs

Other top global cement manufacturers include the USA and Russia. ... Consumers are yet to see the Indian authorities busting drug cartel in India or ...
Read more: Wake-up call for watchdogs

Pharma Reviews: PharmaLytica 2019 Makes a Splendid Debut in the Pharma hub of Mumbai

The expo is well supported by associations, including Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and the Indian Drug ...
Read more: PharmaLytica 2019 Makes a Splendid Debut in the Pharma hub of Mumbai

Pharma Reviews: Policy| Bottle of Lies: What ails India's drug industry

Gauri Kamath. By now, many in the drug industry will be familiar with Katherine Eban's expose of the manner in which some generic drug companies ...
Read more: Policy| Bottle of Lies: What ails India's drug industry

Pharma Reviews: Forensic help for India's pharma industry

Ahmedabad: India's $17 billion-plus pharmaceutical industry relies heavily on exports of generic medicines globally and USA is an important ...
Read more: Forensic help for India's pharma industry

Pharma Reviews: Govt mulls mandatory barcoding of all medicines sold within India

“In current times, our major concern in the pharmaceutical market is ... 20% of all pharmaceutical goods sold in the Indian market are counterfeit.
Read more: Govt mulls mandatory barcoding of all medicines sold within India

Pharma Reviews: Industry blames policies, USFDA probes for 73% drop in pharma FDI

Industry representatives have attributed policies and USFDA investigations into the practices of certain Indian Pharma companies among the key ...
Read more: Industry blames policies, USFDA probes for 73% drop in pharma FDI

Pharma Reviews: One-hit wonders: Smaller pharma companies with blockbuster brands

The Indian Express looks at some of these pharma companies, the success of their brands, the importance of these chart-toppers in their portfolio and ...
Read more: One-hit wonders: Smaller pharma companies with blockbuster brands

Pharma Reviews: Will Aurobindo Pharma be able to get over latest USFDA regulatory compliance woes?

Aurobindo Pharma, the top performing drug company in India by revenue growth and stock returns in FY19, is now faced with USFDA compliance ...
Read more: Will Aurobindo Pharma be able to get over latest USFDA regulatory compliance woes?

US FDA News: FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
Read more: FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

US FDA News: Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day
Read more: Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

US FDA News: FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.
Read more: FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Pharma Reviews: Be selective about banks and NBFCs: Pradip P Shah

We are an interconnected world and India will be affected by that. ... The domestic pharma industry comprises many Indian companies and also some ...
Read more: Be selective about banks and NBFCs: Pradip P Shah

Pharma Reviews: Market Live: Sensex gains 100 pts, Nifty near 11900 in volatile session; Yes Bank down 2%

Rupee Update: The Indian rupee is trading near day's low at 69.47 per .... Market Update: Indian indices are trading flat with Nifty hovering around 11,850. ... Sectors on the weaker side include autos, staples, and pharma," he added.
Read more: Market Live: Sensex gains 100 pts, Nifty near 11900 in volatile session; Yes Bank down 2%

Pharma Reviews: India: The AIDS pharmacy of the world

Two-thirds of HIV/AIDS medicines worldwide are supplied by the Indian pharmaceutical industry, according to Paulomi Tripathi, a First Secretary in ...
Read more: India: The AIDS pharmacy of the world

Pharma Reviews: China's slow and ambiguous drug approval system causing discomfort for Indian drug companies

Indian drug makers who are lining up big plans for China, the world's second largest market for medicines after the US, may have to temper that ...
Read more: China's slow and ambiguous drug approval system causing discomfort for Indian drug companies

Pharma Reviews: PharmaLytica 2019 set for an Impressive Debut in Mumbai

Our focus at PharmaLytica, would be to keep the companies abreast with innovations in the growing businesses of India's pharma industry," he further ...
Read more: PharmaLytica 2019 set for an Impressive Debut in Mumbai

Pharma Reviews: USFDA inspection in progress at Sun Pharma's manufacturing facility at Halol, investors concerned

It has been a tough year on the regulatory front for many Indian pharma companies, industry sources say. It may be noted that Cadila's Moraiya facility, ...
Read more: USFDA inspection in progress at Sun Pharma's manufacturing facility at Halol, investors concerned

Pharma Reviews: Four Cs to determine the course for Indian pharma

ET Intelligence Group: Recovering from regulatory turbulence in the most profitable global market, top Indian pharma companies have zeroed in on ...
Read more: Four Cs to determine the course for Indian pharma

Pharma Reviews: GSP withdrawal by US may have marginal impact on Indian pharma exporters

Industry body Indian Pharmaceutical Alliance (IPA) concurred with Dua. “The impact on formulations that constitute 90 percent of US sales would be ...
Read more: GSP withdrawal by US may have marginal impact on Indian pharma exporters

Pharma Reviews: Domestic Growth Helped Pharma Companies to Offset Pricing Pressure in the US: Fitch

Rising revenues in the domestic market helped Indian pharmaceutical companies counterbalance the ongoing pricing pressure on generic drugs in ...
Read more: Domestic Growth Helped Pharma Companies to Offset Pricing Pressure in the US: Fitch

Pharma Reviews: Domestic market growth helping Indian pharma companies offset pricing pressure in US, says Fitch ...

Rising revenues in the domestic market has helped Indian pharma companies counterbalance the ongoing pricing pressure on generic drugs in the ...
Read more: Domestic market growth helping Indian pharma companies offset pricing pressure in US, says Fitch ...

Pharma Reviews: Domestic market growth helping Indian pharma companies offset pricing pressure in US: Fitch

New Delhi: Rising revenues in the domestic market has helped Indian pharma companies counterbalance the ongoing pricing pressure on generic ...
Read more: Domestic market growth helping Indian pharma companies offset pricing pressure in US: Fitch

Pharma Reviews: 6 stocks that are expected to report high profit growth this year

Though most Indian pharma companies are fundamentally strong, they are going through the pain of increased scrutiny from the US Food and Drug ...
Read more: 6 stocks that are expected to report high profit growth this year

Pharma Reviews: Indian pharma firms compliance with USFDA norms improving of late

Even recent statements by the US Food and Drug Administration (US FDA) support the generic manufacturers in India and China. Moreover, recent ...
Read more: Indian pharma firms compliance with USFDA norms improving of late

Pharma Reviews: US move 'unfortunate', says India as Trump ends GSP trade privileges

... trade with the US, specific exports from India in a diverse set of sectors such as jewellery, leather, pharmaceuticals, ... New Delhi has justified the move, claiming Indian industry had lost out after the Trump administration imposed a ...
Read more: US move 'unfortunate', says India as Trump ends GSP trade privileges

Pharma Reviews: How US pressure is endangering India's access to affordable medicines

The USTR report is clearly giving voice to the US's big pharmaceutical companies, which continuously complain about losing revenue in India due to ...
Read more: How US pressure is endangering India's access to affordable medicines

Pharma Reviews: Indian e-pharma market to touch $2.7 bn by 2023

Hyderabad: Indian e-pharma companies are expected to attain a combined market size of $2.7 billion by 2023 from about $360 million currently in the ...
Read more: Indian e-pharma market to touch $2.7 bn by 2023