US FDA News: FDA approves new oral treatment for multiple sclerosis

FDA approves Mayzent (cladribine), a new oral drug to treat multiple sclerosis
Read more: FDA approves new oral treatment for multiple sclerosis

Pharma Reviews: German Pharma firm Bayer to continue investing in India with new drugs

The Indian pharmaceutical sector is growing impressively and German pharma major Bayer will continue to invest in the country for new drugs, a top ...
Read more: German Pharma firm Bayer to continue investing in India with new drugs

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Helping to facilitate access to promising medicines for patients with serious or immediately life-threatening diseases or conditions when no comparable or satisfactory alternative therapy options are available is a high priority for the FDA.
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

Pharma Reviews: Nitrosamine containing tablets banned in Singapore; ingredient manufactured in India

... of high blood pressure medicine containing losartan, an active ingredient manufactured by an Indian pharma company, which contained higher than ...
Read more: Nitrosamine containing tablets banned in Singapore; ingredient manufactured in India

Pharma Reviews: Singapore recalls BP drugs with India-made ingredient

Singapore recalls BP drugs with India-made ingredient ... containing losartan, an active ingredient manufactured by an Indian pharma company, which ...
Read more: Singapore recalls BP drugs with India-made ingredient

US FDA News: FDA approves treatment for patients with a type of inflammatory arthritis

The FDA is approving Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis. This is the first time that the FDA has approved a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms
Read more: FDA approves treatment for patients with a type of inflammatory arthritis

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

FDA announced several new actions as part of our commitment to ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

US FDA News: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget.
Read more: Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget

Pharma Reviews: Singapore recalls 3 high blood pressure drugs containing Indian company made active ingredient

... an active ingredient manufactured by an Indian pharma company, which contained higher than acceptable levels of a potentially harmful impurity.
Read more: Singapore recalls 3 high blood pressure drugs containing Indian company made active ingredient

Pharma Reviews: Innovation by Indians growing! India marks highest growth in filing for international patents

Interestingly, the patents list is mostly dominated by Indian pharmaceutical companies such as Dr Reddys, Sun Pharma, Cipla and Lupin, among ...
Read more: Innovation by Indians growing! India marks highest growth in filing for international patents

US FDA News: FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

FDA approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.
Read more: FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism

Pharma Reviews: Indian pharma has little to offer on job creation

The Indian pharma is not the space to look at when discussing job creation in the country over the past four years. The sector, where the bulk of major ...
Read more: Indian pharma has little to offer on job creation

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

FDA is taking new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products

US FDA News: FDA advances landmark policy changes to modernize mammography services and improve their quality

FDA proposes landmark policy changes to modernize mammography services and improve their quality
Read more: FDA advances landmark policy changes to modernize mammography services and improve their quality

Pharma Reviews: Finally, Indian pharmaceutical industry scores on compliance with USFDA

After years of struggle, the Indian pharmaceutical industry finally got many things right in 2018 with the American government's drugs regulator.
Read more: Finally, Indian pharmaceutical industry scores on compliance with USFDA

Pharma Reviews: New diabetes drugs to carry warning labels

New Delhi: India's drug regulator on Tuesday directed drug makers to carry a compulsory warning ... The two people cited above said the CDSCO meeting had discussed asking manufacturers to include a warning in the package ...
Read more: New diabetes drugs to carry warning labels

US FDA News: FDA approves new oral drug to treat multiple sclerosis

The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Read more: FDA approves new oral drug to treat multiple sclerosis

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. The FDA has been closely monitoring the situation and working with device manufacturers affected by the closure to minimize any impact to patients who need access to these medical devices.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies

FDA statement on efforts to promote and foster blood pathogen reduction technologies
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies

Pharma Reviews: HWB to supply heavy water in India for non-nuclear use

We intend to make heavy water available for the Indian companies to ... it prudent to collaborate with Indian drug manufacturers and various pharma ...
Read more: HWB to supply heavy water in India for non-nuclear use

Pharma Reviews: Elections 2019: Pharma MSMEs want new govt to focus and stick to policies boosting domestic ...

Talking to KNN India, President of Pharmaceutical Manufacturers Association R L Sharma said, “Government should focus on the fine lines of the ...
Read more: Elections 2019: Pharma MSMEs want new govt to focus and stick to policies boosting domestic ...

Pharma Reviews: No clinical trials in India for new drugs approved in select developed markets

“The move is expected to reduce the time taken by the company to introduce the drug in India and prevent duplication of studies. For example, if a ...
Read more: No clinical trials in India for new drugs approved in select developed markets

Product Recall Alerts: City of Laredo warning public on baby cough syrup recalled over risk of bacterial contamination

The City of Laredo Health Department said it would like to alert the public about the recall by Kingston Pharma of Massena, New York of its 2-fluid ...
Read more: City of Laredo warning public on baby cough syrup recalled over risk of bacterial contamination

Pharma Reviews: HWB to supply heavy water in India for non-nuclear use

According to Mudali, there is a good potential of medical applications of heavy water in the field of deuterated active pharmaceutical ingredients (API) ...
Read more: HWB to supply heavy water in India for non-nuclear use

Pharma Reviews: Anti-infective medicine sales slowing down: Pharmaceutical industry

Analysts say the growth rate in this segment has been slower than that of the general Indian pharma market (IPM). Over recent years, down from 10-12 ...
Read more: Anti-infective medicine sales slowing down: Pharmaceutical industry

Pharma Reviews: The Make In India Story that India really needs

A group of parents, a Mumbai doctor and some NGOs lobbied long and hard to get a local pharma company to manufacture Trientine, a drug that can ...
Read more: The Make In India Story that India really needs

Pharma Reviews: Gujarat pharma firm: Accused in Rs 8100-cr loan fraud held in Albania

The officials later informed Indian investigative agencies about the development and the Enforcement Directorate officials are expected to reach ...
Read more: Gujarat pharma firm: Accused in Rs 8100-cr loan fraud held in Albania

Pharma Reviews: Digital Dose For Pharma

Indian pharma also undergoes similar changes, although at a slow pace. The Indian pharma industry will have to evolve fast and embrace new ...
Read more: Digital Dose For Pharma

Product Recall Alerts: TIMELINE OF COMMON BLOOD PRESSURE DRUGS' RECENT RECALLS

The government-run body issued an alert over four batches of the medication and pulled the products - made by Actavis, now known as Accord - as a ...
Read more: TIMELINE OF COMMON BLOOD PRESSURE DRUGS' RECENT RECALLS

Product Recall Alerts: RECALL ALERT: Kingston Pharma recalling baby cough syrup

Kingston Pharma is recalling one lot of its 2-fluid ounce size bottles of DG ... no illnesses have been reported in connection to the recalled product.
Read more: RECALL ALERT: Kingston Pharma recalling baby cough syrup

Product Recall Alerts: RECALL ALERT: Baby cough syrup could have possible bacteria contamination

RECALL ALERT: Baby cough syrup could have possible bacteria ... You can return the medicine to the store where the product was purchased for a ...
Read more: RECALL ALERT: Baby cough syrup could have possible bacteria contamination

Product Recall Alerts: Recall alert: Baby cough syrup pulled from shelves because of health concerns

Kingston Pharma, LLC is recalling its 2-fluid ounce bottles of 'Health ... to the Food and Drug Administration, Bacillus cereus in food products has the ...
Read more: Recall alert: Baby cough syrup pulled from shelves because of health concerns

Pharma Reviews: World class drugs at affordable prices need of the hour: Naidu

Naidu urged the Indian Pharmaceutical industry to remain committed to high standards of quality in drug manufacturing and quality frameworks.
Read more: World class drugs at affordable prices need of the hour: Naidu

US FDA News: FDA approves new device for treating moderate to severe chronic heart failure in patients

Device to treat heart failure was given Breakthrough Device designation because it treats a life-threatening disease and addresses unmet clinical need.
Read more: FDA approves new device for treating moderate to severe chronic heart failure in patients

Pharma Reviews: Pharma MNCs wary of illegal import of innovator drugs

Hyderabad: Multinational pharmaceutical companies are crying foul over the illegal import of innovator drugs worth crores of rupees into the Indian ...
Read more: Pharma MNCs wary of illegal import of innovator drugs

Product Recall Alerts: Health Alerts: Unicorn boots, gripe water, trampolines, and more recalled

Health Alerts: Unicorn boots, gripe water, trampolines, and more recalled ... to the Food and Drug Administration at https://ift.tt/1ivc3Ps or call ... A searchable food and medical product recall database is available at ...
Read more: Health Alerts: Unicorn boots, gripe water, trampolines, and more recalled

Pharma Reviews: Conflicts of Interest With India's Health Industry: The Need for Legal Intervention

On the other hand, FICCI is a business association whose membership comprises both Indian and foreign pharmaceutical and healthcare firms.
Read more: Conflicts of Interest With India's Health Industry: The Need for Legal Intervention

Pharma Reviews: NITI Aayog Joins Hands With Tech Major To Combat Fake Drugs With Blockchain Technology

Over the years, the counterfeit medicines market in India has grown ... And today, this market forming a big portion of India's domestic drug market.
Read more: NITI Aayog Joins Hands With Tech Major To Combat Fake Drugs With Blockchain Technology

US FDA News: FDA approves first treatment for post-partum depression

FDA approves Zulresso (brexanolone), the first drug for post-partum depression
Read more: FDA approves first treatment for post-partum depression

US FDA News: FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements
Read more: FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements

Pharma Reviews: Colour code for generic medicines a no-brainer

For years, the Indian pharmaceutical industry has developed a culture of 'brand popularity', initially among doctors and then among the public.
Read more: Colour code for generic medicines a no-brainer

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond

New steps to strengthen FDA’s food safety program for 2020 and beyond
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond

US FDA News: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

FDA warned Nutra Pharma for illegally marketing unapproved products with claims about their ability to treat addiction, pain and other serious conditions.
Read more: FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions

Pharma Reviews: Pharma cos have not worked on compliance issues: Amit Rajan, Prosfora Tech

Do you think that Indian pharma companies will again have to up the standards of the various plants to be better compliant and what is the outlook on ...
Read more: Pharma cos have not worked on compliance issues: Amit Rajan, Prosfora Tech

Pharma Reviews: Ensure quality drugs at people at affordable prices, VP exhorts Pharma industry

He exhorted urged the Indian Pharmaceutical industry to remain committed to high standards of quality in drug manufacturing and quality frameworks.
Read more: Ensure quality drugs at people at affordable prices, VP exhorts Pharma industry

Pharma Reviews: Need low-cost drugs for rare diseases: VP

HYDERABAD: Vice President of India M Venkaiah Naidu on Saturday urged the Indian pharmaceutical industry to look into the need for developing ...
Read more: Need low-cost drugs for rare diseases: VP

Pharma Reviews: Pharma wrap: India's predicament of controlling patented anti-cancer medicine prices

A study done by Indian Institute of Management (IIM), Calcutta titled 'Impact of Product Patents on Pharmaceutical Market Structure and Prices' found ...
Read more: Pharma wrap: India's predicament of controlling patented anti-cancer medicine prices

Pharma Reviews: TL-VENKAIAH-QUALITY DRUGS

standards of quality in drug manufacturing and quality frameworks such ... available, he said. It was therefore important for the Indian pharma industry
Read more: TL-VENKAIAH-QUALITY DRUGS

Pharma Reviews: Venkaiah Naidu calls for affordable medicines as healthcare costs soar

Naidu expressed confidence that the goal to make India a global leader in end-to-end drug manufacturer would be achieved in the coming years in ...
Read more: Venkaiah Naidu calls for affordable medicines as healthcare costs soar

Pharma Reviews: India becomes largest provider of generic drugs globally : Venkaiah

He lauded the yeomen service rendered by Indian companies in providing life saving medicines at affordable prices in the developing countries.
Read more: India becomes largest provider of generic drugs globally : Venkaiah

Pharma Reviews: Vice President addresses 2nd decennial celebrations of Sarojini Naidu Vanita Pharmacy Maha ...

He urged the Indian Pharmaceutical industry to remain committed to high standards of quality in drug manufacturing and quality frameworks. Calling ...
Read more: Vice President addresses 2nd decennial celebrations of Sarojini Naidu Vanita Pharmacy Maha ...

Pharma Reviews: E-pharma on fast lane as companies diversify

With the use of cutting edge technology like Machine Learning, Artificial Intelligence, Predictive analytics, pharma companies have built up capabilities ...
Read more: E-pharma on fast lane as companies diversify

Pharma Reviews: Jan Aushadhi scheme may disrupt 20% of Indian pharma market sales: Report

Mumbai: The Jan Aushadhi scheme, under which the government provides quality medicines at affordable rates may disrupt around 20 percent of ...
Read more: Jan Aushadhi scheme may disrupt 20% of Indian pharma market sales: Report

Pharma Reviews: Make available quality drugs at affordable prices; VP

It was therefore important for the Indian pharma industry to look into the need to develop low-cost drugs for treating rare diseases, he said.
Read more: Make available quality drugs at affordable prices; VP

Pharma Reviews: Vice Prez urges pharma industry to remain committed to high standards of quality in drug ...

Hyderabad, Mar 16 (KNN) The Vice President of India, M. Venkaiah Naidu urged the Indian Pharmaceutical industry to remain committed to high ...
Read more: Vice Prez urges pharma industry to remain committed to high standards of quality in drug ...

Pharma Reviews: Govt's Jan Aushadhi scheme may disrupt domestic pharma market

Govt's Jan Aushadhi scheme may disrupt domestic pharma market ... rates may disrupt around 20 percent of Indian pharmaceutical market sales, says ...
Read more: Govt's Jan Aushadhi scheme may disrupt domestic pharma market

Pharma Reviews: Jan Aushadhi scheme may disrupt 20% of Indian pharma market sales: Report

The Jan Aushadhi scheme, under which the government provides quality medicines at affordable rates may disrupt around 20 per cent of Indian ...
Read more: Jan Aushadhi scheme may disrupt 20% of Indian pharma market sales: Report

Pharma Reviews: Jan Aushadhi scheme may disrupt domestic pharma market

The report by Edelweiss expects that around Rs 6,000 crore of the Bureau of Pharma PSUs of India (BPPI) drugs could adversely impact around Rs ...
Read more: Jan Aushadhi scheme may disrupt domestic pharma market

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 efforts to evaluate materials in medical devices to address potential safety questions

The FDA is working to further evaluate materials like metals that are used in medical devices to learn more about how these materials interact with the immune system.
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 efforts to evaluate materials in medical devices to address potential safety questions

Pharma Reviews: Jan Aushadhi scheme may disrupt domestic pharma market

The Jan Aushadhi scheme, under which the government provides quality medicines at affordable rates may disrupt around 20 percent of Indian ...
Read more: Jan Aushadhi scheme may disrupt domestic pharma market

Pharma Reviews: Pharma & Healthcare Analytics Is Going To Be The Next Big Thing In India

The Indian pharmaceutical industry has emerged as a significant contributor to the global pharmaceutical industry. As per the report by the Federation ...
Read more: Pharma & Healthcare Analytics Is Going To Be The Next Big Thing In India

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety

FDA implements agricultural water requirements for produce safety
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety

US FDA News: FDA allows marketing of new device to help treat carbon monoxide poisoning

FDA allows marketing of a new device, ClearMate, intended to be used with patients suffering from carbon monoxide poisoning. This is the first carbon monoxide poisoning device authorized for marketing by the FDA for use in an emergency room setting.
Read more: FDA allows marketing of new device to help treat carbon monoxide poisoning

Pharma Reviews: What happens if India boycotts Chinese products

Pharma sector: India's pharmaceutical sector is critically dependent on Chinese imports used in drugs manufacturing. n 2018-19, China supplied over ...
Read more: What happens if India boycotts Chinese products

Pharma Reviews: Podcast | Pick of the day: What Scott Gottlieb's exit from USFDA means for the Indian pharma sector

India's pharma sector mostly concurs. One executive at an Indian pharmaceutical company told Moneycontrol that Gottlieb's tenure was 'action ...
Read more: Podcast | Pick of the day: What Scott Gottlieb's exit from USFDA means for the Indian pharma sector

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

US FDA News: FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

Device is for treatment of patients to reduce mitral regurgitation in certain patients with heart failure symptoms who fail to respond to traditional therapy
Read more: FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars

Pharma Reviews: Deven Choksey on why Reliance stock could appreciate 100% in next 2-3 years

How are you looking at the way oil marketing companies are moving? .... A good part on the Indian pharma companies side is that from branded ...
Read more: Deven Choksey on why Reliance stock could appreciate 100% in next 2-3 years

Pharma Reviews: India to push for strict source country norms in FTA with Peru

While Peru has expressed interest in Indian Pharma companies setting up generic medicines production facilities there, India is keen to up its import of ...
Read more: India to push for strict source country norms in FTA with Peru

US FDA News: FDA approves a new generic valsartan

FDA has approved a new generic of Diovan (valsartan). The agency prioritized the review of this drug application to help relieve a recent shortage of the drug.
Read more: FDA approves a new generic valsartan

US FDA News: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Read more: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services

Product Recall Alerts: America's Unsafe Medical Products

There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are ...
Read more: America's Unsafe Medical Products

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply

FDA is requesting new funding to continue to advance robust regulatory framework for oversight of e-cigarettes and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply

Pharma Reviews: Dishman Carbogen Amcis: Potent tonic (Buy)

Indian pharma players selling generic drugs have been on the back-foot ... The global pharmaceutical companies are, therefore, driven to outsource ...
Read more: Dishman Carbogen Amcis: Potent tonic (Buy)

Pharma Reviews: Cancer Research Initiative: Cabinet approves MoU between India,UK

Despite the surge in technological, biomedical, clinical, and pharmaceutical innovations aimed at improving cancer outcomes, the overburdened ...
Read more: Cancer Research Initiative: Cabinet approves MoU between India,UK

US FDA News: FDA takes steps to help reduce risks associated with surgical staplers and implantable staples

FDA takes steps to help reduce risks associated with surgical staplers and implantable staples
Read more: FDA takes steps to help reduce risks associated with surgical staplers and implantable staples

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon

Pharma Reviews: Few cancer drugs may see price drop despite NPPA cap

EVEN AS the National Pharmaceutical Pricing Authority (NPPA) last week ... The regulator relies heavily on data supplied by private pharma market ... it is being supplied directly to the hospitals,” Singh told The Indian Express.
Read more: Few cancer drugs may see price drop despite NPPA cap

Pharma Reviews: Lupin gets USFDA nod for best selling prescription drug in world history; to sell Lipitor in US

Indian pharmaceutical firm Lupin has got USFDA approval for selling its generic version of cholesterol drug Lipitor in the US, it said in a statement.
Read more: Lupin gets USFDA nod for best selling prescription drug in world history; to sell Lipitor in US

Pharma Reviews: How Ajanta Pharma Plans To Beat Its Africa Business Slump

Ajanta Pharma Ltd. expects growth in India, Asia and U.S. to make up for the loss in business in its key market of Africa, which contributes a quarter of ...
Read more: How Ajanta Pharma Plans To Beat Its Africa Business Slump

US FDA News: USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA’s Food Safety and Inspection Service and FDA announce a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry
Read more: USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

Pharma Reviews: Is It Good For New Entrepreneurs To Enter Into The 'Pharma Industry'?

How Developments In Pharma Sector Impacted The Indian Lives ... At present, the Indian pharmaceutical industry is the largest producer of generic ...
Read more: Is It Good For New Entrepreneurs To Enter Into The 'Pharma Industry'?

Pharma Reviews: Buys not enough, Aurobindo needs to show M&A benefits

ET Intelligence Group: At a time when Indian pharma companies are facing headwinds and are setting their house in order, Aurobindo Pharma is busy ...
Read more: Buys not enough, Aurobindo needs to show M&A benefits

US FDA News: FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

FDA approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults with treatment-resistant depression
Read more: FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Pharma Reviews: US to Terminate Preferential Trade Agreement with India, Newmont Rejects Barrick's Takeover Bid ...

You May Leave: US President Donald Trump may terminate India's ... Rock Bottom: Growth of the Indian Pharmaceutical industry hit a four-year low in ...
Read more: US to Terminate Preferential Trade Agreement with India, Newmont Rejects Barrick's Takeover Bid ...

Product Recall Alerts: FDA: Voluntary recalls of blood pressure drugs expands with 3rd impurity found

The Food and Drug Administration has issued consumer alerts on two expanded voluntary recalls of medications associated with the treatment of high ...
Read more: FDA: Voluntary recalls of blood pressure drugs expands with 3rd impurity found

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Pharma Reviews: Academia-Industry Interaction: A way forward

Delivering a talk on “Study of Solid State Properties of Pharmaceutical ... has contributed in making India the global leader in the vaccine industry, not ...
Read more: Academia-Industry Interaction: A way forward

Pharma Reviews: Indian Pharma Firm Complains About Documentary; Dutch Council Stands by It

New Delhi: “It smells terrible here,” says Dutch journalist Jos van Dongen in his documentary on Indian medicines, broadcast in 2018. Red in the face, ...
Read more: Indian Pharma Firm Complains About Documentary; Dutch Council Stands by It

Pharma Reviews: Weekly wrap: Indian pharma loses its powerful voice with demise of DG Shah

The fourth edition of India Pharmaceutical Forum, held this week in Mumbai, that brings together industry leaders, regulators, and quality heads of ...
Read more: Weekly wrap: Indian pharma loses its powerful voice with demise of DG Shah

Pharma Reviews: Indian Pharma Firm Complains About Documentary; Dutch Council Stands by It

The council said that it “does not share” Aurobindo's view that the documentary makes people believe that the pharma company is guilty of something ...
Read more: Indian Pharma Firm Complains About Documentary; Dutch Council Stands by It

Pharma Reviews: Need to enhance trade with LAC countries: Minister

Prabhu informed that owing to its competitive advantage in the sector, pharmaceutical products have also emerged as one of India's main exports to ...
Read more: Need to enhance trade with LAC countries: Minister

US FDA News: FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced
Read more: FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

Pharma Reviews: Indian drug makers show improvement in USFDA inspection outcomes

Indian pharmaceutical industry, which has been facing the heat from the US Food and Drug Administration (USFDA) over the last few years in the form ...
Read more: Indian drug makers show improvement in USFDA inspection outcomes