Tuesday, April 30, 2019

Pharma Reviews: Pharma may see a price war in good news for diabetics

MUMBAI: A price war is brewing in India's growing diabetes drug market, drawing comparisons with the recent tariff battles in the telecom sector.
Read more: Pharma may see a price war in good news for diabetics

US FDA News: Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety

FDA announces steps to usher the U.S. into a new era of smarter food safety
Read more: Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas on steps to usher the U.S. into a new era of smarter food safety

US FDA News: FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

FDA has authorized the marketing of new tobacco products manufactured by Phillip Morris Products S.A. for the IQOS “Tobacco Heating System.”
Read more: FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

US FDA News: FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

FDA approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17.
Read more: FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

US FDA News: FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem
Read more: FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

FDA announces programs to promote adoption of innovations in drug manufacturing
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

US FDA News: FDA statement 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: FDA statement on approval of OTC Primatene Mist to treat mild asthma

US FDA News: FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing

FDA issues information to industry on advanced pharmaceutical manufacturing
Read more: FDA statement on FDA’s modern approach to advanced pharmaceutical manufacturing

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

US FDA News: La FDA emprende una campaña de educación ciudadana para instar a la eliminación segura de los analgésicos opiáceos sin usar del hogar

La campaña “Elimine el Riesgo“ va dirigida a mujeres de entre 35 y 64 años de edad, quienes son las más proclives a participar en las decisiones de salud en el hogar, y con frecuencia son las que controlan el acceso de los opioides y otros medicamentos de prescripción médica en el hogar.
Read more: La FDA emprende una campaña de educación ciudadana para instar a la eliminación segura de los analgésicos opiáceos sin usar del hogar

US FDA News: FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers
Read more: FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

Pharma Reviews: Omkar Speciality wins patent for Saccharin making process

... of India for its process to manufacture artificial sweetener sodium saccharin. ... Sodium Saccharin is also used in the food and beverage industry in diet ... It manufactures products used in various sectors such as pharmaceutical ...
Read more: Omkar Speciality wins patent for Saccharin making process

Monday, April 29, 2019

Pharma Reviews: CHP set to bridge advocacy gap with US

At a time when world's largest market for pharmaceuticals, the US is sparing no words to accuse India as a source of counterfeit medicines, and ...
Read more: CHP set to bridge advocacy gap with US

Pharma Reviews: Council for Healthcare and Pharma to Hold Legislative Day at Capitol Hill, DC

CHP members include domestic and global Pharmaceutical companies, ... Headquartered in New Delhi, India, the Council focuses on Africa, Brazil, ...
Read more: Council for Healthcare and Pharma to Hold Legislative Day at Capitol Hill, DC

Saturday, April 27, 2019

Pharma Reviews: Nearly 20% of all pharma products sold in India are counterfeit, US trade body claims

The USTR report said almost 20 per cent of all pharmaceutical goods sold in the Indian market are counterfeit — a damning claim considering the ...
Read more: Nearly 20% of all pharma products sold in India are counterfeit, US trade body claims

Friday, April 26, 2019

US FDA News: FDA approves device to help increase access to more lungs for transplant

The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant
Read more: FDA approves device to help increase access to more lungs for transplant

US FDA News: FDA approves first treatment for pediatric patients with lupus

FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs
Read more: FDA approves first treatment for pediatric patients with lupus

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

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

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

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

US FDA News: FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.
Read more: FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

US FDA News: La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica

La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica
Read more: La FDA autoriza la primera prueba de comercialización directa al consumidor para la detección de variantes genéticas que pudieran estar relacionadas con la metabolización farmacológica

US FDA News: La FDA aprueba nuevo medicamento para tratar la influenza

La FDA aprueba nuevo medicamento para tratar la influenza
Read more: La FDA aprueba nuevo medicamento para tratar la influenza

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

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

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

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

US FDA News: FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Read more: FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

FDA announces new plan to advance the development of plant and animal biotechnology innovation
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

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

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

US FDA News: FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act
Read more: FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

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

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

US FDA News: 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

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

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

US FDA News: FDA approves device to help increase access to more lungs for transplant

The device enables doctors to better assess lungs that were initially deemed to be unsuitable for transplant
Read more: FDA approves device to help increase access to more lungs for transplant

US FDA News: FDA approves first treatment for pediatric patients with lupus

FDA approves Benlysta for treatment of children with systemic lupus erythematosus (SLE), a chronic disease causing inflammation and damage to tissue and organs
Read more: FDA approves first treatment for pediatric patients with lupus

Pharma Reviews: Jamia Hamdard in collaboration with CSIR organises a session on Phytopharmaceuticals

... School of Pharmaceutical Education and Research, Jamia Hamdard, New ... bringing clarity and extending thrust on phyto Pharmaceuticals in India.
Read more: Jamia Hamdard in collaboration with CSIR organises a session on Phytopharmaceuticals

Pharma Reviews: Rakesh Sharma on space exploration and technology

Meanwhile, India has become the world's 12th biggest biotechnology ... This has, as analysts point out, prompted major drug companies to acquire ...
Read more: Rakesh Sharma on space exploration and technology

Thursday, April 25, 2019

Pharma Reviews: The bubbly doctor is back to uncovering hard truths of life in Laakhon Mein Ek

Back with its second season, Laakhon Mein Ek, explores the dark world of India's medical and pharma industry. The first season was about a young ...
Read more: The bubbly doctor is back to uncovering hard truths of life in Laakhon Mein Ek

US FDA News: FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

“Remove the Risk” to raise awareness about proper disposal of prescription opioids
Read more: FDA launches public education campaign to encourage safe removal of unused opioid pain medicines from homes

Wednesday, April 24, 2019

Product Recall Alerts: Alert: These toys and baby products were recalled in 2019, sometimes for deadly reasons

Alert: These toys and baby products were recalled in 2019, sometimes for ...... Reason: The medication may contain higher levels of ibuprofen than ...
Read more: Alert: These toys and baby products were recalled in 2019, sometimes for deadly reasons

Pharma Reviews: European demand pushes up Indian pharma exports

The Indian pharma industry is considered as the largest generic drug supplier. Generic drugs form the largest chunk of the domestic pharmaceutical ...
Read more: European demand pushes up Indian pharma exports

Pharma Reviews: Pharmaceutical exports rise 11 percent to $19.2 bn in 2018-19

India's pharmaceutical exports have registered growth of 11 percent to $19.2 billion in 2018-19. The increment has been attributed to huge demand in ...
Read more: Pharmaceutical exports rise 11 percent to $19.2 bn in 2018-19

Pharma Reviews: Growth 'Pill': Indian Pharma Exports Increase For Third Straight Year, Top $19.2 Billion In 2018-19

According to commerce ministry data, pharmaceutical exports from the country surged 11 per cent to $19.2 billion in 2018-19, driven primarily by ...
Read more: Growth 'Pill': Indian Pharma Exports Increase For Third Straight Year, Top $19.2 Billion In 2018-19

Pharma Reviews: Look which stocks found favour with the largest domestic investor in Q4

Life Insurance Corporation of India (LIC), India's largest institutional investor, .... “Indian pharma market will tend to grow faster than it has grown.
Read more: Look which stocks found favour with the largest domestic investor in Q4

Pharma Reviews: India a major player in Kenya's healthcare sector: High Commissioner Chhabra

"The Indian healthcare industry has established its roots in Kenya. ... "This opens up a window of opportunity for pharma companies keen to invest in ...
Read more: India a major player in Kenya's healthcare sector: High Commissioner Chhabra

Pharma Reviews: India a major player in Kenya's healthcare sector: High Commissioner Chhabra (IANS Interview)

"Over 10,000 Kenyan patients travel to India (annually) for medical purposes and this underscores the need for affordable healthcare in Kenya," ...
Read more: India a major player in Kenya's healthcare sector: High Commissioner Chhabra (IANS Interview)

Pharma Reviews: 5 Reasons B Pharmacy Admission Is Right for You

Pharmacy is a great career option that has a strong scope with many lucrative opportunities. The pharmacy industry is massive in India and was ...
Read more: 5 Reasons B Pharmacy Admission Is Right for You

Pharma Reviews: Pharmaceutical exports rise 11 per cent to $19.2 billion in 2018-19

North America constitutes about 30 per cent of Indian pharma exports, followed by Africa and the European Union with 19 per cent and 16 per cent ...
Read more: Pharmaceutical exports rise 11 per cent to $19.2 billion in 2018-19

Tuesday, April 23, 2019

Pharma Reviews: Pharma exports zoom 11% at $19 bn in FY19

The country's pharmaceutical exports rose by 11 per cent to $19.2 billion in ... North America constitutes about 30 per cent of Indian pharma exports, ...
Read more: Pharma exports zoom 11% at $19 bn in FY19

Pharma Reviews: Egypt rolls out the red carpet for India Inc

India Inc led by over 50 companies have already invested over USD 3 ... zone, especially in sectors like chemicals, petrochemicals, pharma, textiles, ...
Read more: Egypt rolls out the red carpet for India Inc

Pharma Reviews: Podcast | Editor's pick of the day: Oil, Hans Raj Hans, and drug exports

Generic drugs form the largest segment of the Indian pharmaceutical sector, with 75 per cent market share (in terms of revenues). India supplies 20 ...
Read more: Podcast | Editor's pick of the day: Oil, Hans Raj Hans, and drug exports

US FDA News: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
Read more: Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples

US FDA News: Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

New steps to strengthen the process of initiating voluntary recalls
Read more: Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls

Pharma Reviews: Pharmaceutical exports rise 11% to $19.2 bn in 2018-19

It is one of the top five sectors in the exports segment. Generic drugs form the largest segment of the Indian pharmaceutical sector, with 75 per cent ...
Read more: Pharmaceutical exports rise 11% to $19.2 bn in 2018-19

Pharma Reviews: History Maker: Dilip Sanghvi - Founder the Sun Pharmaceuticals

History Maker: Dilip Sanghvi - Founder the Sun Pharmaceuticals ... Accordingly, Dilip Sanghvi is an Indian billionaire businessman and one of the ... Apparently, Shanghvi started Sun Pharmaceutical Industries with a capital of Rs.
Read more: History Maker: Dilip Sanghvi - Founder the Sun Pharmaceuticals

Monday, April 22, 2019

US FDA News: Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

The FDA wants to underscore our continued confidence in the safety and effectiveness of the vaccines that are highly successful at preventing – in some cases, nearly eradicating – preventable diseases. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%.
Read more: Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine

Sunday, April 21, 2019

Pharma Reviews: Investigation: Did J&J's pharma arm illegally push the opioid Ultracet in India?

Now, the company could be staring at another body blow. Janssen India, J&J's pharmaceutical division which had so far maintained a clean image, ...
Read more: Investigation: Did J&J's pharma arm illegally push the opioid Ultracet in India?

Saturday, April 20, 2019

Pharma Reviews: Local pharma companies to challenge MNCs in pneumonia vaccine space

The duopoly of pneumonia vaccines in India is in for some shake-up soon, as homegrown players like Aurobindo Pharma, Cadila Healthcare (Zydus ...
Read more: Local pharma companies to challenge MNCs in pneumonia vaccine space

Friday, April 19, 2019

US FDA News: FDA permits marketing of first medical device for treatment of ADHD

FDA permits marketing of first medical device for treatment of ADHD
Read more: FDA permits marketing of first medical device for treatment of ADHD

US FDA News: FDA approves first generic naloxone nasal spray to treat opioid overdose

FDA granted approval of the 1st generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose
Read more: FDA approves first generic naloxone nasal spray to treat opioid overdose

Pharma Reviews: Manufacturing and Simulation are two pillars for Dassault Systemes

In this interview with Elets News Network, Shree Harsha, India Marketing ... industries such as life sciences, pharma and industrial equipment sector.
Read more: Manufacturing and Simulation are two pillars for Dassault Systemes

Thursday, April 18, 2019

Pharma Reviews: India to be one of the world's 'fastest growing bio' hubs in 2019: CPhI data

India's growing biosimilars industry is the primary driver of growth, with ... Cara Turner, Brand Director, Pharma, commented; “CPhI and P-MEC India ...
Read more: India to be one of the world's 'fastest growing bio' hubs in 2019: CPhI data

Pharma Reviews: India poised for best decade in growth, says Rakesh Jhunjhunwala

Big Bull Rakesh Jhunjhunwala says India will outpace the growth record past ... Indian pharma market will tend to grow faster than it has grown.
Read more: India poised for best decade in growth, says Rakesh Jhunjhunwala

Pharma Reviews: Health, pharma cos increase marketing investment: McCann Health's Matt Eastwood

Health, pharma cos increase marketing investment: McCann Health's Matt Eastwood ... He said, “Healthcare industry is expanding into newer spaces and ... Commenting on the lack of specialised health-oriented agencies in India, ...
Read more: Health, pharma cos increase marketing investment: McCann Health's Matt Eastwood

Wednesday, April 17, 2019

Pharma Reviews: Health, pharma cos increasingly investing in marketing: Matt Eastwood

Health, pharma cos increasingly investing in marketing: Matt Eastwood ... Commenting on the lack of specialised health-oriented agencies in India, ...
Read more: Health, pharma cos increasingly investing in marketing: Matt Eastwood

Tuesday, April 16, 2019

US FDA News: FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
Read more: FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements

US FDA News: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to remove all devices from the market

FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market
Read more: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to remove all devices from the market

Pharma Reviews: Godrej Medical Refrigerators Product Group Head Jaishankar Natarajan: We are at the fringe to ...

We are the only Indian company that is Performance, Quality and Safety (PQS) certified and is also ... How big is the market for medical refrigeration?
Read more: Godrej Medical Refrigerators Product Group Head Jaishankar Natarajan: We are at the fringe to ...

Pharma Reviews: India is said to cut trade deficit with China by $10 Billion

Last year, India won market access for sugar, rice, pharma, grapes, fish meal, fish oil, rapeseed meal, and tobacco. It is now working to export soybean ...
Read more: India is said to cut trade deficit with China by $10 Billion

Monday, April 15, 2019

Pharma Reviews: Exports grow to five-month high of 11% in March; trade deficit narrows

NEW DELHI: India's exports rose to a five-month high of 11 per cent in ... growth mainly in pharma, chemicals and engineering sectors, marking the ...
Read more: Exports grow to five-month high of 11% in March; trade deficit narrows

Pharma Reviews: Network18 reports consolidated net loss of Rs 75.57 crore in Q4

The company had reported a net loss of Rs 39.32 crore in the .... The year is likely to end on a good note for Indian pharma companies as analysts ...
Read more: Network18 reports consolidated net loss of Rs 75.57 crore in Q4

Pharma Reviews: From Lupin to Dr. Reddy's, year may end on a good note for pharma firms

The year is likely to end on a good note for Indian pharma companies as analysts expect an uptick in US sales. Around 13 -15 per cent year on year ...
Read more: From Lupin to Dr. Reddy's, year may end on a good note for pharma firms

Friday, April 12, 2019

US FDA News: Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
Read more: Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

US FDA News: FDA approves first targeted therapy for metastatic bladder cancer

The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.
Read more: FDA approves first targeted therapy for metastatic bladder cancer

US FDA News: Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.
Read more: Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk

Thursday, April 11, 2019

US FDA News: FDA orders important safety labeling changes for Addyi

FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.
Read more: FDA orders important safety labeling changes for Addyi

Pharma Reviews: Indian Pharma sector growth to moderate at 8-10% CAGR over FY'2018-21 period: ICRA

The growth trajectory for the Indian pharmaceutical industry is likely to be moderate at 8-10% over FY2018 to FY2021, on the back of healthy demand ...
Read more: Indian Pharma sector growth to moderate at 8-10% CAGR over FY'2018-21 period: ICRA

US FDA News: FDA issues final rule on safety and effectiveness of consumer hand sanitizers

FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.
Read more: FDA issues final rule on safety and effectiveness of consumer hand sanitizers

Pharma Reviews: 5 Indian pharmas mentioned in price fixing lawsuit in US

Apart from the aforementioned Indian companies, some other pharma companies who were named include Apotex, Teva, Heritage Pharma and Par ...
Read more: 5 Indian pharmas mentioned in price fixing lawsuit in US

Pharma Reviews: Combination drug market declines 56% in March as govt clamps down

Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance (IPA) that represents the research-based pharma companies in India pointed ...
Read more: Combination drug market declines 56% in March as govt clamps down

Wednesday, April 10, 2019

Pharma Reviews: Indian execs 'named' in US pharma case

Connecticut, which is leading a multistate investigation of an anti-trust lawsuit against 18 generic pharma companies, including five Indian firms, over ...
Read more: Indian execs 'named' in US pharma case

Pharma Reviews: Recovery in US business to lift pharma companies' Q4 earnings

Recovery in US business to lift pharma companies' Q4 earnings ... in Indian pharmaceutical market (IPM) growth, the Nirmal Bang report said.
Read more: Recovery in US business to lift pharma companies' Q4 earnings

Pharma Reviews: Pharma to see moderate growth till FY21

The pricing pressure in the US generic market started affecting the Indian pharma companies in Q4 of FY17, which led to a de-growth in FY18.
Read more: Pharma to see moderate growth till FY21

US FDA News: Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos legítimos de células madre bajo las regulaciones existentes

Declaración de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos
Read more: Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos legítimos de células madre bajo las regulaciones existentes

US FDA News: FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.
Read more: FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

Pharma Reviews: OTC drugs: Can pharma move fast-enough?

With healthcare being the need of the hour, we believe pharmaceutical ... timelines became leaders in penetrating emerging markets like India.
Read more: OTC drugs: Can pharma move fast-enough?

Tuesday, April 9, 2019

Pharma Reviews: Cosmetic claims need scientific credibility : Rashmikant Mohile

Thereafter in 1989 I switched from pharma to consumer product industry and worked with a big Indian consumer product company for 17 years, ...
Read more: Cosmetic claims need scientific credibility : Rashmikant Mohile

Pharma Reviews: Pharma exports from Gujarat rise 11% in FY19

Ahmedabad: In line with India's strong performance in exports of pharmaceutical products, Gujarat has ended the fiscal 2018-19 with double digit ...
Read more: Pharma exports from Gujarat rise 11% in FY19

US FDA News: USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

The agencies announced the release of a federal interagency strategy to address food waste.
Read more: USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste

US FDA News: FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).
Read more: FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

US FDA News: Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects
Read more: Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

Monday, April 8, 2019

Pharma Reviews: With $100 Mn from General Atlantic, India's Rubicon Research to Back Early/Seed Stage Startups ...

Rubicon holds more than 50 issued patents in drug delivery technologies and with its new R&D centre can develop pharmaceutical products across ...
Read more: With $100 Mn from General Atlantic, India's Rubicon Research to Back Early/Seed Stage Startups ...

US FDA News: FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.
Read more: FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

US FDA News: FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin
Read more: FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

Pharma Reviews: Market Research's Recent Study Predicts Indian Pharmaceuticals Market to Reach $73.5 Billion by ...

Market Research Future, a Pune-based Market Reseach firm, recently expedited a study to better ascertain various aspects of the current ...
Read more: Market Research's Recent Study Predicts Indian Pharmaceuticals Market to Reach $73.5 Billion by ...

Pharma Reviews: East Africa and BIMSTEC: Aligning private sector to public health goals

India has emerged as one of the major global players in pharmaceutical manufacturing: the country is an important supplier of medicines to the two ...
Read more: East Africa and BIMSTEC: Aligning private sector to public health goals

Friday, April 5, 2019

Pharma Reviews: Arinna Lifesciences in to raise around Rs 75 crore in latest round of funding

PE funds' interest in pharma companies continues to be high in the Indian market. As per the latest report by Indian Brand Equity Foundation, the ...
Read more: Arinna Lifesciences in to raise around Rs 75 crore in latest round of funding

Thursday, April 4, 2019

US FDA News: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
Read more: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

US FDA News: FDA expands approved use of metastatic breast cancer treatment to include male patients

The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
Read more: FDA expands approved use of metastatic breast cancer treatment to include male patients

US FDA News: FDA and CBP bolster collaboration to protect public health and safety

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities.
Read more: FDA and CBP bolster collaboration to protect public health and safety

US FDA News: E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users.
Read more: E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

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 the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers
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 the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

Pharma Reviews: How patents have transformed the Health Care Sector

Below are the changes that Indian Pharmaceutical Industry has gone through during the pre-compliance (till 2005) and post compliance(after 2005) ...
Read more: How patents have transformed the Health Care Sector

Wednesday, April 3, 2019

Pharma Reviews: Dr Reddy's readies plan to scale China operations

The Edelweiss report states that a growing Chinese pharma market and a relaxed Chinese drug regulator, CFDA, are likely to attract many Indian ...
Read more: Dr Reddy's readies plan to scale China operations

Product Recall Alerts: Baby Cough Syrup Recalled

A baby cough syrup sold nationwide has been recalled due to possible ... Kingston Pharma recalled the product DG™/Health Naturals Baby Cough ... in 1 in 10 bottles of the mentioned product alerting the company for the potential ...
Read more: Baby Cough Syrup Recalled

Pharma Reviews: We have made an offer to America to help resolve difficult trade disputes, says Govt

Although officials of India and the US have been negotiating a trade ... month so far, on account of healthy growth in sectors such as pharmaceuticals.
Read more: We have made an offer to America to help resolve difficult trade disputes, says Govt

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs

US FDA News: FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA takes new steps to increase access to adverse event report data for medical products used in animals
Read more: FDA takes new steps to increase access to adverse event report data for medical products used in animals

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations

FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults

FDA issues statement on agency’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults

Tuesday, April 2, 2019

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices

Pharma Reviews: Sudarshan Jain, former Abbott top executive, is IPA Secretary General

The Indian Pharmaceutical Alliance (IPA), the industry body that represents large domestic drug makers, announced the appointment of industry ...
Read more: Sudarshan Jain, former Abbott top executive, is IPA Secretary General

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

US FDA News: USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month

The agencies kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials.
Read more: USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month

US FDA News: FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.
Read more: FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

FDA is announcing a public hearing to discuss access to affordable insulin products.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access