Friday, March 31, 2017

US FDA News: EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Read more: EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device

US FDA News: FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
Read more: FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

US FDA News: Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
Read more: Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use

Pharma Reviews: Sun Pharma, Aurobindo, Lupin, Cipla witness fall in US sales

The US is one of the top markets for Indian pharma companies; in 2015, India was one of the five sources of pharma imports for the US, valued at ...
Read more: Sun Pharma, Aurobindo, Lupin, Cipla witness fall in US sales

Thursday, March 30, 2017

Pharma Reviews: India's meek submission to MNCs

Central government is capitulating to demands of pharma MNCs and denying Compulsory Licence to Indian firms to produce generic versions, which ...
Read more: India's meek submission to MNCs

Pharma Reviews: Lupin, Cipla, other top drugmakers in fray for Novartis' brands

Indian drug makers have been pursuing M&A opportunities in North America and Europe. Last year, companies like Sun, Aurobindo and Intas led ...
Read more: Lupin, Cipla, other top drugmakers in fray for Novartis' brands

Pharma Reviews: Pharma M&A Deals Touch $4.6 Billion In 2016

India's pharmaceuticals sector witnessed 51 deals being announced in the year 2016, with aggregate disclosed deal value of $4.6 billion. Unlike the ...
Read more: Pharma M&A Deals Touch $4.6 Billion In 2016

US FDA News: LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

Sibutramine may substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Read more: LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient

Wednesday, March 29, 2017

Pharma Reviews: Project development fund for investment in CLMV countries

She also said that it was informed to SME Pharma Industries Confederation (India) that the bar code on drugs and pharmaceuticals meant for exports ...
Read more: Project development fund for investment in CLMV countries

Pharma Reviews: Free drugs, diagnostics to all in new health policy: Govt

... Europe," she said, adding 80 per cent of the anti-retroviral drug which is used globally to combat AIDS is supplied by Indian pharmaceutical industry.
Read more: Free drugs, diagnostics to all in new health policy: Govt

Pharma Reviews: Bar coding for pharma exports was made mandatory after several stakeholders consultation ...

With a view to protect the brand value of Indian pharma and counter the allegations against Indian Pharma Industry as exporter of spurious/counterfeit ...
Read more: Bar coding for pharma exports was made mandatory after several stakeholders consultation ...

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

On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.
Read more: FDA approves new drug to treat multiple sclerosis

Tuesday, March 28, 2017

Pharma Reviews: Moscow, New Delhi agree to jointly fight cartelisation by pharma companies

India and Russia have agreed to fight cartelisation by pharmaceutical companies, Russia's Federal Antimonopoly Service (FAS) said on March 27.
Read more: Moscow, New Delhi agree to jointly fight cartelisation by pharma companies

US FDA News: FDA approves new eczema drug Dupixent

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
Read more: FDA approves new eczema drug Dupixent

Pharma Reviews: Wrong to say USFDA has been unduly harsh on Indian pharma: Piramal

The USFDA has strong reasons for most of the actions against the Indian pharma industry, says Ajay Piramal, Chairman, Piramal Group . Excerpts ...
Read more: Wrong to say USFDA has been unduly harsh on Indian pharma: Piramal

Monday, March 27, 2017

Pharma Reviews: Indian drug industry opposes price caps

India's ongoing programme of capping drug prices has led the pharmaceutical industry to protest against the government. While the controls aim to ...
Read more: Indian drug industry opposes price caps

US FDA News: FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.
Read more: FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

Friday, March 24, 2017

US FDA News: HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
Read more: HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

Pharma Reviews: Systech participates in exclusive seminar series organized by US consulates in India

Systech International, a global technology solutions leader and innovator in serialization for the pharmaceutical industry, has recently participated in a ...
Read more: Systech participates in exclusive seminar series organized by US consulates in India

Pharma Reviews: Make In India: Pharmacy Sector

Indian pharmaceutical market is the third largest in the world in terms of volume. The pharmaceutical sector has grown at 17 per cent and is expected ...
Read more: Make In India: Pharmacy Sector

Thursday, March 23, 2017

US FDA News: FDA approves first treatment for rare form of skin cancer

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer.
Read more: FDA approves first treatment for rare form of skin cancer

Pharma Reviews: Ministry of Health to assess Indian drug makers

Indian pharma companies are reeling under pressure due to the USFDA inspections. Indian drug makers export drugs to nearly 200 companies which ...
Read more: Ministry of Health to assess Indian drug makers

Tuesday, March 21, 2017

Pharma Reviews: Pharma stocks take a beating on renewed US FDA scrutiny

Divi's Lab and Dr. Reddy's troubles with US FDA indicate Indian pharma firms face a long and uphill struggle to meet quality standards in world's ...
Read more: Pharma stocks take a beating on renewed US FDA scrutiny

US FDA News: FDA approves drug to treat Parkinson’s disease

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking.
Read more: FDA approves drug to treat Parkinson’s disease

Pharma Reviews: A message for Indian pharma: Do what you say, say what you do

Over the last decade, “data integrity” has turned out to be the most discussed and perhaps the most dreaded word for the Indian pharmaceutical ...
Read more: A message for Indian pharma: Do what you say, say what you do

Pharma Reviews: Bulk drug imports from China drop after govt scraps customs exemption

Imports from China have come down even as the domestic formulation industry has grown by about 10 per cent, as per India Drug Manufacturers ...
Read more: Bulk drug imports from China drop after govt scraps customs exemption

Pharma Reviews: Big Boss USFDA hits pharma stocks harder

US Food and Drug Administration (USFDA) is haunting the Indian pharma companies for the past few months. The performance of pharma companies ...
Read more: Big Boss USFDA hits pharma stocks harder

US FDA News: Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
Read more: Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Pharma Reviews: Is USFDA playing a spoilsport in pharma stocks rally

The performance of pharma companies on Indian bourses is much dependent on the USFDA inspections. The pharma companies are shedding in ...
Read more: Is USFDA playing a spoilsport in pharma stocks rally

Pharma Reviews: Indian pharma cos ready to move into South East Asian market by setting up mfg facilities

Indian pharma companies are readying to themselves with market build-up strategies in the South East Asian region. This is even as countries like ...
Read more: Indian pharma cos ready to move into South East Asian market by setting up mfg facilities

Monday, March 20, 2017

Pharma Reviews: Policy changes: Indian pharmaceutical companies face strong headwinds in US

indian pharmaceutical companies, pharmaceutical companies US, medicines india, national health policy, USFDA As per ICRA's sample study, ...
Read more: Policy changes: Indian pharmaceutical companies face strong headwinds in US

Saturday, March 18, 2017

US FDA News: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
Read more: Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

US FDA News: Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Read more: Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

US FDA News: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Read more: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

US FDA News: Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease operations until they come into compliance with federal laws.
Read more: Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Pharma Reviews: Pharmaceutical industry degrading soil in city

A study that was conducted by collecting soil samples from four areas located close to pharmaceutical industries in Medchal, Maisammaguda(near ...
Read more: Pharmaceutical industry degrading soil in city

Friday, March 17, 2017

Pharma Reviews: Indian drugmakers face squeeze in US healthcare market

J. Jayaseelan, who owns Nuray Chemicals, a maker of drug ingredients, said many Indian firms are reconsidering, or putting on hold, U.S. expansion ...
Read more: Indian drugmakers face squeeze in US healthcare market

Thursday, March 16, 2017

Pharma Reviews: Expect IT, pharma sector to turn corner in India's good growth story: Mihir Vora

The market sentiment is bullish and India's growth story looks positive according to market expert Mihir Vora who believes India is a good shining spot.
Read more: Expect IT, pharma sector to turn corner in India's good growth story: Mihir Vora

Pharma Reviews: Stay (Financially) Healthy With This Stock

These policies may lead to significant fall in the prices of Indian pharma products in the US. Considering the volatility in the pharma sector stocks, Sun ...
Read more: Stay (Financially) Healthy With This Stock

Pharma Reviews: Vinita Gupta: Always On The Move

Lupin, today, is the third largest pharmaceutical company in India. ... Gavis deal, the largest foreign acquisition by the Indian pharma company till date.
Read more: Vinita Gupta: Always On The Move

Pharma Reviews: Sun Pharma's Mohali plant gets a breather; all eyes now on Halol

For Sun Pharmaceutical, the 'Ides of March' brings hope for a new ... unitBombay Stock Exchang issued by this largest Indian pharma company, ...
Read more: Sun Pharma's Mohali plant gets a breather; all eyes now on Halol

Wednesday, March 15, 2017

Pharma Reviews: Quality culture: A big test for Indian pharma

Manufacturing company CEOs the world over, have tried this over the years, with varying degrees of success. India's pharmaceutical industry is ...
Read more: Quality culture: A big test for Indian pharma

Pharma Reviews: TOWARDS GLOBAL COMPLIANCE

And the manufacturing facilities of all the top Indian pharma companies used to get inspected by the US FDA and the European regulatory authorities ...
Read more: TOWARDS GLOBAL COMPLIANCE

Pharma Reviews: Pharma funds disappoint. Is it time to move out?

Pharmaceutical sector has been plagued by Trump presidency and regulatory hurdles abroad. For example, Indian pharma giant, Sun Pharma's ...
Read more: Pharma funds disappoint. Is it time to move out?

Pharma Reviews: Is Indian pharma finally out of intensive care?

The industry's inability to deal with regulation in its biggest market was ... Singapore : India's generic drug-making industry is getting wheeled out of ...
Read more: Is Indian pharma finally out of intensive care?

Pharma Reviews: 2017 onward we are getting a lot of good news in pharma sector: Gurudatta GG

Gurudatta GG, Director & CEO, Estima Pharma talks to ET Now about the ... Pharma's Mohali plant and other the trend in the Indian pharma industry.
Read more: 2017 onward we are getting a lot of good news in pharma sector: Gurudatta GG

US FDA News: Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
Read more: Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Pharma Reviews: 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta GG, Estima ...

Whatever observations US FDA had, were answered appropriately by the Indian pharma companies which are accepted by US FDA that is why we ...
Read more: 2017 onward we are getting a lot of good news in the Pharma industry: Gurudatta GG, Estima ...

Pharma Reviews: Indian pharma must comply with govt's Jan 1, 2018 deadline to upgrade staff skill sets for pharma ...

Indian pharmaceutical industry must treat January 1, 2018 deadline issued by the Drug Controller General of India (DCGI) as sacrosanct for upgrading ...
Read more: Indian pharma must comply with govt's Jan 1, 2018 deadline to upgrade staff skill sets for pharma ...

Pharma Reviews: Indian Pharmaceutical Alliance to release quality culture monitoring guidelines next year

The Indian Pharmaceutical Alliance, a representative body of research-based pharmaceutical companies in India, has taken up an initiative to develop ...
Read more: Indian Pharmaceutical Alliance to release quality culture monitoring guidelines next year

Tuesday, March 14, 2017

US FDA News: Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren, requiring Floren’s businesses to immediately cease operations until they come into compliance with federal laws.
Read more: Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

US FDA News: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
Read more: SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Pharma Reviews: Why Scott Gottlieb, the new US FDA chief, could be good news for Indian drug makers

The US FDA appointment is closely watched by Indian pharmaceutical industry which supplies 40 percent of the generic medications consumed in the ...
Read more: Why Scott Gottlieb, the new US FDA chief, could be good news for Indian drug makers

Monday, March 13, 2017

Pharma Reviews: Cost advantage & talent pool to help Indian pharma meet challenges in the US & EU: Dilip Surana

The cost advantage and availability of quality technical talent will boost Indian pharma industry's growth prospects in the regulated markets of US and ...
Read more: Cost advantage & talent pool to help Indian pharma meet challenges in the US & EU: Dilip Surana

Pharma Reviews: 50% pharma industries still unprepared for second phase of US Drug Supply Chain Security Act

Even as about eight months are left for the implementation of second phase of US Drug Supply Chain Security Act (DSCSA), 50 per cent of Indian ...
Read more: 50% pharma industries still unprepared for second phase of US Drug Supply Chain Security Act

Sunday, March 12, 2017

Pharma Reviews: Investors in pharma stocks need to temper expectations

“In our view, investors are not in a hurry to bottom fish,” JP Morgan said in a note on Indian pharma sector last week. “We do get queries on ...
Read more: Investors in pharma stocks need to temper expectations

Thursday, March 9, 2017

Pharma Reviews: KPMG in India announces appointment of Dr. Ajaz Hussain as Senior Advisor, Risk Consulting

Dr. Ajaz Hussain brings a wealth of international pharmaceutical regulatory and business experience to KPMG in India, including his decade-long ...
Read more: KPMG in India announces appointment of Dr. Ajaz Hussain as Senior Advisor, Risk Consulting

Wednesday, March 8, 2017

Pharma Reviews: Indian pharma cos rates WHO's stability testing norms for APIs & finished drugs high

Indian pharma industry sees the significance of the World Health Organization's update to its guidelines for API and finished drug stability testing.
Read more: Indian pharma cos rates WHO's stability testing norms for APIs & finished drugs high

Pharma Reviews: Relief for patients? Substandard medicines in retail shops just 3.2%, shows survey

The Indian pharmaceutical industry is valued at approximately $30 billion, and more than half of it is exported to different countries across the globe.
Read more: Relief for patients? Substandard medicines in retail shops just 3.2%, shows survey

Pharma Reviews: 'Trump to hasten desi pharma rejig'

Mumbai: This year's JP Morgan healthcare conference in San Francisco, which sets the tone for the industry, saw a sombre mood among Indian ...
Read more: 'Trump to hasten desi pharma rejig'

Pharma Reviews: Waste generated pharmaceutical industry posing enviornmental

Most of hazardous waste is generated by pharmaceutical and medical ... three-day conference, organised by the CSIR-Indian Institute of Petroleum ...
Read more: Waste generated pharmaceutical industry posing enviornmental

Pharma Reviews: Indian drug makers can export patented meds for approval: Delhi High Court

NEW DELHI: The Delhi High Court has allowed Indian companies Alembic and Natco Pharmaceuticals to export — for research and regulatory ...
Read more: Indian drug makers can export patented meds for approval: Delhi High Court

Pharma Reviews: Indian drug market growth moderates to 7.1% in February

The domestic drug market grew at 7.1 percent in February compared to 13.5 percent growth in the same period last year, according to data from ...
Read more: Indian drug market growth moderates to 7.1% in February

Pharma Reviews: Generic Firms Can Export Bayer Drugs For R&D in India Ruling

The two Indian companies, Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd., can respectively export sorafenib, the active ingredient in Bayer's ...
Read more: Generic Firms Can Export Bayer Drugs For R&D in India Ruling

Pharma Reviews: Delhi HC rules in favour of Indian pharma manufacturers Natco and Alembic

The Delhi High Court on Wednesday allowed Indian drug manufacturers Natco Pharma and Alembic Pharmaceuticals to export Sorafinat and ...
Read more: Delhi HC rules in favour of Indian pharma manufacturers Natco and Alembic

Pharma Reviews: Delhi High Court favours Natco, Alembic; allows them to export generics of Bayer's drugs

NEW DELHI: The Delhi High Court has ruled that Indian companies Alembic and Natco Pharmaceuticals can export generic versions of two of German ...
Read more: Delhi High Court favours Natco, Alembic; allows them to export generics of Bayer's drugs

US FDA News: Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
Read more: Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

Tuesday, March 7, 2017

US FDA News: Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Read more: Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

Pharma Reviews: Indian pharma sector faces growth pains

Bengaluru, March 6 (IANS): The Indian pharmaceutical industry growth is projected to be in single digit this fiscal (2016-17) due to several headwinds, ...
Read more: Indian pharma sector faces growth pains

Monday, March 6, 2017

Pharma Reviews: Pharma sector growth will be moderate, says ICRA

“The revenue growth for Indian pharma industry remains moderate...with base business in the US continuing to face high single digit price erosion, ...
Read more: Pharma sector growth will be moderate, says ICRA

Pharma Reviews: Pharma sector growth to be moderate: ICRA

"The revenue growth for Indian pharma industry remains moderate...with base business in US continuing to face high single digit price erosion, ...
Read more: Pharma sector growth to be moderate: ICRA

Pharma Reviews: Indian pharma sector faces growth pains

The Indian pharmaceutical industry growth is projected to be in single digit this fiscal (2016-17) due to several headwinds, a study said on Monday.
Read more: Indian pharma sector faces growth pains

Pharma Reviews: ICRA: Indian pharmaceutical industry continues to face headwinds; aggregate growth expected to ...

ICRA expects growth trajectory for Indian pharmaceutical industry to moderate on back of slowing growth from US, increased competition, and ...
Read more: ICRA: Indian pharmaceutical industry continues to face headwinds; aggregate growth expected to ...

Sunday, March 5, 2017

Pharma Reviews: Indian pharma firms anxious over Trump's policy reforms

Major pharma entities in India are keenly watching the US policy reforms as the President, Donald Trump has promised to lower drug costs.
Read more: Indian pharma firms anxious over Trump's policy reforms

Pharma Reviews: Indian Pharmaceutical Alliance urges Centre to join PIC/S to improve global recognition and boost ...

Indian Pharmaceutical Alliance (IPA), a representative body of 20 research based pharmaceutical companies, has urged the government of India to ...
Read more: Indian Pharmaceutical Alliance urges Centre to join PIC/S to improve global recognition and boost ...

Saturday, March 4, 2017

Pharma Reviews: Time the pharma industry popped the quality pill

With representation of drug regulators from India, the US, the UK and France, the conclave came at a time when some of the industry's top drugmakers ...
Read more: Time the pharma industry popped the quality pill

Friday, March 3, 2017

Pharma Reviews: Indian pharma firms seek Trump's appointment to trade low cost medicines against lower import tax

With speculations rife over Trump's health policies after repeal of Obamacare, India's big pharmaceutical firms have also set their eyes on the US ...
Read more: Indian pharma firms seek Trump's appointment to trade low cost medicines against lower import tax

Pharma Reviews: Pharmexcil to organize India Pavilion at Pharmaconex 2017 in Egypt

According to Uday Bhaskar, director general of Pharmexcil, Pharmaconex-2017 is an apt platform for the Indian pharmaceutical manufacturers and ...
Read more: Pharmexcil to organize India Pavilion at Pharmaconex 2017 in Egypt

US FDA News: FDA approves first treatment for frequent urination at night due to overproduction of urine

The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.
Read more: FDA approves first treatment for frequent urination at night due to overproduction of urine

Pharma Reviews: Trump administration would be good for India: USIBC

“India can support the US very much on pharma side. Indian pharma companies provide cost benefits to American companies and the country. Trump ...
Read more: Trump administration would be good for India: USIBC

Pharma Reviews: Trump administration would be good for India: US industry group

India can support the US very much on pharma side. Indian pharma companies provide cost benefits to American companies and the country. Trump ...
Read more: Trump administration would be good for India: US industry group

Pharma Reviews: Trump rhetoric spooks Indian pharma, cos wary of US cutting down on Indian imports

In a letter to Arvind Panagariya, vice-chairman, Niti Aayog, the Indian Pharmaceutical Association (IPA) has asked the Commerce ministry and India's ...
Read more: Trump rhetoric spooks Indian pharma, cos wary of US cutting down on Indian imports

Pharma Reviews: Fighting cartelisation in pricing of medicines

D G Shah, Secretary Ggeneral of the Indian Pharmaceutical Alliance, which has many leading Indian pharma companies as its members, says: "If ...
Read more: Fighting cartelisation in pricing of medicines

Thursday, March 2, 2017

Pharma Reviews: Indian pharma companies rattled by Donald Trump's protectionist rhetoric

MUMBAI: Indian IT companies are not the only ones spooked by US President Donald Trump's protectionist rhetoric. Drug company honchos, rattled ...
Read more: Indian pharma companies rattled by Donald Trump's protectionist rhetoric

Pharma Reviews: Pharma lobby cries foul on GIPC's poor ranking to India

HYDERABAD: Indian domestic drug lobby group Indian Pharmaceutical Alliance (IPA) said the latest Global Intellectual Property Centre (GIPC) index ...
Read more: Pharma lobby cries foul on GIPC's poor ranking to India

Pharma Reviews: Indian pharma companies lobby to win Donald Trump over on generic imports

Mumbai: India's largest pharmaceutical firms are looking to convince US President Donald Trump that his promise to lower drug costs should take ...
Read more: Indian pharma companies lobby to win Donald Trump over on generic imports

Pharma Reviews: Spooked by Donald Trump, Indian pharma cos seeks government help to woo Capitol Hill

MUMBAI: US President Donald Trump has not just spooked the Indian IT companies, even the billion dollar Indian drug industry is rattled by the ...
Read more: Spooked by Donald Trump, Indian pharma cos seeks government help to woo Capitol Hill

US FDA News: Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
Read more: Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union

Pharma Reviews: Indian Drugmakers Lobby to Win Trump Over on Generic Imports

(Bloomberg) -- India's largest pharmaceutical firms are looking to convince U.S. President Donald Trump that his promise to lower drug costs should ...
Read more: Indian Drugmakers Lobby to Win Trump Over on Generic Imports

Pharma Reviews: Fighting cartelisation in pricing of medicines

Those within the pharmaceutical industry will however tell us that drug prices in India are one of the lowest in the world. However, irrespective of how ...
Read more: Fighting cartelisation in pricing of medicines

Wednesday, March 1, 2017

Pharma Reviews: Pharma group IPA hits out at local drug regulators

The Indian Pharmaceutical Alliance – a powerful grouping of twenty leading Indian drug companies – has written to Arvind Panagariya, vice chairman ...
Read more: Pharma group IPA hits out at local drug regulators

Pharma Reviews: Deutsche Bank upgrades Pharma sector

Report pointed out that over the past three months, large Indian pharma companies such as Lupin, Cadila, Aurobindo, Glenmark and Cipla have ...
Read more: Deutsche Bank upgrades Pharma sector

Pharma Reviews: MINISTRY FOR PHARMA & DEVICES

India's pharmaceutical industry has grown into a major sector over the last 30 years having an annual production in excess of Rs. 2 lakh crore with as ...
Read more: MINISTRY FOR PHARMA & DEVICES

US FDA News: FDA approves Odactra for house dust mite allergies

The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.
Read more: FDA approves Odactra for house dust mite allergies