Pharma Reviews: Kerala falls back on Nipah formula: Tracing virus patient's contacts

AFTER INDIA'S first confirmed case of coronavirus was detected in Kerala's ... Explained | Why coronavirus virus could hit Indian pharma industry.
Read more: Kerala falls back on Nipah formula: Tracing virus patient's contacts

US FDA News: FDA approves first drug for treatment of peanut allergy for children

FDA approves first drug for treatment of peanut allergy for children
Treatment with this product may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older.
Read more: FDA approves first drug for treatment of peanut allergy for children

Pharma Reviews: Budget 2020 - Efforts should be to move from Make in India to Discover in India : Sudarshan Jain

The Indian pharmaceutical industry is the world's third largest of drugs by volume. In the course of the industry's journey to annual revenues of about ...
Read more: Budget 2020 - Efforts should be to move from Make in India to Discover in India : Sudarshan Jain

Pharma Reviews: Economic Survey raises more questions than answers for pharma industry

For instance, Sudarshan Jain, secretary general of the Indian Pharmaceutical Alliance, which has leading Indian pharmaceutical companies as its ...
Read more: Economic Survey raises more questions than answers for pharma industry

Pharma Reviews: Learnings from the unravelling of the Indian pharma industry

The U.S. Food and Drug Administration's (USFDA) record warning letters to Indian pharma majors in the recent years, Katherine Eban's hard-hitting ...
Read more: Learnings from the unravelling of the Indian pharma industry

Pharma Reviews: Coronavirus a public health emergency; what does WHO declaration mean?

India has reported its first case of coronavirus infection on Thursday when a ... Explained: Why coronavirus virus could hit Indian pharma industry.
Read more: Coronavirus a public health emergency; what does WHO declaration mean?

Pharma Reviews: SCHOTT increases sales in India and plans record investments

India sales growth by 18% to INR 388.6 crores (EUR 49.5 million) ... Business with special glass tubing for pharmaceutical packaging and the ...
Read more: SCHOTT increases sales in India and plans record investments

Pharma Reviews: Why coronavirus virus could hit Indian pharma industry

The density of population in India, low levels of public awareness, and vulnerabilities in the healthcare network present strong challenges to ...
Read more: Why coronavirus virus could hit Indian pharma industry

Pharma Reviews: Coronavirus outbreak: China shutdown to hit Indian drug manufacturers

Indian drug manufacturers are to a large extent dependent on China for sourcing their drug ingredients or the active pharmaceutical ingredients, ...
Read more: Coronavirus outbreak: China shutdown to hit Indian drug manufacturers

Pharma Reviews: SCHOTT increases sales in India and plans record investments

Business with special glass tubing for pharmaceutical packaging and the ampoules, vials, syringes and cartridges produced from it, contributed ...
Read more: SCHOTT increases sales in India and plans record investments

US FDA News: Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors.
Read more: Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

Pharma Reviews: India's production of paracetamol, top antibiotics could be hit by China coronavirus crisis

Indian drugmakers import around 70 per cent of their total bulk drugs from China. The bulk drugs, also known as the active pharmaceutical ingredients ...
Read more: India's production of paracetamol, top antibiotics could be hit by China coronavirus crisis

Pharma Reviews: Budget 2020 : Healthcare industry expects infrastructure push, tax incentives for R&D

“One of our greatest challenges in scaling up healthcare across India is the shortage of trained medical providers. The government's Ayushman Bharat ...
Read more: Budget 2020 : Healthcare industry expects infrastructure push, tax incentives for R&D

Pharma Reviews: US offers $30 billion more market to domestic pharma companies

US offers $30 billion more market to domestic pharma companies ... Despite being the largest export market for domestic pharma makers, they ... per cent of American drug imports and but the share of Indian companies in 2018 was ...
Read more: US offers $30 billion more market to domestic pharma companies

US FDA News: 2020 Medical Device Recalls

List of Medical Device recalls in 2020.
Read more: 2020 Medical Device Recalls

US FDA News: FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

FDA launches an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.
Read more: FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

Pharma Reviews: Pharma firms brace for raw material supply issues due to coronavirus outbreak

Pharmaceutical companies in India are bracing for a hit on supply of key raw materials, majority of which is imported from China, if the current outbreak ...
Read more: Pharma firms brace for raw material supply issues due to coronavirus outbreak

Pharma Reviews: Expectations from Union Budget 2020 - Mahendra Patel, MD, Lincoln Pharmaceuticals

Indian Pharma industry is facing challenges such as increased scrutiny from drug regulators, stalled new product approvals and price control in the ...
Read more: Expectations from Union Budget 2020 - Mahendra Patel, MD, Lincoln Pharmaceuticals

Pharma Reviews: Torrent Pharmaceuticals puts faith in local market, to focus on new drug launches

MUMBAI: Torrent Pharmaceuticals is optimistic that the future of Indian drug makers is in the domestic market, as it looks at new launches in the ...
Read more: Torrent Pharmaceuticals puts faith in local market, to focus on new drug launches

Pharma Reviews: Cipla ready with repurposed HIV drug to combat coronavirus

Now the Indian pharmaceutical major is readying a stockpile of medicines to combat the deadly coronavirus. Yusuf Khwaja Hamied, Chairman of ...
Read more: Cipla ready with repurposed HIV drug to combat coronavirus

US FDA News: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.
Read more: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

US FDA News: Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated.
Read more: Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

Pharma Reviews: Indian pharma industry likely to grow at 10-13% in FY21: Icra

New Delhi: The growth trajectory for the Indian pharmaceutical industry is likely to remain at 10-13 per cent in 2020-21 despite challenges, according ...
Read more: Indian pharma industry likely to grow at 10-13% in FY21: Icra

US FDA News: FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
Read more: FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

Pharma Reviews: Indian Pharma Industry Likely To Grow At 10-13% In FY21: ICRA

The growth trajectory for the Indian pharmaceutical industry is likely to remain at 10-13 percent in 2020-21 despite challenges, according to rating ...
Read more: Indian Pharma Industry Likely To Grow At 10-13% In FY21: ICRA

Pharma Reviews: Indian pharma industry likely to grow at 10-13 per cent in FY'21: Icra

NEW DELHI: The growth trajectory for the Indian pharmaceutical industry is likely to remain at 10-13 per cent in 2020-21 despite challenges, ...
Read more: Indian pharma industry likely to grow at 10-13 per cent in FY'21: Icra

Pharma Reviews: Indian pharmaceutical industry likely to grow at 10-13 pc in FY'21: Icra

Indian pharmaceutical industry likely to grow at 10-13 pc in FY'21: Icra ... The growth trajectory for the Indian pharmaceutical industry is likely to remain ...
Read more: Indian pharmaceutical industry likely to grow at 10-13 pc in FY'21: Icra

Pharma Reviews: Pharma industry calls for digitisation, say experts

It may be noted that Indian pharmaceutical industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in ...
Read more: Pharma industry calls for digitisation, say experts

US FDA News: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures
Read more: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

Pharma Reviews: Pharma industry calls for digitisation, say experts

New Delhi [India], Jan 27 (ANI): As digital technology has taken a leap in the country, the pharma industry needs to transform itself from traditional to ...
Read more: Pharma industry calls for digitisation, say experts

Pharma Reviews: What industry experts expect from Union Budget 2020-21?

The Union Budget of India for FY2020–21 will be presented by Finance Minister, Nirmala Sitharaman on Saturday, February 1, 2020, the quotes from ...
Read more: What industry experts expect from Union Budget 2020-21?

Pharma Reviews: To shake off slowdown, businesses pin hopes on Budget

Research and Development (R&D) is a key to India's growth in the pharmaceutical sector. To encourage R&D, the government provides weighted tax ...
Read more: To shake off slowdown, businesses pin hopes on Budget

Product Recall Alerts: Recalls That Should Be on Your Radar Week of January 19, 2020

We've compiled a list of recalls issued by the US Food and Drug ... FDA Issues Public Health Alert Concerning Salud Natural Entrepreneur, Inc.
Read more: Recalls That Should Be on Your Radar Week of January 19, 2020

Pharma Reviews: Cilicant Chem to set up facility in Hyderabad, invests Rs 50 crore

Jain has pegged the Indian pharma desiccant market size at Rs 500 crore, with India being the largest provider of generic drugs globally. Presently ...
Read more: Cilicant Chem to set up facility in Hyderabad, invests Rs 50 crore

US FDA News: King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub
Read more: King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

Pharma Reviews: Want to Budget-proof investment? Go for insurance stocks: Sudip Bandyopadhyay, Inditrade Capital

There are different sectors with different expectations. ... If there is significant growth happening in Indian pharmaceutical industry, companies like ...
Read more: Want to Budget-proof investment? Go for insurance stocks: Sudip Bandyopadhyay, Inditrade Capital

Pharma Reviews: Industry opens bag of expectations from Union Budget 2020-21

Entire industries and job markets in India come from exports, like the IT ... Indian Pharma industry is facing challenges such as increased scrutiny from ...
Read more: Industry opens bag of expectations from Union Budget 2020-21

Pharma Reviews: India: The Dichotomy Of IPR Protection And Social Welfare- An Analysis Of The Indian Patents Act ...

This means the thriving pharmaceutical industry which took advantage of the process patent could no longer take molecules patented by other ...
Read more: India: The Dichotomy Of IPR Protection And Social Welfare- An Analysis Of The Indian Patents Act ...

Pharma Reviews: Realtors want TS-IbPass for swifter bids

This is due to the increased investments in IT, aviation and pharma industries. Krishna Rao was speaking at the launch of CREDAI's ninth edition of ...
Read more: Realtors want TS-IbPass for swifter bids

US FDA News: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection
Read more: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

US FDA News: FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

FDA is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Read more: FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers

US FDA News: Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication

FDA is informing health care providers and facility staff about cybersecurity vulnerabilities that may introduce risks to patients while being monitored using certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.
Read more: Cybersecurity Vulnerabilities in Certain GE Healthcare Clinical Information Central Stations and Telemetry Servers: Safety Communication

US FDA News: 2020 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
Read more: 2020 Safety Communications

Pharma Reviews: India: Protecting The Patent Regime For Pharmaceutical Companies In India

The patent system allows for a drug company to charge high prices for ... Patent protection for pharmaceutical products in India should strive to strike a ...
Read more: India: Protecting The Patent Regime For Pharmaceutical Companies In India

Pharma Reviews: Budget 2020: A look at pharma sector's wishlist for FM Nirmala Sitharaman

The Indian pharmaceutical industry expects the government to restore the tax benefit offered on research and development expenditure in the ...
Read more: Budget 2020: A look at pharma sector's wishlist for FM Nirmala Sitharaman

Pharma Reviews: 18% of Indian pharma launches to be delayed in US, says Crisil

MUMBAI: Rating agency Crisil has said the woes of Indian generic companies are likely to continue as the regulatory action by the US Food and Drug ...
Read more: 18% of Indian pharma launches to be delayed in US, says Crisil

US FDA News: FDA approves first treatment for thyroid eye disease

FDA approved Tepezza for the treatment of adults with thyroid eye disease. Today’s approval represents the first drug approved for the treatment of thyroid eye disease.
Read more: FDA approves first treatment for thyroid eye disease

Pharma Reviews: Glenmark sells gynac business for Rs 115 crore

Rating agency CRISIL has said the woes of Indian generic companies are likely to continue as the regulatory action by the US Food and Drug ...
Read more: Glenmark sells gynac business for Rs 115 crore

Pharma Reviews: Alliance of Doctors for Ethical Healthcare, urges Government to make Ethics Code Mandatory for ...

The UPCMP code, which was prepared by the Department of Pharmaceuticals in 2014 as a code of marketing practices for the Indian Pharmaceutical ...
Read more: Alliance of Doctors for Ethical Healthcare, urges Government to make Ethics Code Mandatory for ...

Pharma Reviews: Divi's Labs Vying For No. 2 Spot Among India's Generics-Dominated Pharma Stocks

It now vies with Dr. Reddy's Laboratories Ltd. to be India's second-largest pharma company with a market valuation of more than Rs 50,000 crore ($7 ...
Read more: Divi's Labs Vying For No. 2 Spot Among India's Generics-Dominated Pharma Stocks

Pharma Reviews: Unclear intentions

The Indian Pharmaceutical Alliance (IPA) has however, denied any such discussion; "The meeting was called to discuss the future roadmap for the ...
Read more: Unclear intentions

Pharma Reviews: Pain for big Indian pharma companies continue warns CRISIL, as FDA woes remains unresolved

MUMBAI: Rating agency CRISIL has warned that woes of Indian generic companies will continue as the regulatory action by the US Food and Drug ...
Read more: Pain for big Indian pharma companies continue warns CRISIL, as FDA woes remains unresolved

Pharma Reviews: About 18% of Indian pharma cos' new products to be delayed as US FDA warning letters double ...

NEW DELHI : About 180 new product launches, or 18% of the total pipeline, of large Indian pharmaceutical firms is likely to be delayed as the US Food ...
Read more: About 18% of Indian pharma cos' new products to be delayed as US FDA warning letters double ...

Pharma Reviews: Alliance of Doctors for Ethical Healthcare wants standardised pharma marketing

“It may be pointed out here that the companies spend crores of rupees ... The Indian Medical Council (Professional Conduct, Etiquette & Ethics) ...
Read more: Alliance of Doctors for Ethical Healthcare wants standardised pharma marketing

Pharma Reviews: Alliance wants standardised pharma marketing

The alliance also criticised the Medical Council of India's decision to amend The Indian Medical Council (Professional Conduct, Etiquette & Ethics) ...
Read more: Alliance wants standardised pharma marketing

Pharma Reviews: US pharma cos get more FDA 'warnings' than Indian firms

Mumbai: The Indian pharma industry, which is rapped for poor manufacturing practices globally, seems to be cleaning up its act, at least in relative ...
Read more: US pharma cos get more FDA 'warnings' than Indian firms

Pharma Reviews: Indian Pharma Fraud and Beyond

In 2002, he left BMS to shift to India and joined Ranbaxy, which was then the largest Indian pharma company. However, within months of joining ...
Read more: Indian Pharma Fraud and Beyond

Pharma Reviews: PROMO: Is Indian Medical Industry Clean?

The Indian Medical Association has been at loggerheads with Prime Minister Modi after he alleged at an event that Pharma companies often bribe the ...
Read more: PROMO: Is Indian Medical Industry Clean?

Pharma Reviews: Ajay Piramal does it again, sells data analytics business for a profit of Rs 3350 crore

Piramal, who built a pharma business empire by acquiring Australian firm Nicholas Laboratories' India business for Rs 16.50 crore in 1988, and later ...
Read more: Ajay Piramal does it again, sells data analytics business for a profit of Rs 3350 crore

Pharma Reviews: What ails India's pharmaceutical sector?

It has been a rough end to 2019 for India's pharmaceutical industry. While like the rest of India Inc, companies in this sector have been bogged down ...
Read more: What ails India's pharmaceutical sector?

Pharma Reviews: Doctor bribery: IMA seeks PM's clarification, evidence; promises action

The Indian Pharmaceutical Alliance in its statement released on 15 January said: "There was no discussion at all on the alleged bribes being given by ...
Read more: Doctor bribery: IMA seeks PM's clarification, evidence; promises action

US FDA News: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.
Read more: FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

US FDA News: Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

The medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs.
Read more: Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

US FDA News: Statement on quality issues with certain Cardinal Health surgical gowns and packs

Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs
Read more: Statement on quality issues with certain Cardinal Health surgical gowns and packs

Pharma Reviews: No Discussion On Uniform Code For Pharmaceutical Marketing Yet: IPA

Industry body Indian Pharmaceutical Alliance on Wednesday said there was no discussion on uniform code for pharmaceutical marketing practice in ...
Read more: No Discussion On Uniform Code For Pharmaceutical Marketing Yet: IPA

Pharma Reviews: These two job generating industries lead India's exports from front; shine amid trade slump

Pharma and textiles are these two industries that are not only fulfilling the country's domestic demand but have huge trade surplus due to high exports.
Read more: These two job generating industries lead India's exports from front; shine amid trade slump

Pharma Reviews: No discussion on uniform code for pharmaceutical marketing practices in meeting with PM Modi: IPA

NEW DELHI: Industry body Indian Pharmaceutical Alliance (IPA) on Wednesday said there was no discussion on 'uniform code for pharmaceutical ...
Read more: No discussion on uniform code for pharmaceutical marketing practices in meeting with PM Modi: IPA

Pharma Reviews: IMA seeks clarification over PM Modi's alleged statement on pharma companies

New Delhi: The Indian Medical Association (IMA) has written to Prime Minister Narendra Modi seeking clarification over his alleged statement that top ...
Read more: IMA seeks clarification over PM Modi's alleged statement on pharma companies

Product Recall Alerts: FDA and Pharmacy Weekly Digest - January 2020 #2

FDA Issues Import Alert for Several Foods – The FDA published import alerts for ... Pharmaceutical Company Recalls Lamotrigine Tablets – A pharma ... FDA Releases Recent Drug Shortages – The FDA issued a list of drug products ...
Read more: FDA and Pharmacy Weekly Digest - January 2020 #2

Pharma Reviews: IMA, IPA differ over PM's reported remark of 'pharma cos bribing docs'

However, drug industry body Indian Pharmaceutical Alliance (IPA) said the issue of code of marketing practices was not discussed at the meeting.
Read more: IMA, IPA differ over PM's reported remark of 'pharma cos bribing docs'

US FDA News: Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation

Romaine outbreaks declared over, investigation advances, root cause analysis continues
Read more: Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation

Pharma Reviews: Healthcare bodies IPA, IMA differ on media reports of doctors taking bribes

Indian Pharmaceutical Alliance (IPA) - the lobby group that represents large Indian drug makers, said no discussion took place with Prime Minister ...
Read more: Healthcare bodies IPA, IMA differ on media reports of doctors taking bribes

US FDA News: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

FDA is sharing recommendations and updates to help improve duodenoscope reprocessing.
Read more: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Pharma Reviews: PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets

New Delhi: Prime Minister Narendra Modi has warned India's top pharmaceutical companies to strictly adhere to marketing ethics, and not to bribe ...
Read more: PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets

US FDA News: Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin).
Read more: Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

Pharma Reviews: Centre Mulling Action Against US Journalist's Allegations About Indian Pharma

The global pharmaceutical industry put its own pressure on India as these generics have been a game-changer in terms of being able to provide ...
Read more: Centre Mulling Action Against US Journalist's Allegations About Indian Pharma

Pharma Reviews: Infy, Tata Steel, Coal India among 60 stocks readying to rally, shows MACD

December was another month of double-digit domestic growth for the pharma industry, especially for Ipca, Glenmark and Lupin. CLSA expects 11% ...
Read more: Infy, Tata Steel, Coal India among 60 stocks readying to rally, shows MACD

Pharma Reviews: Indian healthcare: The needs and demands

According to Dr Panda, the current biggest challenge India's public and private healthcare sector is facing is revolutionising medical education.
Read more: Indian healthcare: The needs and demands

US FDA News: Michigan-based food manufacturer agrees to stop production after repeated food safety violations

Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.
Read more: Michigan-based food manufacturer agrees to stop production after repeated food safety violations

US FDA News: 2020 Medical Device Recalls

Class I Medical Device Recalls posted in 2020.
Read more: 2020 Medical Device Recalls

US FDA News: Galemed Recalls the Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

Recall due to system not holding pressure when initially set up on a patient.
Read more: Galemed Recalls the Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

US FDA News: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers.
Read more: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

Pharma Reviews: Stalwarts Unscramble Knotty Secrets of Economic Policy

Millions of lives all over the world have been saved by the innovation of Indian generic pharma companies. With a majority of pills consumed around ...
Read more: Stalwarts Unscramble Knotty Secrets of Economic Policy

US FDA News: Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.
Read more: Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

US FDA News: Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator

Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
Read more: Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator

Product Recall Alerts: Cancer risks prompt FDA to recall more heartburn medication

Cancer risks prompt FDA to recall more heartburn medication ... (NDMA) including Ranitidine Tablets, according to a Wednesday alert from the FDA.
Read more: Cancer risks prompt FDA to recall more heartburn medication

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation

Pharma Reviews: Indian pharma market sees growth of 9.6% in Q3FY20

The Indian pharmaceutical market (IPM) registered a growth of 9.6 percent for the quarter ended December 31, according to market research firm ...
Read more: Indian pharma market sees growth of 9.6% in Q3FY20

Pharma Reviews: Brokerages see a steady but lacklustre Q3 for Indian pharma sector

A weak rupee and strong API exports during the October-December period have fuelled the hopes that the pharma sector will post better numbers in ...
Read more: Brokerages see a steady but lacklustre Q3 for Indian pharma sector

Pharma Reviews: 3rd Annual Pharma Regulatory Summit 2020

KIRAN MARTHAK, Directors-Mgmt, Lambda(Vice Chairman of Medical Committee, Indian Drug Manufacturers' Association. · RAJENDRA SANGHAVI ...
Read more: 3rd Annual Pharma Regulatory Summit 2020

Pharma Reviews: Modi govt plans action against US writer who said Indian drugs are 'flea-market quality'

In her book, Eban accused Indian pharmaceutical companies of major lapses, such as “toxic impurities” in drugs, fudging data on quality control, and ...
Read more: Modi govt plans action against US writer who said Indian drugs are 'flea-market quality'

US FDA News: FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation
Read more: FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

US FDA News: FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

FDA, USDA and EPA launch Unified Website for Biotechnology Regulation to streamline information about agriculture biotechnology products.
Read more: FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

Pharma Reviews: Mahindra Logistics opens distribution centre in north India

MLL is a portfolio company of Mahindra Partners, the one billion dollar ... it has launched a distribution centre for the pharma industry in north India, ...
Read more: Mahindra Logistics opens distribution centre in north India

Product Recall Alerts: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the ...

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine ... When a company announces a recall, market withdrawal, or safety alert, the FDA ... The finished products are manufactured by Mylan Pharmaceuticals Inc.
Read more: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the ...

Pharma Reviews: China's Baidu to Work with Indian Institutions on AI-led Intelligent Economy

China's largest search engine Baidu is planning to work with Indian ... student can have a personal assistant while the pharma industry accelerate the ...
Read more: China's Baidu to Work with Indian Institutions on AI-led Intelligent Economy

Pharma Reviews: Experts to decide on inclusion and exclusion of antibiotics from NLEM today

All major pharma companies like Sun pharma, GlaxoSmithKline ... to be removed from the NLEM as Indian population has become resistant to them.
Read more: Experts to decide on inclusion and exclusion of antibiotics from NLEM today

US FDA News: Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Read more: Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination

Pharma Reviews: Focus on API industry, cutting imports needs of the hour, says Satish Reddy, president of IPA and ...

The Indian pharmaceutical industry is the world's third largest in terms of volume. In the course of its journey to become a $38-billion industry, the ...
Read more: Focus on API industry, cutting imports needs of the hour, says Satish Reddy, president of IPA and ...

US FDA News: Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un
Read more: Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

US FDA News: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve
Read more: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Pharma Reviews: Sun Pharma eyes China, Japan markets

NEW DELHI: Dilip Shanghvi, MD of India's most valuable drug firm Sun Pharmaceutical Industries and one of the richest first-generation billionaires in ...
Read more: Sun Pharma eyes China, Japan markets

Product Recall Alerts: Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 ...

Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, ... Ranitidine Hydrochloride Capsules are being recalled because of the ... email or other communication with recall notification communication.
Read more: Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 ...

Pharma Reviews: Sun Pharma eyes China, Japan mkts

Dilip Shanghvi, MD of India's most valuable drug firm Sun Pharmaceutical Industries and one of the richest first-generation billionaires in the country ...
Read more: Sun Pharma eyes China, Japan mkts

US FDA News: Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)
Read more: Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Pharma Reviews: Baidu Seeks to Collaborate with Indian Institutes on Artificial Intelligence

He said the company is looking to work with Indian institutions in the future to ... Since its inception in 2000, Robin has led the company to be China's ... pharma industry, organizations can expedite the pace of drug development with ...
Read more: Baidu Seeks to Collaborate with Indian Institutes on Artificial Intelligence

Pharma Reviews: Mc in India

The “Make in India” is a great movement, just about priming innovative minds ... Only more APC (active pharma ingredients) manufacturing centres are ...
Read more: Mc in India

Pharma Reviews: After capping trade margins on 42 cancer drugs in 2019, govt may expand move to other medicines

The National Pharmaceutical Pricing Authority (NPPA), along with the ... in how prices of medicines and medical devices in India may be regulated this ...
Read more: After capping trade margins on 42 cancer drugs in 2019, govt may expand move to other medicines

Pharma Reviews: Lifestyle brand Shoppers Stop to start unit in KTR's constituency

Minister KT Rama Rao, flanked by IT & Industries Principal Secretary ... from pharma sector and representatives of the Indian Pharmaceutical Alliance, ...
Read more: Lifestyle brand Shoppers Stop to start unit in KTR's constituency

Product Recall Alerts: Anti-nausea medication recalled

The U.S. Food and Drug Administration (FDA) is alerting animal professionals about a recall on a drug commonly used to treat nausea and vomiting in ...
Read more: Anti-nausea medication recalled

Pharma Reviews: Importance of establishing a patent regime in pharmaceutical industry

The biggest example of the importance of maintaining a patent regime can be seen in the growth of the pharma industry in India post the amendments ...
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Pharma Reviews: The problem for biosimilars

Not that Roche is targeting just Indian companies. In 2018 it sued Pfizer, a fellow pharma giant, for patent infringement, soon after the latter applied for ...
Read more: The problem for biosimilars

US FDA News: FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
Read more: FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

Pharma Reviews: NCLT rejects Sun Pharma's plan to demerge overseas subsidiary

India's pharma and healthcare sector may see some stability in 2020, industry reports suggest. The next wave of growth could come from increasing ...
Read more: NCLT rejects Sun Pharma's plan to demerge overseas subsidiary

Pharma Reviews: Top 10 biz headlines: Rs 1 trn GST mop up, surge in new projects, and more

In a booster dose, pharma industry gets 'green' signal in New Year. In what can be a game changer for the Indian pharmaceutical industry, the Ministry ...
Read more: Top 10 biz headlines: Rs 1 trn GST mop up, surge in new projects, and more