Search Results for Pfizer

Showing 1 – 25  of 47

Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars By Zachary Brennan - Published 24 March 2017

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017) By Nick Paul Taylor - Published 14 March 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Pfizer, NPPA, stents

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables By Zachary Brennan - Published 28 February 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Pfizer, Hospira, Copaxone, Teva, warning letter

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations By Zachary Brennan - Published 26 January 2017

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: Pfizer, Novartis, Celgene, GLP for nonclinical lab studies, FDA proposed rules

European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) By Nick Paul Taylor - Published 08 December 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance

Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss By Zachary Brennan - Published 01 December 2016

At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you?

Categories: News

Tags: Regeneron, Eli Lilly, Pfizer, Astellas, Gilead, Forbes

Four Pharma Companies Lead in Regulatory, Legal Compliance By Zachary Brennan - Published 14 November 2016

Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Bill & Melinda Gates Foundation’s Access to Medicines Index.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, WHO, Biologics and biotechnology, Drugs

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices By Zachary Brennan - Published 27 September 2016

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: News, US, FDA, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance

FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date By Zachary Brennan - Published 14 September 2016

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the websites incorrectly suggest that the investigational new drug is safe and effective.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: opioid, Durect, Pain Therapeutics, Pfizer, abuse deterrant opioids

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections By Zachary Brennan - Published 08 August 2016

Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site.

Tags: Pfizer, Wockhardt, India drug manufacturing, GMP inspections

Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels By Zachary Brennan - Published 03 August 2016

Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label.

Categories: News, US, FDA, Biologics and biotechnology, Labeling

Tags: Novartis, Amgen, Pfizer, Sandoz, AbbVie, Takeda, Boehringer, biosimilar, labeling guidance, biosimilar labels, interchangeability

TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators By Zachary Brennan - Published 29 June 2016

The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients.

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Clinical, Crisis management, Drugs

Tags: TransCelerate, Lilly, Pfizer, AstraZeneca, Amgen

Senators Question Pfizer, Mylan and Three Other Companies Over Opioid Overdose Treatment Price Hikes By Zachary Brennan - Published 07 June 2016

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Postmarket surveillance

Tags: Pfizer, naloxone, opioid overdose, Narcan, opioids

EMA, MHRA, Janssen Warn of Increased Risk of Toe Amputation With Type 2 Diabetes Drug By Zachary Brennan - Published 11 May 2016

A two-fold higher incidence of lower limb amputation, primarily of the toe, has been seen in a clinical trial with canagliflozin, Janssen, the European Medicines Agency (EMA) and UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in a letter to health professionals.

Categories: News, Europe, EMA, MHRA, Active pharmaceutical ingredients, Biologics and biotechnology, Crisis management, Drugs, Labeling, Postmarket surveillance

Tags: Janssen, Johnson & Johnson, Pfizer, GlaxoSmithKline, canagliflozin, Celgene, Novartis

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

Updated: FDA Investigates Study Showing Yeast Infection Drug Increases Risk of Miscarriage By Zachary Brennan - Published 26 April 2016

The US Food and Drug Administration (FDA) said Tuesday that it’s evaluating the results of a Danish study that found a possible increased risk of miscarriage with the use of Diflucan (fluconazole), a Pfizer treatment for yeast and other fungal infections.

Categories: News, US, FDA, Crisis management, Drugs, Postmarket surveillance

Tags: Pfizer, yeast infection, miscarriage, Diflucan, fluconazole

Pfizer, Health Canada Recall Children’s Advil After 'Clump' Concerns By Zachary Brennan - Published 15 February 2016

Pfizer is voluntarily recalling 126 lots of Advil liquid products for infants and children in Canada because “clumps” may form in the bottles affected and lead to higher or lower doses given to infants and children if the products are not shaken well before each use.

Categories: News, Canada, Health Canada, Crisis management, Product withdrawl and retirement, Quality

Tags: Pfizer, children's Advil, infant Advil, Health Canada

Updated: Pfizer Receives FDA Untitled Letter Over YouTube Video By Zachary Brennan - Published 20 January 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Pfizer subsidiary Hospira over the company's "misleading" YouTube video on its sedative Precedex. [Editor's note: This story was updated on 21 January with a Pfizer statement on the video.]

Categories: News, US, FDA, Advertising and Promotion, Crisis management, Drugs

Tags: Pfizer, Precedex, Hospira, untitled letters, OPDP

FDA Warns Chinese API Manufacturer for Serious Data Manipulation By Zachary Brennan - Published 12 January 2016

The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence

Tags: FDA warning letters, Hisun, Pfizer, Merck

Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside? By Zachary Brennan - Published 21 October 2015

In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week.

Categories: News, US, FDA, Business Skills, Drugs, Government affairs, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: FDA, approval, NME, Ostroff, Pfizer, AstraZeneca, Shire

Pfizer Launches Expanded Access Program for Breast Cancer Drug By Alexander Gaffney, RAC - Published 21 August 2014

The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly different approach for a new expanded access trial for its breast cancer drug palbociclib.

Categories: News, US, Clinical, Prescription drugs

Tags: Pfizer, EAP, Expanded Access Program, Expanded Access, Breast Cancer, Compassionate Use, Palbociclib

Pfizer Announces Adoption of Trials Transparency Policy, Illustrating Industry-Led Effort By Alexander Gaffney, RF News Editor - Published 05 December 2013

Tags: Clinical Data, EFPIA, Pfizer, PhRMA, Transparency, clinical trials

Wyeth Agrees to Pay $491 Million to Resolve Federal Off-Label Marketing Charges By Alexander Gaffney, RF News Editor - Published 30 July 2013

Categories: US, DOJ

Tags: Wyeth, Pfizer, Lawsuit