Search Results for Pfizer

Showing 1 – 25  of 63

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017) By Nick Paul Taylor - Published 10 October 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

Tags: Asia Regulatory Roundup, China accelerated approval, Pfizer, FDC manufacturers

When Pfizer Needed Customized Training, The Enterprise Member Company Turned to RAPS By Zachary Brousseau - Published 05 October 2017

Pfizer partnered with RAPS to develop a customized on-site, two-day training session for several groups with different, but related, regulatory roles within the company.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: training, on-site training, Enterprise, Pfizer

Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing

Tags: continuous manufacturing, Pfizer, AAM, Vertex, AstraZeneca

Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars By Zachary Brennan - Published 20 September 2017

Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance on the US market for its blockbuster Remicade (infliximab) despite recently introduced competition.

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

Tags: Pfizer, J&J, infliximab, Remicade, Inflectra, Renflexis

FDA Warns Pfizer Subsidiary Over Faulty EpiPen Components By Michael Mezher - Published 07 September 2017

The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan.

Categories: News, US, FDA, Combination products, Drugs

Tags: Meridian Medical Technologies, Pfizer, Mylan, EpiPen, Warning Letter

Updated: FDA Form 483 for Celltrion Site Manufacturing Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017) By Nick Paul Taylor - Published 05 September 2017

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

Categories: News, Asia, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Pfizer, inspections

FDA Approves Pfizer’s Mylotarg 7 Years After it was Pulled From the Market By Zachary Brennan - Published 01 September 2017

The US Food and Drug Administration (FDA) on Friday approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML) and for patients aged two years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment. 

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

Tags: Pfizer, Mylotarg, cancer, AML

Pfizer Wins Indian Patent on Prevnar 13 Vaccine By Zachary Brennan - Published 22 August 2017

India’s patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims.

Categories: News, Asia, Europe, US, Crisis management, Drugs, Regulatory strategy

Tags: Prevnar 13, Pfizer, PCV, pneumonia vaccine

Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar By Zachary Brennan - Published 10 August 2017

The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy

Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen

FDA Extends Use Dates for Pfizer Injectables to Ease Shortage By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing

Tags: Pfizer, Hospira, Shortage

FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote By Michael Mezher - Published 25 May 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

Categories: News, US, FDA, Biologics and biotechnology, Submission and registration

Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: J&J, Pfizer, Allergan, combination products and FDA

FDA Warns Pfizer Clinical Investigator Over Chantix Study By Zachary Brennan - Published 05 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).

Categories: News, US, FDA, Clinical, Compliance, Drugs, Due Diligence

Tags: Chantix, Pfizer, clinical trial, warning letter

Pfizer Proposes to Make Viagra Available in the UK Without a Prescription By Zachary Brennan - Published 29 March 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies.

Categories: News, Europe, MHRA, Over the counter drugs

Tags: Pfizer, Viagra, Cialis, over the counter drugs, erectile dysfunction

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