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Breakthrough Agreement On EU HTA Regulation “Falls Short”

The European Parliament and EU Council have reached an agreement on taking forward proposals for greater cooperation on health technology assessments.

Europe Health Technology Assessment Market Access

US FDA Investigating Auto-Injector Problems With Copaxone Generics

Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.

Generic Drugs Safety Regulation

Vaccines For COVID Variants Will Require Clinical Data, US FDA Says

Safety and immunogenicity data may not be sufficient to get FDA authorization of COVID-19 vaccines against a variant, FDA’s Doran Fink says. For now, agency expects to see clinical data. Eventually, strain changes might be based on manufacturing information.

Coronavirus COVID-19 Vaccines FDA

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: US FDA Clears Pfizer’s Prevnar 20; Dermavant Submits Tapinarof; Adamis Returns With Zimhi

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Drug Approval Standards Approvals


Global Pharma Guidance Tracker – May 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

Immunocore and Argenx Among Fast-Track Hopefuls At EMA

EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.

Europe Review Pathway

mRNA COVID-19 Vaccines To Add Warning Language On Myocarditis Risk

US FDA will rapidly update fact sheets with information on myocarditis/pericarditis occurring primarily in young men and adolescent males following the second dose, agency's Doran Fink tells the CDC’s Advisory Committee on Immunization Practices, which said benefit-risk of the Pfizer/BioNTech and Moderna vaccines remains favorable.

Coronavirus COVID-19 Vaccines

Incyte/MorphoSys Await EU Verdict On Tafasitamab For DLBCL

Is the benefit-risk profile of tafasitamab good enough for it to be recommended for EU-wide marketing approval? Codevelopers Incyte and MorphoSys may find out this week.

Europe Approvals

BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma

The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU. 

Europe Drug Review

Woodcock Attributes Aduhelm Approval Controversy To ‘Process Problems’

US FDA’s approval after a near-unanimous advisory committee vote against Biogen’s Alzheimer’s drug is central to many critics’ arguments, but the acting commissioner says that panel did not vote on the issue of accelerated approval, and that airing of internal agency disagreements could have influenced committee members.

Advisory Committees Review Pathway

Oncology Accelerated Approval In Spotlight (Again) With US FDA AdComm Review Of Incyte Retifanlimab For Anal Cancer

US FDA questions suitability of accelerated approval based on marginal response rate in a single-arm trial of Incyte’s PD-1 inhibitor candidate for relapsed squamous carcinoma of the anal canal.

Advisory Committees Drug Review

Latest From Policy

Merger Scrutiny A Bigger Risk To Pharma Than Drug Price Reform, Orzag Predicts

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Pricing Debate M & A

US Supreme Court Gives PTO Director Chance To Impact Outcome Of Patent Disputes

High court finds PTAB judges were unconstitutionally appointed; ruling is unlikely to benefit one party over another in inter partes review proceedings, attorneys say, but that could depend on the director. PTO is expected to provide guidance on how and when to request review of Patent Trial and Appeal Board decisions.

Intellectual Property Legal Issues

How Do You Build A Clinical Trial Network Focused On Diversity?

Stakeholders discuss network models, barriers to their creation, and what is needed for them to be successful at PhRMA meeting.

Clinical Trials Diversity & Inclusion

Clinical / R&D Explore this Topic

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Latest From Research & Development

COVID-Era Trial Flexibilities, Equity Focus, Could Be Used To Reshape Cancer Study Enrollment

US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.

Diversity & Inclusion Clinical Trials

US FDA Plans To Get Tougher On Oncology Dose Optimization

FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.

ASCO Cancer

BIO 2021 Notebook: Going Fast And Being Precise

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Clinical Trials Drug Safety

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Latest From Commercial

Merger Scrutiny A Bigger Risk To Pharma Than Drug Price Reform, Orzag Predicts

US antitrust regulators appear poised to take a broader view of disease areas when reviewing mergers, Lazard Freres financial advisory CEO Peter Orszag cautioned.

Pricing Debate M & A

Sanofi/Merck Launch First 6-In-1 Combo Vaccine In US After Two-And-A-Half Year Supply Buildup

Five years after European licensure and launch, and 30 months after FDA approval, Vaxelis enters the US market offering an advantage of fewer shots than current pentavalent vaccines for protection against six diseases in children six weeks to four years old.

Vaccines Launches

BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work

BARDA’s suspension of funding for COVID-19 therapeutics risks repeating mistakes of past pandemics as it may cause industry to pull out of the development space, experts say. Industry sources are concerned the Biden administration is focusing on funding NIH at the expense of BARDA.

Coronavirus COVID-19 Research & Development

Manufacturing Explore this Topic

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Latest From Manufacturing

Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity

MSF is pressuring Moderna and Pfizer/BioNTech to share their vaccine know-how with manufacturers in developing countries, and companies have just a few days to answer the European Commission's questions about COVID-19 therapies they have in development.

Europe International

PIC/S Wants To Know: What About ‘Authorized Persons’ For Batch Release Outside The EU?

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Manufacturing Quality

Domestic In-Person Inspection Work Could Be Back To Normal This Summer, Woodcock Says

Foreign facility visits may take longer to reach usual levels because of the ongoing coronavirus outbreaks in other countries.

Coronavirus COVID-19 Manufacturing
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