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Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Clinical Trials Drug Approval Standards Regulation

COVID-19 Redefining Clinical Trial Transparency Expectations & Challenges

A senior Pfizer executive talks about the high regulatory expectations for public disclosure of clinical trial data for Comirnaty, the COVID-19 vaccine it developed in partnership with BioNTech. There were also concerns about re-identification of trial participants as many subjects took to social media to share their experiences with the Comirnaty study.

International Clinical Trials Compliance

US CDC Panel’s Pneumococcal Vaccine Recommendations Leave Confusion In Their Wake

Advisory Committee on Immunization Practices’ October vote on use of Pfizer’s Prevnar 20 and Merck & Co’s Vaxneuvance was more restrictive than intended, inadvertently leaving out guidance for people who were previously vaccinated with Prevnar 13.

Vaccines Advisory Committees Policy

Spotlight On Coronavirus

IP Questions Could Dog The WHO's BioHub Pandemic Project

The World Health Organization’s BioHub project is gathering momentum, with the spotlight on the equitable and timely sharing of viruses and other biological materials to develop medical products for use in future health emergencies such as a pandemic. But while its objectives are lauded by many, concerns have been raised about the intellectual property implications of the project.

Pink Sheet Perspectives International

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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: Breakthrough Designations Fuel Expansion Of Genomically-Defined NSCLC Therapy

News and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Review Pathway Drug Review


Global Pharma Guidance Tracker – December 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

Soft Capsule, Hard Truth: Will Chugai Lawsuit Usher In New Era Of China Patent Linkage?

Few drug patent infringement cases go to court in China, where a murky and lengthy process deters many from pursuing litigation. But a newly enacted Patent Law with patent linkage provisions is spurring a rise in infringement lawsuits, with one recent case involving a major Japanese pharma firm underscoring the remaining challenges.

China Intellectual Property

Fatigue Benefit With Janssen’s MS Drug Ponvory Not Clinically Relevant – US/EU Regulators

In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.

Drug Review Profile Drug Review

EU, US Reviewers Differed On Ponvory’s Secondary Endpoints, But Hierarchy Didn’t Matter In The End

Janssen went against EMA’s advice on the choice of secondary endpoints for its multiple sclerosis drug Ponvory (ponesimod), but still enjoyed a relatively brisk review. The hierarchical order of endpoints did not seem to ruffle any feathers among US FDA reviewers.

Drug Review Profile Drug Review

Bayer Pulls Aliqopa Combo Filings In EU, US & Other Markets – But May Resubmit

The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.

Drug Review International

Australian Regulator Proposes Fee Increase To Offset Rising Costs

A growing role in dealing with medicines shortages, COVID-19-related pressures and the costs of relocating to new premises are among the factors behind the TGA’s proposal to raise the fees it charges pharma firms for its regulatory services.

Regulation User Fees

Immunocore Expects EU Verdict This Week On Novel TCR Immunotherapy

Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.

Approvals Drug Review

Latest From Policy

Beyond Vaccines: CDC's ACIP To Look At Antibodies For Respiratory Syncytial Virus Prevention

New maternal/pediatric work group will consider recommendations for use of RSV vaccines and monoclonal antibodies targeting protection of children <18 years. With several products in the late-stage pipeline, group has begun reviewing RSV epidemiology and discussing cost-effectiveness.

Advisory Committees Cost Effectiveness

‘Skinny Label’ Litigation: Generic Firms Rethinking Strategy, May Pursue Legislation

Generic manufacturers are being cautious on label carve-outs to avoid claims of induced infringement. Bright line rules are necessary, attorney says, and if GSK v. Teva decision is not reversed, legislation will be needed to preserve skinny label. Insurers also face potential liability for placement of skinny-label generics on formularies.

Generic Drugs Intellectual Property

Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

Medicare Reimbursement

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Latest From Research & Development

Hits, Misses & Key Firsts For EMA’s PRIME Scheme

The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.

Europe Research & Development

Pfizer’s COVID-19 Vaccine Data In Young Children Could Place US FDA In Awkward Position Again

The agency is considering how to move forward as Pfizer studies a third shot after missing an efficacy endpoint in children age 2 to 5.

Coronavirus COVID-19 Vaccines

‘Challenges Ahead’ For Cell And Gene Therapy, Notes Catapult’s New Chairman McCubbin

The ex-GSK supply head Ian McCubbin will join the independent UK organization aimed at advancing cell and gene therapies, but notes issues with scale and manufacturing ahead.

Executive Changes Personalized Medicine

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Latest From Commercial

Entry Reminder For Pharma Intelligence Awards Japan

The 4 February entry deadline is looming for the inaugural Informa Pharma Intelligence Awards Japan, which will be held in Tokyo on 12 May 2022 to recognize and reward the very best innovations and achievements in pharma and biotech, highlighting Japan's integral role in the global healthcare market.

Japan Commercial

J.P. Morgan Day 4: Preparing For The Year Ahead

Daily notebook from the virtual J.P. Morgan Healthcare Conference: Updates from Galapagos, Ipsen, LG Chem and Hanmi; experts discuss deal and financial outlook at Biotech Showcase, plus the impact of RMAT and the changing landscape for rare diseases. 

Companies Deals

Aduhelm & Medicare: HHS Reconsideration Of Premium Hike May Ease Blowback On Coverage

Biogen’s Alzheimer’s drug may not cause as much of a financial headache to American seniors as expected, which could dampen criticism of Medicare’s upcoming coverage determination. But questions remain about what exactly HHS will be able to do about Part B premiums.

Pricing Debate Medicare

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Latest From Manufacturing

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

Manufacturing Quality

Robotic Aseptic Filling Could Help Production, But Faces Regulatory Inconsistency

Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.

Manufacturing Quality

GAO Examines How US Learned To Use Defense Production Act More Effectively Against COVID-19

Report says agencies took steps to use DPA more effectively, but HHS still working on a strategy for DPA use that will strengthen domestic supply chains and manufacturing.

Manufacturing Regulation
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