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.

China’s new Five-Year Plan for drug quality aims to address hurdles in clinical study ethics committee review while leaving out other restrictions including genetic material export and substandard clinical sites.

International regulators have broadened their discussions on the possible use of bivalent and multivalent vaccines, and the French presidency of the Council of the EU has called for “international solidarity” on vaccine provision.

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.

Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.

Almost 30 generics firms based across 11 countries have signed up to agreements with the Medicines Patent Pool to facilitate the supply of oral COVID-19 treatment molnupiravir to 105 low- and-middle-income countries. The move follows an agreement signed in October by the MPP with Merck.

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.

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.

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.

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.

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.

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.

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.

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. 

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.

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.

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.

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.