The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses.
Pyxis Oncology Inc., a company building a portfolio of antibody-drug conjugates (ADCs) and immunotherapies for cancer, has closed a $152 million series B financing co-led by Arix Bioscience and RTW Investments LP. The fresh funds will help the company advance multiple ADC candidates in-licensed from Pfizer Inc. and Legochem Biosciences Inc. as well as its discovery-stage pipeline, CEO Lara Sullivan told BioWorld. The ADCs are expected to move to the clinic in 2022.
If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration.
The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of the Biotechnology Innovation Organization’s (BIO) executive committee, told BioWorld.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd.
With the December PDUFA date already blown, Pfizer Inc. is headed into a day-and-a-half FDA advisory committee meeting this week to make the case for 2.5-mg tanezumab, a potential first-in-class treatment in the U.S., partnered with Eli Lilly and Co. Inc., for chronic pain due to moderate to severe osteoarthritis.
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration.
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
