LONDON – C4X Discovery Holdings plc has out-licensed its preclinical oral interleukin-17 (IL-17) inhibitor to Sanofi SA in a potential €414 million (US$493.4 million) deal. Under the terms of the agreement, Sanofi is paying €7 million up front and a further €11 in short-term preclinical milestones, with the balance to follow on reaching development, regulatory and commercialization milestones.
Companion diagnostics-focused Celcuity Inc. CEO Brian Sullivan said the deal with Pfizer Inc. for rights to pan-PI3K/mTOR inhibitor gedatolisib was “an organically developed opportunity, because of the research we had done on gedatolisib” in the course of investigating PI3K inhibitors. “We hadn’t shifted our strategy and said, ‘Oh, let’s start in-licensing drugs.’”
LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use continue to outweigh the risks. The possibility of cerebral venous sinus thrombosis and splanchnic vein thrombosis in the abdomen will now be listed as rare side effects and the EMA’s guidance to health care professionals will be updated.
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.
