Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Cansino Biologics Inc. has received marketing approval from the NMPA for its ACYW-135 meningococcal conjugate vaccine, Menhycia, making it the first of its kind to be authorized in China. The approval marks “an important step in accelerating the development of China’s meningococcal vaccine immunization strategy,” the company said.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
The deals continued to flow during day two of the J.P. Morgan Healthcare Conference. Privately held Arrakis Inc., which specializes in aiming at small-molecule RNA targets, primarily cancers, has signed onto a collaboration with Amgen Inc. that could bring in billions in future payments should it hit all the milestones and program options are exercised. Dren Bio Inc., meanwhile, will collaborate with Pfizer Inc. to develop bispecific antibodies for oncology targets. Dren could receive more than $1 billion in the deal that includes a $25 million in cash up-front payment from Pfizer.
A raft of potentially high-value drug development collaborations, most for gene and RNA therapies, led the first day of the 40th Annual J.P. Morgan Healthcare Conference Monday. Pfizer Inc. enlisted Beam Therapeutic Inc. to advance in vivo base editing programs for up to $1.35 billion, while Bayer AG tapped Mammoth Biosciences Inc.’s in vivo CRISPR systems expertise in a potential $1 billion-plus deal. Selecta Biosciences Inc. inked a new $1.1 billion partnership with Ginkgo Bioworks Inc. to develop next-generation gene therapy capsids, while Acadia Pharmaceuticals Inc. agreed to pay Stoke Therapeutics Inc. as much as $967 million to develop RNA-based medicines. Work on new mRNA vaccines and therapies is also proceeding, with both Pfizer and Biontech SE announcing new collaborations in the space.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
Be careful who you’re doing business with. That’s the warning the U.S. Court of Appeals for the District of Columbia Circuit sent this week to multinational drug and device companies doing business in terrorist hot spots around the world. Reversing a lower court, the D.C. Circuit cleared the way Jan. 4 for 21 drug and device companies to potentially be held accountable for doing business with Jaysh al-Mahdi terrorists, operating through the Iraqi Ministry of Health, who injured or killed hundreds of U.S. troops and civilians in Iraq.
Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.
Pfizer Inc.'s oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Great Britain after the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorization for the medicine, called Paxlovid (PF-07321332, ritonavir).
Preliminary data from a phase IIIb study of Johnson & Johnson’s Ad26.COV2.S COVID-19 vaccine showed a homologous booster dose was 85% effective against hospitalization in participants from South Africa.
