The amount of money raised in January by biopharma companies has fallen 55% from the same month in 2021 and 31% from January of 2020, indicating less enthusiasm from investors and a potential slowdown in financings for 2022. In total, January of 2022 has recorded significantly less fundraising than each of the past two years, with $4.8 billion (79 transactions), well below 2021’s $10.79 billion (159 transactions) and down from 2020’s $6.95 billion (131 transactions). Read More
The U.S. FDA has approved Sanofi SA’s treatment for cold agglutinin disease (CAD), sutimlimab, after the drug was initially rejected by the regulator for technical reasons in 2020. Paris-based Sanofi’s drug will be branded as Enjaymo. Read More
Endeavor Biomedicines Inc.’s $101 million series B round will let the firm forge ahead with ENV-101 (taladegib), a small-molecule inhibitor of the PTCH1 receptor in the Hedgehog signaling pathway, for cancer and idiopathic pulmonary fibrosis (IPF), as well as ENV-201, described as a potentially best-in-class small-molecule inhibitor of ULK1/2 in KRAS-driven cancers. Read More
Redhill Biopharma Inc. continues pushing ahead with efforts to add to the limited arsenal of therapies for treating hospitalized severe COVID-19 infections, with the latest data, based on prespecified analyses from a phase II/III study showing its SK2 inhibitor, opaganib, significantly reduced mortality when given on top of standard-of-care (SOC) Veklury (remdesivir, Gilead Sciences Inc.) and corticosteroids. The Tel Aviv, Israel-based company said potential emergency use and marketing applications are planned in the first half of this year. Read More
The U.S. House of Representatives passed the COMPETES Act of 2022 in a narrow Feb. 4 vote that may help restore U.S. manufacturing of pharmaceuticals and the semiconductors that are critical for medical devices. However, the House bill also includes unrelated provisions such as a section dealing with health insurance costs, just one of several elements that are not seen in a similar Senate bill and which foreshadow a drag-inducing showdown between the two bills. Read More
As the U.S. FDA struggles to meet a massive court-ordered release of documents related to its approval of the Pfizer Inc.-Biontech SE COVID-19 vaccine, it could help itself by being more proactive in publicly releasing documents related to the approval and labeling of prescription drugs, according to a U.S. regulatory expert. Read More
The U.S. FDA appears to be on a roll when it comes to rolling out new guidance pertaining to prescription drugs. In recent days, the agency has released draft guidances on antibody-drug conjugates and immunogenicity information in labeling, revised a draft guidance on assessing pressor effects of drugs and finalized a guidance on population pharmacokinetics. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomunex, Nanopass Technologies, Navidea, Varsity . Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytokinetics, Mylan Laboratories, Novavax, RDIF, Revolo, Roche, TG, Tiziana, Viatris. Read More
