Sierra Oncology Inc. plans an NDA in the second quarter of this year for momelotinib (MMB), thanks to data from the phase III Momentum study with the drug in myelofibrosis (MF) patients who are symptomatic and anemic after treatment with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. MMB inhibits JAK1/2 and ACVR1/ALK2. Shares of San Mateo, Calif.-based Sierra (NASDAQ:SRRA) closed Jan. 25 at $22.68, up $7.17, or 46%. Read More
Leyden Laboratories BV has raised $140 million in a series B financing round to develop drugs that treat whole families of viruses, including a wide-spectrum flu antibody licensed from Johnson & Johnson’s Janssen Pharmaceuticals Inc. unit earlier this month. Read More
With a potentially pivotal trial of its Duchenne muscular dystrophy (DMD) candidate CAP-1002 starting up, Capricor Therapeutics Inc. has tapped Nippon Shinyaku Co. Ltd. subsidiary NS Pharma Inc. to sell and distribute the cell therapy, pending U.S. FDA approval. The deal brings Capricor $30 million up front to fund the phase III trial, while also lining it up for as much as $705 million in milestone payments from its Japanese partner, which launched its own DMD therapy, Viltepso (viltolarsen), in the U.S. in 2020. Capricor shares (NASADQ:CAPR) rose 21.6% to $3.44 Jan. 25. Read More
LONDON – Cytovation AS has raised $20 million in a series A, enabling it to expand the monotherapy arm of a phase I/II trial of its tumor membrane immunotherapy, Cypep-1, and to test it in three combination arms with the checkpoint inhibitor Keytruda (pembrolizumab). Read More
Pfizer Inc. CEO Albert Bourla has been talking for the past few weeks about creating a vaccine to control the omicron variant. Now the company, with partner Biontech SE, has initiated a clinical study of its new candidate by testing it in healthy adults. Bourla has said the company can adapt its vaccine to new variants in under three months and could have one ready to go in March if necessary. Read More
The European Council adopted a regulation Jan. 25 giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices during a crisis. Read More
The amount of clinical data reported in January so far is currently 30% below the amount reported during the same month last year, which was the slowest month of 2021. Read More
LONDON – The industry is expressing divergent views of changes to how the U.K. health technology assessment agency, the National Institute for Health and Care Excellence (NICE), will in the future select what products to assess and the methods and processes it will use to carry out its evaluations. Read More
Eli Lilly and Co. has the dubious distinction of receiving the first untitled letter in 2022 from the FDA’s Office of Prescription Drug Promotion. The letter, sent Jan. 19 and posted this week, takes the Indianapolis-based company to task for an Instagram ad promoting Lilly’s diabetes drug Trulicity (dulaglutide). Read More
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would take a more proactive role in identifying and facilitating labeling updates, the U.S. FDA issued a draft guidance Jan. 25 intended to help holders of abbreviated new drug applications (ANDAs) keep their labels up to date with that of the RLD. Read More
New hires and promotions in the biopharma industry, including: Adarx, Adjuvance, Cingulate, Herophilus, Immunovant, Lakewood-Amedex, Loqus23, Telix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aculys, Aqualung, Boehringer Ingelheim, Cytoimmune, Evotec, G1, Gilead, Immix, Inmune, Monte Rosa, Neurelis, Opiant, Regenerx, Siga, Spago, Yeda. Read More
