Shares of Sierra Oncology Inc. (NASDAQ:SRRA) were trading midday at $22.79, up $7.28, or 46%, as Wall Street greeted much-anticipated data from the phase III Momentum study with momelotinib in myelofibrosis patients who are symptomatic and anemic and who have been previously treated with an approved JAK inhibitor. Momentum, which pitted momelotinib against the androgen danazol, met all of its primary and key secondary endpoints. Momelotinib inhibits JAK1/2 and ACVR1/ALK2.

Leyden Labs raises $140M, prepares nasal flu antibody for the clinic

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. The latest round, led by Casdin Capital and co-led by GV (formerly Google Ventures), also attracted prominent investors including Softbank. It brings the total raised by the Amsterdam and Boston-based company since March 2021 to nearly $200 million.

Capricor picks Nippon Shinyaku to sell DMD cell therapy, pending approval

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 12.1% by midday.

New EU mandate strengthens EMA’s emergency preparedness role

The European Council today adopted a regulation giving the EMA a stronger role in crisis preparedness and the management of drugs and medical devices. The revised mandate allows the agency to closely monitor and mitigate shortages of medical products during major events and public health emergencies and facilitate faster approval of drugs that could treat or prevent a disease causing a public health crisis. Although the regulation will be applicable March 1, there will be a 12-month grace period for its provisions on monitoring medical devices for shortages.

Just in case: Pfizer-Biontech study an omicron-targeted vaccine

Data showing vaccine-induced protection against omicron and its mild to moderate incarnations wanes more rapidly than previous variants is driving Pfizer Inc. and Biontech SE to develop a new vaccine. The of first of three study cohorts composed of 1,420 healthy adults ages 18 through 55 have begun receiving different regimens of the companies’ mRNA-based COVID-19 vaccine or an omicron vaccine. The initial cohort is made up of 615 participants who received two doses of the current vaccine 90 to 180 prior to enrollment and will then receive one or two doses of the new, omicron-based vaccine. Pfizer CEO Albert Bourla said the company can adapt its vaccine to new variants in under three months.

Despite a busy 2021, clinical data slows to pre-pandemic levels

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. COVID-19 also seems to be losing its stronghold on the clinical headlines, while cancer and infectious disease continue to dominate the reported data. BioWorld tracked 4,124 clinical entries in 2021, including 1,549 for phase I, 1,497 for phase II, and 1,078 for phase III. The total is nearly a 6% increase over 2020.

NICE set to expand scope of HTAs, but industry still sees gaps

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 future select what products to assess, and the methods and processes it will use to carry out its evaluations. The approval to go ahead with implementing the changes came after a two-year long appraisal, involving extensive consultation with industry and other stakeholders. This has been the “largest and most comprehensive review” NICE has ever undertaken, Helen Knight, program director at NICE’s Center for Health Technology Evaluation told fellow board members, meeting on Jan. 19 to approve publication at the end of January of the manuals setting out details of its new approach.

Lilly tagged for Trulicity social media post

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 (OPDP). The letter, sent last week, takes the Indianapolis-based company to task for an Instagram ad promoting Lilly’s diabetes drug Trulicity (dulaglutide). In addition to its own objections to how the ad minimalized serious risks and miscommunicated the drug’s approved indication, OPDP noted that it had received a complaint about the ad, and similar ones, through its Bad Ad program.

Also in the news

89bio, Achieve Life Sciences, Aculys, Annovis, Applied Biomath, Aqualung, Arcturus, Athira, Bioarchitech, Biomea Fusion, Biontech, Boehringer Ingelheim, Bond, Cartesian, Catalyst, Cerevance, Checkpoint, Chiesi USA, Cindome, Cytoimmune, Daewoong, Deciphera, Effector, Eleison, Evotec, Genentech, Gilead, Imara, Immix, Inmune, ITM, Loki, Metagenomi, Mina, Mindmed, Monte Rosa, Mustang, Nanoscope, Neurelis, Neurophth, Novartis, Opiant, Oric, Pfizer, Regenerx, Remegen, Senhwa, Sierra, Siga, Snipr Biome, Spago, Summit, Swanbio, Yeda