Bluebird Bio Inc.’s elivaldogene autotemcel (eli-cel) gained U.S. approval late Sept. 16 for use in early active cerebral adrenoleukodystrophy (CALD), making it the firm’s second gene therapy to clear the FDA in as many months. Branded Skysona, eli-cel is expected to be available commercially by the end of 2022 and its launch will require only “incremental” company resources on top of those required for the ongoing launch of beta-thalassemia gene therapy Zynteglo (betibeglogene autotemcel), Bluebird said. Read More
Versantis AG has agreed terms with Genfit SA in an acquisition deal that involves CHF40 million (US$41.4 million) up front, plus up to CHF65 million in milestones, and one third of the proceeds from a potential sale of a rare pediatric disease priority review voucher, should the U.S. FDA grant one. Read More
Virios Therapeutics Inc. said most likely COVID-19 had a hand in the phase IIb failure of IMC-1 (famciclovir + celecoxib), a dual COX-2/COX-1 inhibitor for treating fibromyalgia. The drug failed to hit statistical significance in dampening pain severity when compared to placebo (p=0.302). Read More
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms. Read More
In an effort to get drug regulators in the various EU member states on the same page, the EMA issued a Sept. 19 statement confirming that all biosimilars approved in the EU are interchangeable with other approved biosimilars referencing the same biologic, as well as the reference biologic itself. Read More
Claiming it would be impossible to carve out a so-called skinny label that would comply with generic drug “same labeling” rules, Novartis AG is petitioning the U.S. FDA, for the second time, not to approve generic versions of its blockbuster heart drug, Entresto (sacubitril + valsartan), that attempt to carve around a cardiovascular indication that has exclusivity until Feb. 16, 2024. Read More
The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Ltd. have launched Radiopharm Ventures LLC, a joint venture (JV) that will develop radiopharmaceutical therapies for cancer. Radiopharm Theranostics owns 51% of shares in the new entity, while MD Anderson owns 49%. Read More
The U.S. NIH is not generally regarded as a wellspring of concepts and policies in the world of artificial intelligence (AI), but that perception may change soon thanks to the agency’s Bridge2AI program. The agency announced recently that it will drop $130 million into this program over four years in an effort to develop standards for data used in AI research, a key development for device makers seeking to sell products that use these complex algorithms. Read More
New hires and promotions in the biopharma industry, including: Agios, Aktis, Everest Medicines, Gamida Cell, Hemostemix, Mallinckrodt, Pasithea, Provention, Viracta, Zentalis. Read More
Biopharmas raising money in public or private financings, including: Biolinerx, Edgewise, Genelux, Kamari, Larimar, Point, Syros, Ventyx and Zucara. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzecure, Astrazeneca, Intellia, Oryzon, Regeneron, Revive, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biohaven, Bolden, Coherus, GSK, IDT, Thervance and Valneva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ADC, Agios, Astrazeneca, Belite, Biontech, Gilead, Kite, Marengo, Merck & Co., Novavax, Pfizer, Sanofi, Stada, Takeda, Xbrane. Read More
