Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine. Read More
Scribe Therapeutics Inc., another CRISPR-based genome editing firm out of the Jennifer Doudna stable, launched with $20 million in series A funding and a deal with Biogen Inc. in amyotrophic lateral sclerosis (ALS), which brings in another $15 million up front and up to $400 million in development and commercial milestones. Read More
Just as financings are hitting record levels, biopharma deals should finish out 2020 on top, based on solid partnerships signed in the first three quarters of the year. While mergers and acquisitions have slowed this year, particularly in the third quarter, several big-money M&As slated to close in the fourth quarter could move the needle, putting this year within the top three highest values. Read More
New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo. Read More
HONG KONG – Shanghai-headquartered Inventisbio Inc. brought in $147 million from a series D funding round to move its main products into phase II trials in the U.S. and China. Read More
Federation Bio Inc., which just closed a $50 million series A, had enough preclinical data in engineering bacteria to drive the immune system up or down that it actually could have become two separate companies, its new CEO told BioWorld. Read More
Exploring new regulatory territory, Iovance Biotherapeutics Inc. hit a snag that will delay the submission of the BLA for its tumor-infiltrating lymphocyte (TIL) therapy, lifileucel (LN-144), in metastatic melanoma. Read More
HONG KONG – Cambridge, U.K.-based Astrazeneca plc has resumed phase I/II trials in Japan for AZD-1222, the experimental, adenovirus vector-based candidate coronavirus vaccine that it is co-developing with the University of Oxford. Read More
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation. Read More
The annual med-tech conference hosted by the Advanced Medical Technology Association, always features an FDA town hall, but this year’s town hall labored under the overhang of the COVID-19 pandemic. Nonetheless, Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), repeatedly gave voice to frustration with the statutory authorities currently enjoyed by the center, stating on more than one occasion that the Medical Device Amendments of 1976 are more than 40 years old and are in need of updates to cope with modern medical technology. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: FDA’s PRV fees drop again; PMDA offering early COVID-19 vaccine advice; NICE, SIGN go long on COVID-19. Read More
New hires and promotions in the biopharma industry, including: Alx, Arca, BIO, Caris, Etherna, Maze, Neogene, Nugenerex, Nkarta, Supernus, Tryp. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegle, Amag, Amphastar, Biogen, Biontech, Curtana, Glycomimetics, Huya, Iovance, Oncternal, Oragenics, Pfizer, Samsung, Y-mabs. Read More
