Bavarian Nordic A/S plans to buy two travel vaccines plus a phase III chikungunya vaccine candidate from Emergent Biosolutions Inc. for about $380 million. Emergent will receive a $270 million up-front payment and perhaps as much as $110 million in future milestone payments. The vaccines are Vivotif, for preventing typhoid fever, and Vaxchora, for preventing cholera caused by Vibrio cholerae serogroup O1. Both oral vaccines have U.S. FDA and European approvals. Read More
A trio of proposed Medicare drug payment models that made a Feb. 14 debut in the U.S. is playing to mixed reviews. Two of the models to be tested by the U.S. Centers for Medicare & Medicaid Services (CMS) Innovation Center seem to “address the real problems underlying prescription drug pricing – patient out-of-pocket expenses and better payment systems that reward the value a medicine brings to the patient and the overall health care system,” said John Murphy, chief policy officer for the Biotechnology Innovation Organization. But he called the third model, which is expected to restrict Medicare payment for some Part B drugs that have indications with accelerated approval, “an attack on the accelerated approval pathway,” which Congress mandated to spur investment and innovation in areas of unmet medical need. Read More
Fresh off an end-of-year IPO, Coya Therapeutics Inc. is gearing up for clinical testing with its lead Treg-enhancing biologic in neurodegenerative disease, aiming to build on a wealth of academic-generated data highlighting the potential of Treg therapy to attack the neuroinflammation underlying diseases such as amyotrophic lateral sclerosis and Alzheimer’s disease. Read More
Maxion Therapeutics Ltd. has raised $16 million in a series A to take forward a new method for drugging G-protein coupled receptors (GPCRs) and ion channels with antibodies. The technology brings together naturally occurring knottin peptides that are derived from sources such as snake venom and which can engage GPCRs and ion channels, with antibodies that deliver them to these notoriously difficult, shape-shifting targets. Read More
Medicinal cannabis company Zelira Therapeutics Ltd. secured $8.6 million in cornerstone funding from U.S.-based Cantheon Capital LLC that will progress Zelira’s Hope1 cannabinoid medicine to formal phase II/III clinical trials for behaviors associated with autism spectrum disorder. Read More
The False Claims Act is perhaps the primary vehicle for U.S. federal authorities to extract penalties and fines from life science companies for violations of the law, but a new report by Gibson Dunn & Crutcher LLP suggests a mixed signal. The report notes that the U.S. Department of Justice (DOJ) recovered $2.2 billion via the FCA last year, but while that is not a conspicuous number for the past decade plus, what was conspicuous was that those sums were recovered by the second highest level of FCA actions settlement in the history of the FCA, suggesting that DOJ is keen on enforcement with no regard to the size of the target. Read More
New hires and promotions in the biopharma industry, including: Bausch + Lomb, Chinook, Delix, Direct, Epiendo, Johnson & Johnson, Keiferx, Telum, Trethera. Read More
Biopharmas raising money in public or private financings, including: Codagenix, Eumentis, Fusion, Galera, Glycomimetics, Immunitybio, Mineralys, Morphoceuticals, Supernus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Athersys, Avidity, Biocon, Healios, Lemonex, Mirum, Neurona, Soligenix, Verve, Viatris. Read More
