Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space. Read More
In an ideal world, when a patient takes a medicine, it acts only at the specific site of disease in the human body whilst sparing healthy tissues. But it almost goes without saying that with many drug regimens, side effects or complications are part of the package. Working behind the scenes to address this limitation over the past couple of years, Cambridge, Mass.-based venture capital company Flagship Pioneering is now publicizing its platform of “programmable medicines” that directly and precisely target diseased tissue, funnelling $50 million of investment in the technology and recognising its achievements formally through the launch of Ampersand Biomedicines. Read More
Swiss orphan biotech AB2 Bio Ltd. has completed enrollment in a pivotal phase III trial for its recombinant interleukin-18-binding protein drug tadekinig alfa for an inherited form of the ultra-rare condition hemophagocytic lymphohistiocytosis that results from an excess of the pro-inflammatory cytokine IL-18. Read More
A California man agreed to settle insider trading charges related to Tokyo-based Astellas Pharma Inc.’s buyout offer of San Francisco-based Audentes Therapeutics Inc. in December 2019 for $3 billion. Read More
A deficiency in fumarate metabolism could be behind a new mechanism of inflammation mediated by mitochondrial DNA and RNA. Two independent and simultaneous studies described how the accumulation of fumarate in the mitochondria released the genetic material of this organelle through vesicles, activating an inflammatory signaling pathway. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abveris, Allergan, Alnylam, Endo, F-star, ICER, Icon, Invox, Leo Pharma, Les Laboratoires, Medicinova, Medison, Novelion, Olema, Orchard, Par, Qiagen, Sino, Sumitovant, Sumitoma, Twist Bioscience, Myovant. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Areteia, Astellas, Astrazeneca, Bergenbio, Bionomics, Clene, CNS, Eli Lilly, First Wave, Genfleet, Gensight, Lantern, Microbion, Ribon, Springworks, Vaccinex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenue, Biocryst, Estrella, Janssen, Novo Nordisk, Scisparc, Soligenix, Vertex. Read More
