One of Pfizer Inc.’s last decisions of 2021 was to shell out $6.7 billion for San Diego’s Arena Pharmaceuticals Inc., a deal centered around the pipeline inflammatory disease pill etrasimod. A potential successor to Xeljanz (tofacitinib), the price New York-based Pfizer paid suggests blockbuster potential for etrasimod. Phase III results announced March 23 suggest Pfizer’s big acquisition, the fifth largest in biopharma in 2021, was money well spent. Read More
A spring of hope has emerged for BioWorld’s Drug Developers Index (BDDI) with stocks moving in a positive direction in recent weeks, much in line with the broader markets. The BDDI is currently down for the year by 15.5%, but that is an improvement over the 21% decline at the end of February. Likewise, the Nasdaq Biotechnology Index and the Dow Jones Industrial Average are showing similar upward trajectories, but are still down by 11.1% and 4.2%, respectively. It is the first time this year stocks have begun to rise. Read More
Fungal biosphere specialist Lifemine Therapeutics Inc. has struck a goldmine through a $175 million series C financing and an R&D collaboration allowing Glaxosmithkline plc (GSK) to use the company's platform to identify small-molecule leads. Read More
Researchers at the Albert Einstein College of Medicine have turned pancreatic cancer’s immunosuppressive properties, and mechanisms, against itself. The team have used the bacterium Listeria monocytogenes as a delivery vehicle for tetanus toxoid protein, a highly immunogenic antigen that is used in childhood tetanus vaccinations. In mouse models of pancreatic cancer, treatment reduced both primary tumors and metastases, and extended survival. Read More
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval. Read More
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23. Read More
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax. Read More
New hires and promotions in the biopharma industry, including: Eikon, Graphite, Heat, Mammoth, Merck, Ocelot, Ocugen, Onk, Orum, Synthetic Biologics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Argenx, Cali, Kalvista, Lung, Neurana, Obseva, Plus, Ribon, Terns, Vertex, Viridian, Visus, Windtree, Zai, Zentalis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: BMS,Merck, Oragenics, Pfizer, Pharmacyte, Pharvaris, Philochem, Philogen, Transcenta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atrogi, Calliditas, Cansino, Marinus, Merck, Orphazyme, Palisade, Takeda. Read More