Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said. Read More
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it. Read More
Atea Pharmaceuticals Inc., of Boston, brought in a $215 million series D financing to support development of its COVID-19 antiviral, which is designed to inhibit the viral RNA polymerase enzyme, a key element in RNA virus replication. Read More
DUBLIN – Kancera AB is the latest contender to reposition a clinical-stage small molecule with an immunomodulatory mechanism as a drug candidate for COVID-19. Read More
HONG KONG – New York and San Diego-based Zentalis Pharmaceuticals Inc. has gained $20 million in a series A financing round to support a Chinese joint venture called Zentera Therapeutics. Read More
LONDON – MGB Biopharma Ltd. is looking for new investors or a commercialization partner to take its lead program, MGB-BP-3, through to market, after reporting 100% initial and sustained cure of Clostridium difficile infections in a phase IIa dose-ranging study. Read More
Rapid Micro Biosystems Inc. scooped up $120 million in a series C financing led by Ally Bridge Group, with participation by Endeavor Vision and existing investors Bain Capital Life Sciences, Longitude Capital, Xeraya Capital and Asahi Kasei. The Lowell, Mass.-based company has earmarked the funds to expand the global footprint of its contaminant testing platform for biopharmaceutical and vaccine manufacturing and for new product development. Read More
BEIJING – After being a health care investor for 21 years, Jonathan Wang decided to co-found biotech startup Inmagene Biopharmaceuticals Co. Ltd. in July 2019 to seek success in the China market using the experience and insights he had accumulated over the years. With $20 million in its war chest so far, the startup aims to excel in immunology-related therapeutic areas in China. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alkermes, Arch, Astex, Beyond Air, Cidara, Cyclo, Diffusion, Forma, KBP, Roche, Santhera. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Atea, Eiger, Evoke, Fate, Foundation, Incyte, Karyopharm, Merck, Morphosys, Octapharma. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: International Trading Pharmaceuticals Laboratories Inc. Read More
