Neurology August 7, 2023 Sage and Biogen receive FDA approval for PPD therapy By PBR Staff Writer Said to be the first and only oral, once-a-day, 14-day treatment, ZURZUVAE can provide quick improvements in depressive symptoms for women with PPD. Shortly after scheduling as a
Hematological Disorders August 4, 2023 Agios and Alnylam sign agreement for siRNA candidate By PBR Staff Writer As per the terms of the exclusive worldwide agreement, Agios will acquire the rights to develop and market Alnylam’s preclinical candidate that targets TMPRSS6, a key driver of
Ulcerative Colitis August 3, 2023 InDex receives new formulation patent in Europe for ulcerative colitis drug By PBR Staff Writer The company received the patent from the European Patent Office. The drug is being assessed in the ongoing Phase III programme CONCLUDE for treating patients with moderate to
Research & Development August 2, 2023 Solu Therapeutics raises funds to develop CyTaC platform and drug candidates By PBR Staff Writer Co-led by Santé Ventures and Longwood, the financing round has seen participation from Alexandria Venture Investments, Astellas Venture Management, and DCVC Bio. Solu Therapeutics’ CyTaC platform has been
Research & Development August 1, 2023 Viatris, Kindeva launch Breyna to treat asthma and COPD patients By PBR Staff Writer The drug-device combination product, Breyna is claimed to be the first US Food and Drug Administration (FDA)-approved generic version of AstraZeneca’s Symbicort. It will be immediately available in
Approvals July 31, 2023 FDA approves nonprescription use of RiVive naloxone nasal spray By PBR Staff Writer RiVive is designed to provide access to naloxone without a prescription and is available as 3 mg naloxone hydrochloride nasal spray. This is the second over-the-counter product with
Drug Manufacturing July 27, 2023 Cell therapy CDMO Kincell Bio launches with $36m infusion By PBR Staff Writer The start-up facilitates analytical and process development, CMC consulting as well as early-stage GMP manufacturing of cell therapies. Initially, its emphasis will be on manufacturing immune cell therapies, such
Drug Manufacturing July 26, 2023 Biovian to expand Turku manufacturing unit with $55m investment By PBR Staff Writer To be spread over a 69,000ft2 area, the expanded production unit will feature innovative technologies and equipment that aid in developing, producing and analysing advanced therapy medicinal products (ATMP). The
Drug DiscoveryApprovals July 25, 2023 NMPA accepts Overland ADCT BioPharma’s BLA for ZYNLONTA By PBR Staff Writer Overland ADCT BioPharma is a joint venture between Overland Pharmaceuticals and ADC Therapeutics. This therapy is seeking an indication to treat adults with relapsed or refractory (r/r) diffuse
Oncology July 24, 2023 Bristol Myers gets positive opinion from CHMP for Opdivo By PBR Staff Writer The therapy is intended for adults and adolescents aged 12 years and above. This recommendation will be forwarded to the European Commission (EC), which will make a final