Industry News

Taiwan-based Formosa Pharmaceuticals (6838.TWO) and AimMax Therapeutics (United States) announced today that the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery.

Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.

Bayer has acquired the exclusive marketing rights for acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.. Acoramidis is a highly potent and selective small molecule, orally administered transthyretin (TTR) stabilizer for the treatment of patients suffering from ATTR CM, a progressive fatal disease presenting as an infiltrative, restrictive cardiomyopathy resulting in heart failure.

Takeda and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments in endemic countries by 2030 at the latest to support National Immunization Programs.

Roche Pharma launches ocrelizumab in India, six years after global release. Ocrelizumab is an FDA-approved CD20-directed humanized monoclonal antibody indicated to treat adult patients with primary progressive or relapsing multiple sclerosis.

Lykos Therapeutics a company dedicated to transforming mental healthcare, announced that the U.S. Food and Drug Administration has accepted its new drug application for midomafetamine capsules used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder (PTSD). The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act target action date of August 11, 2024.

The NIHR has selected the University of Birmingham to run the National Collaborative for its Research Support Service (RSS) from 1 February 2024.

The RSS was launched on 1 October 2023. The service provides expert research design, methodological support, advice, and collaboration to all researchers in England throughout the pre- and post-application/research process, regardless of geographic location and research interest.

BioNTech SE a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases, and Autolus Therapeutics plc a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, announced a strategic collaboration aimed at advancing both companies’ autologous CAR-T programs towards commercialization, pending regulatory authorizations. In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Novartis announced that it has entered into an agreement to make a voluntary public takeover offer to acquire MorphoSys AG, a Germany-based, global biopharmaceutical company developing innovative medicines in oncology.