Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Alloplex, Beone, Clearpoint, Glooko, Inmune, Kyowa Kirin, Taiho, Taiho Oncology.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aardvark, Ant Neuro, Apellis, Biogen, Edap, Innoviva, Kariya, Kurin, Magnolia Medical, Neuralight, Neuronetics, Telix.
Clinical updates for biopharma and med tech, including data readouts and publications: Astrazeneca, Atamyo, Biogen, Cabaletta, Celcuity, Corvus, Endra Life Sciences, Galmed, In8bio, Medipost, Mira, Regenxbio, Senti, Shionogi, Tiziana, Vor.
New hires and promotions in the biopharma and med-tech industries, including: Catalyst Orthoscience, Corbus, Create, Myomo, Oncusp, Organox, Owens & Minor, Pharmazz, Venus Concept.
Biopharma deal value through the first four months of 2026 reached $92.98 billion, outpacing every recent year and running well ahead of 2025’s strong $79.82 billion over the same period. January and February each cleared $30 billion, while March and April totaled $18.05 billion and $13.3 billion, respectively.
Temperature matters when determining pH levels. Whether that level should be measured at a standard room temperature or refrigerated matters even more, at least in Actelion Ltd.’s infringement litigation against Mylan Inc. According to Johnson & Johnson’s Actelion, the pH level in epoprostenol, the key ingredient in its hypertension drug Veletri, should be measured at a refrigerated temperature when it comes to Mylan’s generic formulation.
In further fallout from the COVID-19 pandemic, the EU has now reached agreement on the Critical Medicines Act, which aims to boost European manufacturing capacity for drugs and their active ingredients, and enable member states to organize joint procurement to improve access to orphan drugs.
Sonomind SAS raised €20 million (US$23 million) in a series A funding round for its ultrasound-based neuromodulation technology for depression. The funds will be used for clinical trials of the non-invasive device, which uses a custom-made acoustic lens to precisely target deep regions within the brain to bring relief to patients suffering from treatment-resistant depression.
If the recent hantavirus outbreak wasn’t enough to keep public health officials busy, a new Ebola virus disease outbreak has been confirmed by authorities in the Democratic Republic of the Congo. While sequencing is ongoing to identify the Ebola strain, experts have noted early results suggesting it appears to be different from the Zaire strain that has caused previous outbreaks, including the deadliest outbreak in West Africa a decade ago, meaning existing vaccines and antibody treatments likely will not be effective.