Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.
The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research programs will affect tomorrow’s treatments and cures. Who is going to bridge research from idea to company if grants from the U.S. NIH are no longer an option?
Named after Swiss mountains, Granite Bio AG emerged from stealth with $70 million in funds through a series B to advance two immunology treatments incubated at Versant Ventures.
After dropping development in December of its lead program, Spruce Biosciences Inc. has found new life by acquiring a BLA-ready enzyme replacement therapy for the rare genetic neurodegenerative disease Sanfilippo syndrome type B. If approved, the therapy, tralesinidase alfa, could bring Spruce a priority review voucher.
When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new company called Merida Biosciences focused on removing misdirected antibodies and their negative effects using Fc biotherapeutics.
When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new company called Merida Biosciences focused on removing misdirected antibodies and their negative effects using Fc biotherapeutics.
President Donald Trump’s executive order on global tariffs have pushed downward the stocks of biopharma and med-tech companies, even though the impacts of his 10% baseline tariff – which excludes pharmaceuticals – and his reciprocal tariffs affecting about 60 countries across the globe, are still unclear. “The story for the day is there’s still a lot of uncertainties in terms of pharmaceuticals,” said Wayne Winegarden, senior fellow and director of the Center for Medical Economics and Innovation at the Pacific Research Institute, a free-market think tank. “It’s going to pressure margins, pressure availability. This is just a complete negative for the industry. It’s self-inflicted. It’s not just unnecessary, it’s unwarranted.”
As it prepares to advance its lead RNA editing candidate, AIR-001, into a phase I/II trial for alpha-1 antitrypsin deficiency, Airna Corp. Inc. closed an oversubscribed $155 million series B financing less than a year after completing its series A round. The company, based in Cambridge, Mass., with research operations in Tübingen, Germany, focuses not only on repairing harmful genetic variants found in rare genetic disorders, but also on introducing beneficial variants that improve health in common conditions.
