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BioWorld - Tuesday, May 13, 2025
Home » Authors » Karen Carey

Karen Carey

Articles

ARTICLES

FDA clears Satsuma’s Atzumi for migraine

May 6, 2025
By Karen Carey
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.
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3D illustration of headache

FDA clears Satsuma’s Atzumi for migraine

May 2, 2025
By Karen Carey
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.
Read More

FDA clears Satsuma’s Atzumi for migraine

May 1, 2025
By Karen Carey
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.
Read More
Stacks of coins separated by a crack

Filling the NIH funding gap to protect biopharma research

May 1, 2025
By Karen Carey
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?
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Blue dollar sign on white background
Newco news

Granite Bio emerges with $100M raised and two immunology assets

April 24, 2025
By Karen Carey
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.
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Spruce acquires Biomarin’s Sanfilippo drug, tralesinidase alfa

April 15, 2025
By Karen Carey
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.
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Illustration of antibodies attacking neurons
Immune

Aiming for autoimmunity, Merida Bio launches with $121M series A

April 10, 2025
By Karen Carey
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.
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Illustration of antibodies attacking neurons
Newco news

Aiming for autoimmunity, Merida Bio launches with $121M series A

April 8, 2025
By Karen Carey
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.
Read More
Gold dollar sign and gray question marks

Tariffs pressure industry markets; uncertainty remains

April 3, 2025
By Karen Carey
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.”
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Single strand RNA
Genetic/congenital

Airna’s $155M series B advances RNA editing drug AIR-001 for AATD

April 2, 2025
By Karen Carey
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.
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View All Articles by Karen Carey

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