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.
Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
Alteogen Inc. signed its first billion-dollar partnership this year for ALT-B4 technology through two separate contracts with Astrazeneca plc’s U.K.- and U.S.-based Medimmune subsidiaries worth up to $1.35 billion combined.
Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share.
Ascentage Pharma Group Corp. Ltd. has priced the first IPO of the year in the U.S. The offering of 7.32 million shares has the Suzhou, China, and Rockville, Md.-based company looking for gross proceeds of about $126.4 million, assuming a price of $17.25 per share.
Data from two out of three positive studies faced the U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee as members examined the package submitted by Seikagaku Corp., of Tokyo, for SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
Data from two out of three positive studies faced the U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee as members examined the package submitted by Seikagaku Corp., of Tokyo, for SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
The U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will scrutinize Jan. 10 the safety and efficacy of Ferring Pharmaceuticals Inc.’s SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
Genentech Inc. didn’t need to wait until Thanksgiving for the U.S. FDA to make up its mind. More than a month ahead of its PDUFA date, the agency approved the firm’s first-line breast cancer treatment, Itovebi (inavolisib), providing the oral therapy a place with other niched therapies from Astrazeneca plc and Novartis AG. Itovebi is to be combined with Pfizer Inc.’s palbociclib (Ibrance) and Faslodex (fulvestrant, Astrazeneca) for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
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