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Novartis plots 'innovative' payment models for pricey Luxturna's EU launch biospectrumasia
December 10, 2018
It’s been almost a year since Spark Therapeutics won a groundbreaking gene therapy approval in the U.S. for Luxturna, and now its marketing partner Novartis has done the same across the pond.
ASH: With Gamifant launch rolling, Sobi unveils more data backing the rare disease drug fiercepharma
December 05, 2018
Armed with last month's FDA approval, Sobi is rolling out its newly minted rare disease drug Gamifant with a small, targeted sales force, and Monday it unveiled more of the data that won the agency’s favor in the first place.
FDA berates Chinese drugmaker tied to global valsartan recall fiercepharma
September 30, 2018
The FDA last month went back into China's Zhejiang Huahai Pharmaceutical and produced a Form 483 with observations that strike at the heart of its manufacturing changes.
Protagonist Therapeutics Announces Fast Track Designation Granted by U.S. FDA to Hepcidin Mimetic PTG-300 pharmafocusasia
September 29, 2018
Protagonist Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to therapeutic candidate PTG-300 for the treatment of chronic anemia due to ineffective erythropoiesis in patients with beta-
Moderna picks up FDA vaccine executive Wellington Sun fiercepharma
September 07, 2018
Moderna Therapeutics named former FDA official Wellington Sun, M.D., its head of vaccine strategy and regulatory affairs.
Ascend scolded—again—for estrogen drug promos in OPDP's 4th warning this year fiercepharma
August 30, 2018
The FDA's policing arm, OPDP, sent another warning letter to Ascend Therapeutics over misleading marketing materials for estrogen therapy EstroGel.