Parts of the FDA’s recently updated draft guidance on the content and formatting of REMS documents are overly prescriptive, stakeholders said in public comments to the agency. Source: Drug Industry…
Biotechs are taking notice as a new pool of funding is being made available by venture capital Andreesen Horowitz. Source: BioSpace
Asklepios BioPharma is forming a new biotech portfolio company, Actus Therapeutics. Source: BioSpace
Perrigo is expected to face competition from Swiss food giant Nestle and the private equity owners of German drug firm Stada. Source: BioSpace
The approval was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program. Source: BioSpace
Amgen tapped two companies to receive its coveted 2017 Golden Ticket at LabCentral. Source: BioSpace
Bruno Strigini, the CEO of Novartis Oncology, plans to exit the company's Executive Committee by Dec. 31, 2017, and leave entirely in early 2018. Source: BioSpace
Galapagos assumes 35% of the co-promotion efforts in Germany, France, Italy, Spain, the United Kingdom, the Netherlands, Belgium, and Luxembourg. Source: BioSpace
Nelson Cabatuan, Rigel's vice president, finance will serve as the company's interim principal accounting officer. Source: BioSpace
Industry analysts were shocked when in July the FDA reversed course on Amicus' Phase III treatment for Fabry disease. Source: BioSpace