Valeant Sells Sprout Pharma to a New Company 'Associated' With Sprout Founders
A little more than two years after acquiring Sprout, Valeant is selling off the developer of the female sex drive drug Addyi. Source: BioSpace
Billionaire Businessman Looking to Take Stake in Debt-Ridden Teva
Shares of Teva are up more than 5 percent this morning after Israeli media reported billionaire businessman Len Blavatnik is considering taking a large stock position in the pharma giant.…
Two-Year Old Biotech NousCom Nabs $49M to Fund New Drug Into Clinic
The round was led by new investor Abingworth with participation from another new investor, 5AM Ventures, LSP and Versant Ventures. Source: BioSpace
TherapeuticsMD Soars on Plans to Resubmit TX-004HR NDA Without New Pre-Approval Study
Shares of TherapeuticsMD have shot up more than 51 percent in morning trading after the FDA reversed course on its rejection of that company's vaginal pain medication. Source: BioSpace
The Battle Between Two $1B+ Biotech Unicorns
Two of the top companies in the field are German-based CureVac and U.S.-based Moderna Therapeutics. Source: BioSpace
Politically Connected Patrick Soon-Shiong Questioned Over Genetic Tests
Patrick Soon-Shiong touted sales of his closely scrutinized test without revealing the purchaser was on his payroll. Source: BioSpace
FDA Will Widen Expanded Access Tool to Cover Orphan Drugs
Writing in an FDA blog post, Commissioner Scott Gottlieb said the agency will broaden the scope of its Expanded Access Navigator tool — an information resource created by the Reagan-Udall…
FDA Guidance Outlines Formal Dispute Appeal Process
The FDA published a guidance for industry and its reviewers on the formal CDER and CBER procedures for resolving scientific disputes with sponsors that cannot be settled at the division…
FDA Updates Priority ANDA Pre-submission Guidance for GDUFA II
Responding to changes introduced by the GDUFA II program, the FDA revised its draft guidance on sponsor pre-submissions of facility information used to assess the need for manufacturing site inspections…
Data Integrity is ‘Mission Critical,’ FDA Enforcer Says
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference.…
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