FDA Issues New Draft Guidance for Alzheimer’s Trials that Could Open Up Approvals
The U.S. Food and Drug Administration (FDA) issued new draft guidance for preclinical trials in Alzheimer’s. Source: BioSpace
OPKO Health’s Annual Report a Mixed Bag
OPKO Health’s fourth-quarter report highlighted positive activities in the face of a net loss of $213.9 million during the most recent quarter. Source: BioSpace
MeiraGTx Earns EMA PRIME Designation for Achromatopsia Gene Therapy Candidate
A new gene therapy to treat a debilitating eye disorder is one step closer to regulatory approval in Europe. Source: BioSpace
Biogen and AbbVie Voluntarily Pull Multiple Sclerosis Drug Off the Market
Biogen and AbbVie have voluntarily pulled their Zinbryta for relapsing multiple sclerosis (MS) off the market after safety concerns. Source: BioSpace
Say “No” the Right Way: How Declining a Job Offer can Advance Your Career
Figuring out the best way to turn down a job offer is a “good” problem to have. If anything, receiving one or multiple job offers gives you a sense of…
Cardiologist Pleads Guilty to Giving Aegerion Patient Information to Boost Prescriptions
A pediatric cardiologist pleaded guilty to illegally supplying Aegerion Pharmaceuticals with information about his patients. Source: Drug Industry Daily
McCaskill Bill Would Kill Tax Breaks for Direct-to-Consumer Drug Advertising
Sen. Claire McCaskill (D-Mo.) introduced legislation that would eliminate tax breaks for drugmakers that advertise directly to consumers. Source: Drug Industry Daily
FDA Releases New Draft Guidance on DSCSA Tracking Standards, Definitions
The FDA issued two draft guidances aimed at implementing the Drug Supply Chain Security Act’s provisions for an electronic track-and-trace system for certain prescription drugs extending throughout the supply chain…
Finch Therapeutics Raises $36 Million Series B, Bringing Total to $77 Million
Finch Therapeutics closed on an oversubscribed Series B financing worth $36 million. Source: BioSpace
Gelesis Secures $30 Million to Support Potential Approval of Weight Loss Drug
Boston-based Gelesis snagged $30 million to support potential manufacturing and commercialization of its anti-obesity drug. Source: BioSpace
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