Archive for February 2018
U.S. Department of Justice to Take on Opioid Manufacturers and Distributors
With no end to the national opioid crisis in sight, the U.S. Department of Justice announced a plan to form a task force that will target opioid manufacturers and distributors. Source: BioSpace
Read MoreGelesis 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
Read MoreMylan Teams Up with Revance Therapeutics to Develop Botox Biosimilar
Mylan N.V. signed a global collaboration and license deal with Revance Therapeutics to develop and market a biosimilar to Botox. Source: BioSpace
Read MoreRubius Therapeutics Raises $100 Million in Crossover Financing
Rubius Therapeutics has closed on an oversubscribed $100 million crossover financing. Source: BioSpace
Read MoreFinch 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
Read MorePortola Plunges After Hint of Delay for FDA Approval of Factor Xa-inhibitor
Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa. Source: BioSpace
Read MoreSorrento Nabs FDA Approval for Shingles Pain Patch That Could Hit Blockbuster Status
Sorrento Therapeutics, Inc. nabbed regulatory approval for ZTlido, a non-opioid pain treatment in the form of a super-sticky patch. Source: BioSpace
Read MoreEMA Issues Revised Guidance on Biomarkers, Diagnostic Criteria for Alzheimer’s Medicines
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a revised guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease, focusing on the design and analysis of safety studies and the potential use of biomarkers in various stages of medicinal development. Source: Drug Industry Daily
Read MoreFDA Issues Guidance on ICH Good Clinical Practices
The FDA released guidance on the International Council for Harmonization’s good clinical practice guidelines and its addendum on advances in clinical trial design. Source: Drug Industry Daily
Read MoreFDA’s Office of Pharmaceutical Quality Releases First Annual Report
In its first ever annual report, the Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300 officers deployed for inspections in the aftermaths of Hurricanes Harvey, Irma and Maria. Source: Drug Industry Daily
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