Sorrento 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
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.…
Mylan 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
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
Portola 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
EMA 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…
FDA 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
FDA’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…
Drugmakers Say Guidance on Patient Experience Data Should Cover All Development Stages
Commenting on FDA’s planned patient-focused drug development guidance, industry stakeholders said the agency needs to clarify how it will incorporate patient experience data into specific stages of development. Source: Drug…
Galera Therapeutics Doses First Patient in Pancreatic Cancer Trial
Galera Therapeutics has initiated its Phase I/II clinical trial of GC4419 in locally advanced pancreatic cancer (LAPC). Source: BioSpace
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