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January 18, 2017
A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.
January 17, 2017
FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.
January 11, 2017
Industry experts identify the future focus of the biopharma industry in a new survey.
January 05, 2017
FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.
J&J’s Innovation Global announced the company has entered into 15 new collaborations.
December 15, 2016
Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.
December 01, 2016
The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.
November 30, 2016
Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.
November 22, 2016
Shire plans to establish a 550,000-square-foot campus that will focus on innovation in rare diseases and highly specialized conditions.
November 09, 2016
What’s ahead for the healthcare and pharmaceutical industries?