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Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Articles

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

Reproducibility Project only Partially Able to Validate Findings of Prominent Cancer Studies

Randi Hernandez was science editor at BioPharm International from September 2014 to May 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.

FDA Clarifies How It Handles 180-Day Exclusivity

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

Switching Studies Crucial to Demonstrate Biosimilar Interchangeability

Industry experts identify the future focus of the biopharma industry in a new survey.

NIBRT Summarizes Top Trends in the Biopharma Industry

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.

Deficiencies in Manufacturing Derail CDER Approvals in 2016

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

J&J Announces 15 New Collaborations

Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.

Lonza to Acquire Capsugel

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

House Approves Revised “Cures” Bill

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

Takeda Builds Dengue Vaccine Manufacturing Plant in Germany

Shire plans to establish a 550,000-square-foot campus that will focus on innovation in rare diseases and highly specialized conditions.

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