Industry News
Pharmacy Associations Ask FDA to Delay Track-and-Trace Requirements
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
FDA Issues Guidance on Allowable Excess Volume for Injectables
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
European Pharmacopoeia Commission Updates Ph.Eur.
The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
FDA Fights Online Counterfeit Drugs
The agency takes action against websites that illegally sell unapproved medications.
ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage
The International Conference on Harmonization finalizes Q&A document on APIs.
NIH Outlines Corrective Action for Sterile Manufacturing Facility
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
R&D Pipeline Value Jumps 18% to $493 Billion
EvaluatePharma report shows continued pharma and biotech sector confidence.
FDA Launches New REMS Website
The agency streamlines risk and mitigation information.
Continuous Manufacturing Shines at BIO
BIO to Add Innovation to Name
The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
EMA Creates Pediatric Drug Pilot Project
The agency launches initiative to stimulate pediatric drug development.
CPhI Adds Biologics Development Innovation Award
CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.
FDA Releases Guidance on Treatment for Duchenne Muscular Dystrophy
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
FDA Guidance Seeks More Effective Postapproval Change Strategies
FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
Amgen and Sandoz: Battle Over Neupogen Biosimilar “Shall” Continue
Turkey Expands Reach in Pharma Market
CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.
FDA Officials Comment on China Visit
Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.
Drug Contamination Problems Hit NIH
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
FDA Issues Warning Letter to API Manufacturer
The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.
Contamination Shuts Down NIH Pharma Development Facility
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
Bringing a Biologic from the Bench to the Marketplace
Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.
EDQM Releases 2014 Annual Report
The directorate highlights achievements accomplished during the year of its 50th anniversary.
ICH Steering Committee to Meet in Japan
The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.
FDA Releases Guidance on CMC Changes for Biologics
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
Generic Opioids Create Policy Issues
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
MIT Scientist to Present at BIO 2015
MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.
“Cures” Debate Far From Over
The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.
International Neonatal Consortium Launched
The Critical Path Institute launched a consortium to help develop therapies for newborns.
CPhI Worldwide Announces 2015 Expert Panel
CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.
Rx-360 Establishes Working Group in India
Supply chain consortium establishes a working group to address quality problems in India.
