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CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The exclusive manufacturing collaboration will establish production for adeno-associated virus gene-therapy treatments incorporating REGENXBIO’s NAV Technology.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

The supplier will add Allied Laboratories and AR Brown to its list of global partners.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

A year after its merger with DSM Pharmaceutical Products, Patheon announces that it has filed an IPO.

The Canadian Green Cross facility will produce intravenous immunoglobulin and albumin.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

CPhI Pharma Insights’ Turkey Market Report reveals, the growth and strategic plans for the future of the pharmaceutical industry in Turkey.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.

Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.

A new demonstration facility in New York gives Sartorius’ customers hands-on access to bioprocessing systems and lab instruments.

EMD Millipore debuts a new cell-culture media compacting technology that will turn messy, dry powders into granules.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Prescription drug usage data on more than one million Marketplace enrollees suggest that costs for specialty drugs are 36% higher for people with Obamacare.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

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.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Waters announces it will introduce its new technology at the 63rd Society of Mass Spectrometry conference.

MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.