Pharmaceutical Technology Editors

FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.

New International Council on Biotechnology Associations advocates biotechnology growth.

Catalent appoints a new country leader and expands facilities.

Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million.

The FDA approved Beleodaq for the treatment of patients with peripheral T-cell lymphoma.

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.

The oncology center and its manager were charged with obtaining and selling unapproved, potentially counterfeit, cancer-treatment drugs.

FDA releases guidance documents and rules on requirements for compounding human drug products.

Sandoz will supply antibiotic to developing countries as part of the United Nations' Every Newborn Action Plan.

Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders

The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

This work marks the first joint project between regulators and HTA bodies on a European level and is part of their ongoing dialogue to support policymaker decisions in the future.

Onyx Scientific has announced plans to invest in continuous flow manufacturing to allow its customers to explore alternatives during product research and development programs.

PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.

GSK and Save the Children announce criteria for awards that recognize innovation in healthcare for the world&s poorest children.

New toxicology study demonstrates decreased mortality and better tolerability of ADC generated with Smartag platform versus conventional technology.

Covance MarketPlace is designed to enable partnerships between the company';s emerging biotechnology and established pharmaceutical clients.

Cytovance Biologics completes GMP manufacture of ARMO BioSciences& lead product.

Aesica Pharmaceuticals S.r.I. collaborates with QAD to meet China&s Food and Drug Administration's shortened serialization deadline.

Frontage Labs will expand its CMC facility in Exton, PA.

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

Rentschler plans to build two stainless-steel bioreactors to target market supply.

Medicenna Therapeutics selects Kalon Biotherapeutics to manufacture a new brain cancer drug for children and adults.

Recipharm and CTC will offer packages for Phase I studies.

SGS introduces the Cobas 6000 Analyzer System for its France-based laboratory.