BioPharm International Editors

Aesica adds roller compaction unit for dry granulation production.

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

New International Council on Biotechnology Associations advocates biotechnology growth.

The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.

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

OCE and OBI partner with CQDM on $3 million inter-provincial drug discovery innovation programs.

BioOutsource will expand its US presence, opening a new laboratory facility in Massachusetts to support the company's biosimilar and biosafety service offerings.

Eurobiomed and Biocom sign a cooperation agreement at the BIO International Convention.

PlantForm and PharmaPraxis announce plans to develop six biopharmaceutical targets for the Brazilian market.

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

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

BIO 2014 hosted more than 29,000 one-to-one partnering meetings.

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

European Medicines Agency clarifies advanced-therapy medicinal products classification.

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

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

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

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

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

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

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.

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

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

FDA approved Cubist's treatment for skin infections including MRSA.

Shire reports that AbbVie offer undervalued company.

Arecor and the Center for Process Innovation (CPI) Biologics are working on a project to enhance the compatibility of biologics with their containers.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

New services manage clinical or drug manufacturing data in the Verizon cloud or from data centers.

EDQM details the agency?s accomplishments in 2013.