News

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

VWR International has signed a global distribution agreement with Thermo Fisher Scientific.

Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

CordenPharma will acquire Peptisyntha SA, based in Belgium.

Zealand will join efforts with Eli Lilly to design and develop therapeutic peptides for Type 2 diabetes and obesity.

Merck & Co gets FDA approval to manufacture bulk varicella at its in Durham, North Carolina for use in chickenpox and shingles vaccines.

FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.

Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.

A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.

Sangamo BioSciences has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus gene therapies.

Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.

AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.

Vical's restructuring will leave the company with approximately 74 employees.

Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.

INTERPHEX and the Parenteral Drug Association (PDA) announced a three-year sponsorship agreement, which aligns the objectives of both organizations to service key needs of the global pharmaceutical and biopharmaceutical industry.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.

Amgen, Servier collaborate ivabraline and other cardiovascular products.

FDA receives adverse event reports related to calcium gluconate infusions.

New NIH policy requires researchers to apply for access to the full genome sequence data from HeLa cells.

ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.

The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.