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EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre
EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.
FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology.
EFPIA Responds to EMA Policy on Publication and Access to Clinical-Trial Data
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, Thermo Fisher Sign Global Agreement
VWR International has signed a global distribution agreement with Thermo Fisher Scientific.
Myriad Genetics Expands Companion Diagnostic Pact with AstraZeneca
Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.
FDA Issues Guidance on Bioequivalence
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
California State Senate Passes Biosimilars Bill
Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.
CordenPharma to Acquire Peptisyntha SA from Solvay
CordenPharma will acquire Peptisyntha SA, based in Belgium.
Zealand Announces Collaboration with Eli Lilly
Zealand will join efforts with Eli Lilly to design and develop therapeutic peptides for Type 2 diabetes and obesity.
Waters Corporation Announces CEO Transition Plan
CEO of Waters Corporation will retire within in the next two years.
Merck & Co. Gets FDA Nod to Manufacture Bulk Vaccine at North Carolina Facility
Merck & Co gets FDA approval to manufacture bulk varicella at its in Durham, North Carolina for use in chickenpox and shingles vaccines.
BioReliance Opens Clearance Services Laboratories in US
BioReliance opens Clearance Services Laboratories in Maryland for downstream bioprocessing studies.
FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products
FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.
Agilent Technologies Opens Spectroscopy Center
Agilent Technologies opens multimillion dollar Spectroscopy Technology Innovation Center in Australia.
California State Assembly Passes Biosimilar Legislation
The California State Assembly becomes the latest state to specify requirements allowing substitution of biosimilars.
Amarin Targets Novasep as Fourth Supplier of Vascepa API
Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.
Sanofi Pasteur's High-Dose Flu Vaccine Shows Superior Clinical Benefit in Older Adults
A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.
Sangamo BioSciences to Acquire Ceregene
Sangamo BioSciences has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus gene therapies.
Sanofi Pasteur Selects Freeslate to Improve Formulation Development
Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.
AstraZeneca's MedImmune To Acquire the Biopharmaceutical Company Amplimmune
AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.
Shire, and Santaris Extend Alliance to Develop LNA-drugs
Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.
Vical Restructures and Reduces Staff
Vical's restructuring will leave the company with approximately 74 employees.
Amgen to Acquire Onyx Pharmaceuticals in MultiBillion Deal
Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.
Single-Use Continuous Chromatography Overcoming Limitations of Traditional Protein Purification
Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.
Novartis Receives Third FDA Breakthrough Designation
FDA has granted Novartis breakthrough therapy designation to BYM338 for sporadic inclusion body myositis.
INTERPHEX and PDA Announce Sponsorship Agreement
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.
FDA Reviews Outdated Guidance Documents
CDER withdraws some outdated guidance documents and makes plans to finalize others.
EMD Millipore, PharmaCell Collaborate on Large-Scale Bioreactor Production of Stem Cells
EMD Millipore and PharmaCell have entered into a collaboration to develop optimized large-scale expansion and harvest of HepaRG cells using bioreactor technology.
Alice E. Till Selected AAPS President-Elect
Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.
Amgen and Servier Complete Product Collaboration Transaction
Amgen, Servier collaborate ivabraline and other cardiovascular products.
