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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.
FDA Warns of Possible Contamination of Sterile Products from Compounding Pharmacy
FDA receives adverse event reports related to calcium gluconate infusions.
NIH, Lacks Family Reach Understanding on Genomic Data of HeLa cells
New NIH policy requires researchers to apply for access to the full genome sequence data from HeLa cells.
ScinoPharm, Sundia MediTech Partner for Pharma Outsourcing in China
ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.
Lonza Licenses Gene Expression Technology to Sorrento
The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.
Gallus Biopharmaceuticals Enters Clinical Supply Agreement with Genzyme for Niemann Pick Type B Disease
Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.
FDA Issues Final Guidance for Oversight of Clinical Investigations
The guidance describes a risk-based approach to monitoring of clinical trials.
Oncobiologics and InVentive Health Clinical Form Biosimilars Pact
The companies initially focused on five biosimilar products.
LSNE Successfully Completes MHRA Inspection
Lyophilization Services of New England (LSNE) received a Certificate of GMP Compliance for its New Hampshire facility.
uniQure to Build Therapy Production Plant in US to Leverage AAV Manufacturing Strength
uniQure B.V. announced it has commenced build-out of a 55,000 ft2 US manufacturing plant in Lexington, Mass.
