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ISPE Announces Quality Metrics Pilot Launch
ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.
FDA Issues Guidance on Identifying Suspect Drugs
FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.
FDA Licenses First US Facility for Cell-Culture Influenza Vaccines
Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.
Catalent and AAPS Announce Winners of Annual Academic Competition
Catalent and AAPS announce the five winners of its annual academic competition.
Research Firm Predicts Negative Impact of Biosimilars
A new report from GlobalData states that biosimilars will overtake the market share after 2019.
Total Facility Solutions Opens Hygienic Fabrication Center
The fabrication facility will supply modular construction to the US life-science market.
Glenmark Pharmaceuticals Opens Monoclonal Antibody Manufacturing Facility
The new mAb manufacturing facility in Switzerland will supply material for clinical development.
FDA Releases Draft Guidance on ANDA Submissions
Draft guidance from FDA includes information essential for the completion of ANDA applications.
Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.
Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion.
EMA Changes Guideline on Drug Name Acceptability
EMA publishes revised guideline on the acceptability of names for drugs.
Wockhardt Cited by FDA for Quality Control Failures
FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.
Sartorius Stedim Biotech Launches New Generation of Single-Use Bags, Flexsafe
Innovative polyethylene film sets new benchmark
Roche Acquires Genia Technologies
Genia's DNA-sequencing platform will strengthen Roche's pipeline.
Provence Technologies Acquires Synprosis
Provence Technologies? strengthens its expertise in therapeutic chemistry with acquisition of Synprosis.
AMRI to Acquire Oso Biopharmaceuticals Manufacturing
AMRI adds commercial-scale sterile injectable manufacturing capabilities with acquisition of Oso Biopharmaceuticals.
PharmaCell to Finalize Purchase of Cell Therapy Production Facility
PharmaCell has finalized its purchase of the cell therapy production facility from TiGenix.
Aastrom Acquires Sanofi's Cell Therapy and Regenerative Medicine Business
Aastrom acquires Sanofi's CTRM business unit for $6.5 million.
Repligen Acquires Bioprocessing Business of Refine Technology
Repligen acquired Refine Technology and its Alternating Tangential Flow system for continuous bioprocessing.
FDA Creates Easy Access to FDA Public Data
FDA launches openFDA to provide easy access to FDA public data.
Alexion Recalls Certain Lots of Soliris Concentrated Solution for Intravenous Infusion
Alexion initiates a voluntary nationwide recall of certain lots of soliris (eculizumab) concentrated solution for intravenous infusion because of visible particulate matter in a single lot.
Bone Marrow-on-a-Chip Developed to Test Drug Effects
Researchers from Harvard have reproduced the structure, functions, and cellular make-up of bone marrow, to create a device known as bone marrow-on- a-chip.
Stem Cells From Human Body Fat Used to Fight Brain Cancer
Johns Hopkins researchers use stem cells derived from human body fat to deliver treatment for brain tumors.
NIH Study Reveals New Cancer Immunotherapy Method
NIH study reveals a new cancer immunotherapy method could be effective against a range of cancers.
FDA Issues Guidance on Expedited Programs for Serious Conditions
FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.
PacificGMP Increases Production Capacity
PacificGMP doubles its GMP production capacity with the addition of a second System 1000 Bioreactor platform.
GE Healthcare Launches Cytiva Plus Cardiomyocytes
GE Healthcare introduces the Cytiva Plus Cardiomyocytes, a high fidelity human heart cell model.
Bristol-Myers Squibb Enters Cancer Research Collaborations
Bristol-Myers Squibb announced collaborations with CytomX on probodies and with Incyte in an immunotherapy clinical trial.
Report:Positive Outlook for Investment in Global Pharma and Biotech Industry
Research from Frost & Sullivan indicates a strong comeback of IPOs suggesting a positive outlook for investment in the pharmaceutical and biotechnology industry.
GSK Selects Genedata Biologics as Antibody Discovery Platform
GSK selects Genedata Biologics as an R&D data management and workflow-support platform.
