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USP Helps Expand Worldwide Access to Tuberculosis Drugs
USP and USAID give prequalification status to Capreomycin, an anti-tuberculosis injectable.
Merck to Acquire Idenix
Merck acquires Idenix Pharmaceuticals for $3.85 billion.
Cellectis Enters Agreement With CELLforCURE
Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.
Xcelience Opens European Packaging and Distribution Facility
Xcelience opens a clinical packaging and distribution facility in Birmingham, UK.
APIC Publishes New Industry Best Practices Documents
APIC provides guidance on cleaning validation in API plants and how to implement GDP for APIs.
USP Welcomes New Partners to "Fight the Fakes" Campaign
Eleven new organizations join the global "Fight the Fakes" campaign.
EMA Reinstates GMP Certificate for Ranbaxy's Toansa Facility
Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.
Bayer Extends CEO Contract
Bayer extends its CEO contract with Marijn Dekkers until 2016.
Malvern Instruments to Acquire MicroCal
Malvern Instruments will acquire the MicroCal business from GE Healthcare Life Sciences.
Roche Acquires Genia Technologies
Genia's DNA-sequencing platform will strengthen Roche's pipeline.
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.
Teva Announces New Organizational Structure and Acquisition of Labrys Biologics
Teva assigns new executive positions and acquires Labrys Biologics.
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.
AMRI to Acquire Oso Biopharmaceuticals Manufacturing
AMRI adds commercial-scale sterile injectable manufacturing capabilities with acquisition of Oso Biopharmaceuticals.
Aastrom Acquires Sanofi's Cell Therapy and Regenerative Medicine Business
Aastrom acquires Sanofi's CTRM business unit for $6.5 million.
PharmaCell to Finalize Purchase of Cell Therapy Production Facility
PharmaCell has finalized its purchase of the cell therapy production facility from TiGenix.
FDA Creates Easy Access to FDA Public Data
FDA launches openFDA to provide easy access to FDA public data.
Repligen Acquires Bioprocessing Business of Refine Technology
Repligen acquired Refine Technology and its Alternating Tangential Flow system for continuous bioprocessing.
Provence Technologies Acquires Synprosis
Provence Technologies? strengthens its expertise in therapeutic chemistry with acquisition of Synprosis.
Capsugel and Bend Research Increase Spray-Dried Dispersion Capacity
Bend Research installs its first commercial-scale spray dryer at its Oregon facility.
Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
Finished Product Monographs in the European Pharmacopoeia
The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.
DCAT Sharp Sourcing Addresses Procurement Topics
DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.
FDA Expands CERSI Network
John Hopkins and UCSF-Stanford join FDA?s Centers of Excellence in Regulatory Science and Innovation.
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.
Turkish Pharma Manufacturers Look to New Markets
The CPhI report warns that Turkey's dynamism is being restricted by the current government reimbursement model.
Lilly Oncology On Canvas Celebrates 10 Years of Cancer Journeys
ASCO meeting attendees give artistic interpretations of cancer journeys in the form of public Hope Murals.
Bristol-Myers Squibb Enters Cancer Research Collaborations
Bristol-Myers Squibb announced collaborations with CytomX on probodies and with Incyte in an immunotherapy clinical trial.
BioPlan Associates Releases 11th Annual Global Biomanufacturing Study
The 11th Annual Global Biomanufacturing Study includes a global analysis of 238 biomanufacturers and 178 suppliers in 31 countries.
