Industry News
Janssen Pharmaceuticals Forms Partnerships with CureVac and DCPrime
Janssen Pharmaceuticals collaborates with CureVac and DCPrime in vaccines.
ABC Laboratories Subsidiary to Relocate to Missouri
ABC Laboratories plans to move operations of its subsidiary, Morse Laboratories, based in California, to Missouri.
Pfenex, BARDA Extends Anthrax Vaccine Pact
Pfenex modifies its contract with US government for Anthrax vaccine.
Carbogen Amcis Expands ADC Capacity
Carbogen Amcis has made several investments to increase capabilities in supplying antibody drug conjugates.
Waters Introduces Mass Detector for Chromatography Separations
The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.
FDA Activities Continue During Government Shutdown
During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.
Malvern Instruments Acquires NanoSight
Malvern Instruments has acquired NanoSight, the UK-based nanoparticle characterization company.
Gallus BioPharmaceutical Aquires CMO Laureate Biopharmaceutical Services
he CMO Gallus BioPharmaceutical has acquired the biologics CMO Laureate Biopharmaceutical Services.
DSM Pharmaceuticals Appoints New CEO
DSM Pharmaceutical Products appoints a new CEO and President.
Merck & Co. Receives Complete Response Letter From FDA Regarding Sugammadex Sodium Injection
Merck & Co. has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection.
West Pharmaceutical Opens Second Manufacturing Plant in China
West Pharmaceutical Services opens its second manufacturing plant in China to expand presence in Asian markets.
Coldstream Laboratories for Parental Dosage Forms NCI Contract
Coldstream Laboratories partners with the National Cancer Institute for developing parental dosage forms for cancer drugs.
Covance Launches External Laboratory-Management Services
Covance launches external laboratory-management services for clinical trials.
J&J's Janssen and PATH Partner to Develop Rilpivirine Formulation
J&J's Janssen and PATH partner to improve drug formulation that could help prevent HIV infection.
ATMI Invests in Sterile Fill and Connector Technology
ATMI has invested in sterile-connector and sterile-fill technology developed by Medical Instill Technologies.
Catalent Applied Drug Delivery Institute Appoints New Advisory Board Member
Catalent Applied Drug Delivery Institute appoints Claus-Michael Lehr to advisory board.
JHL Biotech to Build KUBio Modular Facility
GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.
Judge Approves Consent Decree Against Shamrock Medical Solutions Group
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.
Unilife Signs Supply Contract with Sanofi for Prefilled Syringes
Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.
Theorem Clinical Research, Charles River Form Alliance
Theorem Clinical Research?s alliance with Charles River Laboratories will provide nonclinical testing programs in the areas of bioanalysis, immunogenicity, and immunology.
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.
VWR International, Thermo Fisher Sign Global Agreement
VWR International has signed a global distribution agreement with Thermo Fisher Scientific.
California State Senate Passes Biosimilars Bill
Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.
Waters Corporation Announces CEO Transition Plan
CEO of Waters Corporation will retire within in the next two years.
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.
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 Selects Freeslate to Improve Formulation Development
Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.