FDA Raps J&J’s Knuckles over Clinical Trials of Ceftobiprole Antibiotic
Warning letter covers conduct of trials with the broad-spectrum anti-MRSA drug. European decision also on hold as a result of ongoing GCP inspection.
Crucell Wins $40.7M NIAID Contract to Develop Human Flu mAbs
Based on MAbstract technology, preclinical candidates have shown efficacy against seasonal H1N1 strains, the pandemic H1N1 swine flu strain, and avian H5N1 viruses.
Prolor Biotech to Use The University of Queensland’s Human Growth Hormone...
Nonexclusive license deal allows firm to determine potency of its long-acting version of HGH and identify relevant neutralizing antibodies.
Forest Licenses Antibiotic to AstraZeneca in Europe and Other Markets
Ceftaroline in development treatment of complicated skin and skin structure infections and community-acquired bacterial pneumonia (CABP).
FDA Clears Sandoz’ Generic Competitor to Astellas Transplant Drug
Astellas will push the agency for more rigorous bioequivalence testing of generic immuosuppressants.
Sandoz will launch the first generic version of Astellas’ transplant rejection drug,...
Inovio and NIH Vaccines Research Center Ally on Swine Flu and...
Organizations will evaluate delivery of these candidates by electroporation in preclinical studies.
Inovio Biomedical is partnering with the NIH Vaccine Research Center (VRC) to develop...
Novartis Starts Shipment of Seasonal Flu Vaccine to the U.S.
Trials of swine flu vaccine are under way, and initial delivery could begin by year-end.
Novartis Vaccines started shipping the first of 30 million doses...
ImmunoVaccine Technologies Collaborates with Scancell to Advance DNA Vaccine Delivery
IVT’s DepoVax will initially be tested with Scancell’s preclinical cancer vaccine.
ImmunoVaccine Technologies (IVT) entered an agreement with Scancell to explore the potential of using...
Anesiva and Arcion Merge to Form Company Focused on Pain Therapeutics
Arcion shareholders will own 64% of the new entity.
Anesiva and Arcion Therapeutics inked a definitive merger agreement, which will result in a company with...
Ichor and Partners Awarded $3.3M Grant to Develop Alzheimer’s Vaccine
Vaccines developed by academic collaborators will be coupled with Ichor’s delivery system in preclinical studies.
Ichor Medical Systems along with academic collaborators received $3.3 million...
