FDAnews Drug Daily Bulletin
Oct. 5, 2012 | Vol. 9 No. 196
During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan.
Genzyme is voluntarily recalling nine lots of its kidney transplant drug Thymoglobulin after one product lot failed a periodic stability test, the Sanofi subsidiary says.
India’s patent laws are coming under more intense scrutiny, with cases that could add new difficulties for foreign multinational companies.
Teva Pharmaceutical has suspended testing of its generic version of Rituxan (Rituximab), a $7-billion a year drug, at the third stage of clinical trials.
VentiRx Pharmaceuticals has formed a world-wide collaboration with Celgene Corporation to develop VTX-2337, a highly potent and selective TLR8 agonist for cancer treatment.
Sanofi announced it has signed an agreement to acquire Genfar, a leading pharmaceuticals manufacturer headquartered in Bogota, Colombia.
Celgene said that a Food and Drug Administration panel will not review its multiple myeloma drug pomalidomide in November.
Boston Therapeutics announced the FDAhas approved the petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of the diabetes drug metforminhydrochloride.
India has revoked Pfizer’s local patent for its cancer drug Sutent after hearing a post-grant opposition filed by generic-drug maker Cipla.
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