FDAnews Drug Daily Bulletin
Sept. 7, 2012 | Vol. 9 No. 176
DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter.
The Generic Pharmaceutical Association’s (GPhA) plan to help the FDA deal with drug shortages should launch in the coming weeks, after the FTC found it will not be anticompetitive as sensitive information will be protected.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.
A transdermal patch delivering rivastigmine (Exelon) at a 40% higher rate than the previous maximum strength has been cleared by the FDA for patients with mild to moderate Alzheimer’s disease, its manufacturer said.
Spectrum Pharmaceuticals has completed its acquisition of Colorado biotech Allos Therapeutics.
Swiss drugmaker Roche Holding AG expects results from 19 late-stage clinical trials over the next 18 months, providing a stream of products to offset a potential near-term threat to breast cancer drug Herceptin, its third biggest seller.
India plans to widen the scope of price controls on pharmaceuticals, a senior government official said, creating another potential hurdle for multinational drug companies doing business in the country.
Targacept is planning a Phase IIb study of its experimental drug — TC-5214 — as a treatment for overactive bladder in the first half of next year.
Soligenix Receives IND Clearance From FDA to Initiate Clinical Program to Evaluate SGX203 as Therapy for Pediatric Crohn’s Disease
Soligenix, a development stage biopharmaceutical company, announced that the FDA has completed its review and cleared the IND application for SGX203 (oral beclomethasone 17,21-dipropionate) for the induction treatment of pediatric Crohn’s disease.
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