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Bioxel Pharma Inc., a leading manufacturer and supplier of taxane APIs and developer of targeted oncology drugs, is pleased to announce manufacturing of the first industrial scale cGMP batch of its key intermediate for docetaxel.
CepTor Corporation, a biopharmaceutical company focusing on cell-targeted therapeutic products for neuromuscular and neurodegenerative diseases, announced that it has signed a Letter of Intent (LOI) with Ferring International Center, S.A. in which Ferring plans to divest and CepTor plans to purchase recombinant human copper zinc superoxide dismutase (r-h CuZnSOD or SOD) for prevention of chronic respiratory morbidity in premature newborns.
Schering-Plough Corp. is seriously considering approaching Bristol-Myers Squibb Co. about a possible merger, according to a report in The Star-Ledger newspaper on Friday.
Astellas Pharma US made "unsubstantiated" claims about its anti-rejection drug Prograf and minimized its risks when it placed an ad in a professional journal, the FDA said in a warning letter to the company.
Mylan Laboratories has cleared another legal hurdle in its quest to market a generic version of Johnson & Johnson's incontinence drug Ditropan XL with a court ruling favoring its challenge to the product's patent.
Icelandic generic drugmaker Actavis failed to conduct a follow-up investigation of a fatal adverse event, did not submit required reports on adverse drug experiences (ADEs) to the FDA and "manufactures numerous prescription drug products without approved applications," the agency said in a warning letter to the firm.
Several of the world's top drugmakers may weigh acquiring Bristol-Myers Squibb Co. after it fired its chief executive, although suitors seem unlikely to bid before next summer, analysts said.