• Mylan Inc., of Pittsburgh, said it has been sued by New York-based Forest Laboratories Inc., Forest Laboratories Holdings Ltd. and Royalty Pharma Collection Trust in connection with the filing of an abbreviated new drug application with FDA for Milnacipran HCl Tablets 12.5 mg, 25 mg, 50 mg and 100 mg. Read More
• Applied Integrin Sciences Inc., of Los Angeles, launched a crowdfunding campaign for development of its cancer candidate. The Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California will facilitate the funding initiative, with several other organizations. Read More
• Kempharm Inc., of North Liberty, Iowa, disclosed results from a second pivotal clinical study of KP201 (benzhydrocodone hydrochloride and acetaminophen) in preparation for a new drug application, which the company anticipates filing in the second quarter of 2014. Read More
More than doubling the hoped-for take from its initial public offering (IPO), Ophthotech Inc. raised $167 million by selling 7.6 million shares at $22 each for ongoing Phase III work with Fovista (formerly E10030), an antiplatelet-derived growth factor agent that would be used with anti-VEGF therapy in wet age-related macular degeneration (AMD). Read More
Focus at Infinity Pharmaceuticals Inc., which had shifted in the wake of disappointing data from its Hedgehog inhibitor program in early 2012, narrowed further this week following a Phase II miss with heat-shock protein 90 (Hsp90) inhibitor retaspimycin hydrochloride in non-small-cell lung cancer (NSCLC). Read More
Prioritizing 505(q) petitions asking the FDA to take or stay action in pending approvals of biosimilars, generics and 505(b)(2) drugs is delaying action on more important matters, the agency told Congress in a recently submitted annual report. Read More
An anxious wait for Oncothyreon Inc. has come to an end, as Merck KGaA announced it would continue development of tecemotide (formerly Stimuvax) following last year’s Phase III trial miss. Read More
