Whether to imitate the tortoise or the hare is a constant challenge in drug development. A go-slow approach enables more methodical evaluation of technology, targets and potential applications, with the prospect that precious funds might not be wasted going down a blind alley.
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee (adcom) is slated to meet Wednesday to discuss the potential cardiovascular (CV) risk associated with peripherally acting opioid receptor antagonists in development to treat opioid-induced constipation (OIC).
FDA approval of Biogen Idec's long-acting hemophilia A product upped the ante in the space, as Eloctate (antihemophilic factor [recombinant], Fc fusion protein) became the first recombinant hemophilia A therapy with prolonged circulation in the body and the only treatment indicated to reduce the frequency of bleeding episodes in the indication by offering prophylactic infusions every three to five days.
Pfenex Inc. filed with the SEC for an initial public offering (IPO) of up to $74.75 million, aiming to finance a planned phase III trial of lead candidate PF582, a biosimilar to Lucentis (ranibizumab, Genentech Inc./Novartis AG). Filing as an emerging growth company, San Diego-based Pfenex set its sights on the big board, with plans to list on the New York Stock Exchange as PFNX.
Ah, the summer holidays. Time to unplug – for minutes, hours or days at a time – prop up your feet and kick back. But what about a good read? Should you grab a relaxing snoozer that won’t tax your brain or a thriller that will keep you on the edge of your seat? A topic that relates to the biotech field or a subject as far removed from the office as possible? History or science fiction? Inspiration or cautionary tale? Whatever your preference, BioWorld has options. One respondent to the survey for our 2014 reading list, the 8th in...
Complexa Inc. landed a $13 million series B and new investor Jafco Life Science Investment, a unit of Tokyo-based private equity firm Jafco Co. Ltd., to advance development of two formulations of its lead compound CXA-10. The Pittsburgh-based company has an intravenous formulation of CXA-10 in a phase I study to treat contrast imaging dye-induced nephropathy (CIN), a form of acute kidney injury (AKI), as the compound's proof-of-concept indication.
Macrogenics Inc. enticed another big pharma partner to the table with a candidate from its Dual-Affinity Re-Targeting, or DART platform. Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, took an option to develop and commercialize MGD010, a preclinical asset targeting autoimmune diseases, that uses DART to simultaneously engage the B-cell surface proteins CD32B and CD79B.
In a move that could potentially signal greater flexibility by regulators in reviewing groundbreaking drugs with new mechanisms of action in rare diseases with clear unmet medical need, the FDA provided guidance for a potential regulatory path, under accelerated approval, for drisapersen, the lead program in development by Prosensa Holding NV to treat Duchenne muscular dystrophy (DMD).
Omeros Corp. began its transformation from a drug development company to a commercial venture Monday after the FDA green-lighted Omidria (phenylephrine and ketorolac injection) 1 percent/0.3 percent. The drug, formerly OMS302, was approved to maintain pupil size during cataract surgery or intraocular lens replacement (ILR) by preventing intraoperative pupil constriction, or miosis, and to reduce postoperative pain.
Despite rumors to the contrary, news coming from the American Society of Clinical Oncology (ASCO) meeting in Chicago was not entirely focused on immunotherapy. Privately held Angiochem Inc. was among the companies reporting positive findings from candidates with other mechanisms of action.
