Moving into a chronic indication with numerous approved drugs is a challenge that gives pause to drugmakers, even when millions of patients can't tolerate or don't respond to existing therapies. When the indication additionally falls into the central nervous system (CNS) space, which has bedeviled dozens of drug development attempts in recent years, all but the boldest in the field tend to focus their efforts elsewhere.
TG Therapeutics Inc. will seek to carry two candidates in its pipeline across the goal line in a single play after reaching agreement with the FDA on a special protocol assessment (SPA) for the design of a phase III study combining TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, a glycoengineered once-daily phosphoinositide-3-kinase (PI3K)-delta inhibitor, to treat chronic lymphocytic leukemia (CLL).
A pre-market lift for shares of Xenoport Inc. (NASDAQ:XNPT) quickly deflated Tuesday following release of preliminary top-line results from the phase II trial of XP23829 in moderate to severe chronic plaque-type psoriasis. Shares closed at $4.84 for a loss of $1.89, or 28.1 percent.
Gencia LLC, a nine-person biotech based in Charlottesville, Va., made an auspicious debut on the biotech stage with a potential $500 million deal with Takeda Pharmaceutical Co. Ltd. to develop a class of small-molecule drugs called mitochondrial agonists of the glucocorticoid receptor, or MAGRs. Gencia said its compounds may offer the benefits of conventional glucocorticoids but with improved potency and safety.
Raptor Pharmaceutical Corp.'s program to advance RP103 (cysteamine bitartrate delayed-release) in pediatric nonalcoholic steatohepatitis (NASH) "has always been a little bit left of center," president and CEO Julie Anne Smith maintained Monday. "Our core competency is in rare diseases.
Taking its turn before a joint meeting of the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management advisory committees (adcom), Collegium Pharmaceutical Inc. faced many of the same questions about its tamper-resistant, extended-release (ER) oxycodone candidate, Xtampza (formerly COL-003), that Purdue Pharma LP incurred the previous day about Avridi, its immediate-release oxycodone tablet.
Gencia LLC, a nine-person biotech based in Charlottesville, Va., made an auspicious debut on the biotech stage with a potential $500 million deal with Takeda Pharmaceutical Co. Ltd. to develop a class of small-molecule drugs called mitochondrial agonists of the glucocorticoid receptor, or MAGRs. Gencia said its compounds may offer the benefits of conventional glucocorticoids but with improved potency and safety.
Cipla Ltd., through its UK unit, Cipla EU, inked agreements to acquire the U.S.-based generics company, Invagen Pharmaceuticals Inc., and consulting firm Exelan Pharmaceuticals Inc., in an all-cash deal valued at $550 million. The move represented the second big shift in the U.S. generics market in as many days, coming 24 hours after Lannett Co. Inc., of Philadelphia, said it was purchasing Kremers Urban Pharmaceuticals Inc., of Princeton, N.J. – the U.S. specialty generic pharmaceuticals subsidiary of UCB SA, of Brussels – for $1.23 billion up front and undisclosed contingency payments.
Cipla Ltd., through its UK unit, Cipla EU, inked agreements to acquire the U.S.-based generics company, Invagen Pharmaceuticals Inc., and consulting firm Exelan Pharmaceuticals Inc., in an all-cash deal valued at $550 million.
Incyte Corp. leveraged its positive cash flow to invest in its immuno-oncology (I-O) future through a license and collaboration agreement with Jiangsu Hengrui Medicine Co. Ltd. to develop and commercialize anti-PD-1 monoclonal antibody SHR-1210.
