ZS Pharma Inc., of Redwood City, Calif., published previously unreleased data about its lead candidate, ZS-9, in a letter to the editor of The New England Journal of Medicine describing a combined analysis of two phase III patients with severe hyperkalemia who received a 10-mg dose of the drug, leading to a "rapid and clinically significant reduction in potassium as early as one hour after administration." Read More
4SC AG, of Frankfurt, and Singapore-based Menarini Asia-Pacific Holdings Pte. Ltd. entered a licensing and development partnership for 4SC's cancer compound, resminostat, for the Asia-Pacific region, excluding Japan. Read More
Pernix Therapeutics Holdings Inc., of Morristown, N.J., said it commenced a private offering of $120 million aggregate principal amount of its convertible senior notes due 2021. Most of the gross proceeds – about $80.9 million – will be used to finance the cash consideration portion necessary to consummate its previously announced acquisition of the Zohydro (hydrocodone) ER franchise. Read More
Pacira Pharmaceuticals Inc., of Parsippany, N.J., said it received a subpoena from the U.S. Department of Justice, U.S. Attorney's Office for the District of New Jersey, requiring a broad range of documents pertaining to marketing and promotional practices related to the product Exparel (bupivacaine liposome injectable suspension). Read More
New FDA fast track status for Medicinova Inc.'s phase II nonalcoholic steatohepatitis (NASH) drug MN-001 (tipelukast) invigorated the company's U.S.-listed shares (NASDAQ:MNOV), pushing them 41.3 percent higher to $4.96 in heavy trading Thursday as investors warmed to the company's chances for gaining FDA approval to treat the chronic liver condition, for which no drug is currently approved. Read More
Researchers and executives are gearing up for the annual meeting of the American Association for Cancer Research (AACR), which will be held in Philadelphia from April 18 - 22, where it's safe to say immuno-oncology will continue to rule the roost. Beyond the big data presentations of checkpoint inhibitors and CAR T cells themselves, among the most urgent question is how to help more patients realize the promise of immuno-oncology. Read More
On the heels of last summer's phase IIb failure of TC-5214 in overactive bladder – a disappointment that pushed shares to a then-52-week low of $2.76 – and a string of other duds with neuronal nicotinic receptors (NNRs), Targacept Inc. said top-line results from a phase I/II exploratory study of TC-6499 as a treatment for diabetic gastroparesis also missed its primary endpoint and the program will be discontinued. Read More
The FDA approved the first generic version of Copaxone (glatiramer acetate injection) to treat patients with relapsing forms of multiple sclerosis (MS), giving a green light to the abbreviated new drug application (ANDA) filed by Sandoz Inc. to market Glatopa (glatiramer acetate injection, formerly M356), formulated as a once-daily 20 mg/mL injection. Read More
LONDON – Shares in Active Biotech AB (NASDAQ STOCKHOLM:ACTI) slumped by 60 percent to close at SEK10.90 (US$1.27) on Thursday after the company announced its lead product, tasquinimod, had failed in a 1,200-patient phase III prostate cancer trial funded by partner Ipsen SA. Read More
Glaxosmithkline plc, of London, is collaborating with the ALS Association, Harvard Stem Cell Institute and Massachusetts General Hospital Neurological Clinical Research Institute on a new amyotrophic lateral sclerosis (ALS) trial to include testing using stem cells from patients. Read More
