Takeda Pharmaceutical Co Ltd (ADR) (OTCMKTS:TKPYY) and H LUNDBECK A/S (OTCMKTS:HLUKF) announces FDA approval of Brintellix for Treatment of adults with major depressive disorder. Both companies jointly announce that the FDA has approved Brintellix for the treatment of adults with major depressive disorder, a debilitating mental health illness affecting ~ 14 million American adults in a given year. Takeda Pharmaceutical Co Ltd (ADR) (OTCMKTS:TKPYY) share in after hours gained 0.38% to $23.61. H LUNDBECK A/S (OTCMKTS:HLUKF) shares were up 2.11% to $22.31 in last session.
Biogen Idec Inc (NASDAQ:BIIB) has reported new data showing significant clinical and MRI improvements with PLEGRIDY. Company announces new data analyses from year one of the two-year, pivotal, Phase 3 ADVANCE study of PLEGRIDYTM, which is an investigational subcutaneous injectable for relapsing forms of multiple sclerosis, in which interferon beta-1a is pegylated to prolong the molecule’s exposure in the body and enable the study of a less frequent dosing schedule. Clinical and MRI data from the study demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support the clinical efficacy profile of PLEGRIDY. Biogen Idec Inc (NASDAQ:BIIB) shares were up 1.73% to $244.92 in last session.
Furiex Pharmaceuticals Inc (NASDAQ:FURX) reportedly enters into a loan agreement for $15 million and restructures its existing secured loan. Company announces it has executed a $15 million debt financing transaction with chairman Fred Eshelman, and he is a 27.5% shareholder of company in parallel, Furiex has also entered into a Second Amended and Restated Loan and Security Agreement with MidCap Financial and Silicon Valley Bank for restructuring of its existing $40 million credit facility. Furiex Pharmaceuticals Inc (NASDAQ:FURX) shares went up 1.41% to $44.61 in last session.
Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) launches of generic Zemplar in the US. Company announces the launch of the generic equivalent to Zemplar tablets in the US as of September 30, 2013, and Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) shares fell-0.24% to $37.69 in last session.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) announce FDA Advisory Committee scheduled to review RELISTOR sNDA for opioid-induced constipation in patients with chronic pain. Both Pharmaceutical companies announced that the FDA will convene an Advisory Committee on March 10-11, 2014 at which time Salix’s Supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain will be considered. The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register. Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX) shares were up 5.45% to $5.03 in after hours. Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) shares slipped -5.48% to $66.88 in after hours.
Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY) collaborators to present positive clinical trial data at the 15th Annual World Conference on Lung Cancer. Company announced that abstracts detailing results from two Phase II studies examining the use of REOLYSIN in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (:NSCLC) with Kras or EGFR-activated tumors (REO 016) and in patients with squamous cell carcinoma of the lung (REO 021), are now available on the International Association for the Study of Lung Cancer (:IASLC) World Conference on Lung Cancer website at http://wclc.iaslc.org. The conference is scheduled to start from October 27th to 30th, 2013 in Sydney, Australia. Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY) shares shoot up 4.18% to $2.49 in after hours.
Merck & Co., Inc. (NYSE:MRK) Interim data for MK-3475 to be presented at 15th World Conference on Lung Cancer. It was confirmed by the company that interim data from the company’s Phase IB expansion study (PN 001) evaluating the efficacy and safety of MK-3475 in patients with refractory non-small cell lung cancer (:NSCLC) is scheduled for presentation at the 15th World Conference on Lung Cancer on Oct. 29 at 4:15 p.m., (1:15 a.m. EDT), in Sydney, Australia. An abstract (# 2416) published today summarized preliminary findings from 38 patients with NSCLC treated with MK-3475. Data from additional patients and an analysis of tumor PD-L1 expression is scheduled to be presented by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, during the conference. Merck & Co., Inc. (NYSE:MRK) shares were up 2.38% to $48.74 in last session.