The Centers for Medicare & Medicaid Services (CMS) Tuesday launched its official Open Payments website, an online database consolidating public information on payments made by drug- and devicemakers to doctors and medical schools.
A pivotal trial of Bristol-Myers Squibb Co.'s Opdivo (nivolumab), presented at the European Society of Medical Oncology (ESMO) conference in Madrid, on Monday, heralded a potential end to chemotherapy in treating BRAF wild-type melanoma, with response rates to the programmed death-1 (PD-1) immune checkpoint inhibitor reaching 32 percent of patients vs. 11 percent on chemotherapy.
Cancer therapy specialist Helsinn Group reported that anamorelin, its once-daily ghrelin receptor agonist for the common wasting disease cachexia significantly increased lean body mass (LBM) compared to placebo in two phase III trials in non-small-cell lung cancer (NSCLC) patients.
Celldex Therapeutics Inc. is initiating a pilot study testing the ability of CDX-301, a recombinant FMS-like tyrosine kinase 3 (Flt3) ligand it licensed from Amgen Inc. in March 2009, to mobilize and improve transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies.
Merrimack Pharmaceuticals Inc. got a boost Wednesday after Baxter International Inc. committed to pay the company up to $970 million for rights to advance and market MM-398, a nanoliposomal encapsulation of irinotecan for pancreatic cancer outside the U.S. and Taiwan.
TG Therapeutics Inc., of New York, is exercising an early option to buy exclusive global rights to TGR-1202, a phosphoinositide-3-kinase (PI3K)-delta inhibitor, from its partner, Rhizen Pharmaceuticals SA.
Taurx Therapeutics Ltd. hit full enrollment in the second of two phase III trials of LMTX, the company's tau aggregation inhibitor (TAI) for the treatment of Alzheimer's disease. The multicenter, placebo-controlled trial will assess the therapy's efficacy in 700 subjects with mild Alzheimer's disease over as much as 21 months through both clinical assessments and brain imaging. Completion of both trials is expected in the first quarter of 2016.
Auxilium Pharmaceuticals Inc.'s shares (NASDAQ:AUXL) rose 44.8 percent, or $9.65, to close at $31.17 Wednesday following Endo International plc's unsolicited $2.2 billion bid for the company, a development that could throw a wrench in Auxilium's plans to merge with Canada's QLT Inc. but could offer its shareholders an irresistible path to profit.
Orion Corp. and Bayer Healthcare AG, part of Bayer AG, have begun to enroll patients in a phase III trial of ODM-201, an oral androgen receptor (AR) inhibitor the companies are co-developing to treat castration-resistant prostate cancer (CPRC). Supported by a €50 million (US$68 million) up-front Bayer paid Orion at the collaboration's June start, the study will test ODM-201 in men with non-metastatic CPRC who have rising prostate-specific antigen levels.
Gilead Sciences Inc. has signed licensing deals with seven Indian generic drugmakers to manufacture its flagship chronic hepatitis C virus (HCV) medicine, Sovaldi (sofosbuvir), and an investigational ledipasvir/sofosbuvir combination for distribution in 91 developing countries. The deal will expand access to the medicines for as many an 100 million people living with HCV by steeply discounting the medicines' price tag.
