FDA

FDA approves labeling with abuse-deterrent features for third extended-release opioid The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to...

Ebola cases in Nigeria and Senegal have been so far limited and the World Health Organization is expected to shortly declare outbreaks in those countries contained. It's been 42 days as of Friday since the single known Ebola case in Senegal was reported and 39 days in Nigeria, where the...

Sarepta Therapeutics Inc (NASDAQ: SRPT) opened sharply higher Friday on news that its drug candidate for Ebola didn't present safety concerns in two small human trials. The company announced results of the studies on Thursday, which were performed under a contract with the U.S. Department...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network (DRCR.net) comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), EYLEA® (aflibercept) Injection...

Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that it has entered into a master clinical drug supply agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA(R) (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in...

Diplomat, the nation's largest independent specialty pharmacy, announced today that it has a contract to distribute Esbriet (pirfenidone), which was approved Oct. 15, 2014 by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis. In addition to the breakthrough...

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced encouraging topline data from its Phase 2a exploratory study of duvelisib (IPI-145), its oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with mild, allergic asthma. Data from this randomized, double-...

TherapeuticsMD Inc. (NYSE MKT: TXMD), an innovative women's healthcare company, announced today that positive results from phase 2 and pharmacokinetic studies of TX-004HR will be presented at the 25th Annual Meeting of The North American Menopause Society, October 15-18, 2014, at the Gaylord...

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced the initiation of four expansion cohorts in its ongoing Phase 1 study of AG-221, a first-in-class, selective, potent IDH2 mutant inhibitor. The Phase 1...

Pacific Biosciences of California, Inc., (Nasdaq: PACB) provider of the PacBio® RS II DNA Sequencing System, today announced the release of new chemistry and software designed to enhance the performance and output of the platform by 45%. The latest release increases read length and improves...

Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced preliminary data from its Phase 1/2 study of ADXS-HPV in human papillomavirus (HPV) associated anal cancer that indicate a "clinical complete response" in all 7 patients who have...

TriVascular Technologies, Inc. (Nasdaq: TRIV) announced today that the U.S. Food and Drug Administration (FDA) has approved CustomSeal Technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customized seal by filling the conformable O-rings with the...

Medtronic today announced the U.S. Food and Drug Administration (FDA) approval of its CapSureFix Novus(TM) MRI SureScan® 5076 Lead for use with magnetic resonance imaging (MRI). The lead is approved for MRI scans positioned on any region of the body when paired with a Medtronic dual-chamber MR-...

Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced data demonstrating that EXPAREL^® (bupivacaine liposome injectable suspension) used in peripheral nerve blocks has comparable safety to placebo and bupivacaine HCl. The analysis, based on a review of six Phase 1-3 clinical trials, will be...

AbbVie (NYSE: ABBV) announced new results from PIONEER II, a pivotal Phase 3 study, demonstrating the effect of HUMIRA® (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.4...