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Health Highlights: Feb. 27, 2015

Posted 2 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: U.S. Military Ends Ebola Mission in Liberia The United States' military officially ended its five-month Ebola aid mission in Liberia on Thursday. At one point, there were 2,800 U.S. military personnel in Liberia, but the number gradually fell as the epidemic began to subside. The Pentagon said nearly all troops...

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Otonomy Submits New Drug Application to the FDA for AuriPro

Posted 3 weeks ago in New Drug Applications

SAN DIEGO, Feb. 26, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of AuriPro as a treatment of middle ear...

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Ultrasound Treatment May Be Option for Plantar Fasciitis

Posted today in Medical

SUNDAY, March 1, 2015 -- An ultrasound technique is showing early promise as a quick and minimally invasive treatment for the common and painful foot condition known as plantar fasciitis. The finding is based on a short-term study involving just 65 patients, the researchers noted. "While the long-term outcome studies are in progress, the results we have seen to date are very promising," said study lead author Dr....

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Nerve Treatment Via Nose Shows Promise Against Migraines

Posted today in Medical

SUNDAY, March 1, 2015 -- A procedure that delivers the anesthetic lidocaine (Xylocaine) directly to nerves in the back of the nasal cavity appears to offer significant relief to migraine sufferers, preliminary research indicates. Early findings suggest that a single outpatient treatment can reduce migraine pain levels by about 35 percent for up to a month after the procedure, according to this small, ongoing...

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Tips for Safe Snow Fun

Posted yesterday in Medical

SATURDAY, Feb. 28, 2015 -- Winter sports are a great way to get exercise and fresh air, but they're not without risks. In 2013, more than 343,000 people in the United States received medical treatment for winter sports injuries, according to the Consumer Product Safety Commission. Skiing topped the treatment list, with 138,559 injuries. Snowboarding accounted for 95,348 accidents; sledding, more than 63,000; and ice...

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Monthly News Roundup - February 2015

Posted 2 days ago in Pharma Industry News

Sanofi Receives FDA Approval for Basal Insulin Toujeo The U.S. Food and Drug Administration has approved Sanofi’s Toujeo (insulin glargine [rDNA origin], a once-daily long-acting basal insulin for adults with type 1 or type 2 diabetes. In the clinical trials evaluating Toujeo, all of the primary study endpoints were met by demonstrating similar blood sugar control with Toujeo as compared to Lantus. The most...

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LeafBio Announces Acceptance of Investigational New Drug (IND) Application for Ebola Therapy ZMapp

Posted 2 days ago in New Drug Applications

February 27, 2015 – SAN DIEGO – LeafBio, the commercial arm of Mapp Biopharmaceutical, announced that it has received approval of its application for an Investigational New Drug (IND) from the Food and Drug Administration (FDA). The acceptance of the IND will allow for clinical trials of the company’s Ebola therapy ZMapp™ to begin in Liberia. The U.S. National Institutes of Health and the Liberian government...

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Belief in Acupuncture Key to Effect on Back Pain, Study Suggests

Posted 2 days ago in Medical

FRIDAY, Feb. 27, 2015 -- Acupuncture for back pain is more likely to help people who believe the treatment will work, new research suggests. The study included 485 people who received acupuncture for back pain and completed questionnaires before they began treatment, at two and three months into treatment, and then again at six months after treatment. Patients who had low expectations of acupuncture before they...

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FDA Approves Liletta (levonorgestrel-releasing intrauterine system) to Prevent Pregnancy for up to Three Years

Posted 2 days ago in New Drug Approvals

DUBLIN and SAN FRANCISCO, Feb. 27, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of Liletta (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration (FDA) for use by women to prevent pregnancy for up to three years. Liletta is placed in...

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Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo

Posted 4 days ago in New Drug Approvals

PARIS, Feb. 25, 2015 -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015. "Sanofi is proud of its long heritage in diabetes and...

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FDA Approves Avycaz (ceftazidime and avibactam) for Complicated Abdominal and Urinary Tract Infections

Posted 4 days ago in New Drug Approvals

February 25, 2015 -- The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. Avycaz contains two...

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Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for Belbuca (buprenorphine HCl) Buccal Film for Chronic Pain

Posted 6 days ago in New Drug Applications

DUBLIN and RALEIGH, N.C., Feb. 23, 2015 /PRNewswire/ -- Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), and BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the companies' Belbuca™ (buprenorphine HCl) buccal film under development for the management of...

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Lupin Receives FDA Approval for Generic Lumigan Ophthalmic Solution 0.03%

Posted 6 days ago in Pharma Industry News

Mumbai, India and Baltimore, Maryland -- February 23, 2015: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the United States Food and Drugs Administration (FDA) to market a generic version of Allergan Inc.'s Lumigan Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company's U.S. subsidiary would commence...

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FDA Approves Farydak (panobinostat) for Multiple Myeloma

Posted 6 days ago in New Drug Approvals

February 23, 2015 -- The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die from the disease...

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Taiho Oncology, Inc. Announces TAS-102 NDA for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA

Posted 6 days ago in New Drug Applications

Princeton, NJ – February 23, 2015 – Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced the New Drug Application (NDA) for TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), has been accepted for review by the U.S. Food and Drug Administration (FDA). TAS-102 is an oral combination investigational anticancer drug for the treatment of refractory...

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FDA Approves VenaSeal Closure System to Permanently Treat Varicose Veins

Posted 9 days ago in Pharma Industry News

February 20, 2015 -- The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow...

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FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome

Posted 10 days ago in Pharma Industry News

The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt...

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FDA Grants Genentech's Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma

Posted 11 days ago in New Drug Applications

South San Francisco, Calif. -- February 18, 2015 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA...

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FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma

Posted 11 days ago in New Drug Approvals

SUMMIT, N.J., February 18, 2015 --(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM). Revlimid plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients...

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FDA issues new draft documents related to compounding of human drugs

Posted 2 weeks ago in Pharma Industry News

February 13, 2015 -- Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians. The new category of outsourcing facilities was created under the Drug Quality and Security Act...

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Study of Next-Generation Investigational HIV-1 Maturation Inhibitor Shows Positive Results in Preventing Viral Replication

Posted 3 days ago in Clinical Trials

PRINCETON, N.J.. February 26, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced data supporting the clinical development of BMS-955176, an investigational component designed to prevent the maturation of HIV-1. Presented yesterday in a late-breaking oral presentation and a poster presentation at the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, the Phase...

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Gilead Announces Phase 3 Results for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF)

Posted 3 days ago in Clinical Trials

SEATTLE--(BUSINESS WIRE)--Feb. 26, 2015-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from two Phase 3 studies (Studies 104 and 111) evaluating its investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. A regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10...

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ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir

Posted 3 days ago in Clinical Trials

PRINCETON, N.J., February 26, 2015 --(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from ALLY-2, a Phase III clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) coinfected with HIV – a patient population that historically has been challenging to treat in large part due...

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48-Week Analysis of Investigational HIV-1 Attachment Inhibitor Paves Way for Phase III Trial Initiation

Posted 4 days ago in Clinical Trials

PRINCETON, N.J., February 25, 2015--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced data from a Phase IIb trial of investigational compound BMS-663068, designed as an HIV-1 attachment inhibitor, in treatment-experienced HIV-1 patients. In the study, which compared BMS-663068 to a pharmacoenhanced protease inhibitor (Reyataz (atazanavir sulfate) and ritonavir), virologic response rates (HIV-1...

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Interim Analysis of Clinical Trial Suggests Efficacy of Avigan Tablet 200mg as a Treatment for Ebola Virus Disease

Posted 5 days ago in Clinical Trials

February 24, 2015 -- FUJIFILM Corporation (President: Shigehiro Nakajima) announced that the French National Institute of Health and Medical Research (Inserm) ** released today an interim analysis of the clinical trial suggesting the efficacy of anti-influenza drug Avigan® Tablet 200mg* (Favipiravir), which is being provided to clinical trials in Guinea for patients with Ebola Virus Disease (EVD). For patients...

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