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Health Highlights: April 18, 2014

Posted yesterday in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Scientists Create First Embryo Clones Using Cells From Adults For the first time, scientists say they have used material from cells from two adults to create early stage cloned embryos. They then used those embryos to create tissue that was an exact genetic match of the donors. The aim of the research is to be...

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If Kids Think Someone's Watching, They're More Likely to Wash Their Hands

Posted today in Medical

SATURDAY, April 19, 2014 -- Hand washing is one of the best ways to prevent infectious diseases, and placing cameras over sinks might boost youngsters' hand hygiene, new research suggests. The study included students at four public schools in a slum in Nairobi, Kenya. Video cameras were installed in hand cleaning areas outside the schools' latrines. Teachers were told about the cameras and informed their...

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Spring Cleaning Safety Tips

Posted today in Medical

SATURDAY, April 19, 2014 -- While doing their spring cleaning, families will use a wide range of products that can cause accidental poisonings, an expert says. But taking appropriate precautions will reduce the risk of danger, said Earl Siegel, managing director of the drug and poison information center at Cincinnati Children's Hospital Medical Center in Ohio. "It is vital that people arm themselves with basic...

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Mylan Launches Xulane - First Generic Ortho Evra Patch

Posted yesterday in New Drug Approvals

PITTSBURGH, April 16, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Xulane (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day), the generic version of Janssen Pharmaceuticals Inc.'s Ortho Evra®* (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day). This product is indicated for the...

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Extroverts Happier Regardless of Culture, Study Finds

Posted yesterday in Medical

FRIDAY, April 18, 2014 -- Being outgoing makes you happier no matter where you live, a new international study says. Researchers looked at mood and behavior among college students in the United States, China, Japan, the Philippines and Venezuela. Overall, those who felt or acted more extroverted in daily situations were happier. The investigators also found that the students' behavior was more upbeat when they felt...

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Restaurants in Poor Areas Push Unhealthy Foods, Study Finds

Posted yesterday in Medical

FRIDAY, April 18, 2014 -- Restaurants near public housing developments tend to offer unhealthy meals, a new study finds. Researchers analyzed menus from 61 fast-food and 72 table-service restaurants within a half mile of 13 housing developments and four residential neighborhoods in the Kansas City, Kan., and Kansas City, Mo., areas. The housing developments and residential neighborhoods had similar numbers of...

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FDA Approves Ragwitek for Short Ragweed Pollen Allergies

Posted yesterday in Pharma Industry News

April 17, 2014 -- The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet...

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FDA Approves Tanzeum (albiglutide) to Treat Type 2 Diabetes

Posted 4 days ago in New Drug Approvals

April 15, 2014 -- The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for...

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Mylan Launches Generic Lunesta Tablets

Posted 4 days ago in Pharma Industry News

PITTSBURGH, April 15, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Eszopiclone Tablets 1 mg, 2 mg and 3 mg, the generic version of Sunovion Pharmaceuticals Inc.'s Lunesta®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of insomnia. ...

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FDA Approves Merck’s Grastek as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis

Posted 4 days ago in Pharma Industry News

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. Grastek is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic...

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Boehringer Ingelheim and Eli Lilly Announce NDA Filing for Empagliflozin and Linagliptin Combination

Posted 5 days ago in New Drug Applications

RIDGEFIELD, Conn. and INDIANAPOLIS, April 14, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes (T2D). If granted...

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Alimera Sciences Announces New PDUFA Date For Iluvien

Posted 5 days ago in New Drug Applications

ATLANTA, April 14, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that its recent resubmission of the New Drug Application (NDA) for Iluvien® has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a complete...

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Bristol-Myers Squibb Submits NDA to FDA for Fixed-Dose Combination of Atazanavir Sulfate with Cobicistat

Posted 5 days ago in New Drug Applications

PRINCETON, N.J.--(BUSINESS WIRE) April 14, 2014 --Bristol-Myers Squibb Company (NYSE:BMY) announced today the submission of a new drug application (NDA) on April 4, 2014 to the U.S. Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the...

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Impax Pharmaceuticals Resubmits NDA for Rytary (Carbidopa and Levodopa) Extended-Release

Posted 7 days ago in New Drug Applications

HAYWARD, Calif., April 11, 2014 /PRNewswire/ -- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for Rytary (IPX066) to the U.S. Food and Drug Administration (FDA). IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's...

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FDA Develops Alternative Assay That Could Speed Availability of Pandemic Influenza Vaccines

Posted 9 days ago in Pharma Industry News

April 9, 2014 -- A laboratory assay developed by scientists at the U.S. Food and Drug Administration (FDA) could speed the release of pandemic influenza vaccines to the public by shortening the time it takes to test vaccine potency. The FDA scientists developed the new assay in response to the recommendation of a workshop organized by the World Health Organization (WHO) following the 2009 H1N1 influenza pandemic...

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Teva Announces First Approval and Launch of Generic Lovaza Capsules in the United States

Posted 10 days ago in Pharma Industry News

JERUSALEM--(BUSINESS WIRE)--Apr. 8, 2014-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Lovaza® (Omega-3-Acid Ethyl Esters Capsules, USP), in the United States. Teva believes it is first-to-file and thus far is the only Company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza® Capsules, marketed by GlaxoSmithKline, had...

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MannKind Updates Status of New Drug Application for Afrezza

Posted 11 days ago in New Drug Applications

VALENCIA, Calif., April 7, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Afrezza® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests. About Afrezza Afrezza® (uh-FREZZ-uh)...

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FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism

Posted 11 days ago in New Drug Approvals

Ridgefield, CT, April 7, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in...

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FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older

Posted 12 days ago in New Drug Approvals

BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older. With this approval, KALBITOR is the first and only subcutaneous...

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FDA Approves Evzio (naloxone) Hand-Held Auto-Injector to Reverse Opioid Overdose

Posted 2 weeks ago in New Drug Approvals

April 3, 2014 -- The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. It is intended...

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LX4211 Achieves Positive Results in Type 1 Diabetes Clinical Trial

Posted 5 days ago in Clinical Trials

The Woodlands, Texas, April 14, 2014 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today positive, top-line results in a Phase 2 clinical trial of LX4211 in type 1 diabetes, which achieved the primary endpoint of reducing mealtime insulin use as well as several secondary endpoints, including improved glycemic control. LX4211 is an oral, first-in-class, dual inhibitor of sodium glucose transporters 1...

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Biogen Idec and Sobi Announce Positive Results from Phase 3 Pediatric Study of Eloctate

Posted 8 days ago in Clinical Trials

CAMBRIDGE, Mass. & STOCKHOLM April 10, 2014 - Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today released positive top-line results of the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of ELOCTATE™, an investigational recombinant factor VIII Fc fusion protein product candidate, in children with severe hemophilia A. ELOCTATE was generally...

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Bristol-Myers Squibb Presents Phase III Data Demonstrating Positive Results for Hepatitis C Drugs

Posted 9 days ago in Clinical Trials

PRINCETON, N.J.--(BUSINESS WIRE)--April 10, 2014 -- Bristol-Myers Squibb Company (NYSE:BMY) today announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients. Results showed that the 24-week regimen achieved...

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Stemline Therapeutics Announces FDA Acceptance of IND for SL-701

Posted 10 days ago in Clinical Trials

New York, April 8, 2014 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (Nasdaq:STML) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for SL-701, which enables the company to advance SL-701 into a Phase 2 trial of adults with glioblastoma multiforme (GBM) in first recurrence. SL-701 is a subcutaneously-administered cancer vaccine...

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Ambit Announces Initiation Of Quizartinib QUANTUM-R Phase 3 Trial

Posted 11 days ago in Clinical Trials

SAN DIEGO, April 8, 2014 /PRNewswire/ -- Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with...

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