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Health Highlights: Aug. 29, 2014

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Many Foods' 'Trans-Fat-Free' Claims False: Study Many processed foods contain more trans-fats than you might suspect, according to a New York City health department study. That's because many of the products that claim to be trans-fat-free actually contain some of the unhealthy fats. The researchers examined...

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Take Steps to Control Bunions

Posted today in Medical

FRIDAY, Aug. 29, 2014 -- If you have bunions, taking care of them now can help you avoid more serious treatment later, an expert says. A bunion is a bump that forms on the joint of the big toe when bone or tissue moves out of place and extends beyond the normal anatomy of the toe. Left untreated, bunions can cause debilitating pain and may require surgery to correct, said Brent Rosenthal, a podiatrist and podiatric...

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Faced With Prostate Cancer, It Helps to Know the Enemy

Posted today in Medical

FRIDAY, Aug. 29, 2014 -- Prostate cancer patients lacking knowledge about the disease have difficulty making good treatment decisions. This can lead to worse quality of care and long-term results, new research suggests. The study included 70 men, with a median age of 63. All were newly diagnosed with localized prostate cancer. Poor understanding of the disease was associated with greater difficulty deciding which...

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Monkey Trial Supports Ebola Drug That May Have Helped 2 Stricken Americans

Posted today in Medical

FRIDAY, Aug. 29, 2014 -- An experimental Ebola drug previously given to two American aid workers successfully cured a group of monkeys infected with the deadly virus in laboratory tests, researchers report. The drug, ZMapp, prompted recovery in all 18 monkeys who received it, even if they didn't get the medication until five days after infection. ZMapp even cured monkeys with advanced cases of Ebola who were days or...

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Biggest Ever Weekly Rise in Ebola Cases, U.N. Agency Says

Posted today in Medical

FRIDAY, Aug. 29, 2014 -- The West African Ebola outbreak took a more deadly turn Friday with the World Health Organization announcing an estimated 500 new cases this week -- the biggest jump in infections so far. Most of the new cases arose in Liberia, the U.N. health agency said, but cases in Guinea and Sierra Leone also rose sharply, the Associated Press reported. "There are serious problems with case management...

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Fresenius Kabi Receives FDA Approval for Kabiven and Perikabiven

Posted yesterday in New Drug Approvals

LAKE ZURICH, Ill. August 26, 2014 - Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven and Perikabiven, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States. Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion,...

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FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia

Posted 2 days ago in New Drug Approvals

London, UK -- 26 August 2014 -- GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).1 SAA is a blood disorder where the bone marrow fails to...

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Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

Posted 3 days ago in New Drug Approvals

PHILADELPHIA, August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. This marks the second indication for Zorvolex, approved by FDA...

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FDA takes action against Georgia dietary supplement manufacturer

Posted 3 days ago in Pharma Industry News

MONDAY August 25, 2014 -- A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and...

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FDA Approves Triumeq (abacavir, dolutegravir and lamivudine) for the Treatment of HIV-1 Infection

Posted 6 days ago in New Drug Approvals

August 22, 2014 -- ViiV Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand...

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FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Posted 7 days ago in New Drug Approvals

Thursday, August 21, 2014 - Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. It is estimated that every year,...

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Palbociclib Expanded Access Program Now Open To Eligible U.S. Patients With HR+, HER2- Advanced Breast Cancer

Posted 7 days ago in New Drug Applications

Thursday, August 21, 2014 - Pfizer Inc. today announced that the company has initiated a multi-center, open-label expanded access program (EAP) in the United States for the investigational CDK 4/6 inhibitor, palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor...

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DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

Posted 8 days ago in Pharma Industry News

August 21, 2014 -- On Friday the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data. The Federal...

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FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes

Posted 8 days ago in Pharma Industry News

August 20, 2014 -- Today, the U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease. Type 1 diabetes...

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Boehringer Ingelheim Announces U.S. Filing for the Fixed-Dose Combination Tiotropium Plus Olodaterol

Posted 9 days ago in New Drug Applications

RIDGEFIELD, Conn., August 19, 2014 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat® inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive...

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Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

Posted 10 days ago in New Drug Applications

Monday, August 18, 2014 - Pfizer Inc. today announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced...

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Turkish man pleads guilty to importing illegal cancer drugs

Posted 13 days ago in Pharma Industry News

August 15, 2014 -- Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States. Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and...

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FDA Warns Consumers About Fraudulent Ebola Treatment Products

Posted 2 weeks ago in Pharma Industry News

August 14, 2014 -- The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. There are currently no FDA-approved vaccines or drugs to...

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AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for NDA for Zalviso

Posted 4 weeks ago in New Drug Applications

REDWOOD CITY, Calif., July 25, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for...

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Lightlake Therapeutics Inc. Files Investigational NDA For Naloxone Nasal Spray For Reversing Opioid Overdose

Posted 5 weeks ago in New Drug Applications

LONDON, July 23, 2014 /PRNewswire/ -- Lightlake Therapeutics Inc. ("Lightlake") (OTCQB: LLTP), a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that it has filed an investigational new drug application ("IND") with respect to its naloxone-based opioid overdose reversal nasal spray. Lightlake also announced today that it has received an...

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Pfizer and Merck to Collaborate on Study Evaluating Novel Anti-Cancer Combination Regimen

Posted 2 days ago in Clinical Trials

WHITEHOUSE STATION, N.J. – August 26, 2014 -- Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE: MRK), known as MSD outside the United States and Canada, through a subsidiary, announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI®) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical...

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Alkermes Announces Initiation of Phase 1 Clinical Study of ALKS 7106 for Treatment of Pain

Posted 3 days ago in Clinical Trials

DUBLIN--(BUSINESS WIRE)--Aug. 26, 2014-- Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. ALKS 7106 represents a...

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Advaxis and Merck Form Collaboration to Evaluate Investigational Combination of Two Novel Immunotherapy Candidates for Advanced Prostate Cancer

Posted 4 days ago in Clinical Trials

PRINCETON, N.J., Aug. 25, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, has entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1...

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Baxter Announces Positive Top-Line Results from Its Phase 3 Study of BAX 855, Extended Half-Life Recombinant FVIII

Posted 7 days ago in Clinical Trials

DEERFIELD, Ill., August 21, 2014 - Baxter International Inc. (NYSE:BAX) today announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], which met its primary endpoint in reducing annualized bleed rates (ABR) in the prophylaxis arm compared to...

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Lilly's Ixekizumab Superior to Etanercept and Placebo in Phase 3 Psoriasis Studies

Posted 8 days ago in Clinical Trials

INDIANAPOLIS, Aug. 21, 2014 /PRNewswire/ -- Eli Lilly and Company's (NYSE: LLY) investigational medicine ixekizumab was statistically superior to etanercept and placebo on all skin clearance measures in Phase 3 studies, the company said today in disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis. "These data are important for people suffering from...

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