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GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved Mekinist® (trametinib) for use in combination with Tafinlar® (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations.

9 Jan 2014

Daily antibiotic use is effective for preventing recurrent urinary tract infections in women

While daily antibiotic use is the most effective method for preventing recurrent urinary tract infections in women, daily cranberry pills, daily estrogen therapy and monthly acupuncture treatments also have benefits that may be preferable for some patients, according to a new study by researchers at the Los Angeles Biomedical Research Institute.

9 Jan 2014

Merck announces FDA approval of ISENTRESS for oral suspension

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration recently approved ISENTRESS for oral suspension, a new pediatric formulation of Merck's integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

9 Jan 2014

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

Proteon Therapeutics, Inc., a privately held biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases, today announced that its lead product, PRT-201, has received orphan drug designation in the European Union for the prevention of arteriovenous access dysfunction in hemodialysis patients.

9 Jan 2014

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Actavis plc today announced that it has received approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis intends to launch the product immediately.

9 Jan 2014

Study shows that anticoagulant medicine appears to protect patients against stroke

Heart palpitations. Shortness of breath. Tiredness. More and more people can recognise the symptoms of atrial fibrillation, which is one of the most common types of heart disease.

9 Jan 2014

Epilepsy drug taken during pregnancy not linked with development problems for preschoolers

A new study finds that the epilepsy drug levetiracetam appears not to be associated with thinking, movement and language problems for preschool children born to mothers who took the drug during pregnancy, although the drug valproate was associated with some difficulties in preschoolers.

8 Jan 2014

Hebrew University research could lead to efficient and fast-acting antidepressant drugs

The World health Organization calls depression "the leading cause of disability worldwide," causing more years of disability than cancer, HIV/AIDS, and cardiovascular and respiratory diseases combined.

8 Jan 2014

No added benefit from aflibercept, shows study

For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG) dealt with the drug aflibercept. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute now examined whether aflibercept (trade name: Eylea) offers an added benefit over the appropriate comparator therapy in visual impairment due to macular oedema following occlusion of the central retinal vein.

8 Jan 2014

Apitope-led consortium awarded FP7 Health Innovation funding to develop Graves' disease vaccine

Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announces that the consortium, led by Apitope, which includes GSK Vaccines, Quintiles and KWS Biotest Limited, has been awarded prestigious Framework Programme 7 Health Innovation funding by the European Commission to develop its Graves' disease therapeutic vaccine, including a Phase I first-in-man study in Graves' disease patients.

8 Jan 2014

Study: Combined medications may improve smoking cessation than single drug therapy

Among cigarette smokers, combining the smoking cessation medications varenicline and bupropion, compared with varenicline alone, resulted in higher smoking abstinence rates for one outcome but not the other at three and six months; rates were similar at one year, according to a Mayo Clinic study published this month in JAMA.

8 Jan 2014

IQWiG study finds no added benefit of teriflunomide

Teriflunomide (trade name: Aubagio) has been approved in Germany since August 2013 for adults with relapsing remitting multiple sclerosis. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new drug offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA).

8 Jan 2014

Research highlights potential of newly developed radiopharmaceuticals for imaging melanoma metastases

With low survival rates for patients with metastasized melanoma, accurate staging and effective treatments are critical to extending life. New research published in the Journal of Nuclear Medicine highlights the potential of newly developed radiopharmaceuticals with benzamide for the imaging of metastases and as a targeted systemic therapy.

8 Jan 2014

Added benefit of dabrafenib not proven

Dabrafenib has been approved in Germany since August 2013 for the treatment of advanced melanoma. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care examined whether this new drug offers an added benefit over the appropriate comparator therapy.

7 Jan 2014

PET imaging of brain reveals ketamine may act as antidepressant by regulating serotonin activity

Ketamine is a potent anesthetic employed in human and veterinary medicine, and sometimes used illegally as a recreational drug. The drug is also a promising candidate for the fast treatment of depression in patients who do not respond to other medications.

7 Jan 2014

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

Daiichi Sankyo, Company Limited (hereafter, Daiichi Sankyo) today announced that the Marketing Authorization Application for its investigational, oral, once-daily direct factor Xa-inhibitor edoxaban has been submitted to the European Medicines Agency.

7 Jan 2014

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration has accepted and filed for review the company's Biologics License Application for Natpara (recombinant human parathyroid hormone 1-84, (rhPTH[1-84])) for the treatment of hypoparathyroidism.

7 Jan 2014

Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Tolterodine Tartrate Extended-release Capsules, 2 mg and 4 mg. Tolterodine Tartrate ER Capsules are the generic version of Pfizer's Detrol LA, and are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product.

7 Jan 2014

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today it has entered into a distribution agreement for Lymphoseek (technetium Tc 99m tilmanocept) Injection in Taiwan with Global Medical Solutions Taiwan, Ltd., a leading in-country distributor of nuclear medicine and diagnostic imaging products.

7 Jan 2014

FDA OOPD grants orphan drug designation to Alitair's Erdosteine for treatment of bronchiectasis

Alitair Pharmaceuticals, Inc., today announced that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation for its drug candidate, Erdosteine, for the treatment of bronchiectasis. Erdosteine is a mucolytic with antibacterial, anti-inflammatory, and antioxidant properties.

7 Jan 2014

Pharmaceutical News

GSK receives FDA approval for combination of Mekinist with Tafinlar for treatment of melanoma

Daily antibiotic use is effective for preventing recurrent urinary tract infections in women

Merck announces FDA approval of ISENTRESS for oral suspension

Proteon's PRT-201 gets orphan drug designation for prevention of arteriovenous access dysfunction

FDA approves Actavis' ANDA for Telmisartan Immediate-Release Tablets

Study shows that anticoagulant medicine appears to protect patients against stroke

Epilepsy drug taken during pregnancy not linked with development problems for preschoolers

Hebrew University research could lead to efficient and fast-acting antidepressant drugs

No added benefit from aflibercept, shows study

Apitope-led consortium awarded FP7 Health Innovation funding to develop Graves' disease vaccine

Study: Combined medications may improve smoking cessation than single drug therapy

IQWiG study finds no added benefit of teriflunomide

Research highlights potential of newly developed radiopharmaceuticals for imaging melanoma metastases

Added benefit of dabrafenib not proven

PET imaging of brain reveals ketamine may act as antidepressant by regulating serotonin activity

Daiichi Sankyo submits Marketing Authorization Application for edoxaban to EMA

FDA accepts NPS Pharmaceuticals' Natpara BLA for review

Mylan launches Tolterodine Tartrate ER Capsules, 2 mg and 4 mg

Navidea Biopharmaceuticals, GMST sign distribution agreement for Lymphoseek Injection in Taiwan

FDA OOPD grants orphan drug designation to Alitair's Erdosteine for treatment of bronchiectasis

Advancing Motor Neuron Disease Diagnosis with Non-Invasive Ultrasound and AI

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

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