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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

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, today announced that the European Commission has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.

7 Jan 2014

Epizyme achieves POC milestone in EPZ-5676 DOT1L inhibitor clinical program

Epizyme, Inc., a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced the achievement of the proof of concept milestone in the EPZ-5676 DOT1L inhibitor clinical program, earning a $25 million payment under the company's collaboration with Celgene Corporation.

7 Jan 2014

Cancer cells less likely to develop resistance when multiple drugs delivered simultaneously

Researchers have developed a technique for creating nanoparticles that carry two different cancer-killing drugs into the body and deliver those drugs to separate parts of the cancer cell where they will be most effective. The technique was developed by researchers at North Carolina State University and the University of North Carolina at Chapel Hill.

7 Jan 2014

Antidepressant medications do not increase suicide risk in children

A Vanderbilt University Medical Center study released today shows there is no evidence that the risk of suicide differs with two commonly prescribed antidepressants prescribed to children and adolescents.

7 Jan 2014

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Aeterna Zentaris Inc. today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

7 Jan 2014

Population Council gets USAID cooperative agreement to develop non-ARV microbicides that block HIV, STI

The Population Council today announced it was awarded a cooperative agreement from the US Agency for International Development's (USAID) Office of HIV and AIDS: "Non-ARV Based Combination Microbicide that Blocks HIV and Other STIs."

6 Jan 2014

Pharmaceutical News

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

EC grants approval for ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer

Epizyme achieves POC milestone in EPZ-5676 DOT1L inhibitor clinical program

Cancer cells less likely to develop resistance when multiple drugs delivered simultaneously

Antidepressant medications do not increase suicide risk in children

Aeterna Zentaris announces FDA acceptance for filing of macimorelin acetate NDA for AGHD

Population Council gets USAID cooperative agreement to develop non-ARV microbicides that block HIV, STI

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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