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VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

Shire plc, the global specialty biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the marketing authorisation for VPRIV (velaglucerase alfa), the company's enzyme replacement therapy for the treatment of type 1 Gaucher disease.

28 Jun 2010

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta) or sitagliptin (Januvia).

28 Jun 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Late-breaking Novo Nordisk extension data presented today at the 70th Annual Scientific Sessions of the American Diabetes Association showed that once-daily Victoza in combination with metformin produced sustained and significantly greater reductions in A1c, body weight and fasting plasma glucose than Januvia plus metformin at 52 weeks.

28 Jun 2010

Bayer signs agreement to supply Adalat XL product to Teva Canada

Bayer Inc. and Teva Canada Limited today announced they have entered an agreement regarding Bayer's Adalat XL (nifedipine) 20, 30 and 60 mg product. Effective immediately, Bayer Inc. will supply Adalat XL exclusively to Teva Canada Limited and Teva Canada Limited will become the sole distributor in Canada of brand name Adalat XL product.

28 Jun 2010

Psychotropic medications associated with adverse drug reactions in Danish children: Researchers

Between 1998 and 2007, psychotropic medications were associated with 429 adverse drug reactions in Danish children under the age of 17. Researchers from the University of Copenhagen's Faculty of Pharmaceutical Studies have published an article in the open access journal BMC Research Notes concluding that more than half of the 429 cases were serious and several involved birth defects, such as birth deformities and severe withdrawal syndromes.

25 Jun 2010

Japan's MHLW grants full marketing authorization to REVLIMID

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy. This marketing authorization represents the first regulatory approval of REVLIMID in Japan.

25 Jun 2010

New method to synthesize drug candidates for testing

Some drugs may be more effective the longer they last inside the body. To prevent such drugs from being broken down too rapidly, pharmaceutical manufacturers often attach a fluorine-containing structure called a trifluoromethyl group. However, the processes now used require harsh reaction conditions or only work in a small number of cases, limiting their usefulness for synthesizing new drug candidates for testing.

25 Jun 2010

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

Merck announced that the Committee for Medicinal Products for Human Use adopted a positive opinion on the pending Marketing Authorization Application for SYCREST (asenapine) sublingual tablets. The CHMP has recommended that the European Commission grant a marketing authorization for SYCREST for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. The CHMP did not support an indication for the treatment of schizophrenia.

25 Jun 2010

PecFent receives Positive Opinion from CHMP for treatment of BTCP

Archimedes Pharma, a leading specialty pharma company, today announced that its lead product, PecFent, has received a Positive Opinion from the Committee for Human Medicinal Products, of the European Medicines Agency. The CHMP is recommending PecFent, an innovative fentanyl nasal spray, be authorised for marketing in European Union countries for the treatment of breakthrough cancer pain - sudden, unpredictable episodes of intense pain that occur despite background pain medication.

25 Jun 2010

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

Research and development spending in Canada by brand-name drug companies has dropped to its lowest level in 20 years, according to the latest annual report of the Patented Medicine Prices Review Board.

25 Jun 2010

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

25 Jun 2010

IDRI signs Research Collaboration Agreement with PATH

Two global health non-profit organizations headquartered in Seattle, Washington, the Infectious Disease Research Institute and PATH, have entered into a Research Collaboration Agreement to evaluate novel adjuvants for their ability to enhance the immune response of pandemic influenza vaccines in development. The collaboration supports the goal of PATH's influenza vaccine project to advance the development of promising new influenza vaccines focusing on novel technologies that can be accessible, affordable, and available to people in low-resource countries in a global outbreak.

25 Jun 2010

Cyclosporine treatment develops higher de novo cancer risk in liver transplant patients: Researchers

Researchers at Erasmus MC University Medical Centre in The Netherlands found that cyclosporine treatment is a significant risk factor for the development of de novo cancer in liver transplant patients. Full details appear in the July issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.

25 Jun 2010

PARP inhibitors may be effective in men with prostate cancer due to BRCA2 alteration: Researchers

The way prostate cancer develops in men who have an altered 'breast cancer gene' is the same route by which breast cancer develops in women with the same mutation, reveals a study published in PLoS Genetics today (Thursday).

25 Jun 2010

Study on effects of resveratrol on metabolism of microcebus murinus

Resveratrol is a natural substance that is widely studied, for its anti-ageing properties among other things. For the first time, work by a team in the "Mécanismes adaptatifs : des organismes aux communautés" Laboratory (CNRS/Muséum National d'Histoire Naturelle) has revealed that this compound reduces weight gain in lemurs. Such findings provide new information regarding the effects of resveratrol on energy metabolism and the control of body mass in primates. They may give a clearer understanding of the factors that govern obesity in humans. This study is published on 22 June 2010 in /BMC Physiology/.

25 Jun 2010

Two experimental drugs have potential to restore pumping strength to failing hearts, study finds

We've all experienced the strong heartbeat that accompanies emotions such as fear and rage. But can the body's natural response to these emotions be used to combat heart failure? Results of a study published online today in the journal Circulation Research present a strong case.

25 Jun 2010

Mylan granted final FDA approval for Procardia XL Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL® Tablets, a treatment for angina and/or hypertension.

25 Jun 2010

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

Digoxin drug may increase risk of premature death in patients with kidney disease

For patients with kidney disease on dialysis, the widely used heart medication digoxin may lead to an increased risk of premature death, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

25 Jun 2010

Abbott's new FreeStyle test strips receive FDA clearance

Following the recent clearance of its FreeStyle Lite® blood glucose test strips, Abbott (NYSE: ABT) today announced that it has also received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new FreeStyle blood glucose test strips.

25 Jun 2010

Pharmaceutical News

VPRIV receives positive opinion from CHMP for treatment of type 1 Gaucher disease

New preclinical data of XOMA 052 in animal model of Type 2 diabetes to be presented at ADA 2010

Data shows Victoza produces greater reductions in A1c, body weight and FPG than Januvia

Bayer signs agreement to supply Adalat XL product to Teva Canada

Psychotropic medications associated with adverse drug reactions in Danish children: Researchers

Japan's MHLW grants full marketing authorization to REVLIMID

New method to synthesize drug candidates for testing

CHMP adopts positive opinion on pending MAA for SYCREST sublingual tablets

PecFent receives Positive Opinion from CHMP for treatment of BTCP

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

IDRI signs Research Collaboration Agreement with PATH

Cyclosporine treatment develops higher de novo cancer risk in liver transplant patients: Researchers

PARP inhibitors may be effective in men with prostate cancer due to BRCA2 alteration: Researchers

Study on effects of resveratrol on metabolism of microcebus murinus

Two experimental drugs have potential to restore pumping strength to failing hearts, study finds

Mylan granted final FDA approval for Procardia XL Tablets

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Digoxin drug may increase risk of premature death in patients with kidney disease

Abbott's new FreeStyle test strips receive FDA clearance

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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