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BDSI refutes MonoSol's patent infringement claims relating to BEMA Buprenorphine

BioDelivery Sciences International, Inc. today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC. The purpose in responding at this time is for BDSI to strongly refute MonoSol's claims and to assure BDSI stockholders that the Company remains focused on vigorously progressing its pipeline and not allowing this claim to present a distraction.

24 Jan 2011

FDA approves Clinical Data's Viibryd for major depressive disorder

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD).

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

Rotavirus vaccine significantly cuts child hospitalizations, study says

Developing and developed countries that require children to be vaccinated against rotavirus "have significantly reduced the number of children admitted to hospitals with the disease, a report showed on Thursday," Reuters reports (Kelland, 1/20).

24 Jan 2011

Eckert & Ziegler receives European Commission's indefinite approval for YTTRIGA

Eckert & Ziegler Strahlen- und Medizintechnik AG, a firm specializing in radioactive compounds for the treatment of cancer, has renewed the approval of its drug YTTRIGA (Yttrium-90 chloride) by the European Commission. Five years ago the European Medicines Agency EMA approved this drug for the first time and as a result of the current renewal process the drug has now been granted an indefinite approval.

24 Jan 2011

China Shenghuo's Lixuwang product recieves Chinese Well-Known Trademark Honor

China Shenghuo Pharmaceutical Holdings, a China-based pharmaceutical company engaged in the research, development, manufacture, and marketing of Traditional Chinese Medicine, nutritional supplement and cosmetic products, today announced that "Lixuwang", the trademark of its best selling product, Xuesaitong Capsule, was awarded the Chinese Well-Known Trademark Honor by the State Administration for Industry and Commerce of China.

24 Jan 2011

Boehringer Ingelheim's Prazaxa receives Japanese approval for stroke prevention in AF patients

The Ministry of Health, Labour and Welfare in Japan today approved dabigatran etexilate, Boehringer Ingelheim's novel, oral direct thrombin inhibitor under the brand name Prazaxa for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation marking the first approval of a novel oral anticoagulant in the Asia-Pacific region and specifically Japan in nearly 50 years.

24 Jan 2011

Two studies explore relationship between nutrition and asthma

Asthma is one of the world's most common chronic diseases, affecting as many as 300 million people. It is estimated that by 2025 there could be an additional 100 million people with the disease. This rapid increase in asthma is most likely due to changing environmental or lifestyle factors, and over the last 15 years, changing diet has emerged as a promising contributor. Two studies published in the in the February 2011 issue of the Journal of the American Dietetic Association explore the possible relationship between nutrition and asthma.

24 Jan 2011

Tamoxifen may reduce individual's risk of death from lung cancer: New study

A new study has found that tamoxifen, an anti-estrogen breast cancer medication, may reduce an individual's risk of death from lung cancer.

24 Jan 2011

PGxHealth receives FDA approval for Viibryd tablets to treat major depressive disorder

The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

24 Jan 2011

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund (CVAF), a joint initiative with the Ludwig Institute for Cancer Research (LICR), has completed a new investment agreement with Oncovir, Inc., a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol® (Poly-ICLC).

21 Jan 2011

PenTAG research plays pivotal role in NICE decision to extend availability of Alzheimer's disease drugs

A review of research evidence produced by researchers from the Peninsula Technology Assessment Group, part of the Peninsula College of Medicine and Dentistry, has played a pivotal role in the decision by the National Institute for Health and Clinical Excellence (NICE) to extend the availability of donepezil, galantamine, rivastigmine and memantine for Alzheimer's disease announced on 18th January 2011.

21 Jan 2011

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.

21 Jan 2011

GSK, Valeant receive European CHMP positive opinion for Trobalt

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt™ (retigabine) as an adjunctive treatment of partial onset seizures, with or without secondary generalisation in adults aged 18 years and above with epilepsy.

21 Jan 2011

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Biogen Idec announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.

21 Jan 2011

Adopting pharmacy carve-in approach can help 13 states realize over $11 billion savings in Medicaid

A study sponsored by Medicaid Health Plans of America (MHPA) released today by The Lewin Group finds large-scale savings can be achieved if 13 states abandoned their current pharmacy carve-out model in favor of a carve-in approach -- including prescription drugs in health plans' capitation payments.

21 Jan 2011

WHO executive board meeting addresses agency's policy on counterfeit, substandard medications

According to the news service, WHO "members … raised strong concerns that a working group they mandated last May to address problems with WHO policy on counterfeit and substandard medicines has yet to be formed - with four months remaining before it must report back to members."

21 Jan 2011

Pharmaceutical News

BDSI refutes MonoSol's patent infringement claims relating to BEMA Buprenorphine

FDA approves Clinical Data's Viibryd for major depressive disorder

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Rotavirus vaccine significantly cuts child hospitalizations, study says

Eckert & Ziegler receives European Commission's indefinite approval for YTTRIGA

China Shenghuo's Lixuwang product recieves Chinese Well-Known Trademark Honor

Boehringer Ingelheim's Prazaxa receives Japanese approval for stroke prevention in AF patients

Two studies explore relationship between nutrition and asthma

Tamoxifen may reduce individual's risk of death from lung cancer: New study

PGxHealth receives FDA approval for Viibryd tablets to treat major depressive disorder

CVAF completes new investment agreement with Oncovir for production of Hiltonol

PenTAG research plays pivotal role in NICE decision to extend availability of Alzheimer's disease drugs

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

GSK, Valeant receive European CHMP positive opinion for Trobalt

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Adopting pharmacy carve-in approach can help 13 states realize over $11 billion savings in Medicaid

WHO executive board meeting addresses agency's policy on counterfeit, substandard medications

Major breakthrough: Genome-based medicine for treatment of alcoholism

Supreme Court considers drug-pricing lawsuit

Health Canada approves Labopharm's OLEPTRO for treatment of Major Depressive Disorder

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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