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FDA accepts CSL Behring’s 4-factor PCC BLA for standard review

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

30 May 2012

EPO issues patent to Cytune’s CYP0150 for treatment of cancer

Cytune Pharma, an emerging leader in innovative immunomodulatory agents against cancer and infectious diseases, announced today that it will attend the BIO2012 to present its major achievements over the last 12 months and to foster partnering discussions.

30 May 2012

FDA approves RLI’s Absorica to treat severe recalcitrant nodular acne

Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica, a novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne.

30 May 2012

Watson, Endo and Teikoku Seiyaku enter settlement agreement to resolve Lidoderm patent litigation

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has entered into an agreement with Endo Pharmaceuticals Inc. and Teikoku Seiyaku Co., Ltd to settle all outstanding patent litigation related to Watson's generic version of Lidoderm.

29 May 2012

NSAIDs may offer protection against skin cancer

A new study suggests that aspirin and other similar painkillers may help protect against skin cancer. Published early online in CANCER, a peer-reviewed journal of the American Cancer Society, the findings indicate that skin cancer prevention may be added to the benefits of these commonly used medications.

29 May 2012

EMA CHMP issues positive opinion to Eisai’s Fycompa for treatment of partial-onset seizures

Eisai announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Fycompa (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

29 May 2012

New medicine can start and hasten healing of diabetic and other chronic sores

A unique new medicine that can start and hasten healing of diabetic and other chronic sores is being developed at Umeå University in Sweden. After several years of successful experimental research, it is now ready for clinical testing.

28 May 2012

FDA approves Cipher’s Absorica to treat severe recalcitrant nodular acne

Cipher Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica, Cipher's novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne.

28 May 2012

Overgrowth of bacteria in the gut linked to IBS

An overgrowth of bacteria in the gut has been definitively linked to Irritable Bowel Syndrome in the results of a new Cedars-Sinai study which used cultures from the small intestine. This is the first study to use this "gold standard" method of connecting bacteria to the cause of the disease that affects an estimated 30 million people in the United States.

28 May 2012

Lilly, Boehringer Ingelheim receive positive opinion from EMA for Jentadueto

Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a positive opinion from the European Medicines Agency's medicinal committee recommending approval of Jentadueto,which combines the DPP-4 inhibitor, linagliptin and metformin in a single tablet. If approved by the European Commission, linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with Type 2 Diabetes who need to improve control of their blood glucose.

28 May 2012

Sihuan's Roxatidine passes Chinese SFDA on-site inspection

Sihuan Pharmaceutical Holdings Group Ltd., a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China's prescription market, announced that Roxatidine Acetate Hydrochloride for Injection, Sihuan Pharmaceutical's first-to-market generic drug, recently passed on-site inspection for drug registration conducted by the Chinese State Food and Drug Administration.

25 May 2012

EMA CHMP adopts positive opinion for Pfizer’s axitinib to treat advanced renal cell carcinoma

Pfizer announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the marketing authorization of axitinib in the European Union (EU), for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

25 May 2012

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Merck, known as MSD outside the United States and Canada, welcomes today's launch in Rwanda of Africa's first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine for the prevention of rotavirus disease.

25 May 2012

European CHMP issues positive opinion to Vertex's KALYDECO for treatment of CF

Vertex Pharmaceuticals Incorporated announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion by consensus recommending the approval of KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

25 May 2012

MIT researchers engineer new jet-injection system

MIT researchers have engineered a device that delivers a tiny, high-pressure jet of medicine through the skin without the use of a hypodermic needle. The device can be programmed to deliver a range of doses to various depths - an improvement over similar jet-injection systems that are now commercially available.

25 May 2012

Thioridazine drug successfully kills human cancer stem cells

A team of scientists at McMaster University has discovered a drug, thioridazine, successfully kills cancer stem cells in the human while avoiding the toxic side-effects of conventional cancer treatments.

25 May 2012

Cyanobacterium produces compounds that could treat chronic inflammatory conditions

A seaweed considered a threat to the healthy growth of coral reefs in Hawaii may possess the ability to produce substances that could one day treat human diseases, a new study led by scientists at Scripps Institution of Oceanography at UC San Diego has revealed.

25 May 2012

IUDs, implants far more effective at preventing pregnancy than the pill

A large study of birth control methods in the U.S. found that women using pills, skin patches or vaginal rings were 20 times more likely to have an unplanned pregnancy than women who used intrauterine devices (IUDs) or implants placed under the skin of the upper arm.

25 May 2012

New compound can enhance apoptosis in cancer cells

The BCL-2 protein family plays a large role in determining whether cancer cells survive in response to therapy or undergo a form of cell death known as apoptosis.

25 May 2012

FDA advisory committee votes in favor of Pfizer's tafamidis meglumine

Pfizer Inc. announced today that the United States Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer's clinical data package for tafamidis meglumine.

25 May 2012