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Studies outline dilemmas on new generic heart drugs, hormone replacement therapy

One heart drug's move to generic status has complicated treatment options for some patients and doctors, the Wall Street Journal reports. Also, another study raises concerns about hormone replacement therapy in women.

30 May 2012

First study to look at link between vitamin D and onset of new mobility disability in older adults

Older adults who don't get enough vitamin D - either from diet, supplements or sun exposure - may be at increased risk of developing mobility limitations and disability, according to new research from Wake Forest Baptist Medical Center.

30 May 2012

ONPRC researchers discover new method to create safe and effective vaccines

While vaccines are perhaps medicine's most important success story, there is always room for improvement. Researchers at Oregon Health & Science University's Oregon National Primate Research Center (ONPRC) appear to have done just that.

30 May 2012

Scientists show why leukemia often returns

The fight against cancer is not won in a single battle: Long after a cancer has been beaten into remission, it can return. The reason for this is under debate, and much is unclear. New research led by Weizmann Institute scientists shows that, at least for one type of blood cancer, the source of cancer recurrence is in a set of cells that do not proliferate as quickly as regular cancer cells, and thus able to survive chemotherapy.

30 May 2012

Endo, Watson reach agreement to resolve two LIDODERM patent infringement lawsuits

Endo announced today that it has reached an agreement with Watson Pharmaceuticals (Watson) resolving two patent infringement lawsuits related to LIDODERM.

30 May 2012

Cabazitaxel offers added benefit for men with metastatic prostate cancer

Cabazitaxel has been approved since March 2011 in men with metastatic prostate cancer who no longer respond to conventional therapy with hormone blockers and have already been pre-treated with the cytostatic drug docetaxel.

30 May 2012

PRS launches Global Regulatory Intelligence Database

Pharmaceutical Regulatory Services, Inc., a global provider of regulatory and pharmacovigilance support to the pharmaceutical, biotechnology and medical device industries, is pleased to announce the launch of GRID - Global Regulatory Intelligence Database.

30 May 2012

Scientists develop synthetic peptide that overcomes cancer cells’ survival defenses

Scientists at the Dana-Farber/Children's Hospital Cancer Center have developed an anti-cancer peptide that overcomes the stubborn resistance to chemotherapy and radiation often encountered in certain blood cancers when the disease recurs following initial treatment.

30 May 2012

Exendin-4 significantly minimizes damage in TBI animal models

Although the death toll is relatively low for people who suffer from traumatic brain injury (TBI), it can have severe, life-long consequences for brain function. TBI can impair a patient's mental abilities, impact memory and behavior, and lead to dramatic personality changes. And long-term medical treatment carries a high economic cost.

30 May 2012

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