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FDA concludes no increased risk of cardiac events for patients treated with omeprazole and Nexium

The US Food and Drug Administration (FDA) has issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM (LOTUS study) treatment.

10 Dec 2007

Premature ejaculation drug Dapoxetine submitted for marketing in approval in Europe

Janssen-Cilag companies in Europe have submitted a Marketing Authorisation Application (MAA) for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age.

10 Dec 2007

More good Gleevec news

Gleevec, the targeted cancer pill that has saved more than 100,000 lives, now is saving more children with a dire leukemia, as well as preventing disease progression with long term use in adults with chronic myeloid leukemia.

10 Dec 2007

FDA to review potential anti-arrhythmic claims for Ranexa

CV Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa (ranolazine extended-release tablets) as part of its ongoing review of the Company's supplemental new drug application (sNDA).

10 Dec 2007

Top British scientist warns homeopathic medicine puts lives at risk

Britain's most senior scientist has warned that homeopathic medicine is jeopardising lives.

10 Dec 2007

Court approves Biomira's move to U.S. and name change to Oncothyreon

Biomira Inc. has announced that the Alberta Court of Queen's Bench issued a Final Order approving the plan of arrangement under which the Company will move to the United States and change its name to Oncothyreon Inc.

5 Dec 2007

Caraco Pharmaceutical Labs announces FDA approval to market generic Norvasc

Caraco Pharmaceutical Laboratories has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).

5 Dec 2007

Immtech and BioAlliance sign agreement on Pafuramidine for African sleeping sickness

Immtech Pharmaceuticals has announced that the Company has granted an exclusive license to BioAlliance Pharma SA to commercialize Immtech's oral drug, pafuramidine maleate (pafuramidine), in Europe for the treatment of pneumocystis pneumonia (PCP) in AIDS patients and for the treatment of Human African trypanosomiasis, also known as African sleeping sickness.

5 Dec 2007

Modified form of imatinib becomes more specific

Imatinib (marketed as Gleevec in the US and Glivec in Europe and Australia) is used to treat various cancers, including chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GISTs).

4 Dec 2007

Approval of Diovan (valsartan) in U.S. for hypertension in children and adolescents

Diovan (valsartan), an angiotensin receptor blocker or ARB, has been approved following a priority review by the U.S. Food and Drug Administration (FDA) for the treatment of high blood pressure in children and adolescents ages six to 16.

4 Dec 2007

Do medical schools affect the way future doctors interact with drug companies?

Although more and more drug advertisements are appearing on television, the bulk of the approximately $21 billion dollars that pharmaceutical companies spend annually to market their products is targeted to physicians, doctors in training (residents) and medical students.

3 Dec 2007

Merck Serono's Cyanokit approved in Europe

Merck Serono, a division of Merck KGaA, announced today that the European Commission has granted marketing authorization for its product Cyanokit (active substance: hydroxocobalamin) for the treatment of known or suspected cyanide poisoning in both adults and the pediatric population.

3 Dec 2007

FDA issues approvable letter for Nebivolol for the treatment of hypertension

Forest Laboratories, Inc. and Mylan Inc. announced that Mylan has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for nebivolol (proposed brand name Bystolic), a novel beta blocker under review for the treatment of hypertension.

2 Dec 2007

FDA approves Cymbalta for maintenance treatment of major depressive disorder

Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults.

2 Dec 2007

Bionovo describes a new class of therapeutic compounds

Bionovo, Inc. has announced the publication of a groundbreaking paper in the journal Molecular and Cellular Endocrinology covering the isolation, identification and description of a pure chemical compound, liquiritigenin, which represents a new class of therapeutic compounds showing promise for the safe treatment of menopausal symptoms.

2 Dec 2007

Sirtris Pharmaceuticals unveils promising, novel SIRT1 activators for treating diseases of aging

Sirtris Pharmaceuticals has announced that findings in the journal Nature demonstrate that Sirtris has developed novel drug candidates that offer a promising, new approach to treating diseases of aging, including Type 2 Diabetes, by targeting SIRT1, a gene that controls the aging process.

29 Nov 2007