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Nuevolution partners with Novartis for drug research

Nuevolution A/S today announced that it has entered into a drug discovery collaboration with Novartis.

31 Aug 2009

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte(R) (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

31 Aug 2009

Oral dabigatran etexilate reduces the risk of stroke and systemic embolism

Boehringer Ingelheim today announced data from the landmark RE-LY® study - the largest atrial fibrillation (AF) outcomes trial ever conducted (18,113 patients in 44 countries worldwide) - presented for the first time at the European Society of Cardiology Congress and published online in the New England Journal of Medicine. Results show that dabigatran etexilate 150mg BID significantly reduces the risk of stroke and systemic embolism by 34% (p<0.001) in patients with atrial fibrillation compared to well-controlled warfarin without increasing the risk of major bleeding.

31 Aug 2009

Intermediate dosages of otamixaban reduce acute coronary complications

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the investigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to 42 percent the odds of the composite primary endpoint of death, myocardial infarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the 5 otamixaban tested doses, versus standard UFH/eptifibatide combination in [non-ST] ACS patients suitable for invasive strategy.

30 Aug 2009

Court reverses the summary judgement decision on ANDA Patent litigation between Ortho McNeil and Caraco Pharmaceutical Laboratories

Caraco Pharmaceutical Laboratories, Ltd. announced today that a US Federal Circuit Court has reversed a portion of a previously decided summary judgment on ANDA Patent litigation between Ortho McNeil and Caraco regarding Ultracet(R).

29 Aug 2009

Office of Orphan Products Development of the FDA grants Orphan Drug Designation to Quinazoline495

Families of Spinal Muscular Atrophy (Libertyville, IL) announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation to Quinazoline495 for the treatment of Spinal Muscular Atrophy.

29 Aug 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.

29 Aug 2009

Milestone reached in Biotie Wyeth collaboration for the development of PDE10 inhibitors for schizophrenia

Biotie announced today that it has reached a milestone in its collaboration with Wyeth for the development of PDE10 (phosphodiesterase 10) inhibitors for schizophrenia, triggering a USD 1.0 million milestone payment to Biotie.

28 Aug 2009

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Takeda Pharmaceutical Company Limited ("Takeda") and Takeda Global Research & Development Center, Inc., a wholly owned United States (U.S.) subsidiary, today jointly announced that the latter has received notification that the U.S. Food and Drug Administration (FDA) has agreed to the study design for a cardiovascular (CV) outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise.

28 Aug 2009

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched fluconazole injection in premix bags. IMS Health estimates that 2008 U.S. sales of fluconazole injection approximated $18 million. Sagent will begin marketing and shipping fluconazole bags immediately.

28 Aug 2009

Kenya launches malaria campaign; PBS' newshour airs segment on drug-resistance in Cambodia

Kenya on Thursday launched a national malaria campaign to encourage Kenyans to sleep under insecticide-treated nets (ITNs) every night to prevent infection, the Daily Nation reports.

28 Aug 2009

Elorac offers Zithranol-RR for treating plaque psoriasis

Now patients with mild to moderate plaque psoriasis have a new topical treatment option available by prescription. Zithranol™-RR (anthralin rapid release microcrystalline encapsulated cream, 1.2%), is an innovative topical therapy for plaque psoriasis according to Elorac, Inc., a privately held emerging dermatology company. Zithranol™-RR provides an advanced delivery system for anthralin achieving long remission times with no long-term side effects in a steroid-free, silky cream.

28 Aug 2009

AVANIR raises funds to develop and commercialize Zenvia for PBA

AVANIR Pharmaceuticals, Inc. (NASDAQ:AVNR) today announced it had raised gross proceeds of approximately $10.6 million via the sale of approximately 4.5 million shares of common stock at a weighted average price of $2.34 per share.

28 Aug 2009

Fast Forward selects IntraLinks to support its funding effort

IntraLinks®, the leading provider of critical information exchange solutions, today announced that Fast Forward™ has selected IntraLinks to help streamline the collection, distribution and tracking of information to support their funding of multiple biotechnology and pharmaceutical companies working on new Multiple Sclerosis (MS) treatments.

28 Aug 2009

Kamada finalizes agreement for the distribution of its intravenous alpha-1 antitrypsin in the United States

Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has entered into an exclusive agreement with a large US specialty pharmaceutical distributor company for the distribution of its flagship product, intravenous alpha-1 antitrypsin (AAT-IV) in the United States.

28 Aug 2009

Leicester research reveals the detrimental effects of Beta blockers on central aortic pressures

A University of Leicester-led study may have uncovered the reason why Beta-blockers are less effective at preventing stroke in older people with high blood pressure, when compared to other drugs for high blood pressure.

28 Aug 2009

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International. The preparation is the first generic version of Sanofi Aventis' BenzaClin(R) to be approved by the U.S. Food and Drug Administration (FDA).

27 Aug 2009

Geron provides additional comments on the recent clinical hold of Spinal Cord Injury IND

Geron Corporation today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

27 Aug 2009

Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

Bristol-Myers Squibb Company announced today that clinical data added to the labeling for ORENCIA (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

27 Aug 2009

Pharmaceutical News

Nuevolution partners with Novartis for drug research

FDA approves the usage of Valcyte for preventing CMV disease in pediatric patients

Oral dabigatran etexilate reduces the risk of stroke and systemic embolism

Intermediate dosages of otamixaban reduce acute coronary complications

Court reverses the summary judgement decision on ANDA Patent litigation between Ortho McNeil and Caraco Pharmaceutical Laboratories

Office of Orphan Products Development of the FDA grants Orphan Drug Designation to Quinazoline495

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

FDA approves Watson Pharmaceuticals' ANDA for Levonorgestrel tablets

Milestone reached in Biotie Wyeth collaboration for the development of PDE10 inhibitors for schizophrenia

U.S. FDA agrees to the study design for cardiovascular outcomes trial of alogliptin

Sagent Pharmaceuticals adds fluconazole injection to its line of premixed bags

Kenya launches malaria campaign; PBS' newshour airs segment on drug-resistance in Cambodia

Elorac offers Zithranol-RR for treating plaque psoriasis

AVANIR raises funds to develop and commercialize Zenvia for PBA

Fast Forward selects IntraLinks to support its funding effort

Kamada finalizes agreement for the distribution of its intravenous alpha-1 antitrypsin in the United States

Leicester research reveals the detrimental effects of Beta blockers on central aortic pressures

Mylan Pharmaceuticals markets FDA approved first generic version of Sanofi Aventis' BenzaClin

Geron provides additional comments on the recent clinical hold of Spinal Cord Injury IND

Clinical data added to ORENCIA labeling help treat patients with rheumatoid arthritis

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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