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FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. MICARDIS® is the first treatment in its class to be approved for this indication.

19 Oct 2009

FDA approves GlaxoSmithKline Biologicals' Cervarix for prevention of cervical cancer

The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

19 Oct 2009

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Perrigo Company announced today that the Hatch-Waxman litigation relating to Duac® Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

Vaccinations and preventative hygiene routines can help protect families from H1N1

According to the Centers for Disease Control and Prevention (CDC), 37 states in the U.S. now report widespread influenza activity - and nearly all influenza cases reported to the health authority are 2009 H1N1, also known as swine flu. However, with the release of a 2009 H1N1 vaccine this week, parents have a new preventative tool to help keep their families safe from illness.

19 Oct 2009

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Quotient Biodiagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application (BLA) for the first 15 monoclonal antibodies in its proprietary line of transfusion diagnostics. These products are for use by blood donor centers, reference laboratories, and hospitals to type and screen blood.

19 Oct 2009

Viriom picks ChemDiv's Russian subsidiary for development of innovative HIV compounds

ChemDiv, Inc. of San Diego has proudly announced that its wholly owned subsidiary Chemical Diversity Research Institute (CDRI ) of Moscow, Russia, has been chosen by Viriom Ltd. ( Viriom) of Moscow, Russia as a service partner in developing innovative HIV compounds. The program includes pre-clinical and clinical studies, which are expected to begin in 2010.

19 Oct 2009

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

Talecris Biotherapeutics (Nasdaq: TLCR) today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

Human Genome Sciences, Inc. today announced that it has earned a $75 million milestone payment from Novartis, related to successful completion of the Phase 3 development program and the decision to submit applications seeking regulatory approval to market ZALBIN™ (albinterferon alfa-2b) for the treatment of chronic hepatitis C.

19 Oct 2009

IAVI and Ragon Institute sign MOU to devise new vaccine strategies for AIDS

The International AIDS Vaccine Initiative (IAVI) announced today that it has signed a memorandum of understanding with the Ragon Institute to accelerate the development of new and promising AIDS vaccine candidates for testing.

19 Oct 2009

Lubricin injections can reduce cartilage degeneration

Medical researchers will report findings today (Oct. 19) that demonstrate that injecting the protein lubricin into knee joints can dramatically reduce cartilage degeneration.

19 Oct 2009

Preclinical data of carfilzomib and PR-957 inhibitors to be presented at 2009 ACR/ARHP meeting

Proteolix, Inc. today announced that data from preclinical studies of carfilzomib and PR-957 will be presented at the 2009 ACR/ARHP Annual Scientific Meeting on October 16 - 21 in Philadelphia, PA.

19 Oct 2009

Majority of girls and young women well aware of HPV vaccine's benefits and limitations

Contrary to concerns that the human papillomavirus vaccine might promote promiscuity, a national survey of girls and young women found that the majority of respondents did not believe the HPV vaccine protected them against other sexually transmitted infections.

19 Oct 2009

NCCN Clinical Practice Guidelines in Oncology updated to include pralatrexate drug

NCCN has added pralatrexate (Folotyn(TM), Allos Therapeutics, Inc.) to the NCCN Guidelines for Non-Hodgkin's Lymphomas as one of the options for second-line therapy for relapsed or refractory peripheral T-cell lymphoma.

19 Oct 2009

Parents are concerned about the overuse of prescription medications with their children: Survey

A new nationwide survey released today reveals that just 12 percent of parents with children under the age of 18 have spoken to their child's doctor about complementary and integrative approaches to medicine, yet nearly 90 percent say they want to know more.

19 Oct 2009

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Data presented at the 73rd Annual Scientific Meeting of the American College of Rheumatology highlight effects of baseline characteristics on achievement of serum uric acid (sUA) levels to <6.0 mg/dL and the frequency of flares with ULORIC® (febuxostat) treatment.

19 Oct 2009

Research study on cowpox virus

In the annals of medicine, Edward Jenner's 1796 vaccination of a young boy against smallpox, using fluid from cowpox blisters, remains a landmark case. In a new study, Kathryn Sykes, a researcher at Arizona State University's Biodesign Institute and her colleagues have taken a fresh look at cowpox.

19 Oct 2009

Pharmaceutical News

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

FDA approves GlaxoSmithKline Biologicals' Cervarix for prevention of cervical cancer

Hatch-Waxman patent infringement litigation concerning Duac Gel dismissed

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Vaccinations and preventative hygiene routines can help protect families from H1N1

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Viriom picks ChemDiv's Russian subsidiary for development of innovative HIV compounds

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

Human Genome Sciences completes Phase 3 development program, earns $75 million from Novartis

IAVI and Ragon Institute sign MOU to devise new vaccine strategies for AIDS

Lubricin injections can reduce cartilage degeneration

Preclinical data of carfilzomib and PR-957 inhibitors to be presented at 2009 ACR/ARHP meeting

Majority of girls and young women well aware of HPV vaccine's benefits and limitations

NCCN Clinical Practice Guidelines in Oncology updated to include pralatrexate drug

Parents are concerned about the overuse of prescription medications with their children: Survey

CONFIRMS trial demonstrates efficacy of ULORIC for treating hyperuricemia in patients with gout

Research study on cowpox virus

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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