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Opinions: HIV vaccine; HIV resources help promote global disease control; U.S. fight against world hunger

Seth Berkley, president and chief executive of the International AIDS Vaccine Initiative, in a New York Times opinion piece examines how the "pessimism" over the recent controversy surrounding the results of an experimental HIV vaccine tested in Thailand "may ultimately thwart other efforts to develop an AIDS vaccine.

20 Oct 2009

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Amylin Pharmaceuticals, Inc. today announced that new data from its obesity program will be presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, to be held in Washington, D.C. October 24-28. Phase 2 data from the pramlintide/metreleptin combination treatment clinical program will be the subject of a late-breaking oral presentation.

20 Oct 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

20 Oct 2009

FDA approves new oral medication for renal cell carcinoma

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

20 Oct 2009

WHO recommends antivirals for patients with symptoms of both H1N1, pneumonia

The WHO concluded a three-day meeting on H1N1 (swine flu) in Washington, D.C., on Friday, where health experts issued recommendations that patients with symptoms of H1N1 and pneumonia be treated quickly with antivirals, even before the results of H1N1 tests are complete, the San Francisco Chronicle blog, "ChronRX" reports (Allday, 10/16).

19 Oct 2009

URL Pharma's Colcrys approved by FDA for prevention of gout flares

URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.

19 Oct 2009

Study on the economic impact of antibiotic overuse and antibiotic-resistant infections

The Alliance for the Prudent Use of Antibiotics (APUA) and Cook County Hospital (currently John H. Stroger, Jr. Hospital of Cook County), today announced the release of an eye-opening study on the economic impact of antibiotic overuse and antibiotic-resistant infections (ARIs) sponsored by an unrestricted educational grant from bioMerieux and the Centers for Disease Control and Prevention (CDC).

19 Oct 2009

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

Pharmaceutical News

Opinions: HIV vaccine; HIV resources help promote global disease control; U.S. fight against world hunger

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

FDA approves new oral medication for renal cell carcinoma

WHO recommends antivirals for patients with symptoms of both H1N1, pneumonia

URL Pharma's Colcrys approved by FDA for prevention of gout flares

Study on the economic impact of antibiotic overuse and antibiotic-resistant infections

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

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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