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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

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

Experts: Treat swine flu quickly, even without verification

The World Health Organization 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

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

Morgan Stanley's global initiative to reduce childhood malnutrition and save lives worldwide

Morgan Stanley announced today that the Firm will launch “Step Up to the Plate,” a global initiative to reduce childhood malnutrition and save lives worldwide. This two-pronged approach is designed to address malnutrition by providing food to children most in need in developed nations, while also addressing the medical effects of children already experiencing malnutrition in the developing world.

19 Oct 2009

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Amarin Corporation plc today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

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

Lux Biosciences raises $50 million through Series B venture financing

Lux Biosciences, Inc., a privately held biotechnology company focused on the development and commercialization of therapies for serious ophthalmic diseases, today announced that the company has closed a $50 million Series B venture financing. Participants in the funding were current investors in Lux Biosciences, HBM Bioventures, Novo A/S, Prospect Venture Partners and SV Life Sciences (SVLS), as well as SVLS' publicly traded fund, International Biotechnology Trust plc.

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

Metabolic master switch sets the biological clock in body tissues

Our body's activity levels fall and rise to the beat of our internal drums-the 24-hour cycles that govern fundamental physiological functions, from sleeping and feeding patterns to the energy available to our cells. Whereas the master clock in the brain is set by light, the pacemakers in peripheral organs are set by food availability. The underlying molecular mechanism was unknown.

19 Oct 2009

Chinese SFDA approves China Medical Technologies' SPR System

China Medical Technologies, Inc., a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company has received approval for its SPR- based analysis system (the "SPR System") from the State Food and Drug Administration of China (the "SFDA").

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

Mothers' nutritional and healthy eating habits may impact children's eating behaviors

Healthy eating is on the minds of many moms, but it’s their eating habits and nutritional knowledge that have the most bearing on what their children eat, according to The NPD Group, a leading market research company.

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

Anti-clotting drug may cause problems for elderly trauma patients: Study

A common drug used for preventing heart attacks and blood clots may also cause problems for individuals who suffer some form of trauma, particularly elderly patients, according to a study presented today at the 2009 Clinical Congress of the American College of Surgeons.

19 Oct 2009

Food News and Research

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

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

Experts: Treat swine flu quickly, even without verification

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

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

Morgan Stanley's global initiative to reduce childhood malnutrition and save lives worldwide

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

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

Lux Biosciences raises $50 million through Series B venture financing

FDA approves Quotient Biodiagnostics' BLA for transfusion diagnostic monoclonal antibodies

Metabolic master switch sets the biological clock in body tissues

Chinese SFDA approves China Medical Technologies' SPR System

Talecris Biotherapeutics' PROLASTIN-C receives FDA approval

Mothers' nutritional and healthy eating habits may impact children's eating behaviors

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

Anti-clotting drug may cause problems for elderly trauma patients: Study

Enhancing confidence in chemical ionization spectrometry data eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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