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Astellas suspends patient enrollment from ACT 5 study of KYNAPID

Cardiome Pharma Corp. today announced that its co-development partner, Astellas Pharma US., Inc., has suspended patient enrollment in the ACT 5 study of KYNAPIDTM (vernakalant hydrochloride) Injection following a single unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received KYNAPID.

22 Oct 2010

New epilepsy drugs give more options, but make treatment decisions more complex: Epilepsy specialist

A dozen new epilepsy drugs are giving doctors and patients more options, but making treatment decisions more complex, a Loyola epilepsy specialist reports in the journal Neurologic Clinics.

22 Oct 2010

Nurses in health care facilities may perform better through harm reduction strategies: Researchers

University of Maryland School of Nursing researchers say nurses in hospitals and other health care facilities may perform better by following the lead of airlines, trucking, and nuclear plants, by limiting hours of service, ensuring prompt and definite breaks during shifts, and other scheduling strategies.

22 Oct 2010

Six government drug control laboratories in MENA to join USP to improve quality of drugs

Six government drug control laboratories in the Middle East and North Africa will join together with the United States Pharmacopeial Convention in an effort to improve their capabilities to test the quality of drugs. The MENA Regional Laboratory Network aims to promote communication and exchange of information among participating countries, strengthen the performance and technical skill of the laboratories and their personnel, harmonize methods that facilitate approval of drugs across countries in the region, and help eliminate substandard and counterfeit drugs.

22 Oct 2010

Cephalon signs convertible note subscription agreement with ChemGenex Pharmaceuticals

Today, Cephalon, Inc. announced the signing of a convertible note subscription agreement with ChemGenex Pharmaceuticals Limited, an Australian-based oncology focused biopharmaceutical company.

22 Oct 2010

FDA announces new label for HIV antiviral drug Invirase

The U.S. Food and Drug Administration today announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Norvir (ritonavir), another HIV antiviral medication.

22 Oct 2010

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

A new analysis of data from more than 12,000 people with cystic fibrosis (CF) and Pseudomonas aeruginosa (Pa) lung infection in the Cystic Fibrosis Foundation's Patient Registry shows that use of TOBI (Tobramycin Inhalation Solution, USP) was associated with a 21% reduction in mortality in the following year.

22 Oct 2010

World Bank extends food crisis response fund for countries experiencing high food prices

"The World Bank on Monday cited growing instability in food prices" before announcing that it would extends its Global Food Crisis Response Program through June 2011, Deutsche Presse-Agentur/M&C reports (10/18).

22 Oct 2010

New research center to study effects of BPA, phthalates on children

A new research center based at the University of Illinois will investigate whether regular exposure to bisphenol A and phthalates - chemicals widely used in plastics and other consumer products - can alter infant and adolescent development, cognition or behavior.

22 Oct 2010

$Medtronic's Xpander II receives FDA clearance for vertebral compression fractures$

Medtronic's Xpander II receives FDA clearance for vertebral compression fractures

Medtronic Inc. today announced Food and Drug Administration (FDA) clearance of the Kyphon Xpander II Inflatable Bone Tamp (IBT) for the treatment of vertebral compression fractures with minimally invasive Kyphon Balloon Kyphoplasty

22 Oct 2010

Neoprobe submits BLA response letter to FDA to commercialize RIGS technology

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, today announced that it has submitted a response letter to the U.S. Food and Drug Administration (FDA) regarding its RIGScan technology Biologic License Application (BLA).

22 Oct 2010

Celtic Pharma receives US patent for methods to treat breast, colon cancer

Celtic Pharmaceutical Holdings L.P. today announced that the U.S. Patent Office has issued U.S. patent 7,816,323, for novel methods to treat breast and colon cancers using a combination therapy of Xerecept with Avastin.

22 Oct 2010

Pinch of salt: How much is enough?

Salt restriction in the normal diet has come under debate. While scientists are questioning the complex role of sodium in the body and the need for salt restriction, surveys have found that dietary sodium has not gone down well in large populations despite awareness on the risks of too much salt intake.

21 Oct 2010

Oral cancer linked to oral sex: Study

Swedish researchers have found that the Human papillomavirus (HPV) that causes cervical cancer in women is also a risk factor for oropharyngeal squamous cell carcinoma (OSCC) or oral and throat cancer in men even if they do not smoke or consume alcohol.

21 Oct 2010

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

21 Oct 2010

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Boston Scientific Corporation today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

21 Oct 2010

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

Takeda Canada, Inc. is pleased to announce that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout is now available in Canada. This medication is the first new treatment option in more than 40 years for the approximately three per cent of Canadians who have hyperuricemia associated with gout.1 ULORIC was discovered by Teijin Pharma Limited of Tokyo and licensed to Takeda for the Canada market.

21 Oct 2010

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

PolyMedix, Inc., a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).

21 Oct 2010

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex Tablets, a Parkinson's disease treatment.

21 Oct 2010

Food News and Research

Astellas suspends patient enrollment from ACT 5 study of KYNAPID

New epilepsy drugs give more options, but make treatment decisions more complex: Epilepsy specialist

Nurses in health care facilities may perform better through harm reduction strategies: Researchers

Six government drug control laboratories in MENA to join USP to improve quality of drugs

Cephalon signs convertible note subscription agreement with ChemGenex Pharmaceuticals

FDA announces new label for HIV antiviral drug Invirase

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

TOBI reduces mortality in patients with cystic fibrosis, Pa lung infection

World Bank extends food crisis response fund for countries experiencing high food prices

New research center to study effects of BPA, phthalates on children

Medtronic's Xpander II receives FDA clearance for vertebral compression fractures

Neoprobe submits BLA response letter to FDA to commercialize RIGS technology

Celtic Pharma receives US patent for methods to treat breast, colon cancer

Pinch of salt: How much is enough?

Oral cancer linked to oral sex: Study

Astellas suspends enrollment in ACT 5 study of KYNAPID in atrial fibrillation patients

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Health Canada approves ULORIC to lower serum uric acid levels in patients with gout

PolyMedix plans PMX-60056 Phase 2 clinical trial in interventional cardiology

Mylan receives final FDA approval for Pramipexole Dihydrochloride Tablets

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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