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Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that the Company has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).

28 Apr 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

28 Apr 2010

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

Freedland Russo is pleased that Eric Holder, U.S. Attorney General, announced the $520 million dollar settlement of a lawsuit filed against AstraZeneca. The settlement announced today in Philadelphia indicates marketing practices for Seroquel included promotion of the drug by physicians participating in clinical studies and drug sales representatives encouraging doctors to prescribe for the unapproved uses.

28 Apr 2010

Ranibizumab eye injections plus laser therapy result in dramatic visual improvement

Researchers have shown that ranibizumab (Lucentis) eye injections, often in combination with laser treatment, result in better vision than laser treatment alone for diabetes-associated swelling of the retina.

28 Apr 2010

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

TYRX, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue.

28 Apr 2010

DRCR Network study finds new treatment more effective

28 Apr 2010

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Cardiovascular Systems, Inc., has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010.

28 Apr 2010

A bitter pill to swallow

Reporting for Kaiser Health News in collaboration with The Washington Post, Sandra Boodman writes: "When Jere Carpentier learned last year that she had advanced colon cancer -- her third malignancy in a dozen years -- she worried about spending hours in a clinic tethered to an intravenous line, enduring punishing chemotherapy that would make her hair fall out.

28 Apr 2010

Better vision ahead for many diabetic retinopathy patients

A nationwide, government-sponsored study finds that people with a common form of diabetic retinopathy can benefit from a medication first developed to combat another potentially blinding disease, age-related macular degeneration (AMD). Treating diabetic macular edema (DME) with ranibizumab (Lucentis) eye injections, plus laser treatment if needed, appears to result in better vision than laser treatment alone, according to the Diabetic Retinopathy Clinical Research (DRCR) Network study published today in Ophthalmology online, the journal of the American Academy of Ophthalmology (Academy). DME is the main cause of vision loss in people with diabetes mellitus.

27 Apr 2010

Debiopharm commences treatment in Phase I clinical trial for Debio 0932 small molecule Hsp90 inhibitor

Curis, Inc. announced today that its licensee Debiopharm S.A. has treated the first patient in a Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305.

27 Apr 2010

Antares Pharma, Uman Pharma announce strategic alliance for VIBEX MTX

Antares Pharma, Inc., a leader in self-injection drug delivery technology and Uman Pharma, a manufacturer of top-quality injectable pharmaceutical products based in Quebec, Canada, today announced the formation of a strategic alliance covering Antares' VIBEX™ MTX.

27 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

Pluristem Therapeutics Inc. today announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia, the end-stage of peripheral artery disease. The interim data demonstrated that PLX-PAD is safe, well tolerated and effective.

27 Apr 2010

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

ViroPharma Incorporated today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema.

27 Apr 2010

Nuvo Research's PENNSAID now available in U.S. pharmacies

Nuvo Research Inc., a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.

27 Apr 2010

Study: Cigarette smoking, fructose consumption can worsen NAFLD

Recent studies suggest that modifiable risk factors such as cigarette smoking and fructose consumption can worsen nonalcoholic fatty liver disease. With NAFLD, fat accumulates in the liver of overweight individuals despite drinking little alcohol, causing in some cases liver scarring that can lead to liver failure.

27 Apr 2010

First Edition: April 27, 2010

Today's headlines focus on the details of health reform that continue to emerge -- including states' reactions to high risk pools and questions about the sweeping expansion of Medicaid.

27 Apr 2010

Pharmacological suppression of nonsense mutations effective in treating genetic defects

Genetic mutation can disrupt the way human cells make proteins, which in turn leads to inherited disease. David Bedwell, a professor in the University of Alabama at Birmingham (UAB) Department of Microbiology, says scientists are closer than ever to producing drugs that fix this disrupted-protein pathway and drastically improving treatment of genetic disease.

27 Apr 2010

High levels of phosphate in sodas accelerate signs of aging

Here's another reason to kick the soda habit. New research published online in the FASEB Journal shows that high levels of phosphates may add more "pop" to sodas and processed foods than once thought. That's because researchers found that the high levels of phosphates accelerate signs of aging. High phosphate levels may also increase the prevalence and severity of age-related complications, such as chronic kidney disease and cardiovascular calcification, and can also induce severe muscle and skin atrophy.

27 Apr 2010

Medical Condition News

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Hana Biosciences announces completion of Marqibo pre-NDA meeting with FDA

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

Freedland Russo announces $520M settlement over Seroquel marketing practice lawsuit against AstraZeneca

Ranibizumab eye injections plus laser therapy result in dramatic visual improvement

TYRX receives FDA marketing clearance for AIGISRx ST antibacterial patch for soft tissue repair

DRCR Network study finds new treatment more effective

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

A bitter pill to swallow

Better vision ahead for many diabetic retinopathy patients

Debiopharm commences treatment in Phase I clinical trial for Debio 0932 small molecule Hsp90 inhibitor

Antares Pharma, Uman Pharma announce strategic alliance for VIBEX MTX

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Interim results from Phase I clinical trial of PLX-PAD for treatment of CLI

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

Nuvo Research's PENNSAID now available in U.S. pharmacies

Study: Cigarette smoking, fructose consumption can worsen NAFLD

First Edition: April 27, 2010

Pharmacological suppression of nonsense mutations effective in treating genetic defects

High levels of phosphate in sodas accelerate signs of aging

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