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NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

EMA accepts Merck and ARIAD's MAA for ridaforolimus to treat metastatic bone sarcomas

Merck, known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., today announced that the European Medicines Agency (EMA) has completed its administrative validation process for the regulatory application for ridaforolimus, an investigational oral mTOR inhibitor developed for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy.

18 Aug 2011

Interests line up to guide 'super committee' decisions

The American Medical Association is among the groups taking a message to Congress — but it goes beyond trying to avoid the 2 percent cut that would be triggered if the deficit reduction panel doesn't meet its savings target. The AMA hopes to link fixing the scheduled Medicare physician payment cut to what it terms "any serious proposal" to address the nation's fiscal challenges.

18 Aug 2011

BIS monitor not superior in preventing intraoperative awareness than other alternatives

Anesthesiology researchers have shown that a device approved by the Food and Drug Administration to reduce the risk that patients will recall their surgery does not lower the risk of the problem, known as intraoperative awareness, any more than a less expensive method.

18 Aug 2011

Long-delayed forms to provide coverage details likely to be released today

Part of the health law, these rules will lay out, among other things, a new standard form that will provide consumers who are shopping for health coverage with policy details, such as deductibles and specific costs for certain medical circumstances.

18 Aug 2011

UnitedHealthcare, 4-H to launch new nutrition and wellness program for young people

Texas 4-H and UnitedHealthcare joined together today to launch a new partnership - Youth Voice: Youth Choice - a program to help young people in the state improve their health and well-being through exercise, proper nutrition and attention to personal safety.

18 Aug 2011

UNHCR reports 10 children dying daily and women facing risk of rape in Ethiopian refugee camps

"Ten Somali children under the age of five are dying every day of hunger-related causes in a refugee camp in Ethiopia, according to the U.N. refugee agency," the Guardian reports.

18 Aug 2011

FDA approves Zelboraf (vemurafenib) for advanced skin cancer

A new drug was approved for advanced skin cancer this Wednesday by U.S. regulators, offering the first new treatment for melanoma in 13 years.

18 Aug 2011

FDA approves Mayo Clinic's ovarian and breast cancer vaccines

Mayo Clinic has received investigational new drug approval from the Food and Drug Administration for two new cancer vaccines that mobilize the body's defense mechanisms to destroy malignant cells.

18 Aug 2011

Neoprobe sells gamma detection device business to Devicor

Neoprobe Corporation, a diversified developer of innovative oncology surgical and diagnostic products, announced today that it completed the previously announced sale of its neoprobe GDS line of gamma detection device systems to Devicor Medical Products, Inc. for $30 million in upfront consideration, plus up to an additional $20 million in royalties based on Devicor's achievement of certain revenue milestones.

18 Aug 2011

CEL-SCI receives Chinese patent for Multikine cancer drug

CEL-SCI Corporation today announced that the Chinese patent office has issued a key patent covering CEL-SCI's investigational cancer drug, Multikine.

18 Aug 2011

New research: Sniffer dogs can reliably identify lung cancer

Sniffer dogs could be used for the early detection of lung cancer, according to new research published in the European Respiratory Journal.

18 Aug 2011

Enrollment commences in Allos' FOLOTYN Phase 3 trial for peripheral T-cell lymphoma

Allos Therapeutics, Inc. today announced the enrollment of the first patient in a Phase 3 randomized clinical trial (PDX-017) evaluating FOLOTYN in patients with previously undiagnosed peripheral T-cell lymphoma.

18 Aug 2011

Roche receives FDA approval for Zelboraf to treat BRAF mutation-positive metastatic melanoma

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test.

18 Aug 2011

New gout drug may help severely affected: Study

A new drug for gout could help very sick gout patients who don't get better with usual treatment, according to a new study. The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa (pegloticase).

17 Aug 2011

Harmless bacteria re-engineered to fight a deadly strain

Scientists in Singapore have re-engineered a harmless strain of bacteria to fight another common, drug-resistant microbe that spreads in hospitals and is deadly to patients with weak immune systems.

17 Aug 2011

Zelboraf receives FDA approval for treatment of metastatic melanoma

The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

17 Aug 2011

First Edition: August 17, 2011

In today's headlines, a report about how the timing of the Supreme Court's health law review is in play -- will it happen before or after the 2012 election?

17 Aug 2011

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Protalix BioTherapeutics, Inc., announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.

17 Aug 2011

Mylan confirms Frova patent challenge

Mylan Inc. today confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Endo Pharmaceuticals in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate EQ, 2.5 mg base tablets.

17 Aug 2011