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Cyberonics net sales increase 13% to $53.7M for second quarter 2012

Cyberonics, Inc. today announced results for the quarter ended October 28, 2011.

19 Nov 2011

FDA revokes approval of Avastin for breast cancer

The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling in an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.

19 Nov 2011

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

19 Nov 2011

Abbott receives FDA approval for new Chagas assay

The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi.

19 Nov 2011

Deep brain stimulation benefits highly treatment resistant patients with major depressive disorder

Results from the first multi-center pilot study of deep brain stimulation (DBS) for major depressive disorder were published online today by the Journal of Neurosurgery. The study, conducted at three research facilities in Canada, was designed to replicate and build upon an earlier study by Dr. Andres Lozano and Dr. Helen Mayberg which was published in the journal Neuron in 2005.

18 Nov 2011

Regeneron receives FDA approval for Eylea to treat wet AMD

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

18 Nov 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

The U.S. Food and Drug Administration today approved Erwinaze to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

18 Nov 2011

FDA assigns new PDUFA date for Takeda's investigational type 2 diabetes therapy, alogliptin

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., today announced that the company received notification from the U.S. Food and Drug Administration (FDA) that its review of investigational type 2 diabetes therapy alogliptin, and thus the fixed-dose combination therapy alogliptin/pioglitazone, will be delayed.

18 Nov 2011

Tonix to initiate TNX-102 PK and BA study for fibromyalgia

Tonix Pharmaceuticals Holding Corp., a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system, including fibromyalgia syndrome and post-traumatic stress disorder, will initiate a comparative pharmacokinetic and bioavailability study of TNX-102, a novel dosage oral formulation of cyclobenzaprine for the treatment of FM, following the U.S. Food and Drug Administration clearance of the Company's initial Investigational New Drug Application.

18 Nov 2011

Potential new ways to design vaccines, antibiotics

A University of Louisville scientist has determined for the first time how the bacterium that causes Legionnaires' disease manipulates our cells to generate the amino acids it needs to grow and cause infection and inflammation in the lungs.

18 Nov 2011

Entomologists explain why flies are attracted to beer

Ever wondered why flies are attracted to beer? Entomologists at the University of California, Riverside have, and offer an explanation. They report that flies sense glycerol, a sweet-tasting compound that yeasts make during fermentation.

18 Nov 2011

TAU model discovers adaptable decision-making in bacteria communities

Much to humans' chagrin, bacteria have superior survival skills. Their decision-making processes and collective behaviors allow them to thrive and even spread efficiently in difficult environments.

18 Nov 2011

ACAAI president available to comment on School Access to Emergency Epinephrine Act

Dr. Stanley Fineman, president of the American College of Allergy, Asthma and Immunology, (ACAAI) is available to comment on the School Access to Emergency Epinephrine Act, a federal bill introduced today that will help make epinephrine available in schools for the immediate treatment of anaphylactic reactions to food or other allergens.

18 Nov 2011

Important clues to prevention and management of delirium are being ignored

Important clues to the prevention and management of delirium, a condition affecting an estimated 7 million hospitalized Americans, are being ignored, according to a study from the Regenstrief Institute and the Indiana University School of Medicine.

18 Nov 2011

Doctors, aid workers warn of disease threats to displaced persons in Somalia

Inter Press Service examines how doctors and aid workers in and around Mogadishu, Somalia, "are warning that famine victims in internally displaced camps have become vulnerable to contagious diseases like cholera and measles, as conditions here are ripe for an outbreak."

18 Nov 2011

Longer looks: The Supreme Court and health law politics; Obama and drug shortages

There are eighty-two Planned Parenthood affiliates nationwide, operating nearly eight hundred clinics. Planned Parenthood says that one in five women in the U.S. has been treated at a Planned Parenthood clinic. Critics of Planned Parenthood, who are engaged in a sustained attack on the organization, say that most of those women are going to the clinics to have abortions, paid for, in violation of the Hyde Amendment, with taxpayer money.

18 Nov 2011

VSL#3 classified as refrigerated medical food for three GI conditions

As clinical studies continue to validate the use of probiotics to help promote general gastrointestinal health, a growing U.S. market for probiotics indicates that the U.S. healthcare community and consumers alike are recognizing the value of these beneficial microorganisms. However, because most probiotics are classified as dietary supplements, directing patients to the best probiotic for their individual needs can be challenging.

18 Nov 2011

FDA clears IntriCon's Sirona Event and Holter Recorder

IntriCon Corporation, a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for its Sirona Event and Holter Recorder. Sirona is the company's second-generation cardiac diagnostic monitoring (CDM) device, allowing physicians to monitor patient cardiac events remotely.

17 Nov 2011

Cardica initiates enrollment in MicroCutter surgical stapling study in Europe

Cardica, Inc. today announced that the first patients have been enrolled and discharged from the first two investigative sites in a European clinical study to evaluate its MicroCutter surgical cutting/stapling devices for transections, resections and anastomoses during gastrointestinal surgical procedures.

17 Nov 2011

High-level panel releases recommendations to address food security, climate change in anticipation of U.N. meeting

In advance of a U.N. climate change conference this month in Durban, South Africa, the Commission on Sustainable Agriculture and Climate Change, a high-level international panel, on Wednesday announced its recommendations for achieving food security while addressing the effects of climate change, VOA News reports.

17 Nov 2011