March 7- The U.S. Food and Drug Administration has asked Regeneron Pharmaceuticals Inc and Sanofi SA to assess potential neurocognitive side effects of their experimental cholesterol drug, Sanofi said in its annual report on Friday.» Read More
NEW YORK, Feb 25- While U.S. rates of obesity haven't changed much in a decade, preschool age children are showing signs of a turnaround, with rates nearly halved in that time, according to a new federal study released on Tuesday. "The rapid increase in obesity we saw in the' 80 s and' 90 s has definitely slowed," epidemiologist Cynthia Ogden told Reuters Health.
WASHINGTON-- The Food and Drug Administration has approved the first drug to treat a rare metabolic disorder characterized by abnormally low fat levels. The agency on Tuesday cleared Bristol-Myers Squibb's Myalept for patients with lipodystrophy, a condition in which people are born with little or no fat tissue.
Testosterone therapy is approved by the FDA for men who lack or have low testosterone in conjunction with an associated medical condition, such as a genetic failure of the testicles to produce testosterone.
Feb 25- Bristol-Myers Squibb Co said the U.S. Food and Drug Administration had approved its drug to treat rare and potentially fatal disorders involving loss of body fat. The condition, known as generalized lipodystrophy, involves fat buildup in the blood and organs such as liver and muscle and can lead to diabetes, pancreatitis and fatty liver disease.
Feb 25- InterMune Inc's experimental drug, in a late-stage trial, reduced the progression of a disease that leads to loss of lung function, taking the treatment closer to U.S. marketing approval. The health regulator had asked InterMune to conduct a new trial and the late-stage study, named Ascend, was drawn up to support the drug's U.S. marketing clearance.
Feb 25- InterMune Inc said its experimental lung drug reduced the progression of a disease that leads to loss of lung function in a late-stage trial. InterMune said it expected to submit a marketing application for the drug to the U.S. Food and Drug Administration by early third quarter of this year. They closed at $13.96 on the Nasdaq on Monday.
Feb 24- Pfizer Inc said on Monday that Prevnar 13, its blockbuster vaccine against childhood infections, prevented pneumonia outside of hospitals in people age 65 and older, in one of the largest drug trials ever conducted.
Feb 19- An experimental cancer drug developed by Eli Lilly and Co, touted by some to be the company's next blockbuster, significantly improved survival rates in lung cancer patients, sending the company's shares up 3 percent in early trading.
Feb 19- Eli Lilly and Co said its experimental lung cancer drug significantly improved patient survival rates compared to a placebo in a late-stage trial. The trial also showed that the drug, ramucirumab, improved survival rates without the cancer worsening. Lilly shares rose 3 percent to $57 in premarket trade on Wednesday.
Feb 18- Shares of Prana Biotechnology Ltd rose as much as 31 percent after the company said its experimental brain disorder drug improved cognitive function in a study on patients with Huntington's disease. "In a small trial, you don't expect to hit statistical significance on a secondary endpoint of efficacy," MLV& Co analyst Graig Suvannavejh told Reuters.
NEW YORK, Feb 14- U.S. health regulators have declined to approve proposed wider uses of Bayer AG and Johnson& Johnson's lucrative blood clot preventer Xarelto, the drugmakers said on Friday. An advisory panel to the FDA concluded in January that Xarelto should not be approved to prevent new heart attacks or strokes, a use referred to as secondary prevention.
NEW YORK, Feb 13- The only three insurance companies in Louisiana that sell healthcare policies under President Barack Obama's healthcare law throughout the state are rejecting payments from a federal program intended to help low-income HIV patients, advocacy groups said on Thursday.
Feb 12- U.S. health regulators on Wednesday approved the Johnson& Johnson and Pharmacyclics Inc cancer drug Imbruvica to treat chronic lymphocytic leukemia, a slowly progressing form of blood cancer.
Feb 12- U.S. health regulators on Wednesday approved the Johnson& Johnson and Pharmacyclics Inc cancer drug Imbruvica to treat chronic lymphocytic leukemia, a slowly progressing form of blood cancer. The Food and Drug Administration decision marks the second approval recently for the medicine, known chemically as ibrutinib.
Hundreds of people with HIV/AIDS trying to obtain coverage under Obamacare are in danger of being thrown out of their insurance plan.
NEW YORK, Feb 8- Hundreds of people with HIV/AIDS in Louisiana trying to obtain coverage under President Barack Obama's healthcare reform are in danger of being thrown out of the insurance plan they selected in a dispute over federal subsidies and the interpretation of federal rules about preventing Obamacare fraud.
*2013 sales of Vyvanse in ADHD expected to be about $1.2 billion. LONDON, Feb 7- Pharmaceuticals group Shire has halted development of its top-selling hyperactivity drug Vyvanse as a treatment for depression after it failed to treat patients successfully in two late-stage clinical trials.
The CEO of Sanofi admitted the pharmaceutical giant underperformed in emerging markets last year, after reporting a decline in quarterly sales.
For example, the price discussed for 24 weeks of Sovaldi therapy would run about $2,500 for certain patients at public hospitals, community clinics and non-governmental agencies in India, the Hindu Business Line reported earlier this week.
GSK said sales rose five percent in the fourth quarter of last year, narrowly beating expectations and indicating that the U.K. pharmaceutical giant's fortunes may be picking up.