WASHINGTON-- The Food and Drug Administration said Thursday it approved a new blood test from Roche to help doctors diagnose diabetes. The FDA said Roche's test is the first to be approved to diagnose the disease.
CHICAGO, May 23- U.S. scientists say a dramatic result last year suggesting that a cancer drug already approved by U.S. regulators could quickly clear out Alzheimer's plaques in mice was too good to be true.
WARSAW, Poland-- A 33- year-old Polish man received a face transplant just three weeks after being disfigured in a workplace accident, in what his doctors said Wednesday is the fastest time frame to date for such an operation. It was Poland's first face transplant.
CHICAGO, May 23- Kathrin Jansen is a microbiologist with at least two breakthrough vaccines to her name: she brought the cervical cancer vaccine Gardasil to market for Merck and helped develop the $4 billion a year pneumonia and meningitis vaccine Prevnar 13 for Pfizer.
*FDA panel says suvorexant safe, effective at lower doses. On Monday, the FDA's internal reviewers published a report expressing concern about suvorexant's potential to cause next-day sleepiness and impaired driving.
The advisory panel was convened to help the FDA decide whether to approve the drug, suvorexant, which would be the first in a new class of sedatives designed to help people fall asleep and stay asleep.
NEW YORK-- Shares of Regeneron Pharmaceuticals Inc. edged higher on Wednesday on positive clinical trial data for an experimental asthma drug. THE SPARK: The New England Journal of Medicine's website on Tuesday published the results of a study of the asthma treatment dupilumab, which Regeneron is developing with French drugmaker Sanofi.
NEW YORK, May 22- Little known biotechnology company Merrimack Pharmaceuticals Inc has quietly built a large pipeline of experimental cancer treatments that it aims to deliver at a fraction of the cost spent by larger rivals. Medicare system contending with new cancer treatments that can exceed $100,000 per patient.
NEW YORK-- Shares of Oncolytics Biotech Inc. rose Wednesday after the company reported promising results for its drug Reolysin as a treatment for melanoma, the deadliest form of skin cancer. Oncolytics said it is expanding the trial because of positive early results, as three out of 14 patients had their tumors shrink following treatment with the drug.
Bristol-Myers Squibb could be a big winner with a portfolio of cancer treatments under development that use a patient's own immune system to attack the disease, according to a Citi, which raised its rating on the drugmaker.
*Potential sales of $35 bln a year over next 10 years- Citigroup. That bullish sales forecast by analysts at U.S. bank Citigroup highlights the growing excitement surrounding so-called immunotherapy after positive results from clinical trials conducted by companies such as Bristol-Myers Squibb and Roche Holding.
May 21- A new type of asthma drug meant to attack the underlying causes of the respiratory disease slashed episodes by 87 percent in a mid-stage trial, making it a potential game changer for patients with moderate to severe disease, researchers said on Tuesday.
In a story May 20 about Pfizer Inc. halting a cancer drug study, The Associated Press erroneously reported the uses of two of the drugmaker's existing cancer medicines. Bosulif is approved for use in certain patients with chronic myelogenous leukemia and Inlyta is for advanced kidney cancer.
WESTON, Mass.-- Specialty drugmaker Biogen Idec said Tuesday it submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval. The company also plans to submit the drug to the European Medicines Agency in coming weeks. Shares of Biogen Idec Inc. rose $6.15, or 2.7 percent, to close Tuesday at $231.33.
May 21- A new type of asthma drug meant to attack the underlying causes of the respiratory disease slashed episodes by 87 percent in a mid-stage trial, making it a potential game changer for patients with moderate to severe disease, researchers said on Tuesday.
Drugmaker Pfizer Inc. has halted a late-stage study of an experimental cancer compound being tested in patients with a certain form of non-Hodgkin's lymphoma, because an interim analysis showed the drug wasn't helping patients live longer.
May 20- Pfizer Inc, which has been on a hot streak with three recent approvals of cancer drugs, stumbled on Monday, saying it was halting a late-stage trial of a drug for aggressive non-Hodgkin lymphoma after independent monitors found it was not likely to improve survival.
WASHINGTON-- Shares of Peregrine Pharmaceuticals Inc. surged Monday after the company said it would move ahead with a late-stage trial of its lead product, the experimental lung cancer treatment bavituximab.
Shares of XenoPort Inc. sank Monday after the drug developer said a potential treatment for multiple sclerosis patients failed in late-stage clinical testing, and it will stop developing the drug. XenoPort was testing the drug to treat patients with spasticity due to multiple sclerosis.
May 20- Merck& Co's experimental insomnia drug suvorexant appears generally effective, according to reviewers at the U.S. Food and Drug Administration, but they questioned the company's proposed dosing levels.