glaxosmithkline
FDA Panel Votes to Keep Avandia on Market
GlaxoSmithKline diabetes drug Avandia has been found to have increased heart attack risk compared to similar medication. But a majority of the Food and Drug Administration's panel of outside experts have voted to keep the drug on the market -- though new restrictions are likely.
GlaxoSmithKline Settles 10,000 Avandia Lawsuits
GlaxoSmithKline, whose diabetes drug Avandia is undergoing a safety review by the FDA, has agreed to pay about $460 million to resolve about 10,000 lawsuits from users of the drug, which can allegedly cause heart attacks and strokes.
FDA Panel Scrutinizing Diabetes Drug Avandia
On Tuesday, the FDA will convene a panel of experts to discuss GlaxoSmithKline's type II diabetes drug Avandia. Once a blockbuster, sales of the drug have dropped by more than half since studies suggested it significantly increases risk for serious heart problems.
GSK's Diabetes Drug Avandia Draws More Scrutiny in Europe
Problems for GlaxoSmithKline just seem to be getting worse. The European Medicines Agency said Friday it's launching a new review of Avandia's benefit-risk profile following new data on the possibility of cardiovascular complications.
Achillion Is a Small Biotech on the Verge of Big Moves
Its development of novel treatments for hepatitis C is leading Achillion to seek partnerships with major drugmakers. Many analysts see great potential for its drugs and expect it to strike one or more deals soon.
Avandia Linked to Heart Attacks in Two New Studies
GlaxoSmithKline's diabetes drug Avandia once again captured headlines Monday morning after two new studies linked it to heart attacks and other cardiovascular complications. The authors of the studies say the results should prompt the FDA to pull the drug from the market.
Merck Gets FDA Nod for Asthma Drug
Merck (MRK) today announced that the U.S. Food and Drug Administration has approved its respiratory drug Dulera for Asthma patients 12 years of age and older. Dulera is a new two-in-one, fixed-dose combination, which was developed by Schering-Plough and then inherited by Merck when it acquired its smaller rival last year.
Sanofi-Aventis, Regulus Form Alliance to Develop microRNA Therapies
Sanofi-Aventis announced it has entered into a global, strategic alliance with Regulus Therapeutics to discover, develop, and commercialize therapies for microRNAs -- a class of small RNA molecules that scientists call the master maestros of the genome.
Pharmas Agree to Share Alzheimer's Research Data
Alzheimer's has been a tough area for medical research, resulting in little help to date for the millions of sufferers. But a new database of patient information from failed trials, built by competing drugmakers, may yield clues to a treatment breakthrough.
Buzzkill for Red-Wine Drug: GlaxoSmithKline Suspends Trial
Resveratrol, a substance found in red wine, could slow age-related disease and extend patients' life spans. But GlaxoSmithKline has suspended a trial of a resveratrol drug as a result of safety concerns.
Fund Focus: When Instinct Beats a Spreadsheet
Fund manager Marc Heilweil is an old-school investor who usually outperforms the competition by using his instincts -- not spreadsheets crammed with numbers -- to spot good companies at those rare times when they are trading cheaply.
FDA May Halt Safety Study on Diabetes Drug Avandia
The FDA is considering halting a safety study on GlaxoSmithKline's diabetes drug Avandia, The Wall Street Journal reported Sunday. Previous studies have linked Avandia to an increased risk of heart attacks. The implication is a serious threat to the continued sale of Avandia in the U.S.
Experts Face Off on Prostate Cancer Drugs
If you could prevent cancer by taking a pill, would you? Probably. Should you? That's a matter of debate among doctors. Merck's Proscar and now GlaxoSmithKline's Avodart have been shown in studies to cut prostate cancers. But whether those studies are conclusive is the question.
GlaxoSmithKline, Sanofi-Aventis: Rx for When Drug Patents Expire
GSK has made a new alliance to support its new strategy of targeting rare, serious diseases, while Sanofi-Aventis is revamping its plants for a fresh focus. Both are facing a revenue falloff when their drugs go off patent.
GlaxoSmithKline's Rotavirus Vaccine Suspended for Pig Virus Contamination
The FDA has told pediatricians to temporarily suspend use of GlaxoSmithKline's Rotarix vaccine for rotavirus immunization while the agency investigates the presence of a benign pig virus in the vaccine.
Drugged and Dosed: Do Americans Take Too Many Mind-Altering Meds?
Two new books raise some deep questions about the American concept of mental health: One is a searing investigation of how we export, not just our drugs, but our idea of mental illness. The other is the upcoming revision of the psychiatric diagnostic manual, which proposed some very necessary changes to the standards of treatment.
FDA Approves Pfizer's Pediatric Vaccine Prevnar 13
The FDA has finally approved the vaccine Prevnar 13, developed to protect children aged 6 weeks through 5 years against 13 varieties of the Streptococcus pneumoniae bacteria, which can cause such serious illnesses as sepsis, meningitis and pneumonia.
Now, Two Senators Want GSK's Avandia Pulled from the Market
After a two-year investigation, Democrat Max Baucus and Republican Chuck Grassley have issued a detailed report questioning the safety of GlaxoSmithKline's Diabetes Drug Avandia, renewing concerns that it increases the risk of heart attack.
Pharmaceutical Round-up: FDA Warns About Glaxo's Asthma Drug; Novavax Boosted By Vaccine Study
Here's a roundup of some of the major news moving stocks in the pharmaceutical industry: GlaxoSmithKline shares fell after the FDA warned against long-term use of asthma treatments Advair and Serevent. Meanwhile, a new study shows Novavax's vaccine against swine flu is effective.
What's Really Going On With Jobs?
Entering February, a mixed picture on employment has developed: Job cuts in January reached their highest total since August, but still represent a 70% reduction from the same time a year ago, when they peaked at 241,749. What's going on?
Big Pharma Is Still Cutting Jobs, at Least in the West
First it was restructurings to adjust to fewer patented blockbusters. Then it was the recession. Now it's just more of the same as SmithKlineGlaxo and AstraZeneca add to the unemployment rolls. In the West, that is. Hiring is strong in emerging markets.
The Gates Foundation Goes Big on Vaccines
"We must make this the decade of vaccines," declared Bill Gates today. He and his wife, Melinda, are putting $10 billion of their Gates Foundation funds into helping research, develop and deliver vaccines for the world's poorest countries.
GlaxoSmithKline's Witty: Do-Gooder or Good at PR?
He's young, charismatic, innovative and has got heart. At least that's the impression GlaxoSmithKline CEO Andrew Witty gives to the outside world. GSK is allowing free access to its library of 13,500 potential malaria treatments. Is he genuinely a do-gooder or just good at PR?
Health-Care Sector Appears to Rally As Reform Chances Dim
President Obama can't be pleased by the loss of a Democratic Senate seat which jeopardizes passage of his cherished health-care reform. The news, however, appears to have fueled a mini stock rally in the health-care and pharma sectors wary of how any reform would affect their businesses. The uptrend is expected to continue.
Pharmaceutical Companies Assist Haiti with Medicine, Cash
As Haiti reels from the 7.0 earthquake that devastated its capital, Port-au-Prince, on Tuesday, relief efforts are beginning to make headway. The crisis also gives Big Pharma ample opportunity to help relief efforts, with contributions coming from Merck, GlaxoSmithKline, Abbott, and other heavy-hitters.