Glaxo, Human Genome Say Lupus Drug Worked 16 Weeks Into Study
The 865-patient study, known as Bliss-52, found Benlysta was more effective at easing pain, hair loss and skin rash than a placebo, London-based Glaxo and Rockville, Maryland-based Human Genome said in July, when they announced the initial results of the trial.
A full presentation of the data today showed that the improvement was statistically significant and sustained for both the higher dose and lower dose of the drug from week 24 and week 28, respectively, for the duration of the 52-week test. The rate of improvement was [...]
Sanofi-aventis Sues Sun Pharmaceutical Over Allegra Generic
Sun is pursuing approval from the U.S. Food and Drug Administration to market three dosage forms of the drug before the patents expire, according to the complaint filed Oct. 9 in federal court in Newark, New Jersey. Sanofi, Frances largest drugmaker, is asking a judge to bar Sun from selling the generic and for any damaged incurred if they begin marketing the drug.
Sanofi-Aventis “will be substantially and irreparably harmed by Suns infringement if not enjoined,” the company wrote in a legal filing. [...]
Insurers Oath to Fight Baucus Bill Drugmakers, Hospitals Back
The $829 billion proposal, written by Montana Democrat Max Baucus, now must be reconciled with four competing House and Senate versions, all of which include a government-run medical plan. The insurance industrys criticism of the Baucus bill centers on reduced penalties on individuals who fail to get insurance, and taxes on so-called Cadillac health policies.
The bill extends coverage to more than 30 million uninsured Americans, funded partly by $121 billion in taxes on drug manufacturers, device makers and insurers. The health plans said they wont back [...]
Teva Drug Halved Risk Of Full-blown Multiple Sclerosis In Study
The Teva drug was about as effective at keeping multiple sclerosis at bay as beta interferon therapies sold by Biogen Idec Inc., Bayer AG and Merck KGaA, according to the study, published online today by U.K. medical journal The Lancet. A quarter of patients who took Copaxone over a three-year period had a second attack of symptoms, compared to 43 percent of those who got a placebo.
Copaxone, known chemically as glatiramer acetate, “reduced the frequency of relapses in the short term and might reduce the rate [...]
Fda Sees No Precaution Issues With Pfizer Hiv Drug
However, the FDA said Pfizer studies paint a mixed picture of its drugs effectiveness. A 48-week study comparing Selzentry to Bristol-Myers Squibbs Sustiva failed to meet the goal of showing Pfizers drug was at least as effective at suppressing HIV.
When Pfizer reanalyzed the results using a different test to screen patients, the study met its goal.
Selzentry is currently approved as a secondary option for HIV patients who are not responding to other antiviral drugs. The company is asking the FDA to approve the drug as a first-choice treatment.
FDA scientists appeared to favor the new use in briefing documents posted online [...]
Sandoz Will Sell More Drugs In Japan, Consider Acquisitions
The additions will bring to 13 the number of drugs Sandoz is introducing in Japan this year, Chief Executive Officer Jeff George said at a group interview in Tokyo yesterday, without identifying the treatments. The company plans to sell at least 10 new drugs a year in Japan until 2014, he said.
Sandoz seeks to bolster growth in what George calls emerging generic markets, including France, Italy and Japan, where lower use of copied drugs leaves room for growth. Generics made up 18 percent of drug sales [...]
Fda Panel Backs Schering-plough Cancer Drug
The Food and Drug Administration often follows the panels advice, though it is not required to.
Schering-Plough has asked the FDA to approve its drug PegIntron for patients whose skin cancer has spread to their lymph nodes, requiring surgery. The drug is already approved as a treatment for hepatitis C.
Company studies of the drug showed it lengthened the period of time before cancer recurred by about nine months, though patients ultimately didnt live longer than those who did not receive the drug.
PegIntron was associated with high levels of toxicity, and 44 percent of patients dropped out of the study due to [...]
Allergan Suing U.s. to Void Rules, Market Off-label Botox Uses
The company will seek a court order allowing it to give doctors information about uses for Botox that havent been approved by the U.S. Food and Drug Administration, Allergan said in a statement distributed yesterday. U.S. rules that make it a crime for drugmakers to promote medicines for unapproved uses contravene the First Amendment of the U.S. Constitution and the federal Food, Drug and Cosmetics Act, according to the statement.
While doctors are free to prescribe any drug to treat illnesses regardless of FDA approvals, pharmaceutical companies [...]
Fda Tells Doctors New Heparin Formula Less Potent
The FDA said Thursday new heparin vials scheduled to begin shipping next week will be 10 percent less potent than the original blood thinner. The change is designed to make it easier for manufacturers to spot impurities in the drug, but it will require some adjustments by physicians who administer the drug.
“Health care providers should consider the change in potency of heparin when making decisions about which dose to administer,” said Dr. John Jenkins, director of the FDAs office of new drugs. Doctors may need to use extra heparin to adequately treat some patients, he added.
The FDA said older vials [...]
Fda Probes Precaution Of Glaxo Kidney Cancer Drug
London-based Glaxo wants the Food and Drug Administration to approve its pazopanib pills for advanced kidney cancer, a rare but deadly form of the disease.
In documents posted online, FDA reviewers noted three deaths related to liver damage with the drug, as well as elevated levels of enzymes that often predict liver damage.
The findings “strongly suggest that pazopanib may be associated with a significant risk of severe idiosyncratic hepatic injury if used in a larger patient population,” according to the agencys review.
Along with liver risks, FDA scientists also noted side effects common to other cancer drugs, including hypertension, internal bleeding and [...]