Want proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one [...]
Although President Obama’s proposed $3.73 trillion budget for 2012 calls for more than $1 trillion in slashed spending, it protects doctors from steep cuts in their Medicare payments with a two year reprieve. The budget delays a scheduled 25 percent cut in the Sustainable Growth Rate, Medicare’s physician payment formula that was slated to go [...]
A startling scientific breakthrough on Type 1 diabetes could help pave the way to a cure or perhaps significantly reduce the need for insulin therapy. A researcher at UT Southwestern, Dr. Roger Unger, reports in the February issue of Diabetes that by shutting down glucagon, a hormone that causes blood sugar to spike in patients [...]
Every so often, someone sets up a dartboard of likely targets for Big Pharma buyouts. This time, the target-setter is Barron’s, and the focus is on companies with market values of $10 billion or less. Most of them have at least one marketed product: “It’s less dangerous playing smaller outfits with approved drugs than those [...]
India’s No.2 drugmaker Dr Reddy’s Laboratories Ltd said a U.S. district court has cleared the sale of its generic version of Sanofi-Aventis’ allergy medicine Allegra D24, sending its shares up nearly 4 percent. The U.S. District Court of New Jersey lifted an injunction passed last June against the Indian drugmaker from selling a copycat version [...]
NPS Pharmaceuticals says that it’s on track to file for regulatory approval of Gattex after a late-stage study involving 86 patients demonstrated promising results for reducing the need for IV feeding among a majority of patients with short bowel syndrome. NPS now plans to file in the second half of the year and the news [...]
President Barack Obama said on Friday his healthcare overhaul is an important part of efforts to cut the budget deficit and insisted he will not “refight” the battle to pass the law. With emboldened Republicans vowing to repeal or replace the healthcare law he signed last March, Obama reiterated his case that the changes it [...]
More drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as U.S. guidelines take shape. The topic was at the forefront of plans discussed by several executives at this week’s JP Morgan healthcare conference in San Francisco. Kevin Sharer, chief executive officer at Amgen Inc, said the world’s largest [...]
Merck Serono is teaming up with France’s Domain Therapeutics to take aim at a new target for Parkinson’s and other neurodegenerative diseases. Domain will contribute compounds developed from their chemical series in exchange for a €2 million upfront, research funding and up to €132 million ($175 million) in milestones for the first two products.
The drug development arm of Johnson & Johnson is joining research forces with scientists at the prestigious Sanford-Burnham Institute in an effort to blaze a relatively short path to new drugs for psychiatric disorders as well as Alzheimer’s. And the collaboration–the latest in a string of R&D pacts that have been struck between pharma companies [...]
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