Archive for the 'Clinical Trials' Category
April 27th, 2011 by admin
Thalidomide was introduced as a sedative drug in the late 1950s. In 1961, it was withdrawn due to teratogenicity and neuropathy. There is now a growing clinical interest in thalidomide, and it is introduced as an immunomodulatory agent used primarily, combined with dexamethasone, to treat multiple myeloma. The drug is a potent teratogen in zebrafish, chickens, rabbits and primates including humans: severe birth defects may result if the drug is taken during pregnancy.
Continue reading ‘Researchers Gain More Insight on How Thalidomide Leads to Birth Defects’
February 17th, 2011 by admin
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 in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development. And large molecule drugs are twice as likely to be approved than than small molecule drugs.
Continue reading ‘Rate of Drug Approvals Dropping’
January 26th, 2011 by admin
Eight months after Merck jumped into the driver’s seat to take control of Ariad’s late-stage cancer program ridaforolimus, the biotech is reporting that one of its Phase III study turned in statistically significant results. And the news quickly spurred a 36 percent increase in the biotech’s share price.
Continue reading ‘Ariad Shares Soar after Cancer Drug Clears Late-stage Trial’
November 16th, 2010 by admin
By the end of day Friday shares of Human Genome Sciences ($HGSI) had been trimmed 11 percent as investors fretted over the implications of an FDA staff analysis of its lupus drug Benlysta, which goes in front of an expert panel today.
Continue reading ‘Benlysta Review Spooks Investors’
October 27th, 2010 by admin
The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed. Completion of the initial phase (phase 1a) of trials of INX-189, discovered and first prepared by researchers at Cardiff University’s Welsh School of Pharmacy in 2008, means the chances of it becoming an approved medicine have significantly improved.
Continue reading ‘Potent New Hepatitis C Drug?’
October 1st, 2010 by admin
GlaxoSmithKline and partner Theravance (THRX) say that their planned successor for the blockbuster Advair turned in a positive performance in a mid-stage study involving 60 people with COPD. Significantly, the new drug–dubbed Relovair–outperformed Advair on a key measure that gauges lung function. And that bodes well for the therapy, which is now in late-stage trials for both COPD as well as asthma.
Continue reading ‘GSK, Theravance report promising PhII data for Advair successor’
August 9th, 2010 by admin
Ask just about any biotech CEO about licensing strategies and you can almost guarantee that at some point the chief will mention that the best deal valuations come after the developer has a solid set of proof-of-concept data. But the Wall Street Journal’s Jason Douglas writes that the shopworn biotech strategy no longer applies in an age when Big Pharma companies are spending more on development and less on research.
Continue reading ‘Early-Stage Deals are Getting a Lot Sweeter for Biotechs’
August 3rd, 2010 by admin
Merck (NYSE: MRK) has agreed to purchase bankrupt Hawaii Biotech’s dengue fever vaccine unit for an undisclosed sum. It’s a critical move for Hawaii, which filed for Chapter 11 bankruptcy protection last year and will deplete a $2 million credit line by the end of this month. The sale leaves Hawaii with a West Nile virus vaccine in development.
Continue reading ‘Merck Buys Vax Unit from Bankrupt Hawaii Biotech’
July 29th, 2010 by admin
Milestone payments are becoming an increasingly familiar aspect of many biotech deals, as buyers try to mitigate the risks inherent with big purchases. Take Celgene’s $2.9 billion buyout of Abraxis; the biotech giant set aside $650 million in milestone payments if Abraxis’ key drug Abraxane hit certain goals. “These structures are a great way for buyer and seller to share the risk that’s related to drug development,” says analyst Brett Skolnik. Milestones also encourage buyer and seller to look beyond the merger, making it more likely the deal will be beneficial to both sides in the long term.
Continue reading ‘Milestones Mitigate Risk in Biotech Deals’
July 27th, 2010 by admin
Oncologics, lipid regulators, respiratory agents, antidiabetics and anti-ulcerants are the five largest drug classes by sales. But annual sales are only half the story. Which drug classes are booming, and which have plateaued–or even dropped? IMS Health has released top-line industry data revealing the 15 largest drug classes, and we’ve crunched the numbers to take a closer look at the average sales growth of the 15 largest therapeutic classes over the last five years.
Continue reading ‘Fastest Growing Therapeutic Classes (by Sales)’
