An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.
Continue reading ‘New Drug Shows Unprecedented Weight Loss in Clinical Trials’
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.
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 quickly spurred a 30 percent hike in its stock price in pre-market trading.
Continue reading ‘NPS Soars on Positive Ph3 Data for Orphan SBS Drug’
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’
By Phase III, researchers are supposed to have a pretty good handle on just how promising an experimental therapy can be. There’s proof-of-concept data in the can and some clear indications of just how big a market a new drug can go on to capture.
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.
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’
Boehringer Ingelheim and co-marketer Pfizer could make a bid to capture more of the respiratory drug market. In a new study, the company’s Spiriva drug proved as effective as GlaxoSmithKline’s Serevent in helping asthmatic adults breathe better. Spiriva is currently approved for COPD, or smoker’s lung, so moving it into the asthma market could boost sales.
Continue reading ‘Will Boehringer’s Spiriva challenge Serevent?’
In a bid to break out of its dependence on manufacturing and cheap labor, the Chinese government is planning to invest $1.5 billion into new drug development between 2011 and 2016. And biotechnology is one of seven emerging industries that the Asian powerhouse will use to spearhead the next big step in its economic development, according to a report in China’s 21st Century Business Herald.
With Genzyme in the news, we’ve all been hearing plenty about the wave of M&A deals that’s been rolling through the world’s life sciences industry. Last year, Thomson Reuters tracked more than 1,400 such deals worth $206 billion worldwide, giving the Boston Globe the hard numbers it needs to assert that this is one trend that has yet to crest.
Continue reading ‘Biotech M&A Frenzy Shows no Sign of Slowing’
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