Archive for the ‘Pharmaceuticals’ Category
May
22
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Videos by Damian Garde
In a study commissioned by PhRMA, Battelle reports that countries around the globe are boosting their investments in R&D and instituting innovation-friendly policies to attract biopharma outfits. PhRMA CEO John Castellani said in a statement that regulatory uncertainty and strict IP laws could put the U.S. at a disadvantage, leading big-earning biopharma companies to flee overseas. Castellani points to Germany, which used to be "the world's medicine cabinet," and cautions that if the U.S. government doesn't reaffirm its commitment to biomedical innovation, it could lose its standing in the industry. Release
May
22
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Any forward-looking student of the biotech industry will have to check out Adam Feuerstein's review in TheStreet of 22 Phase II and III clinical trials--21 drugs and one diagnostic test--which are expected to read out by the end of this year.
One of the savviest analysts in the business, Feuerstein runs through snaps on studies for Arqule (the closely watched tivantinib cancer study), Biogen Idec (trying to diversify into hemophilia and ALS), Celgene (apremilast for RA and psoriasis) and, of course, the big Alzheimer's studies for solanezumab and bapineuzumab, among others.
As Feuerstein notes in his report, big studies have a way of either rehabilitating developers' share prices or driving them into the ground. Over the second half of this year we're likely to see plenty of examples of both scenarios as the data hits.
- here's the story from TheStreet
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May
22
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The FDA's demanding requirements on cardio safety data has made diabetes one of the most challenging diseases in the drug development world. Today, Eli Lilly ($LLY) demonstrated that its late-stage diabetes drug dulaglutide cleared an important cardiovascular safety hurdle, impressing analysts with a savvy clinical game plan on an important experimental product in its pipeline.
Eli Lilly CEO John Lechleiter has already made it clear that dulaglutide is one of the company's top blockbuster hopefuls in its late-stage pipeline. Now investigators have data from a mid-stage study of 755 patients--two thirds of whom were diagnosed as hypertensive--demonstrating that dulaglutide is comparable with a placebo in its effect on systolic blood pressure.
In addition, Lilly reported, "the 1.5 mg dulaglutide dose significantly reduced mean 24-hour SBP (systolic blood pressure) compared to placebo." And at the end of 16 and 26 weeks the drug--a once-weekly GLP1 therapy that could end up competing with Bydureon--significantly reduced average blood glucose levels.
"We are very encouraged by these clinical trial results, in addition to the rest of the clinical trial data we've seen to date for dulaglutide," said Gwen Krivi, Ph.D., vice president of product development at Lilly Diabetes in a statement. "Dulaglutide is currently in Phase III clinical trials, where it will continue to be evaluated on its efficacy to lower blood glucose levels, overall safety, weight effects and effects on cardiovascular outcomes. We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes."
- get the press release
- here's the story from Reuters
- read the report from Dow Jones
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May
22
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Pfizer gambled big when it took data from a single study to back its application for tafamidis as a treatment for a rare neurodegenerative disease. And an FDA review of the data concludes decisively that the company lost. After considering the trial's failure to meet its co-primary endpoints and questioning the data gathered at 8 sites, the agency is recommending that the experts gathering to discuss the drug's fate on Thursday reject the therapy.
"I recommend a Complete Response action, based on inadequate evidence of effectiveness," stated the FDA reviewers in a rare, outright slap at an application. The agency isn't bound by either the review or the panel vote on Thursday, but Pfizer's ($PFE) team will face an uphill struggle when it makes its case for tafamidis--a therapy for familial amyloid polyneuropathy--later in the week.
In the review, the agency investigator picks apart the data, wondering why most of the responders were clustered in one site while 7 other sites offered little by way of supporting data. "Overall, Study 005 does not have the characteristics of a single adequate and well-controlled study that could make the study adequate support for an effectiveness claim," the review states.
Pfizer, though, plans to put its case on the drug in the best light possible.
"There is currently no FDA-approved treatment designed specifically to treat TTR-FAP," Pfizer noted in a statement to FierceBiotech this morning. "If approved by the FDA, tafamidis will be the first and only medication in the U.S. to treat patients with this debilitating genetic disease. Pfizer believes that the data for tafamidis provide substantial evidence of effectiveness and meaningful therapeutic benefit where there is a high unmet medical need. We look forward to discussions with the FDA and its Advisory Committee to further the understanding of TTR-FAP and the data supporting our NDA."
Pfizer landed tafamidis when it acquired FoldRx in a buyout back in 2010 as it pushed into the rare disease field. Like other pharma companies, Pfizer was lured by the prospect of big returns for drugs that meet an urgent need in tiny patient populations. About 8,000 people around the world, including 2,500 in the U.S., suffer from the neurodegenerative disease Pfizer was focused on. But the pharma giant, which is still trying to shed its reputation as a poster child for clinical ineptitude, may be rethinking the business plan this morning.
- here's the FDA review
- read the story from Reuters
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