FDA approves Novartis’ combo pill Teklamo

The FDA has approved Teklamo, a high blood pressure medication that combines Tekturna with the calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. Tekturna is part of a new class of medicines known as direct renin inhibitors, which target an...

Pharma pipelines mired by poor productivity, shrinking R&D budgets

With drug approvals for new chemical entities running at about half the level of the peak registered in 1997, pharma companies are actually seeing a reduction in the amount of money they earn from drugs approved in the previous five years, according to new research from Thomson Reuters. And overall R&D spending dipped 0.3 percent last year, as the momentum behind cuts in pharma pipeline budgets continued to gain speed. "The latest data shows that poor productivity in 2009 continued to...

Merck wins FDA approval of combo asthma therapy

The FDA has waved the green regulatory flag for Merck's new asthma drug Dulera, a two-in-one fixed-dose combo drug that is also being studied for chronic obstructive pulmonary disorder. Dulera combines mometasone furoate and formoterol fumarate, which Merck acquired in its buyout of Schering-Plough. "Asthma control is an important treatment goal and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients," said S. Blaiss, M.D., clinical...

Fitch projects 23 new drug filings for 2010

Looking at the new drug approval pace so far, Fitch Ratings estimates that drug authorities will field 23 new drug filings by the end of the year--the same slow pace seen over the past few years. The FDA has OK'd six new molecular entities and one vaccine while the European Medicines Agency authorized the marketing of five NMEs and two vaccines. Fitch also expects that licensing will be favored over consolidation deals in 2010....

GW Pharma’s cannabis drug Sativex wins landmark approval

After a long and complex R&D odyssey, GW Pharmaceuticals (GWP) has finally won UK approval for Sativex, a drug derived from cannabis that can now be used to treat spasticity in MS patients. GW had hoped to get an approval in Britain back in 2003 but faced a long series of regulatory hurdles in its quest. Up until now GW has had to content itself with a 2005 approval in Canada. But Europe appears to be opening up. GW says that Spain appears ready to hand out an approval soon and other...

Analysts score the FDA expert panels’ approval ratings

Analysts at the Washington Research Group recently dissected the decisions of the FDA's influential expert panels to see which ones were the toughest. Overall, according to a piece in the Wall Street Journal's Health Blog, 70 percent of the new apps that came the experts' way were endorsed by the committees. But once you break it down by category, the track records vary considerably. At the top of the toughest critics list you'll find the oncologic drugs committee, which recommended only 12 of...

Analysis: Fewer approvals may prove R&D is getting tougher

Megan McArdle, the economics editor at The Atlantic, reviews two of the most popular explanations for the meager rate of new drug approvals that plagues biopharma: A tougher bunch of FDA regulators cracking down unreasonably on anything that looks risky vs. a preference for marketing over R&D at profit-hungry companies. Actually, she concludes with data from Tufts, pharma is spending far more than ever on R&D. And there's a bunch of people at the FDA who are actually quite interested in...

Amgen wins FDA approval of D-mab

Two months ahead of schedule and just days behind European regulators, the FDA has approved Amgen's denosumab for postmenopausal women with osteoporosis. Once the drug hits the market as Prolia, analysts expect that it will evolve into a multibillion-dollar franchise product--marking a key turning point for the world's biggest independent biotech. Patients will be able to get the two annual injections at a cost of about $1,650. At that price Amgen believes it can snare a significant chunk of...

Dendreon: Provenge to cost $93K for full course of treatment

One of the most pressing questions analysts and patients have had about Provenge is how much Dendreon would charge for its newly approved prostate cancer drug. Following this afternoon's conference call, we now have an answer. Each infusion of Provenge will cost $31,000, bringing the full cost of treatment for three infusions to $93,000. As the company put it, the drug will cost about $23,000 per month of life extension, based on the Phase III study that found the drug extended...

FDA approves Dendreon’s breakthrough cancer vaccine Provenge

The FDA has approved Dendreon's Provenge, a breakthrough cancer vaccine that promises to extend the lives of prostate cancer victims by several months. Widely seen as a likely blockbuster with a cost of around $75,000 per patient, the approval comes after the Seattle-based Dendreon (NASDAQ: DNDN) braved a major setback at the FDA in 2007 and forged ahead with a confirmatory Phase III study of the therapy. Betting that the agency would go ahead with an approval, Dendreon has invested...