NME approvals

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...

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....

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...
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