Derek Lowe's commentary on drug discovery and the pharma industry. An editorially independent blog from the publishers of Science Translational Medicine. All content is Derek’s own, and he does not in any way speak for his employer.

By Derek Lowe

Posts tagged with "Regulatory Affairs"

• Cancer

  Eribulin Gets Reviewed, Finally

  3 June, 2010

  So it looks like the FDA is giving reviewing Eisai’s oncology drug Eribulin (E7389) a priority review. The company had hoped to get it reviewed three years ago, but the FDA told them to get back into the clinic and collect more data. The compound is being reviewed for advanced breast cancer, and the earlier… Read More

• Regulatory Affairs

  Regulatory Approvals in the US versus Europe

  11 May, 2010

  I was looking at the list the other day of the 2009 drug approvals from the FDA. Here’s a breakdown from Nature Reviews Drug Discovery – 25 total, 16 small molecules and 9 biologics. And here, from the same journal, is a look at approvals in Europe. There were 29 – but the weird thing… Read More

• Cancer

  Environmental Cancer?

  7 May, 2010

  I find the President’s Cancer Panel report -at least, the general tone of it – hard to believe. Most of the headlines yesterday focused on the “grievous harm”, “bombarding”, and “grossly underestimated” statements, and suggested that there was an epidemic of environmentally-caused cancer. Since most a… Read More

• Business and Markets

  Intermune: Right Back Down Again

  5 May, 2010

  Back in March, Intermune’s stock saw a sudden jump on news that an FDA advisory committee treated their drug pirfenidone more positively than expected. But the agency is in no way committed to following these recommendations, and yesterday they turned down the drug, sending Intermune stock right back down into the basement again. Pirfenidone… Read More

• Business and Markets

  Treatment INDs – For Any Generex Fans Out There

  29 April, 2010

  Adam Feuerstein schools the Generex folks on what a “Treatment IND” really means, quoting chapter and verse from the FDA. The company’s fans have made much of that designation for its flagship buccal insulin product. As has the company’s CEO – but that link shows her making statements at investor conferences which are… Read More

• Business and Markets

  Novartis, Roche Threaten To Leave the UK

  13 April, 2010

  Now, here’s some hardball negotiating: Roche and Novartis, fighting with the UK government over drug pricing and regulations on clinical trials, are threatening to pull their R&D out of the country. The Swiss drug companies made their threats known in personal meetings with a government minister, according to Whitehall documents seen by… Read More

• Biological News

  Garage Biotech

  12 March, 2010

  Freeman Dyson has written about his belief that molecular biology is becoming a field where even basement tinkerers can accomplish things. Whether we’re ready for it or not, biohacking is on its way. The number of tools available (and the amount of surplus equipment that can be bought) have him imagining a “garage biotech” future… Read More

• Business and Markets

  Intermune’s Rise

  11 March, 2010

  If you want to know why people continue to speculate in biotech stocks, just take a look at the stairsteppy last few days of trading in Intermune (ITMN). Last Thursday it was at $15; now it’s at $38. And all you have to do to cash in on these moves is read the FDA’s mind! Read More

• Autism

  Vaccines in the Court

  10 March, 2010

  The Supreme Court has agreed to hear a vaccine-liability case, in an attempt to untangle conflicting lower court rulings. This all turns on the 1986 act that shields manufacturers from liability suits and a followup law that establishes a separate compensation system for injuries. A Georgia Supreme Court ruling has recently held that such suits… Read More

• Biological News

  The Plasmid Committee Will See You Now

  2 March, 2010

  From Nature comes word of a brainlessly restrictive new law that’s about to pass in Turkey. The country started out trying to get in line with EU regulations on genetically-modified crops, and ended up with a bill that forbids anyone to modify the DNA of any organism at all – well, unless you submit the… Read More