March FDA news in review


In March, the Obama administration announced its choices for the new FDA leadership. Going outside the agency, the administration chose former New York health commissioner Margaret Hamburg as the new agency head, and Baltimore health commissioner Joshua Sharfstein as deputy commissioner. Obama’s picks have led to speculation that the FDA will eventually be split into two agencies, with Hamburg overseeing food and Sharfstein in charge of drugs.

The most notable FDA approval this month was that of Novartis' kidney cancer drug Afinitor (everolimus). Novartis submitted data showing that Afinitor delayed tumor growth by five months, with patients living twice as long without tumor growth as other cancer victims in the study's control arm. Analysts predict that the drug is on track to become a blockbuster, with new approvals for other cancers down the road.

FDA News

  • Hamburg, Sharfstein to lead FDA

  • Grassley tells FDA's Torti to back off staff

  • Pharma execs back FDA divorce

  • Pharma types 'nervous' about Sharfstein

  • FDA's Torti: Shut your flapping traps, stat

  • Obama FDA picks raise some hackles

FDA Delays and Rejections

  • FDA won't review Acorda MS drug

  • Dyax shares sink as FDA rejects drug

  • FDA iffy on Avastin in brain cancer

  • Genzyme shares sink on FDA snag

  • Takeda down on drug delay concerns

  • FDA throws wrench into Erbitux plans

Warnings and regulations

  • FDA cites Genzyme for plant conditions

  • Judge orders broader access to Plan B

  • Device woes show need for FDA overhaul

  • Importation bill mandates FDA inspections

  • FDA tobacco bill advances in Congress

FDA Approvals

  • Novartis wins FDA approval for Afinitor

  • Wyeth's Tygacil gets expanded indication

  • Lilly, Forest get new FDA indications

  • FDA OKs new use for Symbicort

  • Insmed drug OK'd for ALS patients

March FDA news in review

Suggested Articles

It’s been a rocky road for BMS’ immuno-oncology duo in previously untreated lung cancer, but a new addition to the regimen might hold the ticket.

Novartis’ Zolgensma launch has been anything but boring: First a record price, then a data scandal and now a manufacturing-related delay in Europe.

As CEO Paul Hudson focuses Sanofi's R&D program on immuno-oncology and gene therapies, Sanofi is readying a vaccine plant to make viral vectors.