Topic:

Regulatory

Latest Headlines

Latest Headlines

Sarepta rockets up after mapping a shortcut to the FDA with DMD hopeful eteplirsen

After keeping investors on a roller coaster ride of speculation for months, Sarepta says it now plans to shoot for an accelerated approval of its Duchenne muscular dystrophy drug eteplirsen. The biotech says it will file for an early approval by the end of this year after launching a slate of new clinical trials to get the data that the FDA is looking for.

FDA lifts its hold on Juno's cutting-edge cancer drug after deaths trigger delay

The FDA has lifted a clinical hold placed on a study at Memorial Sloan-Kettering of Juno Therapeutics' cutting-edge approach to treating cancer using genetically tailored T cells, FierceBiotech has learned.

Pfizer, PhRMA and others pick holes in FDA social media guidance

Drugmakers received the first slice of FDA social media guidance in January, and now the FDA's mailbag is filling up with letters on First Amendment protections, "jurisdictional creep" and other topics from the likes of Pfizer and PhRMA.

Gardasil dose reduction could boost EU sales for Merck-Sanofi joint venture

Now that the European Commission has officially approved a two-dose Gardasil regimen for early teens, Merck and Sanofi--who market the HPV vaccine in Europe through joint venture Sanofi Pasteur MSD--will see the number of shots per patient fall.

GlaxoSmithKline steps up bribery probes, eyeing potential violations in 9 Middle Eastern countries

GlaxoSmithKline has added two more countries to its bribery-investigation list. The U.K.-based drugmaker now says it faces probes in Jordan and Lebanon, in addition to recently announced investigations in Iraq and Poland.

Endo's AMS hit with an FDA warning letter

As if the more than $500 million fallout from lawsuits regarding its vaginal mesh devices weren't bad enough, American Medical Systems must now deal with an FDA warning letter on its process validation, risk analysis, and corrective and preventative action procedures at its Minnetonka, MN, facility.

EMA warns Herceptin vials stolen in Italy spreading through EU

Vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up in other places in Europe, leading the European Medicines Agency (EMA) to issue an alert and Herceptin maker Roche to recall all of the batches from which the stolen drugs came.

GlaxoSmithKline bribery probe heats up as Polish prosecutors charge 13 people

Polish prosecutors have charged 13 people in connection with the GlaxoSmithKline bribery probe in their country.

Boston Scientific scores FDA approval for a new crop of implantable cardiac devices

Boston Scientific won FDA approval for a new crop of implantable defibrillators and heart failure devices, helping the company move forward with sales and development of its cardiac rhythm management system.

Newly minted GlaxoSmithKline diabetes drug faces formidable foes in GLP-1 market

GlaxoSmithKline's albiglutide, now dubbed Tanzeum for the U.S. market, nabbed FDA approval Tuesday. Now, the drug will go up against a triad of other GLP-1 treatments, including Novo Nordisk's powerhouse Victoza and AstraZeneca's exanatide franchise.