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 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.
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.
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.
Polish prosecutors have charged 13 people in connection with the GlaxoSmithKline bribery probe in their country.
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.
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.
After a three-month delay pushed pause on its commercial plans, GlaxoSmithKline has secured FDA approval for albiglutide, a new diabetes treatment that will contend for market share in a fast-crowding space.
Baxter International, which has had a series of recalls in the last few months, has had a plant in Canada banned by the FDA from shipping products, including saline solution, which is already in serious short supply in the U.S.
As the pediatric medical device sector grows, lawmakers are pushing for the development of innovative products that can treat younger patients and address an unmet need. But most devices that were recently approved for pediatric use were not tested on children first, Reuters reported.