FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.
Roche's cancer blockbuster Avastin has yet another shot at boosting sales. The FDA put Avastin up for priority review in cervical cancer, with a decision date of Oct. 24.
When it comes to expanding Avastin into new cancer territories, Roche has a win-some, lose-some record. Now, Roche is closer to adding cervical cancer to its arsenal of indications in the U.S.
Boston Scientific won a CE mark for its next-generation drug-coated balloon catheter for peripheral artery disease, expanding its presence in the endovascular market and continuing its push to reinvigorate sales.
Pharmaceutical companies, which have been fighting a county drug disposal law in the California Bay area for nearly two years, say they exist to develop and produce drugs, not to be waste disposal companies. But that is what the law in Alameda County would require them to become, they told a federal appeals court.
Add a new set of pricing foes for Gilead Sciences). A U.S. Senate committee has joined the forces arrayed against the company's breakthrough hepatitis C drug Sovaldi and its $84,000 price tag.
The drug is approved for treating--not preventing--hepatitis B, prompting FDA to call the advert misleading.
The FDA panel convened to discuss the risk of upstaging uterine sarcoma cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids recommended upgrading the labeling of power morcellators and ensuring that patients are made aware of the risk prior to surgery, among other measures.
The European Medicines Agency approved 39 new drugs in the first half of the year, PharmaTimes reports.
Panelists were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing hysterectomy or myomectomy surgeries during the first day of the FDA panel on the risks of upstaging uterine cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids.