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.
Boston Scientific's Guidant subsidiary faces more legal pushback in its ongoing breach-of-contract lawsuit against Johnson & Johnson, as a federal judge denied the company's request to toss out the case.
In a unanimous Supreme Court decision early last month, a ruling on Biosig Instruments' heart-rate monitor patent was deemed invalid.
The FDA has stamped a full clinical hold on a trial Regado Biosciences had voluntarily paused, shouldering its way into any discussion of resuming the study and sending the biotech's battered shares down further.
Australia's SomnoMed Limited hopes that its just now 510(k)-cleared devices for obstructive sleep apnea give it an advantage over the predominant therapy due to the products' ease of use. Unlike continuous positive airway pressure (CPAP) devices that require a facemask, SomnoMed's oral SomnoDent Fusion Classic and SomnoDent Fusion Flex are worn like a mouth guard.