Topic:

Regulatory

Latest Headlines

Latest Headlines

EMA approves 39 drugs in H1, down from 44 last year

The European Medicines Agency approved 39 new drugs in the first half of the year, PharmaTimes reports.

Day One: Inside the FDA power morcellator panel

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 faces more legal pushback in J&J lawsuit

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.

SCOTUS decision may make it easier to invalidate device patents

In a unanimous Supreme Court decision early last month, a ruling on Biosig Instruments' heart-rate monitor patent was deemed invalid.

Regado slips again as FDA weighs in on halted cardio trial

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.

FDA clears oral sleep apnea device, as search for CPAP alternatives continues

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.

Bristol-Myers races to the FDA with immuno-oncology star nivolumab

Bristol-Myers Squibb plans to submit its closely watched cancer candidate nivolumab for FDA approval to treat melanoma next quarter, outpacing analysts' expectations and setting the stage for a duel with Merck's rival drug.

Vets may soon be able to carry scheduled drugs

Big pharma and veterinarians alike have been stymied by what they saw as an antiquated law passed in 1970 that prohibited animal docs from bringing meds to farm sites. But on July 8, the American Veterinary Medical Association (AVMA) came out with a sweeping victory when the House unanimously passed a bill that would allow licensed vets to dispense drugs at treatment sites.

India faces higher QC costs as Shasun shows value of compliance

Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.

India may alter medical device taxation that favors imports

India's medical device manufacturers hope the government's annual budget will address taxation that skews in favor of imported devices.