Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves seizure drug made with 3-D technology

An Ohio company has gotten FDA approval for its epilepsy drug Spritam, which it claims is the first to use three-dimensional printing technology. Aprecia Pharmaceuticals says the 3D process produces a formulation of levetiracetam that rapidly disintegrates with a sip of liquid, making it easy to ingest for those who have trouble taking medication.

OraSure gets FDA nod for emergency use of rapid Ebola test

OraSure Technologies snagged the FDA's Emergency Use Authorization for its rapid Ebola test, a couple of months after the company got $10.4 million from the U.S. Department of Health and Human Services to develop its product.

Ulthera nabs FDA nod for cellulite treatment, to launch in the fall

The FDA has given aesthetic medical device player Ulthera, a subsidiary of Merz, a clearance for its Cellfina System that is said is the longest that the agency has bestowed for a cellulite treatment. It is cleared to improve the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to two years.

Health experts caution against wide range of scope devices amid superbug outbreaks

Duodenoscope devices have drawn the public's ire this past year, with the FDA and patients pushing back against the products in light of superbug outbreaks and mounting safety concerns. Now, healthcare officials are cautioning against a variety of scopes, saying similar devices could lead to potentially deadly infections.

Ex-Teva employee said she got canned for passing info to the feds in Latin America fraud probe

Teva has long encountered fraud allegations, with the company's own internal investigations showing earlier this year that it "likely" violated the Foreign Corrupt Practices Act and local laws. Now, the drugmaker is facing more pushback as a former employee is sounding the horn, claiming Teva shrugged off her suggestions for improving compliance and axed her job after she cooperated with U.S. officials.

Citing cybersecurity concerns, FDA says not to use Hospira infusion pump

In a strongly worded statement, the FDA told hospitals to stop using Hospira's Symbiq Infusion System because it can be remotely accessed by hackers, allowing the unauthorized user "to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies." The agency's move marks another step to patrol the cybersecurity of medical devices, an issue that has long bedeviled Hospira's infusion pumps in particular. 

Sales of diabetes drugs in Japan are a key H2 performance gauge, Sanofi CEO says

Olivier Brandicourt, CEO of Sanofi, gave his thoughts on the July 30 earnings call about trying to launch a simplification program in the midst of high-profile global rollouts, competition and dealmaking. He also picked one contest to watch in Japan that may be a good gauge of the company's performance on all counts.

GSK also notes slowdown in China, but working on driving volumes

GlaxoSmithKline joins other multinational pharma that witnessed a slowdown in China in the second quarter as heard on the July 29 earning call, with CEO Andrew Witty sounding in fine form, handling many of the questions directly.

Merck eyes opportunity for omarigliptin filing with Japan's PMDA

Merck's July 28 second-quarter earnings call said bon voyage to Joseph Romanelli, vice president of investor relations, as he heads over to run Hong Kong and Taiwan as managing director. It also included a bit about filing plans in Japan and the outlook for China.

Takeda submits post-marketing Actos study that shows no link to bladder cancer

Japan's Takeda Pharmaceutical has submitted a second post-marketing study to regulators in the United States, Europe and Japan that it says shows no increased risk of bladder cancer in patients treated with Actos (pioglitazone) in a key milestone following its April decision to settle thousands of lawsuits related to the diabetes drug.