Topic:

Regulatory

Latest Headlines

Latest Headlines

Gore touts CMS move to increase payments for aneurysm repair procedures

The Centers for Medicare and Medicaid Services put endovascular abdominal aneurysm repair procedures into a new Diagnosis-Related Group that will result in increased reimbursement for the treatment, to the delight of W.L Gore & Associates and other providers of devices used to repair abdominal aortic aneurysms.

Aprecia snags first FDA approval for a 3-D printed drug

The FDA has given the go-ahead for a small Pennsylvania company to launch the first drug made using three-dimensional printing. Aprecia Pharmaceuticals says on Monday the FDA approved Spritam, a formulation of epilepsy drug levetiracetam that uses the 3-D process to create a porous pill that rapidly disintegrates with a sip of liquid.

FDA announces new GDUFA fees and says to pay up by Oct. 1

The FDA has published its GDUFA facility fees for generic drugmakers for its next fiscal year, which are due on Oct. 1, in the Federal Register. Using formulas it lays out in the publication, the FDA says it ended up with a domestic API facility fee of $40,867 and foreign API facility fee of $55,867.

FDA signs off on first 3-D printed drug: Aprecia's quickly dissolving epilepsy tablet

The FDA on Monday approved Aprecia Pharmaceuticals' Spritam, which is the first 3-D-printed product designed for use in the human body. The drug is intended to treat epileptic seizures, and its MIT-created delivery platform allows for oral administration in the form of a small tablet that dissolves quickly in liquid due to its porous nature.

Gilead confirms China talks on pricing for Sovaldi as country works on serious illness coverage

Gilead Sciences is in talks with China on pricing for Sovaldi as the country stands outside of an access program by the U.S. drugmaker that relies heavily on licensing to India-based companies with the discusssions held against a backdrop of China seeking to expand insurance access for serious illness coverage.

Company builds plant for 3DP pill making as it nails first FDA approval

Aprecia Pharmaceuticals is building a small manufacturing facility in Blue Ash, OH, but instead of all of the usual accoutrements of drugmaking, the company will fill it with three-dimensional printing (3DP) technology, technology it is using to make quick-dissolve, easily ingested formulations of highly prescribed high-dose medications.

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.