Topic:

Regulatory

Latest Headlines

Latest Headlines

Pfizer, Bayer and Boehringer meds win backing from U.K. cost agency

This week, the U.K. National Institute for Health and Care Excellence blessed Pfizer's kidney cancer treatment Inlyta, changed its mind in support of Bayer's prostate cancer therapy Xofigo, and backed Boehringer Ingelheim's anticoagulant Pradaxa for blood clots in the legs and lungs.

Belgium's UCB calls it quits on $1.53B sale of U.S. generic drug unit

Weeks after Belgium's UCB announced that it would sell its U.S. generic drug business for $1.53 billion, the company is calling off the sale in light of regulatory pushback over one of the unit's products.

Sanofi's newly approved intradermal quadrivalent Fluzone forgoes the shot

The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.

Pozen gets another FDA cold shoulder for its cardio drugs

The FDA again rejected Pozen's pair of treatments designed to help patients deal with cardiovascular disease, citing the same third-party manufacturing issues that tanked the last application. Pozen claims the supplier has since rectified those concerns but that the agency has been less than cooperative in the process.

Roche expands use of next-gen blood tests for organ and tissue screening

Roche got a green light from U.S. regulatory authorities to expand the use of two tests from its cobas assay line used to detect serious viral infections like HIV, hepatitis B and C and West Nile.

FDA approves diagnostic to spot blood cancer-causing virus

Santa Ana, CA-based MP Biomedicals has nabbed FDA approval for the first supplemental test designed to better identify blood donors that have tested positive for human T cell lymphotropic virus.

Roche's Lucentis nabs FDA 'breakthrough' tag for diabetic eye disease

Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.

FTC plows ahead in pay-for-delay suit over AbbVie's AndroGel

The Federal Trade Commission is urging a Pennsylvania federal court to move forward with its pay-for-delay lawsuit against AbbVie, rejecting the company's arguments that it did not keep a generic version of its testosterone powerhouse AndroGel off the market and contending that the suit meets a precedent set last year by the U.S. Supreme Court.

Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval

It's been a good news, bad news week for Novartis and its oncology business. Monday, the Swiss drugmaker won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder. But Friday, Novartis announced that Afinitor fell short in a HER2-positive breast cancer trial, dashing hopes for what could have been a lucrative new indication.

Novartis wins an FDA nod for a long-acting spin on its rare disease drug

The FDA signed off on a once-a-month version of Novartis' Signifor designed to treat acromegaly, a rare growth hormone disorder that can lead to disfigurement and death.