Topic:

Regulatory

Latest Headlines

Latest Headlines

Roche hustles to FDA with PhII PD-L1 cancer success for 'breakthrough' star atezo

Roche says its closely watched PD-L1 checkpoint inhibitor atezolizumab (MPDL3280A) hit its primary endpoint in a midstage study for bladder cancer, shrinking tumors for a narrowly defined set of patients and setting the stage for early discussions with the FDA about the possibility of an accelerated approval for this "breakthrough" drug.

China's aim to halt malaria gets a thumbs up from WHO as global effort grows

China's efforts to eradicate malaria by the end of this decade appear to be on track, state-run news agency Xinhua said, noting that its Roll Back Malaria partnership with global health bodies is slated to be implemented by the end of 2015 as part of the country's Sustainable Development Goals.

Senate committee, USDA, poultry producers meet to discuss deadly U.S. avian flu outbreak

A Senate committee met with a panel of USDA officials and poultry industry professionals earlier this week to discuss the worst outbreak in U.S. history of a deadly avian influenza that resulted in the deaths of about 48 million birds.

House passes 21st Century Cures bill

Members of U.S. House of Representatives voted 344 to 77 today to approve the 21st Century Cures bill. It now goes to the Senate for consideration. The bill provides more funds for the FDA and NIH, but detractors are concerned about provisions that change the way drugs and devices are developed and approved.

DOJ criminal probe takes a look at trade associations

For more than a year, the Justice Department (DOJ) has been pursuing a criminal investigation into the possibility of pricing collusion among makers of generics. Three companies have acknowledged receiving subpoenas from the feds, and now a report says the probe may also be looking into whether trade associations were used as a conduit to trade drug-pricing information.

UPDATED: 21st Century Cures drug bill triggers a DC dust-up over relaxed development regs

Lawmakers in the House are expected to step up and cast their votes on the 21st Century Cures Act today, a big step toward once again shaking up the legal framework built to guide drug development in the U.S. while significantly boosting the amount of funding that flows to the NIH.

U.K. cost gatekeeper changes its tune on Entyvio for Crohn's

Takeda has hit a few speedbumps lately, struggling with sagging sales and less-than-stellar profits after losing the patent for one of its top sellers. But the company is enjoying a bright point as the U.K. cost gatekeeper gave its thumbs-up to the company's inflammatory bowel disease drug Entyvio, dealing the company some good news as it looks to its gastrointestinal meds to revive its flagging fortunes.

Roche gets NSCLC nod for Avastin from China FDA

China's FDA has approved Roche's Avastin (bevacizumab) for an additional indication of non-small lung cancer, a pending decision that was tipped in the first quarter earnings call.

Fresenius companies fined £550,000 by U.K. court in patient death

Fresenius Kabi and a sister company were ordered by a U.K. court on Thursday to pay more than $860,000 in penalties after a diabetic patient died because the syringes the companies supplied contained no actual insulin. On top of that, the court found that Fresenius and Calea also supplied tobramycin syringes used on another patient that contained three times the prescribed daily dose.

SC high court cuts J&J's Risperdal marketing penalty back again, to $124M

South Carolina's Supreme Court further cut the penalty against Johnson & Johnson stemming from a Risperdal deceptive-marketing lawsuit. Originally ordered to pay $327 million for violations of the state's Unfair Trade Practices Act, J&J's Janssen Pharmaceutica unit now faces a $124 million judgment.