Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Lupin antibiotic products banned by Brazil

Lupin, which has been expanding its manufacturing and marketing footprint internationally via M&A, moved on Brazil in May with the acquisition of generics and OTC maker Medquímica Indústria Farmacêutica. But new markets mean new regulations, and the Indian company has been tripped by some issues that led Brazil to ban some of Lupin's antibiotic products.

Female libido drug lobbying sparks a backlash as FDA decision looms

Five weeks from now, the FDA will face a deadline for making a final marketing decision on flibanserin, a drug designed to treat sexual desire disorder in women. Already a two-time loser at the agency, Sprout Pharmaceuticals--which acquired the treatment from a frustrated Boehringer Ingelheim--managed to make a comeback recently and snag an important 18 to 6 FDA panel vote in its favor. And whatever the FDA officially concludes, the decision will come down as one of the most controversial of the year.

Sawai Pharma ramps up manufacturing in response to Japan's call for more generics

In May, the Japanese government said it would raise its target for the use of generics in public reimbursement to 80% or 90% by 2017--even as it lags an earlier target of 60% this year. That set Japan's Sawai Pharmaceutical into high gear, with the Nikkei Asian Review reporting plans to ramp up generic drug manufacturing capacity by 80% to 18 billion tablets annually by fiscal 2020.

India's Sharon Bio-Medicine told by FDA to pay fees or face ban

India's Sharon Bio-Medicine was issued a warning letter from the U.S. FDA to either pay its generic drug user fees due since 2013 or be barred from shipping products to the U.S., Business Standard newspaper reported.

Ireland moves to woo India drug firms as New Delhi's reforms stall

Ireland plans to woo Indian companies to its shores using the draw of a 12.5% corporate tax rate and access to Europe, according to a story from India Abroad News Service, posing a challenge to New Delhi's efforts to make the domestic industry a centerpiece of economic growth.

Chinese staffer key to negotiating deal to bolster FDA staff in China

Vice President Joe Biden weighed in with the Chinese on FDA's efforts to negotiate an agreement to bump up its inspection staff in the country. So did former FDA Commissioner Margaret Hamburg. But it is locally employed FDA staffer Lixia Wang who has won the prize, in part for her efforts to help seal the deal.

FDA sends drugmakers warning letters reminding them to pay up

Most FDA warning letters are about problems that inspectors have found during visits to plants that manufacture APIs or finished formulations, and they generally will mean cash outlays for companies as they deal with the issues at hand. But sometimes, the letters are just for cash.

Got an idea for an FDA drug study? Send an email

The Center for Drug Evaluation and Research, or CDER, is the FDA's OTC and prescription drug watchdog. Efficacy and safety are the names of its game. But someone has to look after drug market--and that would be the Office of Prescription Drug Promotion (OPDP), probably best-known as the distributor of the dreaded untitled and warning letters that inspire trepidation among pharma marketers.