Topic:

Regulatory

Latest Headlines

Latest Headlines

China provides update on county-level hospital reform efforts

China expects public hospital reforms for 100 cities to be completed by the end of December, with the government also seeing an October start to a massive job of changing the way county-level hospitals operate, China Daily said, citing a National Health and Family Planning Commission report at a press conference.

BeiGene plans wider footprint in China with Suzhou development site

BeiGene is moving to Suzhou, in part, with plans to branch out from its capital city headquarters and develop a novel oncology drug operation that includes a cGMP manufacturing facility in Suzhou's BioBAY, the company said in a press release.

Samsung Bioepis on track for $1B U.S. listing next year for biosimilar powerhouse

South Korea-based Samsung Bioepis has hired lead managers for a U.S. listing next year as the joint venture between Samsung Group and Biogen looks to raise as much as $1 billion to fund development of biosimilars that will compete with some of the world's best-selling drugs,  Reuters  reports.

Takeda rolls toward EU approval with its heir to Velcade

Takeda's top oncology prospect is moving toward approval in the European Union, as continental regulators have accepted the company's application and promised a shortened review period for the blood cancer treatment.

Sarepta and BioMarin race for an FDA tag that could be worth $350M-plus

Rivals Sarepta Therapeutics and BioMarin ​Pharmaceutical are in line to become the next recipients of an FDA coupon for a fast review, each potentially picking up a sellable asset that recently brought in $350 million on the open market.

Beef producers lash out at USDA's choice of Humane Society vet for advisory panel

On July 21, when Agriculture Secretary Tom Vilsack announced the 19 members of the USDA Advisory Committee on Animal Health, a quick look at the names didn't seem like the list would raise any red flags. But now some agricultural groups are speaking out against one of Vilsack's picks: Michael J. Blackwell, a veterinarian and director of veterinary policy for the Humane Society of the United States.

UPDATED: FDA official encourages makers of Low T drugs to work together on a single risks trial

While data on the heart and stroke risks of testosterone enhancers have been mixed, the FDA has held firm on its position that "Low T" drugs should be used only for medical conditions not as a lifestyle drugs. Now the FDA says drugmakers need to provide new data on the heart and stroke risks of using them to boost testosterone in aging men. But, to save everybody a lot of time, effort and cost, it would be great if the drugmakers would do the clinical trial work together.

Drugs just don't get rejected much anymore, report says

Picking apart biopharma's protracted boom, analysts tend to focus on investors' ongoing appetite for risk, readily available early-stage funding and the vibe that getting drugs approved is simply much easier than it once was.  Forbes, with the help of BioMedTracker, has run the numbers on that last point, finding that the FDA has been green-lighting new drugs at an escalating rate for the past few years.

Italian court ruling clears way for Sorin's previously disputed merger with Cyberonics

Italy's Sorin Group fended off an objection to its planned merger with Cyberonics brought by the State's Attorney of Milan. Its stock is up almost 6% on the Milan Stock Exchange, as investors celebrate the news that the planned holding company, LivaNova PLC, is on track to be formed in the U.K. as planned thanks to a favorable court ruling.

Mylan expands recalls from plants spanked in FDA warning letter

Just days after the FDA hammered Mylan sterile injectable plants in India in a warning letter, the drugmaker has said it is expanding a recall of injected cancer meds it manufactures there for Pfizer.