Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves first self-contained, mobile continuous blood glucose monitor from Dexcom

Dexcom had put a bit of a Band-Aid on its mobile strategy--its prior smart device-compatible continuous glucose monitor required a separate worn transmitter and a dedicated handheld receiver. But now the FDA has approved the first CGM system, dubbed G5, which connects an all-in-one adhesive sensor/transmitter combo directly to an app on a smart device.

Pharma junkets for U.K. docs trigger tough new Sunshine rules, penalties

England may have been behind the U.S. in shining the light on financial ties between pharma and physicians, but that's changing. Not only will National Health Service doctors be required to declare all gifts they receive from drugmakers. They'll also face losing their jobs--or even jail--if pharma payments influence their work.

Stem cell laws in Japan a magnet for research, Nikkei says

Japan is building upon efforts last year to boost its standing as a regenerative medicine research hub with Prime Minister Shinzo Abe recently highlighting the field as key to the country's plans to revitalize the economy.

China slowdown for pharma shouldn't be ignored, WSJ says

The widely reported slowdown in sales in China noted across most multinational pharma companies deserves a harder look, The Wall Street Journal  says.

India's Dr. Reddy's widens strategies to move beyond basic generics

India's Dr. Reddy's Laboratories says it is poised to move well beyond its core basic generics business into complex products and biosimilars as it looks to widen its reach globally with a focus on the U.S. market.

Jaguar makes $8M debt financing deal in race to get Canalevia to market

Jaguar Animal Health, which is developing gastrointestinal products for pets and livestock, has agreed to debt financing for up to $8 million that it plans to use to shore up its efforts to get its lead product, Canalevia, to market.

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.