Topic:

Regulatory

Latest Headlines

Latest Headlines

Australia budget is a showdown on cancer drug funding, safety net reach

An Australia government proposal to trim the national drug-coverage budget for innovative drugs by 5%, or U.S.$2.36 billion, has invited a juggernaut of industry opposition already descending on the parliament. The reductions are aimed at the nation's leading drugs, including those for cancer.

China kicks press into high gear to knock down talk on higher drug prices

Within days after China announced an upcoming end to controls on most drug prices, whispers are heard of concerns the move set for June 1 would lead to higher prices at the consumer level. Government information outlets went into high gear to dampen the doubts.

Sumitomo Dainippon, Takeda call it quits on Latuda agreement in Europe

Sumitomo Dainippon Pharma and Takeda Pharmaceutical have canceled a four-year-old license and development agreement aimed at commercialization of lurasidone hydrochloride (Latuda) products following disappointing Phase III trials to treat schizophrenia announced last month.

Details dribble out on Biocon's Syngene unit ahead of India IPO

A contract research organization's initial public offering in India will be closely watched not only for signs of demand but also as to whether the local market may look anew at its broad biomedical sector.

FDA issues warning letter to Smith & Nephew regarding questionable operations at plant in Andover, MA

The FDA slapped Smith & Nephew with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company's mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.

Startup Transcend to submit PMA in second half for glaucoma micro-stent after positive pivotal data

Venture-backed startup Transcend Medical is expecting to submit a PMA for its novel minimally invasive glaucoma surgical implant during the next half of the year. The move comes after the company garnered positive pivotal data, which it has just released.

India's Torrent buys family-owned Zyg, gains FDA-approved plant

India's Torrent Pharmaceuticals said it has bought all of family-run Zyg Pharma in a deal that gives it access to a new product line in dermatology and a manufacturing facility approved by the U.S. FDA and the Therapeutic Goods Administration in Australia.

CFDA grants fast-track nod to Engineering Co., Capital Bio devices in under 5 months

Two new medical devices received China FDA marketing approval authorizations in a submission to approval time of just under 5 months, the regulatory agency said, under a process started in March last year.

India drug pricing body ready to crack whip on registration rules

Several of India's largest drug makers are among at least 59 facing possible court action by regulators claiming they failed to register under a new information system of the nation's price-control agency. A few multinationals also are on the list.

U.K. regulators find issues with Indian-owned API distributor Relonchem

U.K. regulators have revoked the license of an Indian-owned API distributor after finding a host of problems at its operations in Cheshire. But the Medicines and Healthcare Regulatory Agency says that Relonchem will be allowed to import some "critical" meds under strict oversight if it is found to be the key supplier.