Topic:

Regulatory

Latest Headlines

Latest Headlines

Novartis extends lead on psoriasis rivals with a pair of new Cosentyx approvals

Novartis has been working hard to rack up indications for new med Cosentyx before other next-gen psoriasis competitors hit the scene. And now, it's accomplished that goal in the U.S.

Merck to submit Ebola vaccine for regulatory approval in 2017

Merck's candidate is the furthest along in the quest for an Ebola vaccine, having posted interim Phase III data showing 100% efficacy last July. Now, the Big Pharma has won $5 million from Gavi, the global vaccine alliance, to help see its candidate through late-stage trials, licensure and prequalification by the WHO, and plans to submit the vaccine for regulatory approval by the end of 2017.

China FDA plowed through trial and new drug applications in 2015, commissioner says

China FDA went through 9,394 clinical trial and new drug applications in 2015, Commissioner Bi Jingquan said in a press release, which was almost double the previous year's tally, taking a chunk out of a backlog estimated earlier last year of around 20,000 applications

Japan's Daiichi Sankyo, Coherus become players in Enbrel biosimilar race

Tokyo-based Daiichi Sankyo and U.S.-based Coherus Biosciences hit a successful Phase III mark in trials for a biosimilar of Amgen's rheumatoid arthritis therapy Enbrel.

Medical reps in India face the boot from doctors' offices

Medical sales reps in India are facing a rapidly cooler climate just at the time that India's key pharmaceutical industry is scaling up to sell more drugs at home and abroad as countries look to cut costs for national healthcare plans by using more Indian-made generics.

Second Indian state blocks sales of Roche's Avastin

The Indian state of Telangana has become the second state to block sales of Roche's cancer drug Avastin after 15 patients partially lost their sight after using it.

Details on BeiGene's Nasdaq IPO show firm valued around $756M

Details on the initial public offering for Beijing-based biotech BeiGene are out with the offer topping the $100 million early estimate and insiders slated to take more than half in an offering that will be closely watched as sentiment gauge for other China-focused biotech firms into the U.S. market.

FDA expands indication for GSK's Hib vaccine, Hiberix

In 2009, GlaxoSmithKline worked with U.S. health authorities to bring its Haemophilus influenzae Type b (Hib) vaccine, Hiberix, to market. Now, the FDA has expanded the indication of GSK's Hiberix from a booster to a full-series, four-dose vaccine to immunize children aged 6 weeks to four years.

Singaporean company barred from selling devices in U.S. after turning down FDA inspection

A subsidiary of Singapore's Biosensors International can no longer sell devices in the U.S. because it failed to respond to a request for FDA inspection.

Imaging informatics upstart gets FDA nod for oncology screening software

HealthMyne has secured 510(k) clearance for its analytics software package that's designed to offer radiologists information in oncology imaging studies. The software from the Madison, WI-based company is designed to work as part of an Epic electronic health record and to offer tracking of specific nodules or tumors over time. The software is used to analyze its relative size and location.
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