Topic:

Regulatory

Latest Headlines

Latest Headlines

Amgen's Humira biosimilar nears FDA nod, but legal hurdles remain

Amgen's take on AbbVie's top-selling inflammation treatment is in line for FDA approval this year, but a patent fight between the two companies could keep it off the market into the next decade.

India and France committed to restart trade talks stalled on GVK row

The governments of India and France have agreed to make up for lost time and said this week they remain committed to restarting free trade negotiations between New Delhi and the European Union that have been stalled for the past three years.

BMS' Opdivo evens the score in melanoma with two new FDA green lights

Thanks to an FDA decision over the weekend, Bristol-Myers Squibb's immunotherapy Opdivo has caught back up to Merck's Keytruda in melanoma. And it won a new combination approval from the FDA to boot.

German radiosurgery player Brainlab invests $7M+ in Jan Medical for portable concussion Dx

Munich-based radiotherapy company, Brainlab, has invested a $7.5 million Series C financing into Mountain View, CA-based startup Jan Medical. The cash infusion is earmarked for the completion of ongoing clinical trials and submission of its neurological diagnostic software, Nautilus BrainPulse, to regulators.

Shire gets back on track with once-rejected eye drug

Shire has resubmitted the once-rejected eye treatment lifitegrast for FDA approval, handing in new data the company hopes will get its self-described blockbuster drug onto the market.

China FDA HIV treatment nods for Xian Janssen, GSK show going local helps

China FDA has approved two HIV therapies that show the combination of local partners and high unmet need might be a winning one for reaching the market quicker.

Bureaucracy holds up made-in-India heart valves

Prime Minister Narendra Modi has been trying to attract foreign investment with his "Make in India" campaign, but the reality at home was thrown into sharp relief with the news recently that a project to make heart valves in an Indian special economic zone was being stymied because of "pending approvals, delayed clearances and lack of financing options," according to a report by the Economic Times.

Japan scolded for lag in vaccinations

Japan's ban on the combination vaccine for mumps, measles and rubella in routine immunizations, a cumbersome bureaucracy, and a lack of vaccine coverage in the country's healthcare program are putting the nation at risk, various officials and researchers claim.

Chinese hep C patients say access to drugs a key issue

A survey of 600 of China's estimated 13 million hepatitis C sufferers showed a lack of access to direct acting antiviral drugs that can cure at least 95% of them was among the key issues they face.

Amgen's Repatha wins first PCSK9 OK in Japan

Amgen and the Sanofi and Regeneron team have been duking it out with their PCSK9 meds in the U.S., racing to ink payer deals in an effort to get ahead. But now, Amgen has the chance to get ahead start in another of the world's largest pharma markets.