Topic:

Regulatory

Latest Headlines

Latest Headlines

Another legal test for U.S. in case of Chinese scientists accused of stealing GSK secrets

Science Insider has cautioned that a federal indictment against Yu Xue and Lucy Xi and three associates for allegedly stealing trade secrets from GlaxoSmithKline in the U.S. related to work on an anti-HER3 antibody may test prosecutors' ability to get a conviction.

India's drugs for domestic use fall short in quality tests, task force says

Medicines produced in India for domestic consumption are failing quality tests performed by a government task force set up to investigate poor manufacturing practices.

New IP rules in EU could cut Indian pharma shipments

Changes in intellectual property (IP) rules in the European Union have Indian drugmakers worried because the new regulations empower EU countries like Belgium to impound Indian-made drugs that are transshipped via the EU to developing countries in Latin America and Africa, according to a report by the Economic Times.

Takeda's Hib vaccine gets Japanese approval

Almost 7 years after licensing it from Novartis, Takeda picked up a regulatory green light from Japan's Ministry of Health, Labour and Welfare for its Haemophilus influenzae type B (Hib) vaccine. The vaccine, Vaxem Hib, is approved for use in children aged two months to under 5 years.

Aratana shares soar on first FDA filing for approval of canine arthritis drug

Shares of Aratana Therapeutics jumped 25% to $3.99 a share in after-market trading on January 25, after the company announced it had filed for FDA approval of Galliprant (grapiprant), its drug to treat pain in dogs with osteoarthritis. It is Aratana's first FDA filing, and it comes after a turbulent 2015 for the company, which disappointed investors with dashed hopes for its canine lymphoma franchise.

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.