India's patent office came down on the side of pharma giant AstraZeneca when it rejected a compulsory license application filed by Hyderabad-based Lee Pharma.
AbbVie and Roche's cancer drug venetoclax, awaiting FDA approval, picked up another breakthrough therapy nod from the agency for its potential as part of a combination treatment for leukemia.
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'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 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
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 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.
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 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.
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.