Topic:

Regulatory

Latest Headlines

Latest Headlines

Pfizer scores new Prevenar indication in Europe

Pfizer's Prevenar 13 is already the world's best-selling vaccine, and it kept on rolling Tuesday with a European label expansion.

Hutchison China MediTech eyes first modern drug approval in China next year with Eli Lilly candidate

Hutchison China MediTech, based in Hong Kong, expects to file for its first drug approval next year for what it said would be the first modern drug developed in China since artemisinin was developed in the 1970s to treat malaria.

Major policy shift on costs and safety views as China moves to lift price controls on drugs

China Premier Li Keqiang said the government will lift price controls on pharmaceuticals, which would mark a dramatic change of tack in efforts to both widen access to medicines from the cities into the countryside while keeping spending in check.

Denovo Biopharma eyes China trial of licensed Eli Lilly neuroscience drug

Denovo Biopharma will conduct clinical trials in China for its exclusively licensed pomaglumetad methionil, a late-stage neuroscience drug licensed from Eli Lilly.

ASLAN's Carl Firth on Taiwan's biotech momentum and valuations

Taiwan's momentum as a biotech clinical trials hub in Asia remains strong, but valuations for listed biotech firms may not yet reflect a wide smart money view on eventual commercial prospects, according to Carl Firth, the CEO of Aslan Pharmaceuticals.

BMS leapfrogs Merck with Opdivo approval in lung cancer

Bristol-Myers Squibb may have been second to market with PD-1 drug Opdivo, but as of Wednesday, it's the first to snag a second go-ahead for the cancer fighter--and it's a big one.

Bristol-Myers bags a record-fast approval for its cancer blockbuster Opdivo

Bristol-Myers Squibb picked up FDA approval to use its new oncology treatment in lung cancer, significantly boosting the value of a therapy already expected to bring in billions each year.

Orexigen blabs results early, but wins analyst confidence in the process

The FDA isn't happy with Orexigen, which put out some early positive cardio data for obesity drug Contrave on Tuesday. The way the FDA sees it, the data were too early. In fact, it had already asked Orexigen for a second outcomes study because it had shared the info with too many people.

McDonald's ditches antibiotics-raised chicken as legislators launch bill to curb use

Fast-food giant McDonald's announced Wednesday that it will phase out all chicken raised with antibiotics used in human healthcare within the next two years. The policy is part of the company's new Global Vision for Antimicrobial Stewardship in Food Animals, according to a statement from the company.

FDA shoots down Pacira's bid for expanding Exparel

Pacira's hopes of expanding the use of its surgical pain drug took a hit this week, as the FDA rejected its application to get Exparel approved through a new delivery pathway.