New Delhi: The Centre is set to amend the New Drugs and Clinical Trials Rules, 2019, that would halve the statutory time to process applications for test licences to manufacture or use a new drug in clinical trials, promoting ease of doing business in the pharmaceutical sector. The Union health ministry sought public comments on…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Summer is over and the market moves yesterday made that clear. More on that and the latest news below. The need-to-know this morning Wave Life Sciences reported updated results from a mid-stage…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Welcome back from the holiday weekend. Today we have some candor in ALL CAPS from Trump on Covid vaccines, glowy data from Ionis that could lead to an expanded approval for olezarsen, and more….
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. My colleague Allison DeAngelis has been working for months on our annual VC rankings report. Read on for what she found. Third Rock tops STAT’s annual VC ranking Among biotech venture capital…
Third Rock Ventures, the investment firm that has backed biotech startups for nearly two decades, has not only invested in groundbreaking drug companies, but it has generated the best returns on its investments, according to an analysis by STAT. The analysis was part of STAT’s sixth annual “Ranking Biotech’s Top Venture Capital Firms” report. The…
Eli Lilly’s investigational obesity pill helped lower weight and blood sugar in patients with obesity and type 2 diabetes, but the Phase 3 results may not be enough to assuage concerns about the competitiveness of the drug. The medication, called orforglipron, is the most advanced small-molecule GLP-1 in development. Treatment with the drug led to…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hey, good morning. Today, we see CBER suspend the license for a chikungunya vaccine, look at a push to recall a safety and efficacy study for the antidepressant Paxil, and more. FDA pulls license for…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. The Supreme Court is allowing the Trump administration to cut $783 million in research grants tied to DEI work. Also, STAT just unveiled its special report on the 2025 rankings of the…
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Morning. Today, we see fallout from the FDA’s rejection of Replimune’s melanoma drug affecting another biotech, learn how Sarepta’s decision-making has affected a patient population that hasn’t always been in the headlines, and more. As Sarepta…
The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks. The move comes after protracted uncertainty surrounding…
