News
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.
Seagen’s top-selling drug hit the mark in another major indication.
Clovis Oncology officially files for Chapter 11 bankruptcy.
Teaming up with a recruiter can be a smart move in a tight job market or for job seekers looking for a specialized role. To help you in your job search, we’ve outlined how to get the best out of recruiters.
Merck initiated a tender offer Monday to buy all outstanding shares of Imago Biosciences. This follows the November announcement of the buyout.
Affimed will not seek accelerated approval for AFM13 as a monotherapy in advanced-stage relapsed/refractory peripheral T cell lymphoma.
Amgen confirmed Monday it will acquire rare disease giant Horizon Therapeutics for $26.4 billion.
Wall Street is no longer enamored with NASH drug developers.
Combinations including Ibrutinib stood out in hard-to-treat hematological cancers at the 64th American Society of Hematology (ASH) annual meeting.
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.