News
New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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.
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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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In this episode of Denatured, BioSpace’s Head of Insights Lori and guests from Teva Pharmaceuticals and TOWER Capital discuss the opportunities, regulatory challenges and uncertainty surrounding AI.
Driven by copycat versions of Bristol Myers Squibb’s Revlimid and Novo Nordisk’s Victoza, Teva’s generics business was again a top-performer in the third quarter, with U.S. sales growing 30% and bringing in $1.1 billion in sales.
BMO Capital Markets analyst Evan Seigerman in a note to investors called Gilead’s third-quarter performance “consistent” and “steady,” while noting the company continues to demonstrate “reliable strength” in its human immunodeficiency virus business.
Year-over-year BioSpace data shows there are fewer job postings live on the website and far more competition for them.
Novo Nordisk’s total revenue in the third quarter missed analysts’ expectations but sales of weight loss drug Wegovy exceeded the consensus forecast. Still, the Danish drugmaker narrowed its full-year guidance for revenue and operating profit.
Analyst reactions to Donald Trump’s election victory were mixed Wednesday, with potential positives including an FTC that is likely to be more friendly to M&A, and negatives including concerns about what role Robert F. Kennedy, Jr. might play in healthcare.
With climbing biotech M&A and IPO activity following the post-pandemic slump, experts offer insights on maximizing value and otherwise capitalizing on exit opportunities.
The contract manufacturer fell short of Wall Street’s projections for its first quarter of fiscal 2025, which ended Sept. 30, 2024. The miss comes amid growing opposition to Novo Holdings’ proposed $16.5 billion acquisition of Catalent.
Truist Securities analyst Asthika Goonewardene in an investor note said data for anito-cel—particularly its safety profile—will help differentiate the CAR T therapy from Legend Biotech and J&J’s entrenched Carvykti in relapsed and refractory multiple myeloma.
BMO Capital Markets analyst Etzer Darout in a note to investors said the insurance fraud probe represents a “headline risk” to AstraZeneca, but contends that the share selloff is “overdone” and likely a knee-jerk reaction by investors.