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.
FEATURED STORIES
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.
FROM OUR EDITORS
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
Pennsylvania-based Aclaris Therapeutics will stop development of zunsemetinib after it failed to meet the primary endpoint in a Phase II study for rheumatoid arthritis.
The UK-based nanomedicine biotech, previously known as SomaServe, has closed its Series A with some significant biopharma names attached.
At its highest dose level of 608 mg, lepodisiran reduced lipoprotein(a) levels by a median of 94% after 48 weeks.
When given at potentially therapeutic doses, Verve’s base editor led to strong reductions in LDL cholesterol and PCSK9 levels in patients with heterozygous familial hypercholesterolemia.
Novo Nordisk posted new data at AHA 2023 showing that its blockbuster weight loss drug could cut the risk of major cardiovascular events—including heart attack—across patient subgroups.
The allogeneic T-cell immunotherapy company is now approaching penny stock territory after its multiple sclerosis drug failed to reach the primary endpoint in a mid-stage study.
The FDA’s approval of Eli Lilly’s obesity drug Zepbound intensifies an already heated battle with Novo Nordisk’s Wegovy in the lucrative weight-loss drug market, as other drugmakers hope to get a piece of the action.
To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.
The company’s immunotherapy, in combination with chemotherapy Avastin, showed favorable progression-free survival in a late-stage hepatocellular carcinoma study.
Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.