The Latest
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Kendall Davis/BioPharma Dive
Deep Dive10 clinical trials to watch in the first half of 2023
Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.
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J&J, Legend’s cancer cell therapy has early success in key clinical trial
The trial is an important test of Carvykti’s potential for earlier use in multiple myeloma and found treatment helped extend progression-free survival over standard regimens.
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Merck gets a ‘surprise’ win for Keytruda in early lung cancer
The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main supporting study, taking one Wall Street analyst by surprise.
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Celularity warns of layoffs for ‘substantial portion’ of its staff
After a strategic review, the Celgene spinout said it won’t advance two experimental cancer therapies that use “natural killer” cells.
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FDA advisers back agency plan to simplify COVID-19 vaccination
The expert committee supported making primary and booster shots the same composition, while recommending periodic updates to better match the vaccines to circulating variants.
Updated Jan. 27, 2023 -
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Magenta halts study of targeted conditioning drug after participant’s death
The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.
Updated Jan. 26, 2023 -
Adeline Kon/BioPharma Dive
Deep DiveAfter a record run, fewer biotechs are going public. Here’s how they’re performing.
Obesity drug developer Structure Therapeutics set terms for what could be the first large biotech IPO of the year, if its offering prices as planned on Thursday.
Updated 17 hours ago -
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Moderna draws more lawmaker criticism for COVID vaccine pricing plan
Senators Warren and Welch urged the biotech to reconsider a planned price hike to between $110 and $130 a dose, and sought answers to a long list of questions.
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Veteran biotech leader George Scangos to step down as Vir CEO
The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.
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Permission granted by Johnson & Johnson
Sales of J&J, Legend cell therapy plateau amid production challenges
Carvykti, which was approved a year ago for hard-to-treat multiple myeloma, generated $55 million in fourth-quarter sales, on par with the previous quarter.
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FDA advisers back Cidara and Melinta’s antifungal treatment
The drug, if approved, would be the first new treatment in more than a decade for two conditions that stem from Candida fungus.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is picking back up. Here are the latest deals.
Four of the past five biotech acquisitions have featured contingent value rights agreements, suggesting a mismatch between buyers and sellers over what companies are worth.
Updated Jan. 26, 2023 -
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Merck reports one success, one setback from late-stage Keytruda trials
The top-selling immunotherapy bested chemo in treating bile duct cancer, but fell short in a study testing it with other drugs for metastatic prostate tumors.
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Finch to lay off 95% of staff, scrap microbiome drug study
The company blamed a range of factors in its decision, including limited funding options, slow trial enrollment and “broader sector trends.”
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J&J puts focus on cancer drugs in push to reach 2025 sales target
The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.
Updated Jan. 24, 2023 -
Permission granted by Roivant Sciences
Q&A // Emerging biotechRoivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant
The year ahead could be turbulent for biotech as investors look for what the Roivant CEO described to BioPharma Dive as “safe harbors in a storm.”
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Lilly to boost diabetes drug production with $450M factory investment
The pharma aims to double its manufacturing capacity for drugs like Mounjaro and Trulicity as competition with rival Novo Nordisk heats up.
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Jacob Bell / BioPharma Dive
FDA to seek outside advice on Biogen’s ALS drug
The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.
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Jacob Bell
Takeda pays $400M to buy into Hutchmed’s colorectal cancer drug
The deal is the second big licensing deal Takeda has signed in as many months and gives the company rights to a drug Hutchmed began submitting to U.S. regulators in December.
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Pliant shares jump on new data for lung disease drug
A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.
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Scott Olson via Getty Images
FDA weighs shift in COVID vaccination strategy
Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.
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Why Wall Street shrugged at Lilly’s Alzheimer’s setback
Analysts argue the FDA’s choice to decline accelerated approval for donanemab, while surprising, is not the main factor that will determine whether it eventually becomes a commercial success.
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Jonathan Gardner / BioPharma Dive
BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca
The drugmaker hopes Brukinsa’s survival data will help its drug compete with Imbruvica and Calquence.
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FDA lifts hold on Astellas gene therapy for Pompe disease
The regulator’s decision ends a seven-month study pause that followed a report of one participant experiencing mild symptoms of peripheral neuropathy.
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Sarah Silbiger via Getty Images
FDA rejects Lilly Alzheimer’s drug, citing insufficient data
The drugmaker had sought an accelerated approval based on data from a small mid-stage trial. Results from a larger study are due in the second quarter.
