The Latest
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Adeline Kon/BioPharma Dive
Deep DiveAfter a record run, fewer biotechs are going public. Here’s how they’re performing.
Mineralys Therapeutics, the developer of a blood pressure drug licensed from Mitsubishi, will try on Thursday to become the second biotech in a week to raise at least $100 million in an IPO.
Updated Feb. 7, 2023 -
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Bayer begins key tests for closely watched blood thinner
The company has begun enrolling patients in one of the largest Phase 3 programs in its history, a pair of trials that will test an anticoagulant it believes can be a future blockbuster.
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Courtesy of Roche
Roche rival to AstraZeneca’s Soliris succeeds in late-stage testing
The company said the experimental injection matched Soliris in a Phase 3 study and would soon be submitted to regulators around the world.
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Courtesy of Leqembi
Eisai gives first glimpse into Alzheimer’s drug launch
In the month since its U.S. approval, Leqembi has had its first sale, its first prescription written and its first administration to a patient.
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Permission granted by Astellas
Astellas switches CEOs amid plans to pursue ‘aggressive’ growth
Naoki Okamura, currently Astellas’ chief strategy officer, will replace current CEO Kenji Yasukawa as the company attempts to “further accelerate growth.”
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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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J&J says drug it acquired from Momenta succeeds in study of ultra-rare condition
Results from a small, mid-stage study of nipocalimab showed promise in treating an autoimmune disorder affecting fetuses and newborns, J&J said.
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Idorsia shares sink on ‘unexpected’ failure of drug study
The Actelion spinout’s drug clazosentan, which is approved for use in Japan, didn’t significantly outperform a placebo in a Phase 3 study of patients with a particular type of stroke.
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Justin Sullivan via Getty Images
FDA approves Gilead’s Trodelvy for expanded use in breast cancer
The agency’s OK is a win for Gilead, which has bet big on the drug. But the company will face tough competition from AstraZeneca and Daiichi Sankyo’s fast-selling Enhertu.
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Courtesy of Roche
Roche writes off $3B on lower sales forecasts for gene therapies, cancer drugs
Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics.
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Pixelimage via Getty Images
Magenta to explore sale, merger after study setback
The biotech recently stopped a trial of its experimental conditioning regimen over safety concerns. Now it’s halting further development work as it undertakes a strategic review.
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COVID-19 vaccine maker Medicago to close down
The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment.
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Lilly reports fast sales for new diabetes drug
Still, fourth quarter sales for Mounjaro were slightly below high Wall Street forecasts and didn’t offset falling revenue from Lilly’s COVID-19 antibodies.
Updated Feb. 2, 2023 -
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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Permission granted by Roche
Roche promotes from within to replace pharma head
Teresa Graham, currently head of Roche Pharmaceuticals’ global product strategy, will succeed former chief Bill Anderson. The reshuffle is one of several recent changes in the pharma’s leadership.
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iStock via Getty Images
GSK moves hepatitis B drug into late-stage testing
The British drugmaker sees potential for the medicine to be a functional cure for chronic infections, and is beginning two Phase 3 trials to test its promise.
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Permission granted by Karuna Therapeutics
Karuna, hoping to find new brain drugs, buys up a shuttering biotech’s pipeline
Though Goldfinch Bio focused on kidney diseases, Karuna believes its experimental drugs may have potential treating psychiatric and neurological conditions.
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Sarah Silbiger via Getty Images
FDA to convene advisers on review of RSV vaccines from GSK, Pfizer
The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.
Updated Feb. 2, 2023 -
Courtesy of GSK
GSK secures FDA approval of anemia drug, but with limitations
The approval is a win for GSK as the FDA had previously rejected two similar drugs from Akebia Therapeutics and Fibrogen. But it comes with restrictions on its use and a safety warning.
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Alvarez via Getty Images
3 more biotechs announce layoffs as industry cost-cutting continues
Evelo Biosciences, Quince Therapeutics and Inovio are the latest to pare down workforces in the face of clinical setbacks and depressed stock prices.
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Sarah Silbiger/Getty Images via Getty Images
Head of FDA gene therapy office set to retire in March
Wilson Bryan, a key decision maker in the agency’s oversight of genetic medicines, is expected to leave next month amid an organizational revamp of his office, the FDA confirmed.
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Novartis
Novartis confirms it has stopped development of experimental Huntington’s drug
Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.
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Finbarr Webster via Getty Images
Pfizer forecasts steep decline in COVID vaccine, drug sales
Yearly revenue from Comirnaty and Paxlovid could fall by nearly two thirds in 2023 amid lower vaccination rates and a shift to private market sales.
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Permission granted by Vector BioMed
A startup launches with plans to open up a gene and cell therapy bottleneck
The pipeline of CAR-T therapies and ex vivo gene therapies has swelled in recent years, but manufacturing hasn’t been able to keep up with demand.
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Bill Oxford via Getty Images
Court rules for drugmakers in 340B fight over contract pharmacies
The decision is a win for Sanofi, Novo Nordisk and AstraZeneca. The drugmakers sued HHS after regulators ordered them to stop restricting sales of 340B drugs to contract pharmacies.
