The Latest
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is picking back up. Here are the latest deals.
Despite newly realized fears of an activist FTC, analysts expect dealmaking to continue this year with small buyouts like Ironwood’s acquisition of VectivBio as well as larger M&A.
Updated May 22, 2023 -
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Pfizer says antibiotic is effective against tough-to-treat infections
A drug the company acquired from AstraZeneca and developed for gram-negative infections — a growing public health threat — could be headed for a regulatory review later this year.
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AstraZeneca abandons experimental bowel disease drug
The drugmaker cited testing delays and an evolving “competitive landscape” in its decision to discontinue development of its IL-23 inhibitor brazikumab.
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Bayer launches precision health unit in latest digital health venture
The pharma company said it will work with startups and other digital health companies as it builds out the consumer-focused business unit.
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National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.
RSV vaccinesPfizer’s RSV vaccine wins FDA approval in older adults
The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.
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Adeline Kon/BioPharma Dive
Deep DiveAfter a record run, fewer biotechs are going public. Here’s how they’re performing.
Though the sample size is small, the majority of biotechs that have gone public in 2023 have so far held their value, in contrast to the sliding stock prices of companies that IPO’d in previous years.
Updated May 26, 2023 -
Courtesy of Biohaven Ltd.
Biohaven sends latest drug to FDA, despite past trial setback
The biotech, best known for its success developing migraine medicines, will seek approval of a treatment that failed a Phase 3 trial but showed signs of a positive effect.
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FDA pauses PepGen’s plans to test muscle disease drug
The company’s oligonucleotide-based treatment is the latest neuromuscular disease therapy to face a regulatory roadblock prior to human testing.
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Permission granted by Amylyx Pharmaceuticals
Amylyx’s ALS drug could face rejection in Europe
The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.
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Pfizer says hemophilia drug succeeded in Phase 3 study
The drug, called marstacimab, could potentially become another option for hemophilia patients just as new gene therapies arrive on the market in the U.S.
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Grigorii Yalukov via Getty Images
Akebia says FDA will give its once-rejected anemia pill a second chance
The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.
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Rain Oncology to cut workforce by 65% after study failure
The company, which went public in 2021 to develop a cancer drug licensed from Daiichi Sankyo, may try to acquire a different tumor-targeting medicine to grow its pipeline.
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Atea rejects takeover bid from Concentra
The COVID-19 drug developer said the offer from the firm that recently took over Jounce Therapeutics “fundamentally undervalues the company.”
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Permission granted by Institute of Protein Innovation
Q&A // Emerging biotechSerial biotech founder Tim Springer on investing in startups and democratizing antibody research
Springer, who became a billionaire after investing in Moderna, highlighted gene therapy and machine learning as two fields he’s optimistic will shape biotech’s future.
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OGphoto via Getty Images
J&J antibody drug combination shows promise in multiple myeloma
Bispecific antibodies, like the two J&J is testing together in multiple myeloma, could compete with CAR-T cell therapies in certain treatment lines.
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ASCO / Scott Morgan
ASCO puts spotlight on advancing antibody-drug conjugate pipeline
Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.
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rightdx via Getty Images
Bristol Myers data make case for earlier use of bone marrow disease drug
Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.
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Leonid Sorokin via Getty Images
BenevolentAI CFO resigns as company lays off staff, restructures
The biotech, one of several AI drug discovery specialists to go public in recent years, is cutting up to 180 jobs and reorganizing its pipeline to conserve cash.
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Courtesy of Illumina
Illumina chair loses to Icahn pick as proxy battle ends
The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.
Updated May 25, 2023 -
Courtesy of Apellis Pharmaceuticals
Apellis abandons ALS drug after study miss
The trial failure is the second for an ALS medicine this week, adding to a lengthy list of study setbacks that have thinned the pipeline of experimental medicines for the disease in recent years.
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Annexon claims a silver lining in failed eye drug study
The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.
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Rebecca Pifer/BioPharma Dive
House lawmakers, PBM lobby spar over committee hearing
At the latest congressional inquiry into pharmacy benefit managers, lawmakers argued the middlemen profit at the expense of patients and taxpayers.
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Digital health funding holds steady in Q1 after year of decline
The sector defied trends seen in the broader venture capital economy, where funding has tightened. But investment is still at years-low levels.
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Courtesy of Sarepta
FDA delays decision on Duchenne gene therapy, considers narrower approval
The agency will extend its review of Sarepta’s treatment by one month as it weighs limiting an initial OK to children with Duchenne aged 4 to 5 years old.
Updated May 24, 2023 -
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PTC lays off staff, fires CFO as neuromuscular drug study fails
The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.
