The Latest
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Janice Haney Carr/CDC/Sickle Cell Foundation of Georgia/AP
Deep Dive // Gene editingWhat if a CRISPR cure isn’t such an easy choice?
A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.
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shutterstock.com/DadBusiness
Sponsored by Target RWEOvercoming scalability challenges in real-world data processing for transformative patient care
Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.
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Erik Karits via Getty Images
Pfizer, after delay, completes enrollment in Lyme vaccine trial
The announcement ends a lengthy setback that began when the company and partner Valneva accused a clinical trial site operator of study misconduct.
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Lilly cancer drug cleared by FDA for expanded leukemia, lymphoma use
Jaypirca, which has been on the market for less than a year, can now be used for more types of blood cancer but not as early as rival drugs from AbbVie and AstraZeneca.
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Zorica Nastasic via Getty Images
EyePoint sees stock surge on AMD drug trial data
The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.
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Michael M. Santiago via Getty Images
Pfizer plans for oral obesity drug hit new setback
The company won’t continue development of a twice-daily dose of its experimental weight loss medicine danuglipron after study data showed high rates of side effects.
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Adeline Kon/BioPharma Dive
Deep DiveBiotech M&A is picking back up. Here are the latest deals.
Roche’s deal for Carmot is the largest acquisition by value of an obesity drug developer this year, eclipsing smaller transactions for Versanis, Inversago Pharma and Embark Biotech.
Updated Dec. 4, 2023 -
artJazz via Getty Images
Obesity drugsEuropean regulators want to know more about the risks of GLP-1 drugs
The EMA's safety committee has more questions for makers of the in-demand therapies as it reviews whether the drugs are linked to the risk of suicidal thoughts.
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Concentra, on the hunt for deals, bids for LianBio
The Tang Capital-controlled company is bidding for LianBio shortly after making takeover offers for Rain Oncology and Theseus Pharmaceuticals.
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Courtesy of AbbVie
AbbVie joins ADC dealmaking with $10B ImmunoGen buyout
The acquisition of ImmunoGen gives AbbVie an approved medicine for ovarian cancer, and continues a pharma spending spree on antibody-drug conjugates.
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Permission granted by Empress Therapeutics
Flagship outlines plans to raise $3B for new fund
The biotech company creator’s last fund, which closed in 2021, brought in $3.4 billion for investing in new drug startups.
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Adeline Kon/BioPharma Dive
Deep DiveAfter a record run, fewer biotechs are going public. Here’s how they’re performing.
Only three biotech IPOs have priced this quarter after an uptick in activity between July and September. A number of startups remain in queue, however.
Updated Nov. 20, 2023 -
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CRO disputes Acelyrin’s implication of trial misconduct
Trial contractor Fortrea is fighting back as Acelyrin unveils a CRO audit in the wake of a major late-stage study failure.
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Justin Sullivan via Getty Images
Gilead to lay off staff at cell therapy unit Kite
The cuts will impact 7% of the cancer drug division’s employees, although about 90 new roles will be created around “areas of growth.”
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Jacob Bell
FDA names chief scientist Bumpus as Woodcock’s successor
Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role next year.
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Courtesy of BioMarin Pharmaceutical
BioMarin secures hemophilia gene therapy coverage in Germany
Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.
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Permission granted by Roivant Sciences
Q&ARoivant’s Matt Gline on raising capital and biotech’s outlook for 2024
Fresh off a $7 billion deal with Roche, the chief executive spoke with BioPharma Dive about this year’s “discordant combination” of major biotech achievements and market headwinds.
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Permission granted by Bristol-Myers Squibb
Bristol Myers pours $100M into RNA drugs for cardiovascular diseases
Tuesday’s deal signals the pharmaceutical giant's confidence in Avidity Biosciences and its so-called antibody oligonucleotide conjugates.
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Peddalanka Ramesh Babu via Getty Images
FDA investigating cancer risk linked to CAR-T cell therapy
Reports of T cell malignancies following treatment triggered the FDA’s alert. But the event appears rare, according to companies and physicians.
Updated Nov. 28, 2023 -
Novartis
Novartis sees brighter sales future as R&D revamp continues
The pharma has overhauled its pipeline this year, cutting R&D programs outside of its four main therapeutic areas.
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Leon Neal via Getty Images
GSK cancer drug Blenrep gets surprise trial win
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
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Courtesy of Sanofi
Regeneron, Sanofi to seek new Dupixent approval in US after COPD success
Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.
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Courtesy of Novo Nordisk
Novo to expand French plant in GLP-1 production push
The planned $2.3 billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy.
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nopparit via Getty Images
Xenon drug misses main goal of depression study
Yet, the company believes there were enough positive findings in the mid-stage trial to warrant further study of its drug, called XEN1101, in depression.
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Michael M. Santiago via Getty Images
Freeline, after cuts, agrees to take-private deal with Syncona
The planned acquisition adds to a string of bargain buyouts and reverse mergers in the gene therapy field.
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Spencer Platt via Getty Images
Emerging biotechFlagship-backed microbiome biotech Evelo to shut down
The company said it had not found “a viable alternative” to closing down in the months since it hit a clinical setback and laid off staff.
