Biotech: Page 4

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    Permission granted by Lindus Health
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    Can a Moderna co-founder change the CRO game?

    Well-known scientist and biotech entrepreneur Robert Langer is helping Lindus Health address longstanding challenges in contract drug research.

    By Michael Gibney • Feb. 28, 2024
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    Elizabeth Regan / Industry Dive
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    Viking data suggest obesity drug could rival Zepbound, Wegovy

    The biotech’s drug led to significant weight loss in a Phase 2 trial, causing shares to double as analysts compared results to the marks set by drugs from Eli Lilly and Novo Nordisk.

    By • Feb. 27, 2024
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    National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.
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    Trendline

    Cell therapy

    Six CAR-T cell therapies are now approved in the U.S., and their continued emergence has helped fueled further research into next-generation approaches.

    By BioPharma Dive staff
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    koto_feja via Getty Images
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    Janux shares triple on early cancer immunotherapy data

    Analysts viewed results for one of Janux’s drug, a T cell engager aimed at metastatic prostate cancer, as potentially best-in-class in a field that’s crowded with competitors.

    By • Feb. 27, 2024
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    Honglouwawa via Getty Images
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    Denali, fresh off study setback, gets $500M lift

    The infusion from unnamed private investors will bolster the company’s balance sheet days after a Sanofi-partnered ALS drug stumbled in a clinical trial.

    By • Feb. 27, 2024
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    ismagilov via Getty Images
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    BioMarin preaches patience amid slow sales for hemophilia gene therapy

    The company earned only $3.5 million last year from its Roctavian treatment, far below the $50 million to $150 million range it had forecast eight months ago.

    By • Feb. 23, 2024
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    Permission granted by Frontier Medicines
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    Frontier gets $80M, Galapagos’ backing to make a better KRAS drug

    The startup’s Series C round will support a clinical-stage drug the company thinks could address the shortcomings of other KRAS-targeting medicines.

    By • Feb. 22, 2024
  • President Joe Biden signs a bill in the Oval Office while First Lady Jill Biden and others look on.
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    Win McNamee via Getty Images
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    Biden administration pledges $100M toward women’s health research

    The commitment is part of an initiative led by First Lady Jill Biden to change how research into diseases that mostly affect women gets funded in the U.S.

    By • Feb. 22, 2024
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    Maddie Meyer via Getty Images
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    Moderna pitches RSV shot, new vaccines after ‘difficult year of transition’

    The biotech is counting on an experimental RSV vaccine, currently under review by the FDA, to drive sales in the future.

    By • Feb. 22, 2024
  • Ampoules of Novavax's COVID-19 vaccine prepared in Berlin, Germany.
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    Carsten Koall/Getty Images via Getty Images
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    Novavax agrees to pay Gavi in settlement over COVID vaccine contract

    Under the deal’s terms, Novavax will pay the vaccine alliance up to $475 million over five years.

    By Kristin Jensen • Feb. 22, 2024
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    FotografiaBascia via Getty Images
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    ORI Capital, the venture firm behind CG’s big IPO, raises new biotech fund

    The $260 million fund will be used to back startups working on new drugmaking approaches like protein degraders and RNA therapies.

    By • Feb. 22, 2024
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    jamenpercy via Getty Images
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    Vir, in midst of restructuring, loses its chief medical officer

    The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.

    By • Feb. 21, 2024
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    Meletios Verras via Getty Images
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    Bavarian Nordic terminates cancer vaccine work

    The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.

    By • Feb. 21, 2024
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    Sarah Silbiger via Getty Images
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    United Therapeutics, in unusual step, sues FDA over rival’s drug application

    The biotech alleges the agency is letting rival Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

    By Kristin Jensen • Feb. 21, 2024
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    Permission granted by Iovance Biotherapeutics
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    Behind the new kind of cell therapy that just won FDA approval

    One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

    By Kelly Bilodeau • Feb. 21, 2024
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    Stock via Getty Images
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    FDA puts hold on Rapt trials of drug for eczema, asthma

    Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.

    By • Feb. 20, 2024
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    Permission granted by ClinicalMind
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    Sponsored by ClinicalMind

    Here are 7 practical ways asynchronous advisory programs can make an impact in 2024

    Can asynchronous advisory programs can add distinct value to your strategic mix? Yes! Here's how.

    Feb. 20, 2024
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    Evgenii Kovalev via Getty Images
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    ALS drug development

    ALS drug from Denali, Sanofi falls short in mid-stage study

    The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.

    By • Feb. 16, 2024
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    Courtesy of Sarepta
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    FDA to review expanded use of Sarepta Duchenne gene therapy

    The agency will decide by June 21 whether to broaden eligibility for Elevidys, and won’t convene a group of outside experts beforehand.

    By • Feb. 16, 2024
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    Justin Sullivan via Getty Images
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    Gilead reviewing drug acquired in $5B buyout after latest setback

    The FDA paused enrollment in the only remaining tests of the drug, as Gilead reviews the program it acquired through a buyout of biotech Forty Seven.

    By • Feb. 16, 2024
  • A photo of a building with the Astellas Pharma logo.
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    Courtesy of Astellas Pharma
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    Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

    Kelonia will receive $40 million upfront through the partnership, and could receive $35 million more if Astellas opts into another program.

    By • Feb. 16, 2024
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    Mohammed Haneefa Nizamudeen via Getty Images
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    Intellia, ReCode partner on genetic medicines for cystic fibrosis

    The partnership will use Intellia's "DNA writing” technology, and focus on people with the lung disease who have limited or no available treatments

    By • Feb. 15, 2024
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    Spencer Platt via Getty Images
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    Aurinia to cut research after sale process fails to find a buyer

    The lupus drug developer said it engaged more than 60 parties during its eight-month business review, but only one expressed interest before walking away.

    By Kristin Jensen • Feb. 15, 2024
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    Jeremy Hogan via Getty Images
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    Emerging biotech

    Versant-backed Firefly Bio wants to make the next generation of ADCs

    Armed with $94 million in funding, the biotech is marrying antibody-drug conjugates with protein degraders to create a new kind of cancer medicine.

    By • Feb. 15, 2024
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    Nenov via Getty Images
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    Sage offers details on launch of new postpartum depression pill

    The company and partner Biogen say signs from payers and doctors suggest the launch of Zurzuvae, the first oral therapy for PPD, is off to a good start.

    By Kristin Jensen • Feb. 14, 2024
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    monsitj via Getty Images
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    LianBio to shut down, return cash to investors

    The biotech is planning to dissolve less than four years after launching with plans to license drugs and market them in China and other Asian countries.

    By • Feb. 14, 2024