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502 stories matching this filter · ← front page

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  • Bristol Myers unveils data for one of its next-gen blood cancer drugs
    Called mezigdomide, the drug is one of two protein-degrading medicines Bristol Myers hopes to soon position as successors to its lucrative Revlimid franchise.
    BioPharma Dive · 2mo ago↗ source
  • Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
    A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.
    BioPharma Dive · 2mo ago↗ source
  • Allogene CEO to step down; Agios drug fails key test
    David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.
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BioPharma Dive · 2mo ago
↗ source
  • Can a chaotic FDA still deliver on faster drug development?
    As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.
    BioPharma Dive · 2mo ago↗ source
  • Pfizer, Innovent strike $10B cancer drug deal
    Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.
    BioPharma Dive · 2mo ago↗ source
  • GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’
    The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
    BioPharma Dive · 2mo ago↗ source
  • CVS obesity drug deal puts Lilly on equal footing with Novo
    The agreement includes Lilly’s new pill Foundayo and restores coverage for Zepbound, erasing what had been a commercial edge for rival Novo Nordisk.
    BioPharma Dive · 2mo ago↗ source
  • BioMarin drug acquired in buyout misses goal in rare disease study
    Tested in a condition known as ENPP1 deficiency, the treatment failed a trial goal that’s important to regulators, spurring doubts about its approval prospects.
    BioPharma Dive · 2mo ago↗ source
  • A migraine drugmaker heads to the public markets through reverse merger
    Mentari Therapeutics, a spinout from the prolific hub-and-spoke biotech Paragon, is developing two medications it hopes can treat migraines that aren’t well controlled by existing drugs.
    BioPharma Dive · 2mo ago↗ source
  • Relay drug shows early promise against rare blood vessel diseases
    While early, the findings suggest the therapy could be superior to Novartis’ Vijoice at treating “vascular anomalies,” a cluster of chronic conditions with few available treatments.
    BioPharma Dive · 2mo ago↗ source
  • FDA approves AstraZeneca’s new kind of hypertension drug
    Baxfendy inhibits a blood-pressure-raising enzyme and, according to AstraZeneca executives, is poised to be a “big product” that should ultimately generate $5 billion or more in annual sales.
    BioPharma Dive · 2mo ago↗ source
  • Merck ADC, licensed from China, hits mark in first big global trial
    The endometrial cancer trial is the first of 17 late-stage studies Merck is running for a therapy that’s important to its ambitions of hitting $70 billion in annual sales next decade.
    BioPharma Dive · 2mo ago↗ source
  • Høeg fired in latest FDA shakeup; 20 people die after taking Amgen drug
    The agency has once again shuffled the leadership for two top drug review offices. Elsewhere, Parabilis partnered with Regeneron and an obesity pill is headed toward an approval in China.
    BioPharma Dive · 2mo ago↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 2mo ago↗ source
  • Unlocking more value from mature drug products through strategic outsourcing
    See how strategic outsourcing can maximize value and reduce costs for mature drug portfolios.
    BioPharma Dive · 2mo ago↗ source
  • Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC
    Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.
    onclive · 2mo ago↗ source
  • Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer
    Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.
    onclive · 2mo ago↗ source
  • Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years
    Two doses of intravesical mitomycin-C administered before TURBT produced a 77% reduction in the risk of recurrence or death vs TURBT alone in NMIBC.
    onclive · 2mo ago↗ source
  • Genomic Disease Burden Markers, PD-L1 Expression Predictive of pOR With Neoadjuvant Gem-iDRS ± Cetrelimab in MIBC
    A biomarker analysis of SunRISe-4 found that high baseline TMB, GBD, and PD-L1 expression were associated with pathologic overall response to the regimen.
    onclive · 2mo ago↗ source
  • Dr Croll on Radiographic Size Change vs irRVT After Neoadjuvant Therapy in RCC
    Benjamin Croll, MD, discusses findings from a study of the correlation between radiographic response and pathologic response in RCC.
    onclive · 2mo ago↗ source
  • FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer
    The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.
    onclive · 2mo ago↗ source
  • Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer
    Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.
    onclive · 2mo ago↗ source
  • Dr Cirstea on Sequencing Considerations in R/R Multiple Myeloma
    Diana Cirstea, MD, discusses sequencing considerations in relapsed/refractory multiple myeloma in the era of T-cell–redirecting therapies.
    onclive · 2mo ago↗ source
  • Dr Hafron on the FDA Approval of Adjuvant Atezolizumab in MRD+ MIBC
    Jason Hafron, MD, discusses the significance of the FDA approval of adjuvant atezolizumab for MRD+ muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source
  • Durvalumab Plus BCG Reduces High-Risk NMIBC Recurrence or Death Risk by 32% in Phase 3 POTOMAC Trial
    Durvalumab plus BCG induction and maintenance yielded an HR of 0.68 vs BCG alone for DFS in BCG-naive, high-risk non–muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source