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Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
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Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
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As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.
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For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
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Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.
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The biopharma industry is projected to raise $24 billion this year, a steep decline from the “high-water marks” of 2020 through 2022, according to a new report from market data firm PitchBook.
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With several key decisions still on the docket, December promises to be an exciting month for FDA watchers as 2023 comes to an end.
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Under an agreement with Johnson & Johnson’s Actelion Pharmaceuticals, the rights to the multiple sclerosis drug Ponvory in the U.S. and Canada will be transferred to Vanda Pharmaceuticals.
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The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.
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Plexxikon, which was acquired by Daiichi Sankyo, and Novartis have agreed to settle a patent case involving the cancer drug Tafinlar and its sale in the U.S.
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Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.
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Arcellx Announces Continued Robust Long-Term Responses from Its CART-ddBCMA (anito-cel) Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at ASH
12/8/2023
Arcellx, Inc. (NASDAQ: ACLX) today announced new clinical data from its Phase 1 expansion study of CART-ddBCMA, now known as anitocabtagene autoleucel (anito-cel). Anito-cel utilizes a novel D-Domain BCMA binder that is compact and stable, which results in a drug product with a high proportion of CAR+ cells and high surface expression, potentially enhancing antigen binding and more efficient Multiple Myeloma cell killing.
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Agrivalle and Ginkgo Bioworks Enter Multiyear Strategic Partnership to Accelerate Next-Gen Ag Biological Products
12/8/2023
Agrivalle, a leading Brazilian agricultural biologicals company, today announced a new partnership with Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity.
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Kura Oncology’s Menin Inhibitor Ziftomenib Selected for The Leukemia & Lymphoma Society’s Pediatric Acute Leukemia (PedAL) Master Clinical Trial
12/8/2023
Kura Oncology, Inc. (NASDAQ: KURA) and The Leukemia & Lymphoma Society (LLS), the largest private funder of blood cancer research, today announced a clinical collaboration to evaluate Kura’s menin inhibitor, ziftomenib, in combination with chemotherapy in pediatric patients with relapsed/refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia.
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European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma
12/8/2023
Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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AMETEK Completes Acquisition of Paragon Medical
12/8/2023
AMETEK, Inc. (NYSE: AME) today announced that it has completed its acquisition of Paragon Medical, a leading provider of highly engineered medical components and instruments, from affiliates of American Securities LLC, in an all-cash transaction valued at approximately $1.9 billion.
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Cancer Monoclonal Antibodies Market Size Estimated to Reach USD 410.95 Billion by 2032
12/8/2023
The global cancer monoclonal antibodies market size is estimated to reach around USD 410.95 billion by 2032, increasing from USD 89.06 billion in 2023.
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Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions
12/8/2023
Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients.
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FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease
12/8/2023
Today, the U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older.
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Genentech’s Kadcyla Is the First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment
12/8/2023
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive long-term follow-up data from the pivotal, Phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment.