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Pharma News
Pharma News
Alkem’s Enzene Unit Gets USFDA Form 483: 6 Observations, No Data Issues
Alkem Laboratories says subsidiary Enzene Biosciences received a Form 483 with 6 procedural observations from USFDA. No data integrity issues found.
Clinical Trials: Nitrous Oxide Offers Hope for Treatment-Resistant Depression
Researchers find nitrous oxide effective for treatment-resistant depression. Multiple doses show sustained improvement in new eBioMedicine study.
Ampersand Capital Acquires Purna Pharmaceuticals: Trans-Atlantic CDMO Deal
Ampersand Capital acquires Purna Pharmaceuticals to build a trans-Atlantic CDMO partnership with MedPharm for liquid and semi-solid drug development.
EC Approves Amgen’s Uplizna for Generalized Myasthenia Gravis Treatment
EC approves Amgen's Uplizna for generalized myasthenia gravis. A new B-cell therapy with twice-yearly dosing for AChR+ and MuSK+ antibody patients.
FDA Grants Orphan Drug Designation to HCB101 for Gastric Cancer Treatment
FDA grants Orphan Drug Designation to HCB101 for gastric cancer. Phase 1b/2a data shows 100% disease control rate in specific efficacy cohorts.
FDA Approves MSD's Keytruda Combo for Platinum-Resistant Ovarian Cancer
FDA approves MSD’s Keytruda combo for platinum-resistant ovarian cancer. KEYNOTE-B96 data shows improved survival in PD-L1 positive patients.
Madrigal Expands MASH Pipeline with $4.4bn siRNA Deal with Suzhou Ribo
Madrigal signs $4.4bn deal with Suzhou Ribo for siRNA MASH therapies. Partnership targets liver disease pathology and Rezdiffra combination potential.
FDA-Approved Seizure Drug Levetiracetam May Prevent Alzheimer's Plaques
Northwestern study finds levetiracetam blocks toxic amyloid-beta 42 in synaptic vesicles, offering a new prevention strategy for Alzheimer's disease.
Devonian Reports Positive Preclinical Data for Thykamine in Lung Fibrosis
Preclinical Study: CAR-T Cell Therapy Clears Alzheimer’s Amyloid Plaques
PNAS study reveals engineered CAR-T cells reduce amyloid plaques in Alzheimer’s models. A potential shift in immunotherapy for neurodegenerative disease.
FDA Issues Refusal-to-File Letter for Moderna’s Seasonal Flu mRNA Vaccine
FDA issues refusal-to-file for Moderna's mRNA-1010 flu vaccine, citing inadequate comparator. Moderna disputes the decision regarding standard of care.
Eli Lilly Buys Orna Therapeutics for $2.4bn: A Bet on In Vivo Cell Therapy
Eli Lilly acquires Orna Therapeutics in a $2.4bn deal, gaining access to circular RNA and in vivo CAR-T therapies for B-cell-driven autoimmune diseases.
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