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Pharma News
Pharma News
Alembic Pharma Secures US FDA Approval for Generic Antifungal Topical
Alembic Pharmaceuticals receives final US FDA approval for its generic Efinaconazole Topical Solution, 10%, targeting the $500M onychomycosis market.
Preclinical Study: Hypoxia Therapy Controls Diabetes via Red Blood Cells
A new preclinical study in Cell Metabolism shows hypoxia therapy and red blood cells can regulate glucose levels, offering a potential diabetes treatment.
START Appoints Dr. Frank Smith as President of XenoSTART Preclinical Unit
The START Center for Cancer Research appoints Dr. Frank Smith as President of XenoSTART to scale preclinical operations and accelerate oncology R&D.
Gilead Acquires CAR-T Specialist Arcellx for $7.8B to Boost Cell Therapy
Gilead acquires CAR-T specialist Arcellx for $7.8bn to secure anito-cel, a BCMA-directed cell therapy for multiple myeloma currently under FDA review.
Preclinical vs Clinical Obesity: New Definitions to Reshape Diagnosis
Researchers evaluate a new definition splitting obesity into preclinical and clinical categories, finding 80% of affected individuals have clinical obesity.
FDA Approves AstraZeneca's Calquence Plus Venetoclax for CLL Treatment
FDA approves AstraZeneca's Calquence plus venetoclax as the first all-oral, fixed-duration regimen for first-line chronic lymphocytic leukemia treatment.
Preclinical Drug Rytvela Blocks Preterm Birth, Outperforming Nifedipine
New preclinical data shows the anti-inflammatory drug Rytvela decreases preterm birth and infant mortality by targeting IL-1ß without immune suppression.
WHO Urges Development of Universal Influenza Vaccines to Save Millions
WHO highlights the need for universal flu vaccines to prevent 18 billion cases and save 6.2 million lives amid evolving pipeline and US regulatory shifts.
Clinical Trial: Dexamethasone Safe in Encephalitis, Early Use May Help
DexEnceph trial finds dexamethasone safe for HSV encephalitis. While overall outcomes didn't change, early use showed promise. Published in Lancet.
ExCellThera's Zemcelpro Grants German NUB Status 1 for Stem Cell Transplant
ExCellThera and Cordex Biologics receive NUB Status 1 in Germany for Zemcelpro. The stem cell therapy aids blood cancer patients lacking donor cells.
PTC Withdraws Translarna NDA for Duchenne Muscular Dystrophy in the US
PTC withdraws Translarna NDA for DMD after FDA cites lack of efficacy evidence. This marks the third failed US approval attempt for the therapy.
Cue Biopharma Reports Positive Safety Data for Autoimmune Drug CUE-401
Cue Biopharma announces positive preclinical safety and tolerability data for CUE-401, a novel biologic for autoimmune and inflammatory diseases.
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