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Peter Marks described the steps the agency is taking to advance the development of gene therapies for rare disorders. This could spell good news in the near future for Sarepta Therapeutics.
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Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer
3/21/2023
Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration for PBP1510, in the treatment of unresectable or metastatic pancreatic adenocarcinoma that has relapsed following and/or is refractory to at least one line of prior therapy.
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Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis
3/21/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
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Press Release: Dupixent® (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
3/21/2023
The European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
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Karuna Therapeutics released data Monday from the Phase III EMERGENT-3 trial showing that KarXT met the primary endpoint, significantly improving symptom severity.
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An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
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Societal CDMO Announces U.S. FDA Approval for Manufacturing of Commercial Tablet at Gainesville, Georgia Site
3/20/2023
Societal CDMO, Inc. announced that the United States Food and Drug Administration has approved the company as a manufacturer of a commercial tablet product.
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Karuna Therapeutics Announces Positive Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia
3/20/2023
Karuna Therapeutics, Inc. announced positive topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT in adults with schizophrenia.
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Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Launch of a Generic Version of Magnesium Sulfate in Water for Injection, in Non-PVC, Single-Patient Use Containers by Their Partner Athenex Pharmaceutical Division (APD)
3/20/2023
Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that its partner, Athenex Pharmaceutical Division, has just started to commercialize its abbreviated new drug application approval from the U.S. Food and Drug Administration for its Generic Version of Magnesium Sulfate in Water for Injection, 2 g/50 mL, 4 g/100 mL and 4 g/50 mL, in Non-PVC, Single-Patient Use Containers.
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Darolutamide approved for additional prostate cancer indication in China
3/20/2023
The Chinese National Medical Products Administration has approved the oral androgen receptor inhibitor darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.
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American Aires Inc. Provides Corporation Update
3/20/2023
American Aires Inc. (CSE: WIFI) (OTC Pink: AAIRF) (the "Company" or "Aires"), a provider of scientifically-proven EMF modulation technology
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Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials
3/18/2023
Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots of the cystic fibrosis drug Cayston on March 1, 2023, due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.
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The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.
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Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
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Aquavit Files Two IND's For Its Botulinum Toxin With FDA
3/17/2023
Announces its IND Submissions to FDA for Aquatox™ at the Annual American Academy of Dermatology 2023
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FDA Roundup: March 17, 2023
3/17/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer
3/16/2023
Novartis announced the U.S. Food and Drug Administration granted approval for Tafinlar® + Mekinist® for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.
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FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™
3/16/2023
Pfizer Inc. announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
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Modra Pharmaceuticals Announces U.S. Patent Issuance for ModraDoc006/r
3/16/2023
Modra Pharmaceuticals announced that the U.S. Patent and Trademark Office has issued to Modra U.S. Patent No. 11,571,408, covering the use of its oral taxane therapeutic ModraDoc006/r. ModraDoc006/r is an oral tablet formulation of docetaxel co-administered with ritonavir, a boosting agent that enhances bioavailability.
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Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
3/16/2023
Biogen Inc. announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency, and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® because of TECFIDERA’s regulatory data and marketing protection.