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Pharma News for AskBio, Almirall, Bayer, Pfizer
Key Updates on Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type; European Commission Approves EBGLYSS; Bayer Stopped OCEANIC-AF Study; Pfizer and Astellas’ XTANDI Approved by FDA; FDA Orphan Drug Designation to Epic Bio’s EPI-321; FDA Fast Track Designation to Chemomab’s CM-101 for PSC

AskBio Announces First Patient Randomized in Phase 1 Trial of AB-1005 Gene Therapy for Multiple System Atrophy-Parkinsonian Type Asklepios BioPharmaceutical, Inc., a gene therapy firm fully owned and independently operated under Bayer AG, announced the initiation of the Phase I REGENERATE MSA-101 clinical trial ...

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Pharma News for Takeda, AskBio, Bayer, Lipella
Takeda’s ADZYNMA Approved by FDA; AskBio Presents Preliminary Data from Phase I Trial of Gene Therapy for CHF; Bayer’s Aflibercept 8 mg Recommended for Approval in EU; FDA Orphan Drug Designation to MAIA Biotechnology’s THIO; First Patient Dosed in Phase III ProstACT GLOBAL Study; FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate

Takeda’s ADZYNMA Approved by FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura Takeda has received FDA approval for ADZYNMA (ADAMTS13, recombinant-krhn) for both prophylactic and on-demand treatment in adults and pediatri...

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Pharma News and Updates for SpringWorks Therapeutics, AskBio, Mitsubishi Tanabe Pharma America, Sage Therapeutics, Biohaven Pharma
SpringWorks’s Desmoid Tumors Therapeutic, Nirogacestat; Orphan Drug Designation to AskBio’s AB-1003; Mitsubishi Tanabe’s Phase 3 Trial of RADICAVA ORS in ALS; EU Orphan Drug Designation to Sage Therapeutics’s SAGE-718; FDA Fast Track Status to Biohaven’s Taldefgrobep Alfa

Sage Therapeutics Receives EU Orphan Drug Designation for Huntington's Disease Treatment Candidate Sage Therapeutics declared the European Medicines Agency granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington's disease. SAGE-718 is developing as a potential oral therapy for cognitive disor...

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