amyotrophic lateral sclerosis
Feb 27, 2024
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...
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May 02, 2023
FDA Grants Priority Review to BMS’ Luspatercept; Teva and MedinCell’s Risperidone FDA Approval; Biogens’s QALSODY FDA Accelerated Approval; FDA IND Authorization to Kiromic’s Deltacel; Atsena’s ATSN-201 FDA IND Clearance
FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...
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Apr 04, 2023
HUTCHMED’s NDA Submission to FDA for Fruquintinib; Cytokinetics to Discontinue ALS Drug Candidate Following Phase III Trial Failure; Enfortumab Vedotin + Pembrolizumab Approved for Urothelial Carcinoma; Nanoscope Gene Therapy Clears Phase II Retinitis Pigmentosa Trial; FDA Clearance to Cabaletta Bio’s IND Application for CABA-201 for SLE Treatment; European Orphan Drug Designation to Gene Therapy Candidate DB-OTO
HUTCHMED Completes Rolling Submission of NDA to FDA for Fruquintinib HUTCHMED (China) Limited announced the completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1,...
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Feb 28, 2023
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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Feb 07, 2023
Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial
Merck Wins Another FDA Approval for Blockbuster Keytruda Merck & Co arrived just two months after GSK celebrated a positive phase III result with its checkpoint inhibitor Jemperli as a first-line therapy for endometrial cancer. Keytruda (pembrolizumab) from Merck improved progression-free survival (PFS) vers...
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Oct 04, 2022
Zealand Pharma’s Phase III Results of Glepaglutide; FDA Approves Amylyx’s ALS Drug Relyvrio; Novo Nordisk and Ventus Therapeutics Signs Licencing Deal; FDA Approves Futibatinib; Sarepta Files Duchenne Muscular Dystrophy for FDA Approval; Biogen and Eisai’s Lcanemab Phase III Study
Zealand Pharma Announces the Positive Topline Results from its Phase III trial of Glepaglutide Zealand Pharma A/S, a biotech company specializing in peptide-based medicines, announced positive topline results from its phase III trial of glepaglutide. In the evenly randomized double-blind trial, 106 patients with...
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Aug 02, 2022
Bristol-Myers Squibb’s Opdivo & Yervoy Combo Trial; Sarepta’s Gene Therapy SRP-9001 for DMD; Ionis’s End-Stage Renal Disease Drugs; FDA Approves Arcutis’s Zoryve Cream; Gilead’s Biktarvy for HIV and Hepatitis B; FDA to Review Biogen’s ALS Therapy Tofersen
Bristol-Myers Squibb’s Opdivo and Yervoy Combo Fails in Phase III Trial Bristol-Myers Squibb has reported that their Opdivo and Yervoy checkpoint inhibitor combo failed a phase III trial as adjuvant (post-surgery) therapy for renal cell carcinoma (RCC), the most frequent type of kidney cancer. The CheckMate -914...
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Jun 21, 2022
Biogen terminates ALS Pact with Karyopharm; AbbVie’s Immunological Drug Skyrizi; NICE Backs Astellas’ Oral Therapy Evrenzo; Roche’s Crenezumab Fails in Clinical Trial; FDA Grants Fast Track Designation to Dianhydrogalactitol; Sierra Oncology Submits NDA for Momelotinib
Biogen terminates USD 217 Million ALS Pact with Karyopharm Biogen has backed out of the four-year-old partnership with Karyopharm on a drug candidate for the neurological disease amyotrophic lateral sclerosis, which could have cost the US biotech up to USD 217 million. The 2018 agreement that granted Biogen righ...
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May 17, 2022
BMS Sells NY Biologics Plant; FDA Approves Mitsubishi Tanabe’s Radicava, Love Pharma Acquires MicroDoz; Sandoz Launches Generic of Roche’s Esbriet; Pfizer to Acquire Biohaven Pharma; eureKARE’s Cell and Gene Therapy CDMO; Atamyo’s LGMD Gene Therapies; FDA approves Eli Lilly’s Type 2 Diabetes Treatment
Love Pharma Completes the Acquisition of MicroDoz Therapy LOVE Pharma Co. has announced the completion of its acquisition of MicroDoz Theraphy Inc. ("MicroDoz"). Love Pharma holds exclusive manufacturing, marketing, packaging, selling, and distribution licenses in Europe, the United Kingdom, and North America. U...
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Apr 05, 2022
Precigen’s PRGN-3006; Yescarta Approved as a First CAR T-cell Therapy for R/R LBCL; Biogen & Ionis’ BIIB078; Nobelpharma’s HYFTOR (sirolimus topical gel) 0.2%; Cerevance Parkinson’s Drug; Sanofi & Regeneron’s Dupixent; Clovis’s Rubraca for Ovarian Cancer; Immunocore Eye Cancer Cell Therapy Approval
FDA Approves Yescarta as a First CAR T-cell Therapy for Initial Treatment of R/R Large B-cell Lymphoma Until now, existing CAR-T therapies have been reserved for patients with blood cancer who have tried multiple treatments. The FDA has approved Yescarta, a CD19-directed CAR-T therapy developed by Gilead Science...
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