ORG
Delaware Judge Rules in Favor of Roivant Subsidiary Arbutus in COVID-19 Vaccine Patent Dispute with Moderna
Moderna, Arbutus Biopharma, Roivant Sciences, COVID-19 vaccine, Patent infringement, Judge Mitchell Goldberg, Lipid nanoparticles (LNP), Claim construction order
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US
Genmab Acquires ProfoundBio for $1.8 Billion to Challenge AbbVie’s Elahere in ADC Market
Genmab, ProfoundBio, $1.8 billion acquisition, Antibody Drug Conjugates (ADCs), Competition with AbbVie’s Elahere, Rinatabart sesutecan (Rina-S), Folate Receptor Alpha (FRα), Midphase clinical trials
Diagonal Therapeutics Secures $128 Million Funding to Target Rare Diseases
Diagonal Therapeutics, Antibody biotech, $128 million funding, Rare diseases focus, Orphan disease treatment, Chronic anemia, Merck’s Winrevair related research, Blue-chip investors
Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder
Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes
Roivant’s Anti-Inflammatory Med Shows Promise in Phase 2 Trial for Non-Anterior Non-Infectious Uveitis
Roivant, Brepocitinib, Phase 2 trial success, Non-Anterior Non-Infectious Uveitis (NIU), Priovant Therapeutics, Stock buyback plan, Sumitomo Pharma stake acquisition, Humira comparison
Acorda Therapeutics Concludes $185M Asset Sale with Merz amid Bankruptcy Filing Following Disappointing Sales
Acorda Therapeutics, $185M asset sale, Merz, Bankruptcy filing, Years of disappointing sales, Multiple Sclerosis drug Fampyra, Biogen returns ex-US rights, Generic competition, Declining sales, Neurological diseases
Gritstone Cancer Vaccine Trial Misses Primary Endpoint, Stock Plummets
Gritstone, Personalized Neoantigen Cancer Vaccine, Colorectal Cancer, Phase 2 Study Failure, Circulating Tumor DNA (ctDNA), Progression-Free Survival (PFS), Stock Market Reaction
Verve Temporarily Halts Lead Base Editing Study Following Adverse Event, Prioritizes Alternative Therapy
Verve Therapeutics, Lead base editing program, Adverse event, VERVE-101, Serious adverse events (SAEs), Grade 3 ALT elevation, Thrombocytopenia, Pause enrollment in Heart-1 study, Alternative therapy focus: VERVE-102, Ionizable lipid delivery system, Phase Ib Heart-2 clinical trial, Q2 2024 initiation of Heart-2 clinical trial.
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024