European Commission Signs COVID-19 Drug Procurement Deal With Gilead
Gilead Sciences Inc (NASDAQ:GILD) and the European Commission signed a joint procurement agreement for rapid and equitable access to the COVID-19…
Scynexis Touts Postive Data For Ibrexafungerp For Vaginal Infections
Scynexis Inc (NASDAQ:SCYX) announced the presentation of positive outcomes from the CANDLE 304s nested sub-study of ibrexafungerp in recurrent vulvovaginal candidiasis…
Inovio Lays Out Corporate Reorganization To Extend Cash Runway Into 2024
Inovio Pharmaceuticals Inc (NASDAQ:INO) has implemented a corporate reorganization designed to extend its cash runway and focus on key clinical programs.…
Impel Commences Mid-Stage Autism Spectrum Disorder Study
Impel Pharmaceuticals (NASDAQ: IMPL) has dosed the first patient in a Phase 2a proof-of-concept study of INP105, nasal olanzapine, a widely used atypical, second-generation antipsychotic.
FDA Lifts Clinical Hold On Viking Therapeutics’ Rare Metabolic Disorder Study
The FDA has lifted the clinical hold placed on Viking Therapeutics Inc’s (NASDAQ:VKTX) trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). …
The Daily Biotech Pulse: FDA Tentatively Approves Avadel’s Narcolepsy Drug, European Approval Broadens AstraZeneca’s Enhertu in Breast Cancer, Pharma Giants’ Earnings
Here's a roundup of top developments in the biotech space over the last 24 hours:
Apellis Shares Climb As FDA Accepts Geographic Atrophy Candidate Submission Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan.
The regulatory agency has assigned target action date of November 26, 2022.
Avadel Secures FDA Tentative Approval For Excessive Daytime Sleepiness (EDS) Candidate
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
Johnson & Johnson Cuts Annual Profit Outlook, Pharma Unit Cushions Fall In Medical Devices
Johnson & Johnson (NYSE:JNJ) has reported Q2 FY22 adjusted earnings of $2.59 per share, up 4.4% Y/Y and slightly ahead…
Novartis Posts Mixed Q2 Earnings, Expects Improved Earnings At Sandoz
Novartis AG (NYSE:NVS) has reported a core EPS of $1.56 in Q2 FY22 compared to $1.66 a year ago, beating the…