Regeneron and Bayer’s blockbuster Eylea (aflibercept) given in three- or four-month intervals demonstrated efficacy against two major eye diseases in a pair of late-stage studies, giving the drugmakers an edge…
In its 2022 Focus Areas of Regulatory Science report released last week, the FDA adds to its list of regulatory priorities research efforts in oncology and rare disease. Source: Drug…
An FDA advisory committee surprised observers on Wednesday night, voting 7-2 to endorse Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug despite FDA doubts and the committee’s own rejection of the…
In just six pages of final guidance released today, the FDA lays out exactly when and how sponsors should include real-world data and real-world evidence (RWD/RWE) in applications for investigational…
Two late-breaking phase 3 studies highlighted advances in breast and colorectal cancer at the annual meeting of the European Society of Medical Oncology in Paris this week. Source: Drug Industry…
Roche is acquiring Good Therapeutics for $250 million in upfront cash, gaining Good’s conditionally active biologics (CAB) to create new immunotherapies for treating cancer. Source: Drug Industry Daily
Drugmakers planning to submit investigational drug, new drug or biologics license applications for pediatric drug studies should conduct clinical pharmacology studies using patients with the disease the drug is intended…
Two years after issuing a refuse to file (RTF) letter to Y-mAbs regarding Omblastys (omburtamab), the FDA has agreed to hear data supporting the development of the radioisotope-linked antibody designed…
UCB Pharma is going big with open-label extension data showing that almost 90 percent of plaque psoriasis patients who responded to Bimzelx (bimekizumab) maintained clear skin after three years of…
Sarepta Therapeutics’ trial of its Duchenne muscular dystrophy drug candidate is back on track four months after the FDA stopped it when a trial participant experienced a serious adverse event…