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Clinical Trials

In order to win regulatory approval, new drugs must pass through the three phases of clinical trials. To continually improve this years-long and arduous process that involves complex regulations, companies can leverage digital platforms and technologies and new strategies for trial design to make it to the finish line.

Articles

Vaccines of the future

There is a new era of vaccinology in pharma's pipelines

AZ, Sanofi closing in on first approval for RSV in 23 years

AstraZeneca and Sanofi have reported positive topline results from a study of a vaccine for respiratory syncytial virus (RSV) — the leading cause of bronchitis in infants.

Bridge Bio, Brainomix partner to use AI in lung fibrosis trial

Bridge Biotherapeutics has inked an agreement with U.K.-based AI medtech, Brainomix, to deliver quantitative imaging biomarker analysis within the phase 2 study of an idiopathic...

FDA lifts hold on Sarepta Duchenne trial

Sarepta Therapeutics announced that the U.S. FDA has removed the clinical hold on the company's investigational peptide-conjugated phosphorodiamidate morpholino oligomer to treat...

Checkpoint to wind down and close cancer trial due to Russia-Ukraine war

The phase 3 study is a global, randomized trial of cosibelimab in combination with chemotherapy as the first in-line treatment for patients with non-squamous non-small cell lung...

News

FDA lifts Celyad clinical hold

Data in hand, Roche readies to file subcutaneous Tecentriq

BMS Opdivo-Yervoy combo fails in kidney cancer trial

FDA lifts hold, first patient dosed in Editas sickle cell gene editing trial

MacroGenics ends cancer drug phase 2 study following patient deaths

FDA puts hold on Astellas gene therapy trial, following nerve damage in patient

Biogen quietly bails on Aduhelm study

Facing an unfavorable national coverage policy in the U.S., Biogen has called it quits on the observational ICARE AD trial, which was designed to evaluate the safety and effectiveness...

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

FDA expands approval of Servier leukemia drug

The FDA has expanded the approval of Servier’s TIBSOVO, the first therapy targeting cancer metabolism for patients with newly diagnosed leukemia

FDA lifts hold on Ocugen COVID vax

After resolving the manufacturing problems outlined in this recent clinical hold, the company is looking to continue searching for a spot in the COVID-19 vaccine market

Janssen-Idorsia blockbuster hopeful hits the mark in hypertension trial

Idorsia and J&J's jointly developed potential first-in-class dual endothelin receptor antagonist has produced positive phase 3 trial results in resistant hypertension.

FDA slaps clinical hold on Foghorn blood cancer trial

The FDA slapped Foghorn’s phase 1 blood cancer gene therapy trial with a clinical hold following the death of a patient.

Enanta RSV antiviral flops mid-stage trial

Enanta Pharmaceuticals reported disappointing top-line results for its phase 2b study evaluating its potent N-protein inhibitor in otherwise healthy adults with respiratory syncytial...

Gilead cleared to resume investigational HIV drug studies

Gilead has been cleared by the FDA to continue studies of its investigational HIV drug lenacapavir

LogicBio to resume gene therapy trials after adverse events in kids resolved

The U.S. FDA has lifted its clinical hold on LogicBio Therapeutics Sunrise phase 1/2 trials, just months after stopping them after complications with children involved in the ...

Vertex surprised by FDA hold on diabetes trial

Vertex Pharmaceuticals diabetes med trials have been halted by the U.S. FDA, and the biotech is confused