Clinical Trials
Positive results from a randomized study in healthy volunteers mark a key milestone for Alvotech’s proposed Entyvio rivals AVT80 and AVT16.
A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?
The co-principal investigator of OCEANIC-STROKE tells Scrip that the oral Factor XIa inhibitor could be paradigm-changing.
The antibody-drug conjugate pipeline has more than doubled to 895 candidates since 2023, with DNA topoisomerase I overtaking HER2 as the dominant target.
India’s budget backs plans to scale production of biologics and biosimilars, shore up its clinical trials network and strengthen the regulatory framework. Customs duty exemptions given to several big pharma therapies, including those of Novartis and Takeda.
The company said the NEAT trial in ataxia telangiectasia did not meet the primary and key secondary endpoints.
The UK MHRA says it is ready to deliver the new Clinical Trials Regulation, which aims to balance faster review of trial applications with greater flexibility to deliver a competitive, innovation-friendly clinical research ecosystem.
From a biofoundry network and pharma industry backed AI research organization to a small-molecule repurposed drug in Duchenne’s muscular dystrophy, experts discuss a number of advances underway as India seeks to move up the innovation ladder.
Multiple Chinese biotechs are seeking to raise new funds through IPOs on the Hong Kong and Beijing stock exchanges to support international clinical trials for their first-in-class molecules.
Responding to recent FDA guidance on a new streamlined pathway for US biosimilars, off-patent industry representatives have urged the agency to make the approach “the new default” for biosimilar filings. However, PhRMA has suggested limiting the route to less complex product types.
The company said amorphous rifaximin solid soluble dispersion did not meet the primary endpoint in two Phase III RED-C trials in the prevention of hepatic encephalopathy in patients with cirrhosis.
The US biotech has upsized its public offering to $175m after the success of soquelitinib in a very early trial for atopic dermatitis.