Drug Development
The first-in-class antibody-drug conjugate—in combination with Merck’s Keytruda—has shown promising results in a Phase II study of patients with metastatic non-small cell lung cancer.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
Preliminary findings from the NEURO-TTRansform trial show Ionis’ and AstraZeneca’s eplontersen is potentially a safe and effective treatment for patients with amyloidosis.
Gilead, Merck, Daiichi Sankyo, HUTCHMED and BMS previewed data to be presented at the European Society for Medical Oncology Congress 2022, taking place Sept. 9-13.
Athira Pharma announced Tuesday it will study the stand-alone effects of its Alzheimer’s candidate fosgonimeton (ATH-1017). The drug failed to meet the endpoint in a Phase II study earlier this year.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.
The FDA approved AstraZeneca’s Imfinzi plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer.
Boehringer announced that the FDA approved Spevigo for generalized pustular psoriasis flares in adults, the first drug approved for this indication.
Immusoft is heading into the clinic with what it claims is the first engineered B cell gene therapy cleared for in-human study, the company announced Thursday.
Finch announced that it is slashing its headcount by around 37% and suspending its planned Phase I study in autism a week after Takeda withdrew from its multi-year collaboration.
It’s been a busy week for research on rare diseases, with several clinical trials from AnaptysBio, Regenxbio, Sangamo and more posting results from ongoing activities.