News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
The neurodegenerative drug development space saw incremental victories in 2022. Leaders from Eisai, Voyager and QurAlis discuss upcoming milestones.
Breast cancer came in as the most studied disease in 2022, according to the patient data analytics firm Phesi.
The FTC issued a Notice of Proposed Rulemaking (NPRM) that could change the landscape for employer-employee relationships nationwide, specifically in the biopharma industry.
Horizon Therapeutics’ dazodalibep met the primary endpoint in a second straight Phase II trial for Sjögren’s syndrome.
The FDA granted Moderna’s RSV vaccine candidate Breakthrough Therapy Designation Monday.
A pre-specified interim analysis of Junshi Biosciences’ Phase III Neotorch trial showed its anti-PD-1 monoclonal antibody, toripalimab, met its primary endpoint in non-small cell lung cancer (NSCLC).
Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.
Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
Edesa Biotech’s EBO1, a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), showed mixed results compared to placebo in Phase II, the company announced Tuesday.
TC BioPharm and MD Anderson signed a three-year collaboration to better understand the role of gamma delta T cells in cancer treatment.