Drug Development
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demeetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.
FEATURED STORIES
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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.
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Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.
Also called an umbrella or basket trial, the master trial allows for a more targeted approach to cancer treatment, faster patient enrollment and the flexibility to pivot.
The combination of Jemperli and chemotherapy followed by Zejula improved progression-free survival in a late-stage study of patients with advanced or recurrent endometrial cancer.
While the candidate was effective in Phase III results, Point’s stock price fell following the announcement.
A GLP-1-based drug from Structure Therapeutics shows clinical promise but not enough for some on Wall Street.
BMS will halt a trial investigating the Opdulag combination in colorectal cancer after determining that it would not hit its primary endpoint.
The biotech reported topline data from a mid-stage study of MM-120, its LSD-based drug, in patients with generalized anxiety disorder.
The combination of Keytruda and an mRNA vaccine reduced the risk of death or relapse in patients with the most deadly form of skin cancer after three years in a Phase IIb study.
This week, we discuss the two major FDA approvals for sickle cell from Vertex/CRISPR and bluebird bio; Axcella and the future of long-covid treatments, Vanda’s $100m purchase and AI regulatory developments in Europe.
Johnson & Johnson and Genmab revealed the first data from a Phase III study of a Darzalex Faspro-based quadruplet therapy in patients with transplant-eligible newly diagnosed multiple myeloma.