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.
IPO
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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This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
The company is hoping the topline results for Veozah, which won FDA approval in May, will support health technology assessments for reimbursement negotiations in Europe.
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.
BioSpace spoke to analysts and players in the contract manufacturing and development organizations space to assess the challenges this year and what lies ahead in 2024.
This week on The Weekly we talk struggles with ⁠GLP-1 drug shortages⁠ and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for ⁠⁠⁠Dupixent⁠⁠⁠ in COPD. Plus, Merck ⁠buys Caraway⁠, Beigene’s ⁠deal⁠ with Ensem, ⁠ups⁠ and ⁠downs⁠ for Flagship.
Using electronic health records, healthcare analytics firm Truveta contends that Eli Lilly’s Mounjaro (tirzepatide) could achieve stronger and faster weight loss than Novo Nordisk’s Ozempic (semaglutide).
The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.