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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THE LATEST
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies.
Despite beating analyst expectations, Takeda sustains a mid-stage defeat in a rare genetic disorder, leaving the fate of an investigational enzyme replacement therapy uncertain.
Two late-stage trial wins for Merck’s V116 investigational pneumococcal vaccine could make it a serious challenger to Pfizer’s Prevnar 20 in the space.
Data from two late-stage studies show that participants on Eli Lilly’s tirzepatide, which targets both GIP and GLP-1 receptors, achieved up to 26.6% mean weight loss.
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
With partner Biogen mum on zuranolone’s prospects as an FDA August 5 review deadline approaches, Sage Therapeutics’ stock fell Wednesday to its lowest level in months.
The Phase III trial, which will test the companies’ mRNA-based personalized cancer vaccine and Merck’s blockbuster Keytruda checkpoint inhibitor, is slated for completion by the fall of 2029.
Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.
Late-stage data, which showed significant overall and progression-free survival benefits in unresectable hepatocellular carcinoma patients, supports Elevar’s New Drug Application filed in May 2023.
Company shares fell over 50% after two late-stage studies failed to demonstrate vision improvements in patients with diabetes macular edema.