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
The approval of Reata Pharmaceuticals’ Skyclarys for Friedreich’s ataxia highlights progress being made in the treatment of rare mitochondrial diseases.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
The layoffs come as the company posts nearly $300 million in net losses and just over $80 million in revenue during the first quarter of 2023.
The deal with BlissBio is the latest in a cascade of multi-million- and billion-dollar acquisitions and collaborations centered on antibody-drug conjugates.
The German biotech is trying to deepen its pipeline in cancer and other infectious diseases as COVID-19 markets contract and the international public health emergency comes to an end.
After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners.
The companies said in first-quarter earnings calls that they want to restructure R&D, cut costs and shift away from high-risk drug development to focus areas.
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
Despite multiple therapeutics approved to treat localized symptoms, there are currently no systemic therapies on the market for Sjogren’s syndrome.