News
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
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FROM OUR EDITORS
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
Early data from the Phase III TALAPRO-2 study showed Talzenna, Pfizer’s oral PARP inhibitor, met its primary endpoint in metastatic castration-resistant prostate cancer patients.
KalVista Pharmaceuticals announced Tuesday that life-threatening safety concerns prompted it to shut down a mid-stage clinical trial for hereditary angioedema.
With ambitions to enter the clinic in the first half of 2023, Keir Loiacono, esq., aims to double down on BlueSphere’s strengths rather than make any major course corrections.
Synlogic, Senti Biosciences and Novome are pioneering the field of synthetic biotics, which is so new there are only a handful of scientific articles using either that term or ‘engineered living therapeutics.
Scandion Oncology, Edesa, Clovis, Lexicon and Cytokinetics share a string of positive news from their clinical trials on heart failure, cancer, COVID-19 and ARDS.
Incyte Corporation will acquire privately-held Villaris and AmplifyBio will acquire PACT Pharma, while Estrella will gain a spot on the Nasdaq Exchange.
Clene’s gold nanocrystal asset CNM-Au8 failed to hit the primary endpoint in the HEALEY ALS trial, but strong survival signals at six months warrant additional exploration in treating ALS.
Intercept Pharmaceuticals’ Ocaliva failed to treat patients with compensated cirrhosis due to nonalcoholic steatohepatitis better than a placebo in a Phase III trial, the company announced Friday.
The third quarter of 2022 saw continued job cuts, a shift in focus away from COVID-19, an unexpected boost in the Alzheimer’s research space and increased scrutiny of accelerated approvals.
Gene therapies developed by Janssen, Atsena, REGENXBIO and AbbVie showed promise against eye diseases this weekend at the American Academy of Ophthalmology 2022 meeting.