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
Alnylam revealed its Phase III APOLLO-B study, which showed that patisiran improves both functional capacity and quality of life in patients with ATTR amyloidosis with cardiomyopathy.
The layoffs trend in the life sciences industry is continuing into the final months of 2022. See inside for details on which companies are reducing staff to increase cash flow.
Roche signed a big $6 billion-plus collaboration deal with Poseida on blood cancers while its partner, AC Immune, parsed failed data on an Alzheimer’s drug to suggest a positive spin.
Although no new safety concerns were observed, Merck’s Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan.
While Moderna’s sole marketable program is its COVID-19 vaccine, CEO Stéphane Bancel said the company is “actively working to prepare...new product launches to help patients and drive growth.”
Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.
Gilead’s total revenue for Q2 increased 1% to $6.3 billion compared to Q2 in 2021. Overall, the company exceeded both its own expectations and the predictions of market analysts for the second quarter.
Whistleblowers Erika Cheung and Tyler Shultz discussed their experiences at Theranos during the recent 2022 AACC Annual Scientific Meeting & Clinical Lab Expo.
AbbVie and Sosei add neurological targets in new deal, TransCode and MD Anderson partner on RNA cancer therapies and Xenetic and VolitionRx unite to develop NETs-targeted therapies against cancer.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.