News
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
FEATURED STORIES
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
THE LATEST
A Kenilworth, NJ, R&D campus that formerly served as Merck’s global headquarters is now set to reopen and become the Northeast Science and Technology (NEST) Center.
The combination therapy was added to standard chemotherapy and lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
Non-alcoholic steatohepatitis patients treated with the company’s efruxifermin saw significant improvements in liver fat and biomarkers of liver damage, fibrosis and cardiometabolic health.
Data from a new head-to-head study showed BMS’ Opdivo induced better progression-free survival among Hodgkin’s lymphoma patients than Seagen’s Adcetris.
After five years of follow-up, AstraZeneca’s Tagrisso reduces the risk of death by 51% as compared with placebo in EGFR-mutated NSCLC patients, according to Phase III ADAURA trial results.
Servier Pharmaceuticals’ Vorasidenib, acquired from Agios in a $1.8 billion deal, slowed the growth of a certain type of low-grade glioma by 61% in a Phase III trial.
Combined with chemotherapy, Keytruda in KEYSTONE-671 significantly improved EFS and reduced the risk of disease recurrence, progression or death by 42%, beating Imfinzi’s EFS in the AEGEAN trial.
Follow news from the American Society of Clinical Oncology 2023 annual meeting—BioSpace will be tracking key updates here throughout the conference.
The Swiss pharma’s CDK4/6 inhibitor reduced risk for recurrence by 25% when added to the standard-of-care endocrine therapy, inviting comparisons to Lilly’s Verzenio.
The company’s Humira biosimilar Yusimry will launch in July with a $995 list price. Mark Cuban’s online pharmacy will sell it at a list price of $569.27 plus fees.