News
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
FEATURED STORIES
Dual and even triple or quadruple track processes have come roaring back in 2026 thanks to a glut of M&A that has refilled investors’ wallets. Big Pharma is being put on notice that time is critical if they want to acquire.
Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.
The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Biohaven.
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THE LATEST
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.
The company’s aztreonam-avibactam matched the cure rate of a meropenem-based regimen in patients with drug-resistant infections.
The recent approval of Biogen’s Qalsody in SOD1–ALS highlighted the potential of ASOs in CNS diseases, while recent failures make it clear there is still work to be done.
ADCs from BioNTech, Daiichi Sankyo and Merck are the subject of high-profile abstracts featured at the oncology meeting, along with Merck’s late-breaking Phase III non-small cell lung cancer data.
Drugs that act on the CFTR protein only work in patients who produce the protein in the first place. That leaves 6% of patients hanging.