Drug Development
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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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.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
Pfizer, Eli Lilly, Novartis, Bristol Myers Squibb and AstraZeneca are all ramping up the use of AI, but drug discovery is not the primary success story—yet.
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GSK reported Wednesday its checkpoint inhibitor Jemperli yielded positive data in non-small cell lung cancer, moving the monoclonal antibody potentially closer to the market in this indication.
TrialSpark and Sanofi announced a new partnership to expedite drug development for areas with high unmet needs by licensing or acquiring six mid-to-late-stage drug candidates.
Araris Biotech AG secured $24 million in financing to advance the development of its proprietary antibody-drug conjugate (ADC)-linker technology and drive its own ADC candidates into the clinic.
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.
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.
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.
Gene therapies developed by Janssen, Atsena, REGENXBIO and AbbVie showed promise against eye diseases this weekend at the American Academy of Ophthalmology 2022 meeting.