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Having secured deals with AstraZeneca and Novartis, Niowave is constructing a second facility to meet rising demand for actinium-225, which can be used to develop next-generation radiopharmaceuticals.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.
In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.
Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.
Eisai and Biogen’s BLA for lecanemab for Alzheimer’s disease received FDA Priority Review with a target action date of January 6, 2023, while Roche’s lymphoma drug scored the same designation.
CureVac has filed a lawsuit against BioNTech and two of its subsidiaries for allegedly infringing on its intellectual property rights over mRNA technology used in the COVID-19 vaccine.
The Phase II study, conducted in the Netherlands, evaluated the single-dose ANEB-001 in treating healthy participants affected by THC. Anebulo plans to file an IND with the FDA by the end of 2022.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
Even though the COVID-19 pandemic appears to be under control, it’s clear that it’s not over, with the rise of more subvariants. Read on for more details.