FDA
Vinay Prasad, the FDA’s Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.
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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Currently, women with breast and ovarian cancers have limited treatment options. Anixa Biosciences, ImmunoGen and IMV are working to change that.
The FDA clinical hold comes after Alpine reported a patient died during the NEON-2 trial.
BMS and Opdivo’s blockbuster checkpoint inhibitor picked up a new regulatory win after the FDA approved the cancer drug in combination with platinum-doublet chemotherapy.
China has become a leader in biotech in the last five years, especially in CAR-T therapies. Companies like Johnson & Johnson are on the prowl to acquire Chinese companies to form collaborations.
As COVID-19 cases fall in the wake of the latest surge from the Omicron variant, the question on the minds of many is, what comes next for these Pfizer and Moderna?
The FDA turned down Ocugen’s Emergency Use Authorization request for Covaxin in children 2 to 18, which the company is co-developing with India’s Bharat Biotech.
Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.