FDA
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
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David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
Pfizer says it expects the U.S. CDC’s ACI to meet in October to recommend the appropriate and safe use of pneumococcal vaccines, including PREVNAR 20, in adults.
Bharat will conduct Phase IV studies to check real-world efficacy against the virus, while Ocugen says Covaxin will be a valuable tool in helping to end the COVID-19 pandemic.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
Results from the Phase III TULIP® study show an antibody-drug conjugate from Byondis significantly prolonged PFS in patients with pretreated HER2-positive metastatic breast cancer.
The tool developed by On Target boosts the ability of surgeons to find and remove cancerous lesions during surgical procedures, increasing progression free and overall survival.
Novartis flexed its clinical muscles over the weekend, announcing results from multiple studies including different types of cancer and kidney disease.
The U.S. Food and Drug Administration granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease.
The FDA lifted the clinical holds on bluebird bio’s sickle gene therapy and its betibeglogene autotemcel gene therapy for adults, adolescents and children with TDT.
United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.