FDA
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.