FDA
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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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.
Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes.
It didn’t take too long before a lawsuit was filed over Bristol Myers Squibb’s failure to meet a deadline for a $9 Contingent Value Rights agreement tied to the company’s merger with Celgene.
REGEN-COV’s 1,200 mg dose is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years and older who weigh 40 kilograms or more.