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'Most' cancer meds approved under FDA's accelerated pathway couldn't prove survival benefit after 5 years: study

Fierce Pharma

One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials. Many cancer meds approved under the FDA's accelerated approval pathway from 2013 to 2017 didn't improve overall survival after more than five years of follow-up research, the study found.

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With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer

Fierce Pharma

It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.

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Look out, Teva. Neurocrine's Ingrezza wins Huntington's disease FDA nod to rival Austedo

Fierce Pharma

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease.

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FDA approves Pfizer spinout SpringWorks' Ogsiveo as first treatment for disfiguring rare tumor type

Fierce Pharma

Thanks to a new FDA approval, patients with ultra-rare desmoid tumors now have an FDA-approved treatment. Patients with ultra-rare desmoid tumors now have an FDA-approved treatment, thanks to a drug made by SpringWorks Therapeutics, which spun out of Pfizer in 2017 with a portfolio of rare disease candidates.

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Idorsia's Tryvio crosses FDA finish line, offering new mechanism to treat hypertension

Fierce Pharma

After Johnson & Johnson last year changed its mind on its 2017 purchase of ap | Idorsia's Tryvio is the first oral anti-hypertensive therapy that uses a new therapeutic mechanism in nearly 40 years, suggesting the dawn of "a new era of endothelin research," the company said.

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Sarepta sells FDA priority review voucher to mystery buyer for $102M as prices continue to slip

Fierce Pharma

the same can’t be said for the cost of an FDA priority review voucher. Since 2017, the company has sold off three PRVs—getting less in return for each successive sale. While the price of just about everything has increased over the last six years in the U.S., Just ask Sarepta Therapeutics. | Just ask Sarepta Therapeutics.

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Study points to weaknesses in FDA accelerated approval path

pharmaphorum

Less than half of the cancer therapies given accelerated approval by the FDA in 2013 to 2017 showed a clinical benefit in a confirmatory trial within the next five years

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