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Merck settles with insurance companies over $1.4B claim tied to 2017 cyberattack: report

Fierce Pharma

billion claim after it was victimized by a crippling cyberattack in 2017. billion claim after it was victimized by a crippling cyberattack in 2017, Bloomberg Law reports. Merck has reportedly settled with insurance companies that contested the pharma giant’s $1.4

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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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PTC wins FDA approval for first brain-delivered gene therapy Kebilidi

Fierce Pharma

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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

Fierce Pharma

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. One hallmark of the FDA's accelerated approval pathway is the requirement that medicines prove their benefits in confirmatory trials.

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Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

Fierce Pharma

When Roche's Genentech gained approval for Ocrevus in 2017, the first-in- | The day after Roche gained an FDA approval for its subcutaneous version of cancer drug Tecentriq, the company also scored with a U.S. nod for its under-the-skin formulation of mega-blockbuster multiple sclerosis drug Ocrevus.

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Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case

Fierce Pharma

In 2017, Daiichi's former subsidiary Plexxikon alleged that Novartis stepped on its Zelboraf patents with its GSK-acquired medicine Tafinlar. After years of back and forth with Daiichi Sankyo over cancer drug patent claims, Novartis has thrown in the towel with a $182 million settlement. |

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