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BioMarin's hemophilia gene therapy Roctavian lands FDA nod with 'glimmers' of enthusiasm among doctors

Fierce Pharma

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.

Doctors 334
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FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls

Fierce Pharma

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases.

FDA 286
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As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. But these immunotherapies also come with various potentially dangerous side effects. |

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US WorldMeds' Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

Fierce Pharma

But now, patients and doctors have a new oral option. | FDA has approved US WorldMeds’ Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky.

FDA 243
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Merck's Keytruda hits overall survival goal in early lung cancer as FDA decision nears

Fierce Pharma

What doctors described as a “messy” treatment landscape in early-stage non-small cell lung cancer (NSCLC) could get clearer thanks to a first-in-class overall survival win from Merck & Co.’s s Keytruda.

Doctors 297
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Another reason change is needed at FDA? Fair balance

World of DTC Marketing

Pharma TV ads drive people online to search for more information. Safety pages on Pharma product websites continue to have high utility. As we have seen over the past few years, Pharma companies are a business, a regulated business, but still a business. This is normal, and the FDA should take note.

FDA 165
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Should pharma be in the app business?

World of DTC Marketing

So should pharma be in the app business? If, for existence, a pharma developed app requires patients to “check-in” everyday it could be a reminder that they are living with a chronic health issue. Should pharma, for example, collect data on users and how much should they collect and for what purpose?

Pharma 230