pharmaphorum

MAY 10, 2022

The two partners have also requested a priority review for the Biologics License Application (BLA) for lecanemab, which if granted by the FDA could result in an approval before the end of the year. The post Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go appeared first on.

FDA 40

FDA 40

pharmaphorum

DECEMBER 17, 2021

Biogen and partner Eisai have said they will provide details next March for the confirmatory trial that will be needed to upgrade the drug’s accelerated approval for controversial Alzheimer’s drug Aduhelm to a full one.

FDA 52

FDA 52

pharmaphorum

OCTOBER 29, 2021

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? Trodelvy is also approved to treat metastatic urothelial cancer in the US, and Gilead has just reported third-quarter sales of $101 million for the drug, which were actually a little lower than analyst expectations.

Chemotherapy 52

Chemotherapy FDA 52

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. Accelerated approval is probably a reasonable middle ground here. Broad label questioned.

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FDA Labelling 98

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications. Prior to the program, only 10 drugs were approved for a rare disease.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

NOVEMBER 24, 2022

Johnson & Johnson’s Spravato therapy for treatment-resistant depression (TRD) hasn’t made the impact the company hoped for in the market, and it is looking to new clinical results to accelerate its take-up. Both drugs were given on top of standard antidepressants to patients wo had failed a least two earlier treatments.

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Labelling Hospitals 52

pharmaphorum

SEPTEMBER 15, 2020

Pharma’s go-to-market strategies have tended to be more traditional than those seen in non-regulated sectors, but there are some signs this is changing, with an acceleration in the pace of change forced by the COVID-19 pandemic that is allowing the industry to close its gap with faster, more nimble consumer brands. Jeremy Richter, Tag.

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Communication Documentation Labelling Vaccines 116

pharmaphorum

JUNE 2, 2022

R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. This is based on the relative success orphan drugs have achieved, in terms of the number of approvals and the sales figures achieved for this area. Raising questions.

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Compounding Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

MAY 24, 2021

It is a newer concept for pharma marketers, however, who are now turning to modular solutions in response to the accelerated demand for content over the past year. Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. Robb DeFilippis.

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Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 91

The FDA Law Blog

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

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FDA 81