Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028. Leqembi is currently pending approval in the EU and Japan.

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pharmaphorum

JUNE 27, 2022

Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. Ipsen’s CVR offer includes $0.30 The post Ipsen beefs up in oncology, buying US biopharma Epizyme appeared first on.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. AbbVie reported a 22.7% Bristol Myers Squibb (BMS) documented a 9.1%

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Pharmaceutical Technology

MARCH 23, 2023

Among other late-stage trials, Padcev is being evaluated in combination with Keytruda (pembrolizumab) in the frontline setting, with the trial granted priority review by the FDA. GlobalData analysts forecast the total revenue from Seagen products to be around $36bn from 2023 to 2028, with a 29.3%

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The FDA Law Blog

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. A “specified drug” means, for 2021, an applicable drug that is produced, prepared, propagated, compounded, converted, or processed by a specified manufacturer. Final Guidance at 2.

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