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.

Compounding 110

Compounding FDA 110

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%

Vaccines 108

Vaccines Documentation Compounding FDA 108

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%

Chemotherapy 59

Chemotherapy Compounding FDA 59

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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Labelling Compounding Payment Processing Vaccines 105