pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

Labelling 76

Labelling FDA 76

pharmaphorum

AUGUST 16, 2021

Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 This first FDA approval triggers a $50 million payment to former Peloton shareholders, with another $50 million due on commercial launch. Merck paid $1.05 billion in milestone payments.

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Labelling FDA 98

Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. GlobalData’s consensus analyst forecast database projects peak sales for pirtobrutinib to reach $892 million by 2028, and $4.8

Labelling 59

Labelling 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. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2. of the total expenditures for all Part D drugs in 2021.

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Labelling Compounding Payment Processing Vaccines 105

Pharmaceutical Technology

SEPTEMBER 2, 2022

Previously, J&J’s/Legend Biotech’s Carvykti (cilta-cel) and Bristol Myers Squibb’s (BMS) Abecma (ide-cel), anti-BCMA chimeric antigen receptor (CAR) T-cells, were approved by both the EMA and the US Food and Drug Administration (FDA) for R/R MM. Should CAR-T cells, or antibodies be used first?

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FDA Labelling 59

The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. Although a generic was approved in 2019, generic apixaban will not be available on the market until at least April 2028. The FDA approved two applications for generic versions of Eliquis by the companies Micro Labs Limited and Mylan Pharmaceuticals, Inc.

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Dosage Labelling Insurance FDA 52

The FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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FDA Labelling 64