Fierce Pharma

NOVEMBER 3, 2023

federal court denied Alvogen's bid to force the FDA to grant full approval to its proposed Xifaxan generic. The agency previously gave the generic a tentative approval before some patents expire in 2029.

FDA 288

FDA Pharmaceutical 288

Pharmaceutical Technology

MAY 10, 2023

The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020. billion in global sales in 2029, while Truvada estimates amount to $30 million.

Government 105

Government FDA Pharmaceutical Sales 105

Clarivate

JANUARY 8, 2024

Clarivate data indicates a 90% probability that datopotamab deruxtecan will win marketing authorization in the United States, and projects 2029 sales of $2.7 billion in 2029 for CASGEVY alone. FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. billion in 2029 revenues.

Marketing 59

Marketing Patients Healthcare Healthcare 59

pharmaphorum

SEPTEMBER 30, 2022

7,326,708) was challenged by Mylan Pharma, now Viatris, before the US Patent and Trademark Office (USPTO), which ruled in Merck’s favour last year. Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. The US patent (No.

Marketing 59

Marketing Sales Competition FDA 59

Pharmaceutical Technology

APRIL 24, 2023

Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. According to GlobalData’s Pharma Intelligence Centre, a sales consensus forecasts Brukinsa to have global sales of $3.98 billion in 2029, while Calquence is expected to make $5.31 billion in 2029. billion in 2029.

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

Pharmaceutical Technology

MAY 16, 2023

trillion in Q1 2023, according to GlobalData’s pharma intelligence centre companies database. This growth is expected to continue, with a 62% growth in annual consensus sales forecast from 2023 to 2028, fuelled by the company’s semaglutide portfolio, according to GlobalData’s report, ‘Looking ahead to 2023 – the future of pharma’.

Marketing 52

Marketing Sales Pharma Leads 52

PM360

SEPTEMBER 21, 2023

In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market. The product, manufactured by ARS Pharma and Neurelis Pharma, would be the first needle-free epinephrine alternative to autoinjectors, such as the EpiPen.

Management 105

Management Manufacturing Sales Competition 105