FDA

The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. 

FDA

Yesterday the agency ranted accelerated approval to BeiGene’s BTK inhibitor Brukinsa (zanubrutinib), when used in combination with Genentech’s Gazyva (obinutuzumab), to treat patients with relapsed or refractory follicular lymphoma who have undergone at least two lines of systemic therapy.

Novavax reported fourth-quarter 2023 revenue and earnings on Wednesday that missed Wall Street expectations, causing the company’s stock price to fall more than 25% in morning trading. 

Maria Fontanazza

It was last year’s hottest topic, and this year it is sure to be at the top of the list. It dominates conversations, and it sure does dominate my inbox. Artificial intelligence.

Agenda 2024

By nearly unanimous consent artificial intelligence reached an inflection point for pharma marketers in 2023. The question of how best to take advantage of this new tool to support brands and help patients, though, remains to be seen.

Excitement is mounting across the industry going into 2024 about data and digital innovations’ potential for improving engagement among consumers, patients, and caregivers. That excitement is evident in conversations with eight industry leaders who are embracing digital to advance personalization, support health equity, and reach patients on new channels.

In 2024, the industry must acknowledge the interconnected impact of the Inflation Reduction Act (IRA), growing AI and technology usage, and evolving smart data, as these factors create a ripple effect. How market access responds to these effects will impact sales and marketing. Effectively addressing these impacts lies at the heart of industry reform.

Pharma commercial leaders are understandably energized by the prospect of leveraging emerging technology (e.g., advanced AI tools) to amplify the velocity and impact of their promotional efforts. While this potential lies ahead, commercial leaders must first address the age-old organizational challenges that continue to stand in the way of a fully coordinated and customer-centric promotional infrastructure.

Question mark

We at Med Ad News don’t claim to know all the questions. So we challenged our contributors to come up with their own questions and answer them.

Money

Even as they are gathering proof of extensive benefits to patients, the manufacturers of GLP-1s will have to overcome supply chain difficulties and high prices to get payers to fund these medicines for treating obesity.