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FDA approves AstraZeneca’s fixed-duration, all-oral Calquence plus venetoclax regimen for first-line CLL and SLL in adults.

In this video episode, Pratap Khedkar, PhD, CEO of ZS, joins the Pharm Exec Podcast to discuss three distinct industry trends and strategy shifts converging at the moment amid the backdrop of US-driven global policy change.

In today’s Pharmaceutical Executive Daily, the FDA reportedly removes its two-study requirement for new drug approvals, Hims & Hers enters a $1 billion agreement to acquire Eucalyptus, and experts examine how FDA can help ease early-stage clinical trial bottlenecks.

The vaccine advisory committee’s meeting has yet to be rescheduled.

Study results showed that patients saw three years of remission while taking the medication.

Hims & Hers has agreed to acquire Australia-based Eucalyptus for up to $1.15 billion, expanding its international footprint across Australia, Canada, Germany and the U.K.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

In today’s Pharmaceutical Executive Daily, the FDA begins reviewing Moderna’s seasonal flu vaccine under a revised regulatory approach, Eli Lilly signs a $100 million licensing agreement with CSL for an anti- IL-6 monoclonal antibody., and Southern Florida emerges as a growing biotech hub.

Greater Miami is rapidly emerging as an international biotech hot spot—as capital, talent, and infrastructure converge to transform the region from a tourism-driven economy into a globally connected life sciences innovation hub.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

In today’s Pharmaceutical Executive Daily, the FDA approves a monthly dosing schedule for Rybrevant Faspro, HHS Secretary Robert F. Kennedy Jr. revises the agency’s leadership team, and industry expert Sandy Tammisetty discusses what it takes to deliver actual value in today’s pharmaceutical landscape.

HHS Secretary Robert F. Kennedy Jr. reorganized senior leadership at the department to streamline management and advance the administration’s health policy priorities.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.