Sun's new buy faces FDA hold

Today's Big News

May 2, 2023

J&J refuels CAR-T ambitions with $245M upfront to Cellular Biomedicine for pair of therapies


Merck battled 2 other Big Pharmas to the end in pursuit of $11B Prometheus deal


Sun's Concert hits bum note as FDA imposes partial hold 2 months after $576M buyout


Travere fails to beat off-label blood pressure drug in phase 3 but plans talks with FDA anyway

 

Featured

J&J refuels CAR-T ambitions with $245M upfront to Cellular Biomedicine for pair of therapies

Johnson & Johnson may have gone quiet on getting further CAR-Ts into the clinic beyond the success of its Legend-partnered Carvykti, but that’s about to change.
 

Top Stories

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

With analysts expecting a free-fall in sales from COVID products, Pfizer pulled off a surprise with its first-quarter earnings report. Revenue for the period came in at $18.3 billion, routing the analyst consensus of $16.6 billion. With the performance, Pfizer reaffirmed its expectations for 2023 revenue to fall between $67 billion and $71 billion.

Merck entitled to $1.4B in cyberattack case after court rejects insurers' 'warlike action' claim

A New Jersey appellate court ruled that a group of insurers can’t use war as an argument to deny Merck coverage from the notorious NotPetya cyberattack in 2017.

Dual CRISPR therapy plus long-acting ART eliminates HIV in mice

The scientists who used CRISPR to eliminate HIV in mice have done it again, this time with a three-pronged approach that nearly doubled their success rate.

Gilead, US government set for courtroom showdown over PrEP drug patents

Drug companies often have disagreements about the patents behind lucrative medicines, but it's highly unusual for the U.S. to take a top pharmaceutical company all the way to a trial. In the case over Gilead Sciences' PrEP drugs, that's exactly what's happening.

Zimmer Biomet picks up 3D-printed orthopedic implant maker Ossis

Less than two years after they first teamed up to distribute 3D-printed implants throughout the Asia-Pacific region—and only a few months after they expanded that partnership even further across the globe—Zimmer Biomet and Ossis are taking their relationship to the next level.

CVS closes $10.6B acquisition of Oak Street Health to expand primary care footprint

CVS Health has closed its $10.6 billion acquisition of Medicare-focused primary care player Oak Street Health as it moves forward aggressively on its strategy to expand beyond pharmacy into health services.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Pfizer's record-breaking sales, plus headlines

This week on "The Top Line," we talk about how Pfizer became the first company in Big Pharma history with $100 billion in sales. We also dive into a J&J data leak, Eli Lilly's manufacturing spending plan and more of this week's top headlines.

 

Resources

eBook

Decentralized Clinical Trials: The Complete Guide for 2023

Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success.
Research

How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.

Whitepaper

Medical Affairs Metamorphosis VI: The Changing Face of Stakeholder Engagement

This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing.
Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
Whitepaper

eConsent: Flexible Consent Through Enabling Technologies

How can eConsent provide a more flexible approach to informed consent?

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Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

Whitepaper

Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
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Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
 

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