Merck's HIV combo trial back on

Today's Big News

Apr 28, 2023

Gilead’s R&D spending spiked 25% in Q1, shortening investment gap with peers


Amgen cuts lupus programs for futility, hours after Lilly officially walks away from one too


Merck reveals HIV combo trial is back in the running after FDA partial hold lifted


Still under partial hold, Sanofi makes case for safety of MS med from Principia buyout


'Lots of ways for donanemab to win' in Alzheimer's, Lilly says. Now, it just needs the data


Joe Jimenez's Aditum finds fresh twist on old idea, paying $10M for autoimmune BTK inhibitor


Chutes & Ladders—BMS CEO set to leave after 8-year run

 

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Gilead’s R&D spending spiked 25% in Q1, shortening investment gap with peers

Gilead accelerated R&D spending in the first quarter, notching a 25% increase versus the first quarter of 2022. Company executives attributed the rise in part to ramping up a bevy of ongoing mid-to-late-stage trials.
 

Top Stories

Amgen cuts lupus programs for futility, hours after Lilly officially walks away from one too

In a day chock-full of Big Pharma earning calls and accompanying pipeline culls, Amgen is no exception, slicing both of its mid-stage lupus programs for futility.

Merck reveals HIV combo trial is back in the running after FDA partial hold lifted 

The middle of Merck & Co.’s clinical batting order took center stage on the company’s first-quarter earnings call, including a phase 2 HIV combo therapy that once again returned to the lineup.

Still under partial hold, Sanofi makes case for safety of MS med from Principia buyout

Sanofi's multiple sclerosis med tolebrutinib may be under a partial FDA clinical hold after reports of liver injury in a handful of phase 3 studies, but that is not stopping the French pharma from collecting some data to make the case for efficacy and safety.

'Lots of ways for donanemab to win' in Alzheimer's, Lilly says. Now, it just needs the data

Analysts are desperately trying to read the tea leaves comparing Eli Lilly’s Alzheimer’s med and Eisai/Biogen’s Leqembi before the mug is cool, but executives say there are “lots of ways for donanemab to win.”

Joe Jimenez's Aditum finds fresh twist on old idea, paying $10M for autoimmune BTK inhibitor

Joe Jimenez’s VC fund has ponied up $10 million to try to crack a nut that defeated a who’s who of top drug developers. The outlay gives the fund, Aditum Bio, near-global rights to a BTK inhibitor, with a twist, that is in development in autoimmune diseases including rheumatoid arthritis.

Chutes & Ladders—BMS CEO set to leave after 8-year run

Bristol Myers Squibb came in hot with one heck of a news bomb, announcing Thursday that CEO Giovanni Caforio, M.D., plans to retire in November after eight years at the helm.

Quitting Lilly's obesity drug tirzepatide may be difficult for many patients, exec says

On a day when Eli Lilly revealed stellar trial results for its obesity treatment tirzepatide and spent more than half of its quarterly earnings presentation discussing the drug's prospects, there was a disquieting side note. Using tirzepatide might be a lifetime decision.

Quest Diagnostics pens $450M deal for cancer detection startup Haystack Oncology

The clinical testing giant plans to acquire the Baltimore-based Haystack for its technology to detect minimal residual disease, by catching the early signs of a solid tumor’s recurrence by sifting out small pieces of cancer DNA floating in the bloodstream.

Playing catch-up with Merck, Pfizer scores pediatric approval for Prevnar 20

With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.

Walmart Health moves into Oklahoma as part of expansion plans in 2024

Walmart Health continues to grow its health clinic footprint with an expansion into Oklahoma next year. This is in addition to already-announced plans to move into Missouri and Arizona in 2024.

Fierce Pharma Asia—Daiichi's leukemia delay, Enhertu gains; Glenmark's settlement

The FDA has delayed a decision on Daiichi Sankyo's acute myeloid leukemia drug quizartinib. Meanwhile, the company's Enhertu tripled sales in fiscal year 2022. Merck and Glenmark settled a pay-for-delay case around Zetia. And more.

'The Top Line': A special series on Narcan, the life-saving nasal spray

This week on "The Top Line," we're launching a mini-series on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.
 
Fierce podcasts

Don't miss an episode

'The Top Line': A special series on Narcan, the life-saving nasal spray

This week on "The Top Line," we're launching a mini-series on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.
 

Resources

Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
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eConsent: Flexible Consent Through Enabling Technologies

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

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The Hematopoietic Colony Forming Cell (CFC) Assay for Drug Safety and Toxicity

The preclinical hematotoxicity screening method that helps clients eliminate bad players earlier in the drug development process

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Accessing and Analyzing Relevant Content in Today’s Information Chaos – R&D Challenges and Opportunities

We’ve identified four must-have tools to manage today’s scientific information chaos. How many are you utilizing?

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Blueprint for Commercializing Cell and Gene Therapies

How advanced medicines commercial readiness differs and the resources needed to maximize potential.

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Coming to America: Keys to Success for ex-US Digital Health Companies Entering the US Market

This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market.
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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.

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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.
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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.
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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.
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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.
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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.
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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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