Merck looks past Keytruda as heart strategy pays off

Today's Big News

Mar 6, 2023

Incyte's LIMBER lumbers to early end as analysis shows Jakafi cancer combo destined to fail


To ‘keep pace with viral evolution,’ Invivyd is also evolving (again)


Adaptimmune absorbs TCR² to extend cash runway and broaden T-cell pipeline


Merck’s cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2 


Novartis ready to head for deep space with Voyager after a year 'kicking the tires'


2 months after depression fail, Atai lays off 30% and reviews pipeline again


Aclaris stock halves after phase 2a skin study misses goals 


Rallybio reassembles behind version 2.0 of fetal blood disorder med


Harbour ships phase 3 data to take lead over argenx, J&J and UCB in Chinese autoimmune race

 

Featured

Incyte's LIMBER lumbers to early end as analysis shows Jakafi cancer combo destined to fail

Incyte’s first bid to build a better Jakafi regimen is banjaxed. A phase 3 trial of parsaclisib and Jakafi has come screeching to a halt ahead of schedule after the independent data monitoring committee found it was on course to fail.
 

Top Stories

To 'keep pace with viral evolution,' Invivyd is also evolving (again)

Invivyd, which was launched in the early days of the pandemic under the name Adagio to find treatments for COVID-19, is hoping the third monoclonal antibody is the charm.

Adaptimmune absorbs TCR² to extend cash runway and broaden T-cell pipeline

What do TCR² Therapeutics and Adaptimmune have in common? They’re both T-cell-focused drug developers that have been shedding staff in recent weeks to stay afloat.

Broadening the Commercialization Partnership

This story centers on the benefits of implementing a full service commercial model to improve launch success for customers who lack the necessary infrastructure. Watch how Syneos Health expertise in Medical Affairs acted as a bridge to forge this full service commercial partnership, which helped meet critical deadlines for patients.

Merck’s cardiovascular future takes shape as sotatercept overachieves, PCSK9 inhibitor passes phase 2

Merck & Co. has looked to its mid-to-late stage cardiovascular pipeline as a potential goldmine amid the race to replace Keytruda's revenue stream. And a handful of new readouts provide a glimpse into the promise the company is banking on.

Novartis ready to head for deep space with Voyager after a year 'kicking the tires'

It’s been a year since Novartis ventured into orbit with Voyager Therapeutics to find new central nervous system targets. Now, the Big Pharma is ready to go deeper into space with the AAV capsid discovery biotech.

2 months after depression fail, Atai lays off 30% and reviews pipeline again

Weeks after Atai Life Sciences’ ketamine-like drug failed a phase 2 drug in depression, the mental health-focused company is laying off 30% of staff.

Aclaris stock halves after phase 2a skin study misses goals

Aclaris Therapeutics’ investigational immuno-inflammatory drug has failed to hit efficacy targets in a phase 2a trial, sending the biotech’s stock spiraling.

Rallybio reassembles behind version 2.0 of fetal blood disorder med

Rallybio is prioritizing version 2.0 of a therapy to treat a fetal and neo-natal blood condition, squashing work on the med’s first iteration as a result. 

Harbour ships phase 3 data to take lead over argenx, J&J and UCB in Chinese autoimmune race

Harbour BioMed has taken the lead in the Chinese leg of a competitive autoimmune race, becoming the first company to show an anti-FcRn drug improves outcomes in generalized myasthenia gravis in the country. The result is a boost for Immunovant, which has rights to the drug in several major markets.

Drug once tested for hep b could help rare bone marrow syndrome

Scientists have known the genetic mutation behind the rare bone marrow syndrome poikiloderma with neutropenia for some time, but exactly how the mutation causes the condition has remained a mystery. Now, researchers think they’ve cracked the case—and found a potential treatment, too.

Fierce Biotech Fundraising Tracker '23: Bicara bags $108M; Cargo loads $200M

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

CZI in Chi: Chan Zuckerberg Initiative sets first location for $1B biohub expansion

CZ Biohub Chicago will focus specifically on developing new technologies equipped with sensors and probes that can draw out high-resolution biological information from human tissue at a molecular level.

Moderna picks Oxfordshire for future UK manufacturing and R&D site

Moderna pinpointed the Harwell Science Campus in Oxfordshire, England, as the home of its upcoming Innovation and Technology Center. The location places Moderna within the U.K.’s biopharma-rich “Golden Triangle” between London, Oxford and Cambridge.

Modified Abbott CGM sensors score FDA nod for use in automated insulin delivery systems

As diabetes device makers race to build completely hands-off artificial pancreas systems, Abbott’s continuous glucose monitors are getting a significant upgrade.

Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing

After scoring an accelerated approval for Alzheimer's disease drug Leqembi in January, Eisai and Biogen hope to turn that into a traditional approval by July 6. But an advisory committee will get a chance to vote on the drug first.

Walgreens won't sell abortion pills in GOP states after legal threats from state officials

The Walgreens decision stems from a letter written by nearly two dozen Republican state attorneys general at the beginning of February that threatened legal action if the company began distributing Mifepristone in their states.
 
Fierce podcasts

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'The Top Line': The surprising multibillion-dollar medtech megadeals

This week on "The Top Line," we discuss 2022's M&A trends in the medtech sector and the surprising multibillion-dollar megadeals. We also cover the top headlines from this week.
 

Resources

Whitepaper

Answering your specific questions about mRNA/saRNA manufacturing

Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here.
Research

Strategizing for Clinical Trial Diversity

Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials.
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Leveraging Archetypes for Effective Launch Strategy

Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches.
On-Demand Webinar

Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

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Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
Research

Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

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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.
Research

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

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.
Case Study

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

 

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