White House nixes veto in Apple’s ECG patent feud

Today's Big News

Feb 22, 2023

Eli Lilly's diabetes drug Mounjaro back in stock amid heightened obesity interest


Fallout from Quantum Genomics' phase 3 fail claims top executives as biotech searches for a future


White House opts not to veto ITC ruling in favor of AliveCor in ECG patent battle with Apple


Teva gains FDA approval for once-daily formulation of flagship drug Austedo


Hyperfine scores EU approval of portable MRI system, setting up possible global expansion


'We beg you': Biotechs plead for help and funds to find long COVID treatments

 

Featured

Eli Lilly's diabetes drug Mounjaro back in stock amid heightened obesity interest

Eli Lilly said it has resolved a months-long shortage of popular diabetes med Mounjaro by clearing all backorders, although the FDA remains cautious about the situation.
 

Top Stories

Fallout from Quantum Genomics' phase 3 fail claims top executives as biotech searches for a future

After ending all cardiology work in the wake of a failed phase 3 trial, Quantum Genomics is now reorganizing its board of directors, restructuring staff and again conducting a strategic review.

White House opts not to veto ITC ruling in favor of AliveCor in ECG patent battle with Apple

A potential import ban on the Apple Watch is still on the table as an International Trade Commission ruling against the technology cleared presidential review this month.

Teva gains FDA approval for once-daily formulation of flagship drug Austedo

The FDA has cleared Teva’s Austedo extended-release tablets in 6-, 12- and 24-mg doses, teeing up a once-daily formulation of the drug that—for the first time—can also be taken without food. The new formulation boasts therapeutic equivalence to its twice-a-day counterpart, which was first approved back in 2017.

Hyperfine scores EU approval of portable MRI system, setting up possible global expansion

Hyperfine has gotten the green light to take its talents to the EU—but whether the portable MRI tech maker will actually make the transatlantic trip is another story.

'We beg you': Biotechs plead for help and funds to find long COVID treatments

Biotechs are pleading for help to develop new treatments for long COVID, as the U.S. moves past the pandemic. Patients and advocates worry they're being left behind.

As Sanofi contract wind-down prompts layoffs in Boston, Resilience is hiring elsewhere: CEO

Drug manufacturer National Resilience is laying off about 213 employees in Boston, a company spokesperson confirmed via email. The staff reduction is a “function of transition” tied to the end of a manufacturing contract with Sanofi, Resilience chief Rahul Singhvi told Fierce Pharma.

From Roivant to the White House on anti-woke agenda: Ramaswamy unveils presidential bid

Not content with overseeing his ever-expanding ‘vant’ empire, Roivant founder Vivek Ramaswamy has set his sights on a far more ambitious goal: the White House.

Ascensia adds automated food analysis to glucose monitoring system

A collaboration between Ascensia Diabetes Care and the Snaq app-based platform is giving new meaning to the phrase, “Say cheese!”

Fierce Biotech Layoff Tracker 2023: Quantum laying off staff; Bayer cuts 55 jobs

We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech.
 
Fierce podcasts

Don't miss an episode

‘Podnosis’: PE in rural America and Wilson’s career journey

In this week's episode of "Podnosis," we talk about a new report by the Private Equity Stakeholder Project on private equity in rural settings. We also talk with Margaret-Mary Wilson, M.D., about how her lived experience has influenced her career journey.

 

Resources

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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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The Power of Small & Safety: Nanoplasmid™️ Vector Platform

Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies.

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Commercializing Gene Therapies, Part 3 – Cost Drivers

This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years.
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Unlocking the Therapeutic Potential of Previously Undruggable GPCRs

Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs
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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?
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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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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.

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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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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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.

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

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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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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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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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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