Skye’s lead asset fails ph. 2 glaucoma test

Today’s Big News

Jun 10, 2024

Moderna flu/COVID combo beats immune responses for approved shots in phase 3 after speedy season


Alumis sets out IPO ambitions to fund TYK2 inhibitor through phase 3 psoriasis trials


Skye Bioscience ends eye disease R&D efforts after glaucoma drug’s phase 2 fail


Oculis sees promise in dry eye disease subgroup, plans phase 3


NIAID is 'on the ball' with H5N1 research, but gaps in bird flu prevention remain: experts


NIH blends primary care with clinical research in $30M pilot to reach underserved patients

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Featured

Moderna flu/COVID combo beats immune responses for approved shots in phase 3 after speedy season

Moderna’s combo flu and COVID-19 vaccine zipped through a late-stage trial this winter, and the results are showing a higher immune response than licensed comparators—including the famed biotech’s own Spikevax.
 

Top Stories

Alumis sets out IPO ambitions to fund TYK2 inhibitor through phase 3 psoriasis trials

Not content with bringing in one of the largest private biotech fundraises of 2024 so far, Alumis has now become the latest drug developer to set its sights on the public markets.

Skye Bioscience ends eye disease R&D efforts after glaucoma drug’s phase 2 fail

Skye Bioscience’s share price tumbled in pre-market trading Monday, as the biotech announced a strategic refocus in the wake of a phase 2 trial failure.

Innovation, Partnerships & Progress: How Life Sciences Is Booming in Maryland’s Montgomery County

Drive or take the metro in any direction within Montgomery County, Maryland, and you'll come across a life science company responsible for a major innovation.

Oculis sees promise in dry eye disease subgroup, plans phase 3

Oculis is forging ahead with its precision medicine approach to treating dry eye disease, outlining plans to finalize a phase 3 study after seeing some signs of efficacy in a subpopulation in its midstage trial.

NIAID is 'on the ball' with H5N1 research, but gaps in bird flu prevention remain: experts

Against a backdrop of low-volume but growing concerns about bird flu, the National Institutes of Health’s infectious disease arm has laid out its plans to study the virus that causes the illness.

NIH blends primary care with clinical research in $30M pilot to reach underserved patients

A $30 million, two-year pilot program from the National Institutes of Health will set up clinical research at primary care facilities in communities with underserved patient populations, with the goal of eventually establishing the means to conduct research projects on issues unique to them. 

FDA accepts Eisai's subcutaneous Leqembi filing, sets January 25 decision date

The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025.

GSK exec lauds 'great start' to RSV vaccine uptake as Arexvy nabs label expansion in adults 50-59

The FDA approved Arexvy for RSV prevention in adults ages 50 to 59 who are at increased risk of developing RSV disease. The green light marks Arexvy’s first new approval since the vaccine’s original nod to prevent lower respiratory tract disease caused by RSV in adults ages 60 and older last May.

FDA boosts Medtronic recall of brain surgery navigation software

Medtronic said the problem lies in the on-screen displays of submillimeter-sensitive information such as “distance to target” or “tip stop point,” which guides the depth of a biopsy needle.

Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm

Priya Bhambi, 40, pled guilty to wire fraud charges after running a detailed scheme to scam Takeda into paying for non-existent services from a fake consulting firm.
 
Fierce podcasts

Don’t miss an episode

A look at the top 10 pharma drug ad spenders

In this week’s episode of “The Top Line,” the Fierce Pharma Marketing team discusses the annual top pharma drug ad spenders special report.
 

Resources

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Enhance your long-term cell & gene therapy success with pDNA manufacturing solutions

Watch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies.
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A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

New molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more.
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Fresenius Medical Care gets 25x faster kidney disease insights

This detailed case study shows how Fresenius Medical Care achieved 25 times faster insights to help kidney disease patients, launching the world’s largest global database of dialysis care with fully anonymized patient data.
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Adding Rare Disease Products to Your Company’s Portfolio

This paper outlines the challenges, pitfalls, & solutions associated with adding rare disease therapies to a biopharma company’s portfolio.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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