AbbVie cranks heat with $250M Celsius buy

Today’s Big News

Jun 27, 2024

Novo's kidney disease drug fails to improve blood pressure in phase 3, spurring $816M loss


2seventy bio divests again, this time sending hemophilia and gene editing science to Novo Nordisk


AbbVie sweeps up Celsius Therapeutics for $250M in summer heat wave


Silence breaks down phase 1 data on blood disorder prospect, sharing glimpse at pitch for competitive niche


FDA publishes updated draft guidance on clinical trial diversity 


CalciMedica's calcium channel inhibitor helps subgroup of pancreatitis patients eat solids sooner

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Novo's kidney disease drug fails to improve blood pressure in phase 3, spurring $816M loss

Novo Nordisk’s late-stage kidney disease drug failed to evoke significant changes in systolic blood pressure, a loss that will cost the Danish drugmaker more than $800 million.
 

Top Stories

2seventy bio divests again, this time sending hemophilia and gene editing science to Novo Nordisk

2seventy bio has split again, this time sending its hemophilia A program and related staff to Novo Nordisk.

AbbVie sweeps up inflammatory-focused Celsius for $250M cash in summer heat wave

AbbVie is embracing summer’s heat, cranking up the M&A dial with the acquisition of inflammatory disease-focused Celsius Therapeutics for $250 million cash.

Why early market access planning is crucial in CGT commercial strategy

CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch.

Silence breaks down phase 1 data on blood disorder prospect, sharing glimpse at pitch for competitive niche

Silence Therapeutics has spoken up about its phase 1 polycythemia vera clinical trial, providing an early look at how its siRNA prospect may match up to rivals from Incyte and Takeda.

FDA publishes updated draft guidance on clinical trial diversity

Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency issued a new outline of its proposed requirements for the racial and ethnic diversity action plans that will eventually be mandatory components of studies on drugs, devices and other medical products.

CalciMedica's calcium channel inhibitor helps subgroup of pancreatitis patients eat solids sooner

CalciMedica said it is “moving quickly” to take Auxora into phase 3 after the calcium release-activated calcium channel inhibitor was shown to reduce the time before solid food could be consumed by a subgroup of patients with hyperinflamed pancreatitis.

Daiichi's lung cancer ADC rejected by FDA in blow to first project under Merck partnership

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

With FDA nod, Verona's Ohtuvayre is set to Jack up the COPD market

Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder. It is the first novel treatment advancement in the indication in more than a decade.

CDC immunization advisers vote to shrink recommendations for RSV vaccination

The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination.
 
Fierce podcasts

Don’t miss an episode

A closer look at 'friend-shoring' and the drug shortage challenge

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing.
 

Resources

Whitepaper

2024 Life Sciences Industry Outlook

The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.
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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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