Fierce 15 Submissions Due Today

This Week

Jul 14, 2023

CRISPR helps solve 100-year mystery of why cancer cells have extra chromosomes


Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine


Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks


ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events


Novartis retreats from TIGIT, handing $300M candidate back to BeiGene


Novartis slapped with dreaded Clause 2 marketing breach as it brings 'discredit upon' the pharma industry over online Entresto claims


DUE TODAY: Get your Fierce Biotech Fierce 15 submissions in

 

Featured

CRISPR helps solve 100-year mystery of why cancer cells have extra chromosomes

Scientists have long known that cancer cells typically have extra chromosomes, but what exactly was the extra genetic material doing? New research from a team at Yale University has finally provided an answer.
18-19
Jul
July 18-19, 2023 | Jersey City, NJ
 

Top Stories

Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine

After a major phase 2 win that stirred up much excitement within the oncology community, Merck has officially formulated a pivotal trial plan for its Moderna-partnered mRNA cancer vaccine mRNA-4157.

Novo Nordisk's GLP-1 drugs under review in Europe after reports flag possible suicide risks

Two cases of suicidal thoughts and one case of self-harm from users in Iceland of Novo Nordisk’s diabetes and obesity drugs have prompted the European Medicines Agency (EMA) to review the blockbuster products. The regulator will examine Novo’s treatments Ozempic and Saxenda to determine if there was a causal relationship between their use and the adverse events.

ADC puts Zynlonta study on hold after 7 patient deaths, 5 other severe adverse events

A total of 12 severe adverse events were reported among the 40 patients enrolled in the phase 2 trial, 11 of which ADC says were not related to the treatment. The study was assessing the drug in certain patients with previously untreated diffuse large B-cell lymphoma.

Novartis retreats from TIGIT, handing $300M candidate back to BeiGene

Novartis may have insisted earlier this year that it hadn’t given up on anti-TIGIT checkpoint inhibitors, but, now, the Swiss Big Pharma seems to have had a change of heart.

Novartis slapped with dreaded Clause 2 marketing breach as it brings 'discredit upon' the pharma industry over online Entresto claims

Novartis is in hot water with the U.K.’s drug marketing rule maker the PMCPA after it was found to have breached three of its rules, including its most serious: Clause 2.

Lilly's Prevail revises $2.6B biobucks deal with Precision to take on more preclinical work

Eli Lilly’s Prevail Therapeutics has changed up a licensing agreement with gene therapy biotech Precision Therapeutics, dropping the biobucks value and seeking a bigger share of pre-clinical duties.

Samsung Biologics, after expanding Pfizer collab, inks Novartis production deal worth $391M

Samsung Biologics said in a Monday regulatory filing that it’s inked a $390.9 million deal to help crank out Novartis drugs. The latest production pact builds on an earlier tie-up worth $81 million.

Coloplast casts $1.3B to reel in fish-skin-based wound care company Kerecis

There’s something fishy about Coloplast’s latest megadeal—literally. The Danish medtech announced plans on Friday to acquire Kerecis, which uses fish skin as the basis of its wound care products for humans.

Novavax to receive $350M from Canada for canceled COVID vaccine orders

Canada has canceled some COVID-19 vaccine deliveries from Novavax and will pay $350 million to fully compensate the company for those unused doses. The survival of the Maryland-based company now depends on the successful delivery of an updated COVID shot this fall.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The state of digital phenotyping, plus this week's headlines

This week on "The Top Line," we discuss the state of digital phenotyping, plus the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines.
 

Resources

Research

Develop a cost-effective cGMP chemical sourcing strategy

The right sourcing strategy can help save of millions of dollars—learn about developing a strategy for sourcing the cGMP chemicals critical to your processes.
Whitepaper

Five Lessons from Biopharmaceutical Trials for MedTech Companies

Best practices from biopharma clinical studies for medical device manufacturers around the efficient collection and use of data to speed insights into product safety and efficacy
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
Whitepaper

Antibody-based drug discovery at the speed of light

Shave up to six months off the development timeline of a mAb candidate
eBook

Medical Affairs Metamorphosis

This eBook identifies the trends driving major change in the Medical Affairs (MA) function. It also outlines the strategic and tactical implications for MA leaders and team members.
eBook

6 Tools Trial Sponsors Need to Take Action Earlier in Enrollment

Take a look at the reporting tools sponsors need to access insights earlier in the clinical trial enrollment funnel, so you can take informed actions.
Whitepaper

Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
Whitepaper

Modern Software Development and Next Generation IRT

Modern software development and its impact on addressing clinical trial complexity.
Whitepaper

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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