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Today’s Big News

Jun 21, 2024

Zealand lines up Novo challenger as ⁠backbone weight loss therapy after phase 1 data

Swiss biotech Melodia sings $275M song for Alivexis’ preclinical cathepsin C inhibitor

Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

Chutes & Ladders—Third Rock's cardiometabolic biotech unveils C-suite

‘We’re flying blind’: CDC has 1M bird flu tests ready, but experts see repeat of COVID missteps

Featured

Zealand lines up Novo challenger as backbone weight loss therapy after phase 1 data

By Nick Paul Taylor

Zealand Pharma is lining up a challenge to its compatriot Novo Nordisk. The Danish biotech’s CEO said obesity candidate petrelintide can be “the backbone of therapy for weight management” after reporting phase 1b data that suggest it may provide GLP-1-like efficacy without the side effects.

Swiss biotech Melodia sings $275M song for Alivexis’ preclinical cathepsin C inhibitor

By James Waldron

Switzerland’s Melodia Therapeutics has signed a $275 million biobucks deal to get its hands on Alivexis’ preclinical cathepsin C inhibitor.

Sarepta scores 'transformational' FDA label expansion for Duchenne gene therapy Elevidys

By Kevin Dunleavy

The FDA has expanded the label for Sarepta's Elevidys to all Duchenne muscular dystrophy patients ages 4 and older. It’s a major boost for the first gene therapy to treat the inherited disorder, which received an accelerated approval a year ago—nearly to the date—but only for ambulatory boys ages 4 to 5.

Revolutionizing cancer treatment: the potential of immune-modulating cancer vaccines

Chutes & Ladders—Third Rock's cardiometabolic biotech unveils C-suite

By Gabrielle Masson,Andrea Park,Fraiser Kansteiner

Third Rock Ventures’ Marea has unveiled with $190 million and Josh Lehrer, M.D., in the top spot.

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

By Ayla Ellison,Zoey Becker

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.

‘We’re flying blind’: CDC has 1M bird flu tests ready, but experts see repeat of COVID missteps

By Amy Maxmen, KFF Health News

As the outbreak grows—with at least 114 herds infected in 12 states as of June 18—researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing.

Fierce Pharma Asia—BioNTech's ADC clinical hold; Takeda's leukemia bet; China NMPA's meeting with FDA

By Angus Liu

BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. drug authorities met at the FDA's headquarters for the first time since 2017. And more.

Federal judge rules against HHS' 3rd-party web tracker policy for hospitals

By Heather Landi

A federal judge in Texas on Thursday ruled that guidance issued by the Biden administration that prohibits the use of third-party online tracking technologies on hospitals' public-facing webpages was unlawful.

Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention

By Angus Liu

For the first time, an HIV PrEP drug candidate has shown zero infections in a phase 3 trial. For Gilead, it serves as one of two pieces for a potential FDA filing. For GSK, it means a major competitor could be looming around the corner.

Fierce podcasts

Don’t miss an episode

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

Inside this year’s ASCO: Biggest data drops, trends and the best exhibit booth

Cybersecurity lessons from the Change Healthcare hack

Resources

Webinar

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.

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.

Presented by: Lonza

Whitepaper

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.

Sponsored by: Privacy Analytics, an IQVIA company

Whitepaper