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Liquid biopsy tests offer a promising alternative to existing screening methods and the potential to develop cancer detection tests for previously unscreened indications. Due to the risks of false positives and negatives, these tests face stringent regulatory scrutiny, typically following the pre-market approval (PMA) pathway and requiring costly, large-scale validation studies. Download our guideto learn more. +114x60.png)
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Today’s Big NewsJun 21, 2024 |
| 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. |
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By James Waldron Switzerland’s Melodia Therapeutics has signed a $275 million biobucks deal to get its hands on Alivexis’ preclinical cathepsin C inhibitor. |
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. |
Sponsored by IO Biotech Historically, most cancer vaccine trials have fallen short. What is the potential of new vaccines that can dismantle cancer cells' defenses? |
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September 30- October 1, 2024| Boston, MA The Fierce New Product Planning Summit is the only conference focused on how life science professionals make informed, value-based, data-driven decisions about pipeline products. Experts gather annually to discuss resource utilization and key questions for commercial success. Stay Updated! 
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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. |
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. |
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. |
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. |
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. |
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 |
| 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. |
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Webinar 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. Sponsored by: Aldevron |
Whitepaper 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 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 This paper outlines the challenges, pitfalls, & solutions associated with adding rare disease therapies to a biopharma company’s portfolio. Sponsored by: AIM, the strategic leader in life science supply chains |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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