| Today’s Big NewsJun 13, 2024 |
| By Gabrielle Masson Pfizer’s phase 3 gene therapy trial has failed to demonstrate significant improvement in motor function for boys with Duchenne muscular dystrophy. |
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By Annalee Armstrong A week after an FDA committee declined to support an MDMA treatment for post-traumatic stress disorder, Lykos Therapeutics is looking to dispel some concerns about the therapy as the discussion has taken on a life of its own beyond the biotech world. |
By Gabrielle Masson With a former Kite leader at the helm, Santa Ana Bio has unveiled with $168 million and three precision medicine antibodies slated to enter the clinic next year. |
Sponsored by Montgomery County Economic Development Corporation 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. |
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Tuesday, June 25, 2024 | 11am ET / 8am PT Expanded Access Programs can help deliver life-saving access to critical medications. Join us for a deep dive into the benefits of EAPs in Europe. Learn how to leverage for achieving faster access to the European market, facilitating successful commercialization, and navigating the array of regulations and guidelines. Register now. 
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By James Waldron Barinthus Biotherapeutics has used positive interim data from a pair of phase 2 trials for its hepatitis B therapy as justification for sidelining its prostate cancer candidate and jettisoning a quarter of the T-cell-focused biotech’s workforce. |
By Nick Paul Taylor Ultragenyx Pharmaceutical's work to get the FDA to recognize a biomarker as a surrogate endpoint looks to have paid off. With the agency agreeing the biomarker is a reasonable surrogate endpoint, Ultragenyx is preparing to file for approval of its Sanfilippo syndrome gene therapy around the end of the year. |
By James Waldron AbbVie has become the latest Big Pharma to jump on the anti-TL1A train, paying China’s FutureGen Biopharmaceutical $150 million upfront for a preclinical inflammatory bowel disease candidate. |
By Helen Floersh Abbvie, Merck, Roche's Genentech, Sanofi and other big names in biopharma have signed on to a new project from the Digital Medicine Society’s Digital Health Measurement Collaborative Community that aims to set industry benchmarks for digital endpoints in clinical trials. |
By Zoey Becker The BIOSECURE Act was officially left off of the National Defense Authorization Act (NDAA), which was the expected first step to the bill's passage. |
By Fraiser Kansteiner As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along. |
Fierce podcasts Don’t miss an episode |
| In this week’s episode of “The Top Line,” the Fierce Pharma Marketing team discusses the annual top pharma drug ad spenders special report. |
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July 8-9, 2024 | Jersey City, NJ Hear the latest industry trends from leaders in the field, and developed with input from our esteemed advisory board, to ensure you have a sound plan for your company, brands, and yourself.
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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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