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The CRO Awards recognize Contract Research Organizations (CROs) for their exceptional contributions to clinical research and development. These awards honor CROs that excel in innovation, quality, and leadership, highlighting their crucial role in advancing life sciences and improving patient outcomes. LEARN MORE AND ENTER
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Today’s Big NewsSep 6, 2024 |
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September 9-12, 2024 | Philadelphia, PA Join us at Digital Pharma East, the leading event for digital innovation in the pharmaceutical industry. Dive into key topics including Digital Marketing, Data & Analytics, and Patient Engagement. Learn from industry experts, network with peers, and explore cutting-edge strategies to drive your digital initiatives forward. Only 1 WEEK LEFT to Join us in Philadelphia!
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| By James Waldron,Eric Sagonowsky Zenas Biopharma has set out ambitions for a $200 million IPO to fund further studies of its Bristol Myers Squibb-partnered bifunctional antibody in an array of autoimmune indications. Meanwhile, cancer-focused biotech Bicara is seeking to land a similar haul to fund its own bifunctional antibody. |
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By Conor Hale A judge said the company didn't live up to the promises made in its 2019 acquisition, over milestone payments linked to the development of Auris' surgical robot. |
By Fraiser Kansteiner Next week, the U.S. House of Representatives is slated to consider the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with certain Chinese biotech equipment and service providers over national security concerns. |
By Angus Liu A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgAN into a full approval but left a liver toxicity monitoring requirement in place. |
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Shape the Future of Life Sciences Submissions for the Fierce Life Sciences Innovation Awards are coming to a close September 5th, 2024. Click to submit your entry for our new 2024 category: AI Innovation. Enter now!
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By Fraiser Kansteiner On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug. |
By Andrea Park Madrigal Pharmaceuticals broke new ground earlier this year as its Rezdiffra became the first drug approved by the FDA to treat metabolic dysfunction-associated steatohepatitis. Now, with its first marketing campaign for the drug, the company is hoping to direct patients toward that newly paved pathway. |
By James Waldron In a year that has already seen Connect Biopharma walk away from a Pfizer collaboration and halt its preclinical work, the biotech is now in the process of “significantly reducing” its presence in China. |
By Kevin Dunleavy Iterum’s sulopenem, which was initially rejected by the US regulator in 2021 as a treatment for uncomplicated urinary tract infections, is back for another swing, with a target decision date set for October 25. On Monday, an FDA advisory committee will put sulopenem under its microscope, fleshing out concerns that “inappropriate use” of the treatment could cause antimicrobial resistance, according to an FDA briefing document. |
By James Waldron Psyence Biomedical is paying $500,000 in shares to acquire fellow psilocybin-based biotech Clairvoyant Therapeutics and its phase 2-stage alcohol use disorder (AUD) candidate. |
By Conor Hale The medtech giant previously notified its customers of the issue in July, related to its McGrath MAC and MAC EMS video laryngoscopes. |
Fierce podcastsDon’t miss an episode |
| In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines. |
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Wednesday, September 24, 2024 | 11am ET / 8am PT In this webinar, we will explore how real-world healthcare data and artificial intelligence can provide key insights into the hidden aspects of patient journeys. Register now.
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| WhitepaperWe interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
| WhitepaperFinding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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