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When the world is changing, you need a global CDMO with a strong global presence to protect your molecule. Our team of experts help progress any molecule type, however complex, from pre-clinical to commercial.
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Today’s Big NewsSep 16, 2024 |
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Tuesday, September 24, 2024 | 2pm ET / 11am PT The transition from clinical to commercial supply chains is a pivotal challenge for life sciences organizations today. Join us for this important and timely discussion with industry experts for a deep dive into the scaling of logistics operations, and how to successfully navigate the complexities. Register now.
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| By Kevin Dunleavy Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss, or lebrikizumab, to treat atopic dermatitis. |
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By Gabrielle Masson After announcing a phase 3 launch based on positive midstage results, iTeos and GSK are finally sharing the highlights from the phase 2 TIGIT trial, revealing a more than 30% difference in confirmed overall response rates between the investigational treatment versus monotherapy. |
By Nick Paul Taylor AstraZeneca has shared an early look at the performance of its in-house antibody-drug conjugate technology, publishing phase 1 data on candidates that could compete with molecules from AbbVie and Pfizer. |
By Angus Liu In 2021, the FDA blasted Merck for using premature data to pursue a Keytruda approval in early-stage triple-negative breast cancer. Now, the PD-1 inhibitor has gold-standard overall survival data to back its case. |
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Thursday, September 25, 2024 |11am ET / 8am PT In the fast-evolving field of cell and gene therapy, overcoming bottlenecks at every stage of the process is crucial. Join us to learn about best practices, innovative solutions, and strategies to enhance efficiency in cell and gene therapy manufacturing, management, and delivery. Register now.
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By Nick Paul Taylor Cancer patients with wasting syndrome have gained weight after taking Pfizer’s anti-GDF-15 antibody in a midphase study, emboldening the Big Pharma to target a 2025 start date for its pivotal trial program. |
By Conor Hale Presented at the annual meeting of the European Society for Medical Oncology, Exact Sciences said the latest findings may put its upcoming blood screener in the same realm as a fecal immunochemical test in the detection of advanced precancerous lesions. |
By Angus Liu More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important disease areas—first-line non-small cell lung cancer. |
By Gabrielle Masson Regeneron is back with long-term follow-up results for its LAG-3 inhibitor and PD-1 inhibitor combo in advanced melanoma, phase 1 findings that have prompted the company to launch four phase 3 programs with the intent to rival Bristol Myers Squibb's Opdualag. |
By Nick Paul Taylor Bristol Myers Squibb has jettisoned another cancer candidate in-licensed under its former CEO. Immatics is the latest partner to get a termination notice, leaving it in full control of a bispecific molecule that BMS picked up for $150 million upfront late in 2021. |
By Nick Paul Taylor PhRMA is pushing the FDA to expand drug manufacturers’ powers to correct misinformation about their products, including by allowing them to respond to opinions, value judgments or personal experiences and communications made offline. |
By Fraiser Kansteiner Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval. |
By Zoey Becker A New Jersey judge ruled that Sandoz is owed damages in a yearslong dispute with United Therapeutics over the latter's market restriction of a generic to its pulmonary arterial hypertension therapy Remodulin. |
By Andrea Park Cologuard has gone bilingual. The popular mail-in colorectal cancer screening test from Exact Sciences has a new campaign out Monday that marks the first Spanish-language promotional push for the brand. |
By James Waldron Novo Nordisk isn’t letting up on the RNA deals, this time penning a $530 million biobucks deal to work with Korro Bio on two cardiometabolic-related targets. |
By Nick Paul Taylor Almirall has rolled out a new campaign for World Atopic Eczema Day, kicking off its “The True Colours of Atopic Dermatitis” initiative to raise awareness of the mental burden of skin diseases. |
By Andrea Park Palisade Bio is fortifying its brand image. The California-based biotech on Monday unveiled a new logo and website design, while also doubling down on its commitment to advancing its lead candidate in ulcerative colitis. |
Fierce podcastsDon’t miss an episode |
| | In this week's episode of "Podnosis," we look at how practice management companies are meeting the evolving needs of healthcare providers. |
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Who’s Leading the Way in Clinical Research? Nominate Them for the CRO Awards! The Fierce CRO Awards shine a spotlight on the organizations that are setting new standards in clinical research and development. If your CRO excels in innovation, quality, and leadership, it’s time to get the recognition you deserve. Submissions close October 3rd. SUBMIT NOW
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On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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