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Cell therapy developers face many challenges as they transition from benchtop to bedside.Here we examine when and how to consider transitioning from research-use-only to animal-free (AF) and GMP critical reagents. Download now.
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Today’s Big NewsJul 8, 2024 |
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September 25-27, 2024 | Philadelphia, PA Join the Fierce Clinical Summit, the premier event for clinical research and trial management. Explore topics in Clinical Operations, Quality, and DCT & Technology. Learn, network, and connect with peers to advance industry standards and innovations in clinical trials. Secure your pass today!
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| By Nick Paul Taylor Eli Lilly has agreed to buy Morphic for $3.2 billion, giving the Big Pharma control of an oral, midphase challenger to Takeda’s injectable inflammatory bowel disease blockbuster Entyvio. |
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By Eric Sagonowsky Boehringer Ingelheim joins AstraZeneca, J&J and Bristol Myers Squibb in having a case challenging Medicare price negotiations fail to bear fruit. Lawsuits from Novo Nordisk, Merck and Novartis are still pending. |
By Angus Liu Novo Nordisk’s popular GLP-1 analog semaglutide may be linked to a vision loss disorder, a study suggests. But one team of analysts cautioned against reading too much into the analysis. |
By Conor Hale With a new go-ahead from antitrust regulators in the U.K., Thermo Fisher Scientific is on its way to closing its $3.1 billion deal for Olink, the Swedish developer of protein analyzers, antibody tests and research services. |
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Dive into the cutting-edge world of recombinant antibody engineering, from optimizing your antibody plasmid to antibody maturation and humanization. Explore innovative techniques and strategies that enhance antibody efficacy, paving the way for breakthroughs in therapeutic development. Download now.
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By Nick Paul Taylor Keytruda has beaten Roche’s TIGIT drug candidate at the first interim analysis of a phase 2/3 lung cancer trial, prompting the Swiss drugmaker to stop the study and consider changes to the broader program. |
By Nick Paul Taylor The U.K.’s drug marketing watchdog has slammed Novo Nordisk for failing to disclose transfers of around 7.8 million British pounds ($10 million) to more than 150 bodies. |
By Conor Hale The deal includes an upfront transfer of $81 million, including about $65 million in cash—plus the opportunity for up to $385 million more in sales-based milestone payments. |
By James Waldron HilleVax's stock took a nosedive after the vaccine biotech’s sole clinical-stage candidate failed a phase 2b trial in norovirus-related acute gastroenteritis. |
By Kevin Dunleavy Since Roche gained approval for its eye disease medication Vabysmo in 2022, it has stormed a market dominated by Regeneron and Bayer’s Eylea. Roche has taken another step in its advancement of the blockbuster medicine, scoring an FDA nod to provide it in a prefilled syringe. The 6-mg, single-dose shot will give doctors a simplified, ready-to-use alternative to extracting Vabysmo from a vial. |
By Fraiser Kansteiner A U.S. appeals court has tossed a request to resurrect certain lawsuits claiming Merck’s popular shot Zostavax caused patients to develop shingles. The court made its decision after the plaintiffs filed a voluntary dismissal some two years after logging a loss in Pennsylvania. |
By James Waldron When it comes to the red-hot antibody-drug conjugate space, Big Pharmas have tended to head to China to build up their pipelines. But U.K.-based Myricx Bio has caught the eye of a crop of major investors courtesy of its unique science |
By Andrea Park The Skin of Color Society (SOCS) has begun rolling out a new series of videos tackling misconceptions around and nuances in how skin diseases and conditions affect people with darker skin tones. |
By Andrea Park A recent survey shows that many people have less than 20/20 vision when it comes to spotting symptoms of and statistics about dry eye. With the launch of a new online hub, however, Bausch + Lomb is aiming to improve that outlook. |
By Conor Hale After developing its tech for use outside cardiology, Pulse Biosciences has received a boost from the FDA to adapt its approach for atrial fibrillation. |
Fierce podcastsDon’t miss an episode |
| | This week on "Podnosis," Anastassia Gliadkovskaya explores how Jefferson Health's new pavilion incorporates innovative, inclusive features for neurodivergent individuals. |
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Implementing effective corrective and preventive actions (CAPAs) to address rejects is essential to meeting regulatory requirements and to improving the manufacturing of sterile dosage forms going forward. This report examines the causes of high reject rates in sterile dosage manufacturing and describes how biopharmaceutical developers and CDMOs can work together to develop a strong CAPA strategy. Download now.
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| WhitepaperIn this white paper, Lonza experts delve into the common challenges encountered by ADC developers. They explore new drug product capabilities in relation to cytotoxic drug development and manufacturing, therefore fully completing Lonza’s integrated ADC offering. Further, they discuss how this end-to-end approach can significantly accelerate the timeline to investigational new drug filing and beyond. Read this white paper to learn more. Sponsored by: Lonza |
| WhitepaperThe definitive report on the state of our industry. Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond. Sponsored by: AVANT BIO |
| WhitepaperIn a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers. Sponsored by: Blue Matter, strategic consultants in the life sciences |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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