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The BD FACSymphony A5 SE Cell Analyzer adds high-sensitivity detectors to detect the full spectrum of emitted light. Unmix spectral data live, all while retaining the flexibility of familiar compensation-based workflows. Learn more.
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Today's Big NewsNov 8, 2022 |
| By James Waldron BioMarin’s hopes for bringing its hemophilia gene therapy to market remain just out of reach, with the FDA now requesting a look at its manufacturing site and long-term phase 3 data. |
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By Max Bayer Adaptimmune is cutting staff and culling assets as it looks to prioritize a push for FDA approval of its lead asset. The cutbacks come as the company is delaying clinical readiness of its allogeneic program to swap out the cell lines. |
By Annalee Armstrong ADC Therapeutics seems to have run headlong into the FDA’s new strict policy on accelerated reviews: Get your confirmatory study in line before filing, or wait. |
By Gabrielle Masson Insilico Medicine is radiating heat amid the biotech winter, kindling its fires with a Sanofi collab that could be worth up to $1.2 billion in biobucks—the AI drug discovery company’s largest deal to date. |
By James Waldron The efficacy of GSK's hepatitis B treatment may have dropped by over 60% between the interim and end-of-study analysis, but the Big Pharma is still hopeful the antisense oligonucleotide treatment will provide a functional cure for the infection. |
By Gabrielle Masson Zenas BioPharma has raised a $118 million series B to zoom in on a pipeline of immune-based therapies and launch a phase 3 for its lead candidate that was licensed from Xencor less than a year ago. |
By Nick Paul Taylor Galecto is trying to build out the case for its severe liver disease candidate GB1211, presenting phase 1/2 data linking the small-molecule inhibitor of galectin-3 to reductions in several enzymes in post hoc analyses. |
By Robert King As Republicans appear poised to take control of at least one chamber of Congress, experts say GOP lawmakers could scrutinize implementation of the Inflation Reduction Act. |
By Andrea Park With FDA clearance secured for its Bluetooth-connected insulin dose-tracking technology, Eli Lilly is ready to pick up the tempo. |
By Zoey Becker Nearly two years after the rollout of COVID-19 vaccines, risks such as myocarditis are still being assessed. Researchers found that the risk of myocarditis is greater after a second dose of Moderna's shot compared with Pfizer/BioNTech's competing vaccine. |
By Fraiser Kansteiner Even though Bayer achieved gains across all three of its business sectors for the third quarter of 2022, the company has had to "contend with the current unfavorable business environment,” Bayer CEO Werner Baumann told investors on a conference call Tuesday. |
By Conor Hale The goal is to link patient records with ECG data to provide personalized cardiovascular care. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring. |
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Tuesday, November 15, 2022 | 1pm ET / 10am PT In this webinar, learn how Medable is focused on improving access to clinical trials for patients, supporting the innovation of clinical trial delivery and offering greater choices for participation and engagement to patients. Register now.
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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Research Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives Sponsored by: Allucent |
Whitepaper Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: JLL |
Research Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives Sponsored by: Allucent |
Whitepaper This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success. Sponsored by: Blue Matter |
Video Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video. Sponsored by: Thermo Fisher Scientific |
Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent |
Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
Webinar Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics |
Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent |
Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored By: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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