| Editor's note: Fierce Biotech will not publish on Thursday or Friday in observance of the Thanksgiving holiday. We'll be back in your inbox on Monday, Nov. 28. |
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Wednesday, November 30, 2022 | 11am ET / 8am PT In this webinar, we will show how data centricity, digitalization and automation streamlines CMC content authoring and why it is the most viable solution to tackle the associated challenges. Register now.
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Today's Big NewsNov 23, 2022 |
| By Nick Paul Taylor Novartis and Medicines for Malaria Venture have hit go on the phase 3 development of a novel combination therapy, hustling the solid dispersion formulation toward the final R&D hurdle on the strength of evidence it may kill drug-resistant forms of the parasite. |
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By Max Bayer Discussions surrounding the acquisition of Mirati have reignited, according to a new report from Bloomberg. The San Diego biotech is working with an advisor and large pharmas are considering the financial details, although no formal offer has been made, according to the outlet. |
By Nick Paul Taylor Mesoblast has established another pillar of the evidence it thinks will support a second run at the FDA, touting long-term data from the study at the center of its rejected application as the key to its planned resubmission. |
By James Waldron Once the hottest ticket for an ambitious biotech to go public, special purpose acquisition company (SPAC) deals almost died out earlier in the year. But there has been a steady trickle in recent months, with NewAmsterdam Pharma Co. the latest to take the blank-check route. |
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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now.
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By Gabrielle Masson Wanbang Biopharmaceuticals is expanding a years-long partnership with Canadian biotech Sirona Biochem for global licensing rights to an investigational non-insulin diabetes treatment for both people and animals. |
By Zoey Becker CSL Behring and uniQure's newly approved hemophilia B gene therapy, Hemgenix, comes with an eye-popping price tag of $3.5 million. The one-time treatment can replace regular prophylactic infusions of factor IX replacement therapy for patients. |
By Andrea Park Nearly a year-and-a-half into Philips’ recall of about 5.5 million of its CPAP and BiPAP machines and other respiratory devices, complaints about the affected machines are still rolling in. |
By Kevin Dunleavy Three months after gaining its first worldwide approval for its dengue fever vaccine, Takeda is progressing toward a blessing from the FDA. As the European Commission is expected to hand out an approval, the shot has received a priority review from the FDA. |
By Robert King A collection of patient and consumer groups is pressing the FTC to examine the role of group purchasing organizations in supply chain problems. |
By Andrea Park Masimo has declared racial bias a non-issue in its flagship SET pulse oximeter: Study results published this month found no clinically significant difference in the device’s accuracy when used on both Black and white patients. |
Fierce podcastsDon't miss an episode |
| This week on “The Top Line,” we share this week's headlines and discuss the 2022 honorees in our annual Fiercest Women in Life Sciences report. |
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Tuesday, November 29, 2022 | 2pm ET / 11am PT Process development of RNA-LNPs can be time consuming, cost prohibitive and require deep expertise in a field that is very dynamic and accelerating fast. Outsourcing gives you direct access to infrastructure, experience, and a team who has done this before and can quickly generate meaningful data taking the guesswork out of process development. Register now.
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| WhitepaperLearn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Thermo Fisher Scientific |
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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 |
| WhitepaperRead 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 |
| WhitepaperThis 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 |
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| WhitepaperWhat is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent |
| ResearchLearn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent |
| WhitepaperHow can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
| WhitepaperLearn 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 |
| WebinarYpsomed 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 |
| WhitepaperClarus 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 |
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