| Today's Big NewsNov 17, 2022 |
| By Max Bayer Editas is struggling to keep pace with its counterparts in the gene-editing field, announcing its lead asset would be shelved while it searches for a partner. Updated data from the company's phase 1/2 trial for EDIT-101 found that it was most effective in a very small population with little market upside. |
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By Nick Paul Taylor Astellas Pharma’s $1.3 billion oncology bet has delivered a phase 3 win. The clinical trial linked the anti-CLDN18.2 antibody zolbetuximab to improved progression-free survival, moving Astellas a step closer to filing for approval. |
By Gabrielle Masson GSK is doubling down on a retreat from the land of T-cell receptors, terminating a partnership with Immatics that held the potential for up to $600 million in biobucks. |
Sponsored by Phreesia Life Sciences While the industry has yet to address a big barrier to trial enrollment—low patient knowledge—the good news is that patients want to learn more, according to survey data from Phreesia Life Sciences. |
By Nick Paul Taylor Pfizer and BioNTech have opened another front in their push to develop a better COVID-19 vaccine. After moving a shot with an enhanced spike protein design into the clinic, the partners have now set out to turn another arm of the immune system against the virus by trialing a T-cell enhancing vaccine prospect. |
Sponsored by ThermoFisher Scientific Every mRNA manufacturing process step adds complexity and cost, so it’s important to ensure steps are compatible and integrated with each other. Explore each intertwined step in this infographic. |
By Annalee Armstrong Cytomx was in need of a project after abandoning its one and only clinical asset and embarking on a pipeline rebuild. Enter Regeneron, with a research pact to create new bispecific cancer therapies in a deal that could top out at $2 billion. |
By Joseph Keenan Oncology-focused CRO OncoBay has signed up to use physIQ’s latest patient monitoring system to track participants during their clinical trial journey. |
By Fraiser Kansteiner Dipal Patel, who’s served as global commercial head of GSK’s shingles vaccine since 2019, has decamped for Valneva. At the French biotech, she’ll fill the newly minted role of chief commercial officer. |
By Conor Hale The FDA cleared an AI program to screen for the early signs of diabetic retinopathy, a major cause of blindness among people with Type 1 or Type 2 diabetes. |
By Robert King A new survey shows a majority of adults in a family with Medicaid enrollees could lose eligibility when states start coverage redeterminations. |
By Angus Liu The FDA is dealing one more blow to Clovis Oncology. Just as the PARP player warns of a possible imminent bankruptcy, the U.S. regulator is looking to narrow Rubraca's use with a market restriction request. |
By Andrea Park Just a few weeks after beginning a voluntary recall of the remote-control devices used with some of its insulin pumps—and warning that the safety action would take a multimillion-dollar hit to its bottom line—Insulet has received an FDA ruling on the matter. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we share some highlights from Fierce Biotech's Cell and Gene Therapy Forum in case you missed it. |
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Tuesday, December 6, 2022 | 10am ET / 7am PT The development of therapeutic antibodies has been challenged by the difficulty to generate such intricate molecules. Here, we show that ProBio has established proprietary fast CMC platform guaranteeing the delivery of monoclonal antibody with high titer. 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 |
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 |
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 |
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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 |
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Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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