| | | Editor’s note: This is the last regular edition of Fierce Biotech for 2022. The Fierce team will now be on a publishing break until Jan. 3, but check your inbox tomorrow for a recap of our Top 10 stories of the year. Be sure to check www.fiercebiotech.com for the biggest headlines until we return. Enjoy your holiday season, and best wishes for the coming year. |
| Tuesday, January 24, 2023 | 11am ET / 8am PT UGTs are the most common enzymes involved in metabolism after CYP enzymes, followed by numerous hydrolases, carbonyl reductases, aldehyde oxidase and other enzymes. Hear Dr. Brian Ogilvie discuss case studies and strategies to address non-CYP related metabolism questions in your drug’s safety assessment. Register now.
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Today's Big News Dec 22, 2022 |
| Jan 11, 2023 | 2:00pm ET Recent advances in natural language processing (NLP) caused an explosion of practical use cases that have now become viable. This webinar for healthcare & life sciences leaders surveys common NLP applications that are being widely deployed, including real world data extraction from pathology & radiology reports, patient risk adjustment & HCC coding, and more. Register now.
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| | | By Annalee Armstrong,Max Bayer,Gabrielle Masson After a brutal year in the markets that saw companies slashing programs, culling staff and reorganizing, the industry is much leaner and preparing to find its voice again. |
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| By Annalee Armstrong A third patient death potentially tied to Eisai and Biogen’s Alzheimer’s disease drug lecanemab has been reported in a phase 3 extension study, according to a report from Science. |
| By Annalee Armstrong In one of the most lopsided biobucks deals this publication has ever seen, Merck & Co. is offering $175 million upfront to Kelun-Biotech for seven antibody-drug conjugates, plus an eye-popping $9.3 billion in potential milestones on the tail end. |
| Sponsored by Allucent We discuss how small and mid-sized biotechs can succeed at the start of their first clinical trials. We go in-depth about biotech industry innovation and how companies are bringing value to the industry currently, and how they can add value if they aren’t already. |
| By Max Bayer A leak of the Whitehead Institute's investigation into David Sabatini has come to light, detailing claims against the former MIT professor. The report concluded that Sabatini fostered a toxic culture in his lab and interfered in the institute's investigation. |
| By Annalee Armstrong ORIC Pharmaceuticals now has enough cash to run operations through the first half of 2025 thanks to a $25 million equity investment and a new clinical partnership with Pfizer. |
| By Annalee Armstrong RNA expert ProQR Therapeutics is ending a tough year on a high note thanks to a $75 million expansion of a genetic medicines partnership with Eli Lilly. |
| By Gabrielle Masson Lexicon Pharmaceuticals has missed the mark in a phase 2 aiming to treat a common complication of shingles known as postherpetic neuralgia. However, the Texas biotech is standing by its therapy, saying the trial still demonstrates “clear evidence of effect.” |
| By Frank Diamond The FDA yesterday approved Roche’s monoclonal antibody medication for use in patients hospitalized with severe COVID-19. The move comes as the effectiveness of other such medications wane in the face of new subvariants. |
| By Andrea Park Nearly two years after Philips first publicly raised concerns about the potential breakdown of the polyester-based polyurethane foam found in many of its CPAP and BiPAP machines and other respiratory devices, the company has wrapped up safety tests of some of its machines. |
| By Zoey Becker It's no question that Gilead is on top of the HIV game, but throughout the HIV epidemic, one patient population has been left out. The FDA approved Gilead's lenacapivir, a long-acting HIV injectable, for patients whose virus is resistant to multiple drugs. |
| By Conor Hale Sysmex received approval within the country for a two-step test kit that gauges the ratio between two beta amyloid proteins in the bloodstream. |
| By Fraiser Kansteiner Teva, Zydus, Macleods and Amneal are struggling to supply a range of copycat Tamiflu doses in both capsule and powder suspension format, the American Society of Health-System Pharmacists (ASHP) reported in early December. |
| By Robert King A new spending package gives states a concrete deadline of April 1 to start Medicaid eligibility redeterminations. Here's what that means for states and what strings are attached. |
Fierce podcasts Don't miss an episode |
| | | This week on “The Top Line,” we discuss the medtech industry’s highest paid CEOs. Plus, we cover Theranos' COO's prison sentence, highlights from the American Society of Hematology annual meeting and other top headlines from this week. |
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| Tuesday, January 24, 2023 | 11am ET / 8am PT Your CRO is a finalist in a project bid and clinical supplies are one of the aspects that you will manage on behalf of the client via a partner. 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 |
| Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
| Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
| Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
| Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
| Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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