| Editor’s note: Getting ready for #ASH22? Fierce Pharma will talk to Dr. Naveen Pemmaraju at MD Anderson in a Twitter chat about the latest advances in blood cancer. Search #FierceTalksASH starting at 4pm ET on Dec. 8 to join the conversation. Our team will also be on site in New Orleans to bring you fresh data from the annual conference. |
Today's Big NewsDec 8, 2022 |
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Thursday, December 15, 2022 | 11am ET/8am PT Join Aaron Miri and Amy Huveldt from Baptist Health, Jacksonville to learn how they are scaling disruptive, AI-based technology across the enterprise. During this webinar, Aaron and Amy will share best practices of a successful digital transformation as well as the results they have experienced system-wide. Register Now.
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| By Annalee Armstrong PwC is out today with its annual rundown of deals to date and what’s to come in the year ahead, finding that life sciences M&A volume was down by 48% this year while valuations plunged 28%. |
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By Fraiser Kansteiner Plaintiffs in the now-dismissed clutch of cases argued Merck's vaccine Zostavax caused their shingles. But the medical expert attempting to back up that claim failed to consider whether plaintiffs’ disease occurred naturally because they’d had chickenpox as kids, according to court filings published this week. |
By Andrea Park Ramesh “Sunny” Balwani was sentenced to nearly 13 years in prison for the part he played in defrauding investors and patients while helping lead blood testing startup Theranos, a federal judge ruled Wednesday. |
By Paige Minemyer Sign-ups for plans on the Affordable Care Act's exchanges reached 5.5 million during the first five weeks of open enrollment, according to the latest figures from CMS. |
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Thursday, December 15, 2022 |2:00pm ET / 11:00am PT This talk emphasizes the role of partnerships between early- and late-stream analytical assay developers while tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. We will be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics. Register now.
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By Kevin Dunleavy The odd saga of Oncopeptides' multiple myeloma drug—thriving in Europe while sidelined in the U.S.—continued Wednesday with the FDA requesting a withdrawal of the U.S. marketing authorization for Pepaxto. |
By Heather Landi Amazon will no longer support HIPAA compliance on its Alexa devices after launching a program three years ago for some hospitals and payers. |
By Annalee Armstrong Regeneron’s George Yancopoulos drew boos from the crowd at a conference in Washington, D.C., as he touted innovation in pharma above cost considerations for expensive treatments. |
By Andrea Park Dexcom is in seventh heaven: A year after its initial FDA submission, the diabetes tech maker has finally gotten the greenlight to begin rolling out its latest continuous glucose monitor system in the U.S. |
By Dave Muoio Regulators took a deep dive into the controlled substance records at Northeast Hospital Corporation, part of Beth Israel Lahey Health, in 2018 after the system reported 18,000 drug doses had been stolen by a pharmacy technician. |
By Andrea Park More than a year into its patent dispute with Apple over the heart-monitoring technology embedded in the tech giant’s eponymous smartwatch, AliveCor has been dealt a serious blow. |
By Zoey Becker After a positive opinion from regulators back in October, Takeda's dengue vaccine scored a green light from the European Commission. The approval sets up potential nods in other endemic countries. |
By Annalee Armstrong Novartis is hoping to be appointed leader in a rare blood disease, and the latest data that iptacopan increases hemoglobin levels in patients with a disease called paroxysmal nocturnal hemoglobinuria should help. |
By Conor Hale The company’s pair of Elecsys tests—used to determine the ratio between the hallmark proteins known as amyloid beta and tau—are designed to help screen adults age 55 and older who are being evaluated for the condition. |
By Gabrielle Masson As the FDA prepares updated guidance on ways to boost clinical diversity for research trials, the agency’s head is urging administrators to prioritize the issue. |
Fierce podcastsDon't miss an episode |
| | This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. |
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This playbook looks at why insolubility is an issue, and the properties that affect solubility, such as the molecule’s structure; its physical attributes (particle size and dissolution rate); its chemical attributes, including compatibility with excipients; and its biological properties. Download now.
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| VideoRevolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
| 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 |
| WhitepaperPreparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
| 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 Strategies to help scale-up for commercial manufacturing are critical to getting cell and gene therapies to patients as more advanced therapies reach late-stage clinical studies and regulatory decisions. Sponsored by: Catalent |
| WhitepaperHow 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 |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
| 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 |
| WhitepaperExplore 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 |
| WhitepaperLearn 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 |
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