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Thursday, March 23, 2023 | 10am ET / 7am PT In this webinar, we will discuss customer-centric digital innovations that are improving overall process, product quality and performance, as well as transforming CDMO relationships. Register now to learn more!
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Today's Big NewsMar 10, 2023 |
| By Annalee Armstrong,Max Bayer,Gabrielle Masson Silicon Valley Bank’s capital raise of $2 billion has sent shockwaves across the biotech industry and spurred a panic among some top venture capital firms that are urging their companies to withdraw deposits. |
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By Andrea Park Though the FDA has long been aware of the risk that some people with breast implants may develop a rare form of T-cell lymphoma—now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and tracked by the regulator since 2011—the agency has only recently begun warning about other cancer risks linked to the implants. |
By Kevin Dunleavy The key prize in Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals was blockbuster-to-be migraine pill Nurtec OTC. Now, five months after competing the purchase, Pfizer has taken a nasal spray version of the treatment across the FDA finish line. On Friday, the regulator signed off on Zavzpret (zavegepant) for both the treatment and prevention of migraine headaches in adults. |
By Andrea Park Laura Perryman, the former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud insurers. |
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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinar to hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now.
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By Zoey Becker After a long legal battle against a web of fraudsters who allegedly abused Gilead's free PrEP drug program, a Florida judge has issued default judgements against two groups of defendants. |
By Nick Paul Taylor Vyne Therapeutics is putting its mash-up of Pfizer’s Xeljanz and Novartis’ Gilenya on the back burner. After sifting through the data from a failed midphase eczema trial, the biotech has begun searching for a partner for the program to free up its own cash for development of its BET inhibitors. |
By Eric Sagonowsky Novartis may be in the process of spinning out its generics and biosimilar outfit, Sandoz, but that doesn't mean the latter company is pausing manufacturing investments. The generics and biosimilar player revealed plans for a $400 million plant in Slovenia. |
By Andrea Park The FDA’s nascent Safer Technologies Program, or STeP, is getting a major glow-up. |
By Annalee Armstrong,Gabrielle Masson,Max Bayer We had hoped that our Layoff Tracker would stay retired for a while, but 2023 is starting to look a lot like our old friend 2022 when it comes to layoffs in biotech. |
By Teresa Carey This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we take on AI and machine learning in the pharma and healthcare universe. The expectation is that these tools will speed up innovation and open up new markets, helping the sector stay ahead of the curve. Plus, this week's headlines. |
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Tuesday, March 21, 2023 | 11am ET / 8am PT Today’s clinical trials are longer and more complex than ever. Sponsors, sites, and patients need technology that is practical, easy to use, and strengthens studies’ scientific integrity. This webinar will explore how approaches from B2B and consumer technologies can be leveraged to streamline processes, deliver quality outcomes data, and more. Register now.
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| Executive SummaryRead about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
| WhitepaperHave you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
| Whitepaper Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success. Sponsored by: Herspiegel Consulting |
| ResearchLike many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| Case Study 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 |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. 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 |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. 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 |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. 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 |
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