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Today's Big NewsMar 2, 2023 |
| By Max Bayer FDA advisers endorsed the safety and efficacy of GSK's respiratory syncytial virus vaccine in older adults. But advisers expressed concerns with some safety signals and the lack of long-term data. |
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By Nick Paul Taylor MorphoSys’ preclinical team has paid the price for its commercial failures. The biotech, once an engine of innovation for Big Pharma, is stopping all preclinical work and laying off 17% of its staff to throw all its resources behind mid- to late-stage oncology programs. |
By Max Bayer The incessant pace of biotech layoffs continues unabated, with G1 Therapeutics disclosing significant cuts to its staff and Sorrento filing a notice that more than 500 jobs could be on the line. |
Sponsored by North Carolina Biotechnology Center Growth in North Carolina’s life sciences has outpaced most U.S. life sciences hubs. Top talent, infrastructure, and business-friendly climate are why companies are choosing the Tar Heel state. |
By Gabrielle Masson Flamingo Therapeutics is standing on one leg no more, as Dynacure folds into the biotech in a merger agreement that will see the combined company work on RNA-targeted oncology therapies. |
By James Waldron In another sign that Boston continues to wear the U.S. biotech crown, Novo Nordisk will expand its R&D presence in the area at the expense of its Indianapolis and Seattle facilities. |
By Annalee Armstrong Eli Lilly will take the baton on developing a peripheral pain candidate from Confo Therapeutics, handing off $40 million upfront and a potential $590 million total down the track if all goes well. |
By Nick Paul Taylor Inovio’s attempt to make its phase 3 trial better ended up making it worse. Eleven months after changing the primary endpoint of its late-phase cervical dysplasia study, the DNA medicine specialist has revealed the study failed against the new measure—but hit the mark on the old endpoint. |
By Max Bayer Two biotechs are shoring up their pipelines and commercial aspirations, tacking on a clinical-stage rare disease and preclinical cancer med, respectively. |
By Fraiser Kansteiner After last year’s “Free Insulin” Twitter debacle prompted Eli Lilly to do some soul searching over the cost of its insulin in the U.S., the Indianapolis-based company has come back from the drawing board with a major discount in hand. |
By Andrea Park Bigfoot Biomedical is aiming to leave even bigger tracks across the diabetes management tech landscape. |
By Fraiser Kansteiner While 2022 was a doozy for many in the biopharma industry, 2023 isn’t looking any easier, forcing drugmakers to adapt to enduring challenges including inflation, COVID-19 and the war in Ukraine. |
By Joseph Keenan Health tech firm Clario is linking with tech start-up ArtiQ with the aim of leveraging AI for improved patient benefits and solidifying the certainty of data collection in respiratory trials that require spirometry data. |
By Kevin Dunleavy In 2018, Roche's patents protecting a method for manufacturing antibodies finally expired. But the company is still trying to collect the last bit of royalties that it believes are due. Tuesday, Roche filed suit against Biogen, claiming that it is owed royalties on sales of Biogen’s multiple sclerosis blockbuster Tysabri. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Whitepaper Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here. Sponsored by: Aldevron |
Whitepaper This paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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 |
Research Like 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 |
Whitepaper Learn 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
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 |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
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 |
Whitepaper For 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 |
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 |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper How 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 |
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 |
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 Planning 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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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