| Today's Big NewsMar 17, 2023 |
| By Zoey Becker After a late January round of layoffs affecting 300, Amgen axed another 450 jobs citing drug pressure and inflation. The cuts come after an investor lawsuit alleging the company hid a massive $10.7 billion tax bill from its investors. |
|
|
|
By Max Bayer A year after ARPA-H was unveiled, the agency is finally set to take off. But a critical question remains unanswered: What research will the agency invest in? |
By Andrea Park Health tech investors and companies shopping for a new M&A target this year may want to check out the produce section. |
By Kevin Dunleavy In a span of less than three weeks, Eli Lilly, Novo Nordisk and Sanofi have announced price cuts of their insulins in the U.S. Sanofi was the latest to fall in line, saying Thursday that it would slash the price of its most popular insulin, Lantus, by 78% and capping the out-of-pocket cost at $35 per month for all patients with commercial insurance. |
By Nick Paul Taylor A sudden change of heart at the FDA has sunk Sarepta’s stock. Two weeks after saying the FDA would assess its gene therapy without an advisory committee meeting, Sarepta has revealed the agency will now convene experts to dig into the data on its Duchenne muscular dystrophy (DMD) submission. |
By Andrea Park Heart monitor maker iRhythm is marching to a new beat. |
By James Waldron Acer Therapeutics’ ambitions for menopause drug osanetant have hit a roadblock after the candidate failed to reduce hot flashes in a mid-stage trial, missing the primary endpoint. The news comes at a bad time as the biotech hunts for cash to keep operations going. |
By Angus Liu Astellas and Pfizer's Xtandi has been selling for over a decade, and the blockbuster androgen receptor inhibitor is still learning a new trick. |
By Max Bayer Gossamer bio took a few steps forward in December when a high blood pressure med passed a phase 2 trial. But now, the biotech is taking a couple of steps back with news that enrollment is being paused for its second clinical-stage asset due in part to the med’s risk-benefit profile. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss the SVB failure, what to expect next and what it all meant for the biotech industry. We also cover Pfizer's big acquisition, insulin prices and more of this week's top headlines. |
|
|---|
|
|
|
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. 
|
|
Whitepaper Preparation 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 |
Executive Summary Read about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines. Sponsored by: Twist Bioscience |
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 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 |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? 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 |
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 |
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 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 |
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 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 |
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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
|
|
| |
|
