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Tuesday, February 7, 2023 | 11am ET / 8am PT This session will focus upon understanding your knowns and unknowns, best practices for mitigating risk, and addressing the specific drug supply challenges commonly associated with complex trial designs. Register now. 
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Today's Big NewsJan 31, 2023 |
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Thursday, Feb 16, 2023 | 2:00pm ET During this session, NetApp will explore how data is leveraged in Life Sciences to create a data fabric strategy that’s aligned to your business. This includes how to detailing each cycle of the data foundation for data governance and quality, data accessibility, data platforms, data as a service, data as a business, predictive intelligence, optimizing how solutions are managed across the data lifecycle, and more. Register now. 
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| By Robert King CMS finalized a new rule to overhaul risk adjustment audits performed on Medicare Advantage plans, including adding several changes that could draw the ire of insurers. |
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By Angus Liu In an unusual move, the FDA requested an expanded approval of breast cancer drug Ibrance from Pfizer. And the New York pharma won the go-ahead without additional clinical efficacy data. |
By Andrea Park Just a few months after it began a recall of more than 1 million hemodialysis catheters that were found to be at risk of leakages, Medtronic has spotted the same issue in yet another model of its catheters. |
By James Waldron You might have assumed that given the $2 billion launch of Altos Labs—and all the buzz the startup garnered by poaching GSK veteran Hal Barron to become CEO—that funding in longevity research would be sky high in 2022. But a new report suggests otherwise. |
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Tuesday, Feb 28, 2023 | 11:00am ET The heavy lifting for the pharmaceutical industry to comply with the November 2023 DSCSA go-live date is still ongoing. One item now finalized is to ensure that the required data exchange through the supply chain is only done with trusted, authorized, and registered trading partners. Join us for this discussion to stay up-to-date on this important legislation and be prepared for compliance. Register now. 
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By Zoey Becker After an FDA approval way back in 2016, Amgen's Amjevita is finally available in the U.S. Amgen went with two different price options for the launch, but based on history, the lower-priced option might not be as popular. |
By Heather Landi The White House plans to end the COVID-19 national emergency and public health emergency on May 11, the Biden administration said Monday. |
By Andrea Park A month after landing Canadian approval for its updated neuromodulation implant to treat incontinence, Axonics is bringing the fourth-generation R20 device across the border. |
By Gabrielle Masson In the pandemic's third year, Pfizer could do whatever it wanted thanks to billions reaped from the COVID-19 shot Comirnaty and antiviral Paxlovid. Instead, executives are signaling a somewhat restrained approach, cutting rare disease assets, seeking external partnerships and bumping up the R&D budget by 8.7% for 2023. |
By Kevin Dunleavy Despite a plan to significantly jack up the price of Comirnaty when the U.S. goes to a commercial model this year for COVID-19 vaccines, Pfizer expects revenue from the shot to plummet by 64% in 2023. And COVID oral antiviral Paxlvoid will be in no better situation, Pfizer said Tuesday. |
By Andrea Park The third time’s the charm: Two decades after founding Know Labs—then known as Visualant—Ron Erickson is once again stepping into the role of chief executive. |
By James Waldron Six months after laying off 18% of its workforce, Inovio is sending out more pink slips. This round of redundancies will see 11% of remaining employees heading for the exits as the biotech unveils yet another restructuring. |
By Fraiser Kansteiner Euroapi has made short work of its Hungarian manufacturing snafu. Back in November, the Sanofi spinoff halted batch release and temporarily stopped making prostaglandin products. Now, in the span of two short months, Euroapi says it’s built and rolled out a remediation plan. |
By Dave Muoio December was the first month in which the hospital sector logged a positive median operating margin, but it wasn't enough to offset "the worst financial year since the start of the pandemic," per Kaufman Hall's latest monthly report. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we hear from Stacie Dusetzina, Ph.D., a professor at Vanderbilt University's Department of Health Policy, about what the IRA means for the pharma industry. We'll also discuss what we can expect from the biotech industry in 2023. |
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The global demand for biologics is projected to increase considerably by 2030, but the challenges, risks, and costs are also growing. For pharma companies looking to bring a new biologic to market, meeting clinical trial milestones can be difficult. To access important insights, download this executive summary now. .png)
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Whitepaper Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
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 RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
Whitepaper This paper explores how Medical Affairs is adapting medical communications to meet the demands of a new environment (part 5 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences |
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 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 |
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 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 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 |
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