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April 3-4, 2023 | San Diego, CA The only west coast event exclusively for life science communicators to share best practices, benchmarks, and tools, as well as network with peers. Early Bird Rate Ends January 27th. 
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May 1-3, 2023 | Jersey City, NJ Connect on current challenges and opportunities found within your medical affairs role to become better equipped in developing a unified scientific voice. Take advantage of the Early Bird Rates, Register Today! .png)
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| By Max Bayer Merck KGaA is laying off roughly 11% of its U.S. outpost, shrinking a Massachusetts R&D unit by more than 130 employees. The cuts come two months after executives revealed a push to be a leaner organization. |
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By Ben Adams The nonprofit public health advocacy group the Physicians Committee issued a formal complaint that a recent CBS "60 Minutes" segment was a promotion for Novo Nordisk’s obesity drug, Wegovy, that was dressed up as a news segment. |
By Max Bayer A brutal year for biotech has private investors eyeing bets with less risk and more emphasis on single assets over drug discovery engines, but there's plenty of optimism to go around in the opening weeks of 2023. |
By Andrea Park Prosecutors have asked a judge not to allow convicted Theranos founder Elizabeth Holmes to stay out of prison during her upcoming appeal process, citing an instance ahead of her sentencing last year where she appeared to be preparing to flee the U.S. |
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Thursday, February 2, 2023 | 11am ET / 8am PT Regulators have made it abundantly clear - through recent guidance and inspection findings - that demonstrating sponsor oversight of an outsourced study is a critical requirement for TMF health and inspection-readiness. Join this webinar to discover how global biopharmaceutical company Chiesi and its CRO partners collaborate to ensure ongoing oversight compliance, in the face of increasing documentation requirements and trial complexity. Register now. 
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By Fraiser Kansteiner In a lawsuit filed Monday in Delaware federal court, BMS alleged AstraZeneca’s new CTLA-4 inhibitor Imjudo—approved last year alongside AZ’s Imfinzi in liver and lung cancer—treads on a pair of patents linked to Bristol’s blockbuster Yervoy. |
By Helen Floersh Surgically removing a tumor can cure a patient, but if there are any cancerous cells left around the edges, it’s likely to return. Applying a gel containing CAR-T cells to the surgical wound could clear out residual cancer and prevent recurrence, a new mouse study found. |
By Helen Floersh Scientists have uncovered a process that drives inflammation in osteoarthritis and potentially a way to ameliorate it. |
By Kevin Dunleavy In December, Sens. Elizabeth Warren, D-Massachusetts, and Peter Welch, D-Vermont, sent a letter to Pfizer admonishing the company for a proposed increase in the price of its COVID-19 vaccine for up to $130. Six weeks later, they've turned their attention to the world’s other leading producer of COVID vaccines, Moderna, which also has said it might charge up to $130 per dose when the United States stops providing shots for free and goes to a commercial model. |
By Fraiser Kansteiner Lies, shredded documents and a trashcan dowsed in acid: Intas Pharmaceuticals’ new write-up from the U.S. FDA is a textbook example of what not to do when investigators come knocking. |
By Angus Liu Merck's Keytruda just recorded its third phase 3 flop in prostate cancer in less than a year. But there's one more late-stage trial that could read out soon. |
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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Wednesday, February 15, 2023 | 1pm ET / 10am PT Biosimilars continue to gain global acceptance and momentum, with 2023 set to be a landmark year. However, the complex and ever-changing regulatory environment is still a challenge. Join industry experts for an important discussion on biosimilar regulatory trends and key insights for navigating the biosimilar regulatory landscape. Register now. 
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RCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
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 |
Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. Sponsored by: Catalent |
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 |
Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications. Sponsored By: Catalent |
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 |
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 |
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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