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Learn how Transmission Electron Microscopy (TEM) enables precise quantification of virus-like particles (VLPs) in unprocessed bulk material. Discover the importance of TEM in viral safety testing and cell line characterization. Check out our scientific poster! .png)
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Today’s Big NewsOct 25, 2024 |
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Wednesday, October 29, 2024 | 11am ET / 8am PT Real-world data is essential to gaining insights into a patient’s diagnostic journey. However, many pharma companies may not be using lab data to its full potential. Join us to discuss how today’s robust lab data sources can help improve patient access and time to treatment, leading to better patient outcomes. Register now. 
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| By Fraiser Kansteiner Despite Merck & Co. homing in on approval for its infant respiratory syncytial virus antibody clesrovimab, Sanofi thinks Beyfortus can hold its own. On a Friday call with analysts, Sanofi execs pointed to an efficacy edge for its preventive and stressed that more competition in the space is a net positive. |
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By Kevin Dunleavy South San Francisco-based Septerna has scored with an upsized initial public offering of $288 million, which far exceeded the $157.9 million the company said it expected to generate in an SEC filing early this week. Trading for “SEPN” began on Friday. |
By Fraiser Kansteiner Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options. The FDA nod marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. |
By Darren Incorvaia Yet another CRO giant has taken a revenue hit due to a customer demand dip. Icon reported third-quarter revenue of $2.03 billion, underperforming analyst expectations of $2.142 billion. |
By Fraiser Kansteiner In its biggest U.S. manufacturing investment yet, GSK is spending up to $800 million to double the size and capacity of its site in Marietta, Pennsylvania. The upgraded manufacturing campus will be equipped to crank out commercial drugs and vaccines plus medicines for clinical trials. |
By Nick Paul Taylor GenSight Biologics is weeks away from running out of money. Again. The biotech only has enough cash to fund operations into mid-November and, with a revenue stream set to start later than planned, needs bridge financing to survive. |
By Conor Hale Dexcom reported that its overall revenues in the U.S. declined year over year despite overall sales coming in slightly higher than expected. |
By Zoey Becker Johnson & Johnson tested Tremfya in patients with plaque psoriasis involvement in "sensitive or highly visible areas," while Lilly weighed Ebglyss in atopic dermatitis patients who've previously tried Dupixent. |
By Conor Hale Less than a year after obtaining an FDA approval for its first foray into pulsed field ablation for afib, Medtronic has done it again. |
By Nick Paul Taylor AbbVie has returned to the source of its antipsychotic powerhouse Vraylar in search of another blockbuster, paying $25 million upfront to form a new drug discovery pact with Gedeon Richter. |
By Angus Liu A senior executive at BeiGene is under investigation by Chinese authorities, multiple local media outlets report. The company said it believes the investigation is not related to its activities. |
By Darren Incorvaia While cryptosporidiosis, infection by the protist parasite Cryptosporidium, is rare in the United States, it is a common cause of deadly diarrhea in other parts of the world. The only FDA-approved treatment for the infection, nitazoxanide, doesn’t work well in immunocompromised and malnourished children, the group most vulnerable to the pathogen. This has led to cryptosporidiosis being called a “truly neglected tropical disease.” |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," Fierce Medtech's Conor Hale dives into EY's 18th annual Pulse of the MedTech Industry report and chats with EY's John Babbitt about the team's findings and the pace of M&A, venture capital funding and recent IPOs. |
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Thursday, November 14, 2024 | 11am ET / 8am PT Join us for a deep dive into the development and manufacturing of monoclonal antibodies. We’ll explore an industry case study, providing access to key findings, top strategies and solutions for enhancing productivity and efficiency in mAb production. Don’t miss out on important insights, register now. 
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Whitepaper Discover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
Whitepaper Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
eBook Need the superpowers to select the right lab equipment? Sponsored by: PHC Corporation of North America |
Whitepaper Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects. Sponsored by: Lonza |
Whitepaper How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights. Presented by: Blue Matter |
Whitepaper Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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| The Lighthouse at Pier 61 in New York City |
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