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Over our many years of preparing & filing FDA submissions, we have often encountered sponsors who cannot file a New Drug Application or Biologic License Application within expected timeframes; mostly due to a failure to start & complete prerequisite activities before the targeted filing date. Download our checklist to learn how to keep your NDA submission on track.
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Today’s Big NewsOct 26, 2023 |
| By Nick Paul Taylor The race is on. Again. Having already gone up against Moderna in COVID-19 and influenza, Pfizer and BioNTech have now followed their recurring rival in reporting early-phase data on a mRNA combination vaccine against both pathogens—and in outlining plans to start a pivotal trial. |
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By Max Bayer Much of the fervor around Merck & Co.’s work with antibody-drug conjugates has centered on partnerships, namely the most recent $4 billion collaboration announced last week with Daichii Sankyo. |
By Annalee Armstrong,Max Bayer Even with $401 million in the bank—thanks to one of the year’s largest biotech fundraisings—ElevateBio is still shaving off some pre-clinical work resulting in layoffs that will affect 13% of the workforce. |
Sponsored by WCG The FDA and EMA recommend EACs and DMCs be independent from sponsors and CROs. Our industry expert shares how and when to select the right EAC providers and more to de-risk your clinical trials. |
By Annalee Armstrong BioAge Labs has garnered the support of Eli Lilly to run a trial testing a muscle regeneration therapy in combination with the Big Pharma’s tirzepatide for healthier weight loss. |
By Nick Paul Taylor Is gene silencing the future of Alzheimer’s disease treatment? Alnylam and Biogen presented first drafts of their answer to that question this week by publishing early-phase data on their respective RNAi and antisense approaches to treating the neurodegenerative disease. |
By Gabrielle Masson Triveni Bio, the product of a merger between Amagma Therapeutics and Modify Therapeutics, has unveiled with $92 million and a lead preclinical antibody program targeting eczema and asthma. |
By Joseph Keenan Lupus Therapeutics, a clinical research affiliate of the Lupus Research Alliance, inked a partnership deal with AbbVie to help run phase 3 trials for the drugmaker’s upadacitinib treatment in systemic lupus erythematosus. |
By Angus Liu Eisai and Biogen have trotted out data for a subcutaneous version of the Alzheimer’s disease drug Leqembi. The self-injected version showed an encouraging efficacy result but a seemingly increased risk of ARIA, which analysts said shouldn't be too much of a concern. |
By Conor Hale The company described the trial as the first in the U.S. to examine the use of a drug-coated balloon to clear coronary stents that have become obstructed over time. |
By Kevin Dunleavy It’s been grounded in Europe and reduced to irrelevancy in the U.S., but Merck’s COVID-19 pill Lagevrio somehow remains a force. The antiviral treatment racked up sales of $640 million in the third quarter, shocking analysts who figured it would generate $120 million. As a result, Merck has jacked up its 2023 revenue forecast. |
By Dave Muoio Survey data outlining healthcare workers' worsening mental health and workplace difficulties come alongside new calls for action from the CDC and AMA. |
By Fraiser Kansteiner On outgoing chief executive Giovanni Caforio’s last earnings call, Bristol Myers Squibb had some tough questions to answer about a roster of underperforming new products. But according to CEO-elect Chris Boerner, it’s a question of “when, not if” those drugs rise to meet expectations. |
Fierce podcastsDon’t miss an episode |
| In this episode of "The Top Line," Fierce's Fraiser Kansteiner engages in a conversation with Alexander Scott, senior vice president of integrity at Eisai, to discuss the full approval of Leqembi and what it means for Eisai and, most importantly, for Alzheimer's patients. |
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You don’t have to choose between oversized and clean-and-reuse systems. There’s a system that’s fit-for-purpose — which scales all the way up to 200 L and beyond. See how.
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