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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 24, 2023 |
| By Annalee Armstrong Eli Lilly’s Jacob Van Naarden thinks his peers’ rush to snap up every antibody-drug conjugate out there may be a little overblown. It bought in anyway. |
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By Gabrielle Masson AstraZeneca, home of cancer blockbusters like Tagrisso and Daiichi Sankyo-partnered Enhertu, is elevating its portfolio to create a “2.0” cancer pipeline, sharing a peek at data from three bispecific antibody candidates at this year's ESMO. |
By Max Bayer The expected layoffs at Idorsia have now been finalized, with the company cutting 300 employees primarily in R&D. The company warned in July that it needed to cut a considerable number of jobs to save cash. |
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 Max Bayer Aiolos Bio is sprinting out of stealth with nearly $250 million to help advance a phase 2-ready severe asthma med. The drug was acquired from Chinese biotech Jiangsu Hengrui Pharmaceuticals for an undisclosed amount. |
By Annalee Armstrong MADRID—Novartis’ Jeff Legos, Ph.D., is watching peers like Eli Lilly move into radiopharmaceuticals. He knows what’s ahead for them. |
By Max Bayer OrbiMed, one of the biggest global financers of private and public biopharmas, has brought in $4.3 billion to shower on new startups in the coming years. |
By Nick Paul Taylor BrainStorm Cell Therapeutics has responded to its failure to win approval in the time-honored fashion. Yet, while the decision to lay off 30% of its staff is classical, the biotech’s reasoning is unusual. Rather than hunker down, BrainStorm is framing the action as a way to accelerate its journey back to the FDA. |
By James Waldron Eli Lilly has tapped drug delivery specialist Elektrofi to see whether the biotech’s microparticle technology could produce the next generation of subcutaneously administered drugs. |
By Annalee Armstrong MADRID—Moderna and BioNTech have quite a few things in common, one being that both are trying to chart their post-COVID course by reinventing cancer modalities. And both, it seems, have run into the reality of manufacturing challenges. |
By Helen Floersh As Vyant Bio continues its wind-down, neuroscience research assets of its subsidiary StemoniX have officially been picked up by AxoSim, a New Orleans-based drug discovery biotech. |
By Angus Liu Novartis entered a new era after spinning off Sandoz earlier in October. As the pure-play innovative medicines company reports strong growth from the business it’s now built on, one product faces a delay. |
By Andrea Park After spending the better part of the last three decades at Johnson & Johnson, Ashley McEvoy, worldwide chair of its medtech franchises, is charting a new course. |
By Dave Muoio Among a sample of 222 hospitals, about 80% didn't include any information about abortion procedures whereas just 11% didn't mention colonoscopies, according to a recent study. |
By Conor Hale After introducing itself earlier this month, Precede Biosciences is delivering the first clinical data for its cancer-focused liquid biopsy platform. |
Fierce podcasts Don’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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Whitepaper From Assay Development Through Large Molecule Development. Streamline your R&D workflows and gain valuable insights with our Biology Solutions Brochure. Download now to discover how to control your laboratory workflows across various assay techniques, modalities, and data types. Sponsored by: Revvity Signals |
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