| Publisher’s Note: Join Fierce Biotech Editors and industry leaders at the Fierce Biotech Summit to network and gain exclusive insights. Don’t miss out — register now! |
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Drug development requires a delicate balance between innovation, speed, and regulatory compliance. The 505(b)(2) pathway offers a strategic avenue for developers to bring qualifying drugs to market more efficiently.
Learn how in our latest guide. 
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Today’s Big NewsSep 26, 2024 |
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Tuesday, October 1, 2024 | 11am ET / 8am PT The clinical trial landscape continues to evolve at a rapid pace. In this webinar, learn how new biomarker detection technologies drive key breakthroughs. With early detection, biomarker testing research can advance disease understanding and management in many care areas. Register now to join us. 
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| By Fraiser Kansteiner Arch Venture Partners announced the closing of its 13th venture fund, which is infused with more than $3 billion to support the founding and buildup of early-stage biotech companies. |
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By Darren Incorvaia The NIH has found evidence of research misconduct against Eliezer Masliah, M.D., the head of the National Institute on Aging's (NIA) neuroscience division, the NIH said in a Sept. 26 statement. In addition, Science published an investigation finding that 132 papers published by Masliah contain apparently manipulated images. |
By Darren Incorvaia On the same day that some Parkinson’s disease drugs are being called into question, AbbVie has announced that its candidate has significantly reduced the burden of the disease in patients compared to placebo, the company announced. |
Sponsored by MMC + RXMOSAIC Courtney Walker of MMC and RxMosaic discusses the future of communication roles, emphasizing AI's impact and the growing importance of human connection. She also highlights strategies for rebuilding pharma's reputation, effective leadership communication, and engaging diverse audiences. |
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Developing immunotherapeutic antibodies can be challenging, but potency shouldn’t stand in your way of clinical success. Learn more. 
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By Nick Paul Taylor Biogen has administered the last rites to its collaboration with Sage Therapeutics on SAGE-324, scrapping the alliance in the aftermath of a failed study that precluded further development in essential tremor. |
By Angus Liu Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago. |
By James Waldron BioAge Labs is bringing in almost $200 million via its Nasdaq IPO this morning, with the proceeds earmarked for taking its lead obesity drug further into clinical trials. |
By James Waldron Amid the genetic medicines arms race, Flagship Pioneering is unveiling a new company to help biotechs fine-tune the precision of their therapies. |
By Gabrielle Masson Spain-based Asabys Partners has closed a $200 million fund, money that will go toward 12 to 15 companies in biopharma or medtech. |
By Nick Paul Taylor Merck & Co. has picked up options on two Evaxion vaccine candidates, paying $3.2 million and dangling more than $1 billion in milestones for the chance to pick up preclinical prospects against gonorrhea and an undisclosed infectious agent. |
By Nick Paul Taylor Enanta Pharmaceuticals has linked its respiratory syncytial virus antiviral to significant reductions in viral load and symptoms in a phase 2a challenge study. The biotech said the results cleared the bar set by its other candidate, opening up opportunities to test the molecules as single agents and in combination. |
By Conor Hale Immunai has been building a digital map of the immune system by charting each cell type’s function and their interactions with the body and various diseases. |
Fierce podcasts Don’t miss an episode |
| In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East. |
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Whitepaper Unlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
Whitepaper Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner. Sponsored by: IQVIA |
Whitepaper Unique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
Whitepaper When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions. Sponsored by: WCG |
Whitepaper Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more. Sponsored by: DNA Genotek |
Whitepaper Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market. Sponsored by: Veranova |
Whitepaper We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned. Sponsored by: Blue Matter Consulting |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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