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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 23, 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 Nick Paul Taylor AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody-drug conjugate has again failed to improve overall survival in a phase 3 trial. The latest miss happened in breast cancer, a setting in which Gilead’s rival Trodelvy significantly improved OS in a prior late-phase study. |
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By Nick Paul Taylor Biohaven has linked troriluzole to a significant slowing of progression in an ultra-rare disease, setting the biotech up to take another shot at winning approval with an asset that the FDA refused to review last year. Despite questions over control comparisons, investors celebrated the news. |
By James Waldron The respiratory syncytial virus space may have filled up over the past year, but that isn’t deterring Vicebio or its investors. |
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 Gabrielle Masson After a series of trials and tribulations, Ventyx Biosciences has received a $27 million boost from Sanofi, money that is expected to extend the biotech’s cash runway into the second half of 2026. |
By Darren Incorvaia Context Therapeutics is building up its bank of bispecific antibody candidates. The Philadelphia-based company is paying $11 million upfront for a T-cell engaging antibody from BioAtla. |
By Darren Incorvaia Just a couple of weeks after announcing that its Alzheimer’s disease candidate fosgonimeton failed to beat placebo in a phase 2/3 trial, Athira is laying off 70% of its staff and saying goodbye to several executives. The biotech is pivoting to focus on ATH-1105, an oral small molecule for amyotrophic lateral sclerosis. |
By Darren Incorvaia Cataract removal is one of the oldest and most common surgeries in the world. A surgeon makes small incisions in the eye, sucks out the cloudy lens and replaces it with an artificial lens implant. Complications are rare, but can range from blurred vision and light sensitivity to retinal detachment, which can lead to blindness if untreated. |
By Andrea Park It’s time once again to nominate the fiercest women you know in the life science industry for our annual list. |
By Angus Liu Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday. |
By Conor Hale After CEO Kevin Lobo promised earlier this summer a “bullish” M&A pipeline, Stryker is following through with its seventh deal announcement of the year so far. |
Fierce podcastsDon’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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| WhitepaperUnlock the Future of Biotherapeutics with Catalent Biologics! Sponsored by: Catalent Biologics |
| WhitepaperFinding 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 |
| WhitepaperUnique Solutions for Drug Discovery and Development Sponsored by: Cell Signaling Technology |
| WhitepaperWhen 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 |
| WhitepaperPower 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 |
| WhitepaperWe 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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