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IND-enabling nonclinical studies play a crucial role in bringing new medications to market. But these tests require careful coordination & meticulous execution. Read our 5-step checklist to help make sure the data is accepted by regulatory agencies. Attending ACT Nov 12-15? Schedule a meeting with our experts!
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Today’s Big NewsSep 26, 2023 |
| By Nick Paul Taylor Ionis’ phase 3 lipid-lowering clinical trial has hit its primary endpoint, positioning it to file for an approval that would set up its first independent commercial launch. The study linked the high dose to a significant reduction in triglyceride levels and a 100% drop in acute pancreatitis events compared to placebo. |
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By Max Bayer Roivant CEO Matt Gline learned just days into his new gig in 2021 that immunology offshoot Immunovant had a cholesterol problem with its lead asset. Now, the concern that sent him immediately spiraling into "crisis management mode" has come full circle, as a next-gen candidate nailed key biomarker figures in a phase 1 trial. |
By James Waldron With scientific research this year continuing to point to the potential of the PIKFYVE enzyme as a target for amyotrophic lateral sclerosis (ALS), Takeda has decided to join the team. |
Sponsored by IPM.ai IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes |
By Gabrielle Masson Johnson & Johnson has inked a collaboration with the Singapore Economic Development Board to boost life sciences innovation in the region, touting the pact as the “first of its kind.” |
Sponsored by Emulate An introduction to Organ-on-a-Chip technology and how it can improve the quality of drugs entering the clinic. |
By Nick Paul Taylor Investors are swayed by Pliant Therapeutics’ data. The biotech posted early clinical evidence that its lead drug candidate reduces scarring and itching in a chronic liver disease, sending its share price up around 15%. |
By Annalee Armstrong After failing in a phase 3 study for a severe kidney complication of sepsis, AM-Pharma is redirecting its lead program to a different kind of kidney damage. |
By Helen Floersh Researchers have developed a new injectable hydrogel that maintains plasma concentrations of a common HIV drug, lamivudine—also known as 3TC—for six weeks in mice. Eventually, the scientists hope to add other HIV drugs given alongside 3TC to the same hydrogel, so they can all be administered at once. |
By Gabrielle Masson Stand Up To Cancer, also called SU2C, is handing out grants to seven community organizations across the U.S. in hopes of boosting diversity for early-stage cancer clinical trials. |
By Angus Liu As if the talc product liability lawsuits weren’t enough headache for Johnson & Johnson, the New Jersey pharma is now facing another lawsuit from patients, this time about a recent data breach. |
By Andrea Park A storm may be brewing in the medtech industry, as manufacturer Zeus Company is reportedly planning to bring the thunder in a sale to a new owner. |
By Kevin Dunleavy As coronavirus concerns increase with the changing of the seasons, the most commonly used oral antiviral treatments are in the spotlight once again. |
By Dave Muoio The disproportionate frequency of physical restraints puts Black patients at risk of physical and mental adverse harm, researchers said while advocating increased investigation into any potential role individual, institutional and structural mechanisms of racism may play in the trend. |
Fierce podcastsDon’t miss an episode |
| In this episode of "The Top Line," we shine a spotlight on some of the most promising companies in the biotech world and do a deep dive into drug commercialization strategies. |
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October 16-18, 2023 | Boston, MA Hear from leading experts as they share their experiences and insights covering drug development from the earliest stage of research to FDA approval. Time is running out, be left out! Register today
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| Whitepaper15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond. Sponsored by: Blue Matter, strategic consultants in the life sciences |
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