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Boehringer Ingelheim’s Jascayd blocks a protein involved in the lung inflammation that develops from idiopathic pulmonary fibrosis, a rare and ultimately fatal disease with few available therapies. The twice-daily pill doesn’t cure IPF but clinical trial results showed it slowed disease progression.
Healthcare and life sciences are about to face unprecedented AI-driven regulatory changes that will reshape everything from research and development to drug approval submissions. Here are 10 steps healthcare and life sciences organizations should take to strategically prepare.
The current tariff volatility creates a new set of challenges for medtech companies, but uncertainty is here to stay. Companies must act now, building on the trade compliance capabilities they are building to create a resilient supply chain that is ready for future disruptions.
Digital health funding remains strong so far this year, with $9.9 billion raised through Q3 and megarounds driving record deal sizes. However, the path to scale is becoming less predictable, as startups increasingly rely on unlabeled rounds and face longer timelines to reach Series B.
While Skye Bioscience said its drug nimacimab may yet achieve better weight loss results with higher doses, the company and analysts are interested in the drug’s potential to be combined with Novo Nordisk’s Wegovy. Skye’s drug is an antibody designed to preferentially target CB1 receptors in the gut, offering an alternative approach to activating GLP-1 receptors.
The FDA will provide faster regulatory review of generic drugs that are tested in and manufactured in the U.S. using domestically sourced active pharmaceutical ingredients. This FDA pilot program is part of a broader Trump administration strategy to reshore pharmaceutical production.
This requires leveraging technology and partnerships in new ways to break down traditional barriers, designing therapies to fit more seamlessly into patients’ lives, and creating more equitable access to life-sustaining treatments.
Documentation gaps can quietly undermine everything from how your organization is publicly rated, to how they are reimbursed, to how payers evaluate your performance, leading to weaker negotiating power, and decreased ability to recruit top talent or attract patients.
Over-the-counter continuous glucose monitors have been available for people with and without diabetes for more than a year now — but the data they collect doesn’t seem to be as useful for nondiabetic users, according to new research from Mass General Brigham.
Rocket Pharmaceuticals voluntarily withdrew the FDA submission for its Fanconi anemia gene therapy. The move follows a corporate restructuring over the summer that refocused the company on its cardiovascular programs.
Pfizer Ventures led the Series B financing of Cartography Biosciences, whose lead program addresses a promising target for colorectal cancer. The startup’s drugs come from platform technologies that analyze data from healthy cells and cancer cells to identify cancer-specific targets.
Success requires orchestrating an end-to-end experience that connects manufacturing, logistics, clinical sites, payers, and patients seamlessly. The companies that treat this orchestration as a strategic competency, rather than just operational logistics, will be best positioned to scale.
MedCity News Editor in Chief Arundhati Parmar and Samir Batra, managing partner of Health Innovation Pitch, also discussed whether bitcoin would play a greater role in healthcare deals and the Trump administration's mixed messages on autism and Tylenol.
Hackensack Meridian Health launched a clinical trial with Israeli startup SpotitEarly, which is developing a cancer test that combines AI with trained dogs to analyze patients’ breath. The study aims to validate this noninvasive approach alongside traditional screenings, potentially enabling earlier and more accessible cancer detection.
Through new diagnostic methods, integrated approaches and innovative management solutions, patients no longer have to live with discomfort. Here are three major ways the GI field is evolving to better care for patients today.
At INVEST Digital Health 2025, David Snow, Executive Director of Pegasus Park, discussed building a life science innovation hub and why life science startups at the North Texas campus are more likely to survive, scale, and exit.
Novartis drug Rhapsido is now approved as a second-line treatment for chronic spontaneous urticaria, a rare inflammatory skin disease. Additional clinical trials are ongoing to support potential expansion of the twice-daily pill to other immunological disorders.
Newly launched Pfizer drugs will be priced at parity to prices in comparable developed nations, according to the most-favored nation pricing agreement. But industry observers note that big pharma companies are also raising some prices overseas as part of a strategy to protect U.S. revenue.
September has seen a wide range of executive hires, exits, promotions and layoffs across the healthcare industry. For example, Medtronic, Amgen and Kaiser Permanente welcomed new executives. There were also layoffs at organizations including Novo Nordisk and Seattle Children’s.
Successful mergers don’t just consolidate services. They unify people around a shared mission to serve their patients. If we want to see lasting success in healthcare M&A, it’s time to stop leading with checklists and start leading with people.
Crystalys Therapeutics’ gout drug, dotinurad, inhibits a known and validated target for treating the chronic disorder, but in a way that could be safer than other drugs. The oral small molecule was discovered and developed in Japan, where it is approved and has a safety record spanning more than 1 million gout patients.