The U.S. FDA has given a swift and full approval to Precigen Inc.’s gene therapy, Papzimeos (zopapogene imadenovec), for treating adults with recurrent respiratory papillomatosis (RRP), a rare and chronic disease characterized by benign tumors in the respiratory tract. Read More
Eli Lilly and Co. has fallen into line with U.S. President Donald Trump’s May 12 executive order on most-favored nation pricing, announcing it will put up drug prices in Europe in order to make them lower in the U.S. In a statement on Aug. 14, the company said it supports the Trump administration’s objective of more fairly sharing costs of “breakthrough medical research” across developed countries. Read More
The amount of money raised through global biopharma IPOs in the first seven months of 2025 is at the lowest level since 2016, and more than half of the 13 completed through July were done on ex-U.S. exchanges. Only five of the companies have U.S. roots, while the rest are based in Asia: four in China, two in South Korea, one in Taiwan and one in Hong Kong. Read More
In part one of this story on Elysium Therapeutics Inc., published Aug. 14, company officials explained the rationale and technology behind the plan to formulate a longer-lasting opioid-overdose rescue agent – one that remedies the problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active, potentially killing the patient. Read More
A little-known tissue composed of a cluster of immune cells could offer novel insights into the development of neurological disorders. Meninges' immune system changes with age and neurodegeneration. Are they protecting the brain or fueling disease? Read More
Remegen Co. Ltd.’s telitacicept (RC-18) met the primary endpoint in a phase III trial for treating primary Sjögren's syndrome (pSS), and the company plans to submit a BLA to China’s National Medical Products Administration (NMPA) on the data. Read More
In the wake of a lawsuit from the anti-vaccine nonprofit group U.S. Health and Human Services (HHS) Secretary Robert Kennedy founded, HHS is reviving a vaccine safety task force that’s been lifeless for nearly three decades. Read More
Biopharma deal activity (excluding M&As) has surged to record-breaking levels in the first seven months of 2025, reaching $164.03 billion, well above prior years and a 36% jump over the same period in 2024. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Arrowhead, Basilea, Norgine, Sarepta, Schrödinger, Theravia, Vedanta, Venatorx. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Beam, Everest, Halda, Sanofi, Shilpa. Read More
