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. The priority BLA for the first-of-its-kind nonreplicating adenoviral vector-based immunotherapy had an Aug. 27 PDUFA date, which was set in late February. This is Precigen’s first approval and the first FDA-approved therapy for RRP. Precigen ’s stock (NASDAQ:PGEN) was trading up 70% at midday.

Lilly to put up drug prices in Europe

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. This rebalancing “may be difficult” and means the prices paid by governments and health systems need to increase in other developed markets, in order to reduce them in the U.S. Discussions are ongoing with certain governments, and Lilly said it expects to make any necessary pricing adjustment by Sept. 1.

Biopharma IPO drought continues: chance of rain expected?

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. In August, South Korea-based drug delivery company G2G Bio completed an IPO on Kosdaq.

Regulatory precedent to help Elysium with opioid overdose candidate

In the second of a two-part series on treating opioid overdose, Elysium Therapeutics Inc.’s chief scientific officer, Thomas Jenkins, and CEO Greg Sturmer elaborate on their firm’s long-acting Synthetic Opioid Overdose Prevention and Reversal program. They also discuss the future of the business and the regulatory route ahead. The Elysium product likely will follow the trail blazed by the U.S. FDA-approved treatment Opvee (nalmefene) from Indivior plc.

Meninges’ lymphoid structures, not so good, so bad, or so ugly

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?

Remegen’s telitacicept meets phase III endpoints in Sjögren's syndrome

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. Telitacicept is a novel TACI-immunoglobulin fusion protein with a dual-targeting mechanism against both the B lymphocyte stimulator (Blys), also called BAFF, and a proliferation-inducing ligand (APRIL) receptors. The dual-target mechanism helps reduce autoreactive B cells and autoantibody production for treatment of autoimmune disease.

Lawsuit provides excuse to revive vaccine safety task force

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.

Biopharma sees fewer deals but much bigger dollars

Biopharma deal activity (excluding M&As) surged to record-breaking levels in the first seven months of 2025, reaching $164 billion, well above prior years and a 36% jump over the same period in 2024. Monthly totals were especially strong in March, June and July, with each surpassing $25 billion. Deal volume in biopharma has slowed significantly in 2025, with just 694 transactions recorded from January to July, the lowest seven-month total in the past seven years.

Also in the news

Aquestive, Arrowhead, Athira, Basilea, Beam, Creative Medical Technology, Daiichi Sankyo, Halda, Lexeo, Macrogenics, Norgine, Onco-Innovations, Sanofi, Sarepta, Schrödinger, Shilpa Medicare, Theravia, Vedanta, Verastem Oncology, Vivani Medical, Zai Lab