Affibody may not have expected to be working on izokibep again, but the Swedish biotech hasn’t wasted an opportunity to showcase the inflammation drug’s potential to prospective partners.
Longtime FDA leader Lola Fashoyin-Aje, M.D., is adapting to a new role at AstraZeneca as vice president and head of cell therapy regulatory science and strategy. Fashoyin-Aje is well-positioned to help the British pharma giant in this field, given she spent nearly 12 years at the FDA, with her tenure culminating in directing the clinical evaluation of cell and gene therapies.
On Thursday, the public had the first chance to air their grievances about the FDA’s controversial Commissioner’s National Priority Voucher (CNPV) pilot program, the flagship initiative of recently departed agency leader Marty Makary, M.D.
A stimulator of thyroid hormone receptors in the brain has successfully reduced depression severity in patients with bipolar disorder, positioning its maker Autobahn Therapeutics to speed ahead to late-stage testing.
Two federal lawmakers have introduced a bill seeking to apply the review requirements of the Comprehensive Outbound Investment National Security (COINS) Act to investments in Chinese biotechnology.
Parabilis Medicines is gearing up for an IPO that could eventually bring in as much as $476 million to fund the phase 3 development of its desmoid tumor prospect.
Rather than leave the work of developing relationships in China to individual companies, the firm launched an initiative called RA Capital Swiftbridge in mid-2025.
Innovent Biologics has reported a phase 3 victory for IBI343, boosting the prospects of an antibody-drug conjugate (ADC) that Takeda bet big on last year.
Medical device distribution giant Medline has been slammed for a second time since April by an FDA warning letter that has chided the company for repeated problems centered on the presence of toxic bacteria in finished products.
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