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Regulatory action—Tavneos (avacopan) in Europe
The European Medicines Agency (EMA) moved to revoke marketing authorization for Amgen and Vifor’s complement inhibitor Tavneos (avacopan) after concluding the approval basis relied on “incorrect...
FDA advisory momentum—RP1 and next contested product meetings
Replimune’s oncolytic immunotherapy RP1 cleared an FDA regulatory milestone, receiving an early August decision date after a resubmission for advanced melanoma. The FDA set an advisory committee...
Commercial and regulatory—Viridian’s thyroid eye disease launch
The FDA approved Viridian Therapeutics’ thyroid eye disease drug veligrotug, initiating a new competitive cycle for Amgen’s Tepezza franchise. Viridian will market the therapy as Lumvoa, with...
Immunotherapy—Intravesical CAR T-cell approach in bladder cancer
Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center reported preclinical data supporting an intravesical CAR T-cell strategy for bladder cancer. In a Journal of Experimental...
Neuroinflammation—Immunic pushes Nurr1 test for multiple sclerosis progression
Immunic is advancing a Phase III test for vidofludimus calcium with a regulatory and clinical objective aimed at moving beyond what the company describes as multiple sclerosis’s inflammation...
Funding—Bionyra Pharma launches with Series A to build inflammatory disease biologics
Bionyra Pharma emerged from stealth with a clinical-stage focus on inflammatory and immune-mediated diseases after raising $165 million in an oversubscribed Series A. The round was co-led by Jeito...
Regulatory and pipeline—Otsuka’s centanafadine posts Phase IIIb ADHD win
Otsuka reported top-line Phase IIIb results for centanafadine in patients with ADHD and comorbid anxiety, marking another clinical development milestone for its non-stimulant program. The company...
Diagnostics—BioMérieux submits rapid syndromic vaginitis test to FDA
BioMérieux filed for dual 510(k) clearance and CLIA waiver with the FDA for a rapid, point-of-care vaginitis molecular panel. The company submitted its BioFire SpotFire Vaginitis Panel (VG),...
Deals and corporate strategy—Agilent acquires Biocare
Agilent completed its acquisition of Biocare Medical, a deal originally announced in March and valued at $950 million. The move expands Agilent’s pathology offerings with Biocare’s...
Research integrity—Nature Medicine retracts Chinese lung cancer timing study
Nature Medicine retracted a widely publicized Chinese lung cancer study—Lungtime-C01—after the journal found issues that undermined confidence in the reported results. The paper claimed that...
Regulatory withdrawal for Tavneos in Europe
European regulators moved to pull Amgen’s Tavneos from the market, citing that evidence submitted for the original approval could no longer be relied upon. The EMA committee recommended withdrawal...
FDA advisory committee reset for contested melanoma submission
Replimune secured a new timeline for its twice-rejected melanoma therapy RP1 after the FDA accepted the company’s resubmission and set an advisory committee meeting in late July. The agency is...
Sequencing genomics retraction undermines China lung cancer claim
Nature Medicine retracted a widely publicized Chinese lung cancer study, “Lungtime-C01,” after concerns intensified about research integrity and data transparency. The paper had reported that...
Global pharma deals and U.S.-China licensing tightening at BIO
At BIO 2026, U.S. biotech leaders debated how far Congress should go in restricting licensing deals tied to Chinese biotech, amid rising alarm in the industry. Lawmakers signaled interest in...
U.S. policy pressure on China biotech investment and trial acceptance
A new bill before Congress would amend the COINS Act to extend additional licensing restrictions to Chinese biotechnology, according to the piece. The proposal would also include mechanisms that...
Capital infusion for inflammation biologics startup Bionyra
Bionyra Pharma emerged from stealth after raising an oversubscribed $165 million Series A to build next-generation biologics for severe inflammatory and immune-driven diseases. The financing was...
New FDA approval expands sunscreen actives to U.S. OTC
The FDA approved bemotrizinol as the first new sunscreen ingredient permitted for over-the-counter consumer use in the U.S. since 1999. The action allows an ingredient already used in other...
Corporate tie-up: Circio and Tcelltech combine for non-viral in vivo T-cell engineering
Circio and Tcelltech agreed to combine technologies to develop next-generation in vivo CAR-T and TCR-T cells using non-viral DNA delivery. The collaboration pairs Circio’s circVec circular RNA...
Regenerative medicine and diagnostics funding via ARPA-H fetal monitoring grants
ARPA-H committed $90.7 million over four years under its Making Obstetrics Care Smart (MOCS) program to fund diagnostic tests and fetal monitoring technologies aimed at reducing risks during...
Debt and equity financing activity: Adaptive Biotechnologies convertible notes
Adaptive Biotechnologies issued $345 million of zero-interest convertible senior notes due in 2031, with proceeds used in part to refinance and reduce earlier leverage. The financing included an...