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Regulatory leadership shakeup at FDA
Vinay Prasad, M.D., has stepped down again as director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Katherine Szarama, Ph.D., is now acting director while FDA searches for...
Clinical/regulatory action around Tavneos (avacopan)
Amid ongoing FDA scrutiny, Amgen filed a label supplement for Tavneos (avacopan) while the agency escalates efforts to withdraw the treatment from the U.S. market. The move signals that FDA’s...
FDA advisory panel challenges AstraZeneca’s camizestrant switching strategy
Two separate FDA oncology advisory panel votes left AstraZeneca’s camizestrant strategy facing setbacks. On one track, experts voted 6–3 against a “new paradigm” in an AstraZeneca trial for the...
Biopharma portfolio exits and pivots in CAR-T
Johnson & Johnson has axed two CAR-T programs targeting B-cell lymphoma—discontinuing JNJ-9530 and the CD19/CD20 bispecific JNJ-4496—citing an evolving treatment landscape and J&J portfolio...
Chiesi doubles down on rare disease via KalVista acquisition
Chiesi Group is set to acquire KalVista Pharmaceuticals in a roughly $1.9 billion deal, adding Ekterly (sebetralstat) to its rare disease portfolio. Ekterly is positioned as the first oral,...
IPO surge: Avalyn and Seaport/Hemab raise fresh public-market capital
Avalyn Pharma priced a $300 million IPO to fund late-stage studies of inhaled respiratory drugs, joining a wave of biotech listings focused on respiratory and immunology-adjacent franchises....
AAV gene therapy moves toward longer-term HIV suppression
Researchers at Oregon Health & Science University and the Oregon National Primate Research Center reported long-term SHIV suppression using an AAV gene therapy delivering a CCR5-blocking antibody...
Precision platform for programmable RNA targeting via DNA-guided Cas12a
A team reported a DNA-guided CRISPR–Cas12a system that reprograms Cas12a into an RNA-targeting effector using DNA as the guide input. In the described SLEUTH approach, synthetic DNA engages Cas12a...
Early-stage pipeline: FDA IND clearance for LGNA-100 in pediatric/young adult leukemias
Laguna Biotherapeutics received FDA IND clearance for LGNA-100 (QUAIL-100), launching a planned first-in-human phase I study. The trial will enroll pediatric and young adult participants with...
Big funding for sequencing tools and clinical diagnostics infrastructure
GeneMind Biosciences secured NMPA registration for its SURFSeq 5000 Dx sequencer, enabling deployment in China’s clinical market for oncology, inherited disease, reproductive health, and...
Regulatory uncertainty and trial review for AstraZeneca’s camizestrant
The FDA’s oncology advisory process delivered mixed signals for AstraZeneca’s oral SERD camizestrant as multiple votes questioned different trial strategies for switching patients in HR+/HER2-...
Chiesi’s expansion in hereditary angioedema via KalVista acquisition
Chiesi Group moved to deepen its rare disease footprint by agreeing to buy KalVista Pharmaceuticals for about $1.9 billion. The deal adds Ekterly (sebetralstat), a plasma kallikrein inhibitor...
AAV-mediated CCR5 blockade for long-term SHIV suppression
Researchers at Oregon Health & Science University reported that AAV gene therapy expressing a CCR5-blocking antibody can drive long-term viral suppression in SHIV-infected macaques. The approach...
IPO and financing momentum in respiratory and oncology biotech
Two IPO-related items highlighted fresh capital access for drug developers targeting respiratory disease and oncology commercialization. Avalyn Pharma priced a $300 million IPO to fund late-stage...
New FDA leadership for biologics regulation
Katherine Szarama was named acting director of the FDA’s Center for Biologics Evaluation and Research (CBER), overseeing regulation for vaccines, gene therapies, and the blood supply. The...
Securing FDA pathway momentum for gene therapy in Huntington’s disease
UniQure said it plans to seek UK approval for AMT-130, its Huntington’s gene therapy, after a positive meeting with UK regulators. The company plans a marketing application later this year and...
Regulatory restraint and trial-level concern: Tavneos withdrawn in response to trial integrity findings
The FDA’s actions involving ChemoCentryx’s avacopan (Tavneos) came under renewed focus after an investigation prompted steps toward withdrawal from the U.S. market. The allegation centered on new...
Clinical signal in oncology diagnostics and companion testing
Guardant Health and Nuvalent agreed to collaborate on oncology companion diagnostics across multiple clinical studies. Guardant will supply tissue and liquid biopsy tools to support Nuvalent’s...
Biotech deal activity: Leo Pharma enters gene therapy with Replay acquisition
Leo Pharma agreed to acquire Replay Holdings for $50 million, marking its entry into gene therapy through Replay’s high-capacity herpes simplex virus (HSV) vectors. The seed-stage portfolio is...
Diagnostics platform approval: GeneMind’s SURFSeq 5000 Dx registered with NMPA
GeneMind Biosciences reported that China’s NMPA registered its SURFSeq 5000 Dx high-throughput sequencer as a Category III medical device. The registration enables clinical deployment in China for...