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BIO tells Congress to shore up US biotech lead with tax and manufacturing incentives
The Biotechnology Innovation Organization submitted a formal statement to the House Ways & Means Trade Subcommittee urging targeted federal actions to sustain U.S. biotech leadership. BIO...
GSK exits Wave RNA‑editing program; Wave says it will advance candidate
GSK has walked away from a leading Wave Therapeutics RNA‑editing program, a move Wave characterized as reflecting its ability to advance the rare‑disease candidate more quickly outside the Big...
AI rewires CRISPR PAM specificity to widen editing targets
Researchers developed a deep‑learning framework that can reprogram protospacer‑adjacent motif (PAM) recognition for CRISPR–Cas enzymes, enabling tailored targeting specificities. The model...
FDA issues CRL to Pharming over pediatric expansion of Joenja
The FDA issued a complete response letter to Pharming, rejecting the company’s application to expand Joenja’s approval into younger pediatric patients for a rare immunodeficiency indication. The...
FDA halts Regenxbio trials: cancer case stalls gene-therapy push
The FDA has placed tests of two Regenxbio gene therapies on clinical hold after a participant in one study developed cancer, casting fresh doubt on the company’s approval prospects. MedCity News...
US vaccine advisory reconsiders all recommendations: chair signals review
The chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), Kirk Milhoan, announced a comprehensive reevaluation of all U.S. vaccine recommendations, telling the New York Times the...
EU reworks drug rules: orphan developers could face earlier competition
European regulators are finalizing a package of laws that will force drugmakers to reckon with generic and biosimilar competition sooner, according to reporting on new legislation. The changes...
Nasal H5N1 vaccine prevents infection in animal tests – WashU
Washington University School of Medicine reported an intranasal adenoviral-vectored H5N1 vaccine that produced strong mucosal immunity and prevented infection in hamsters and mice, findings...
Phase II data and leadership exit – Cardiff shares halve in two days
Cardiff Oncology reported positive Phase II data for onvansertib in RAS-mutated metastatic colorectal cancer while simultaneously announcing the departures of its CEO and CFO. The twin disclosures...
Thermo Fisher shutters Mass. site: layoffs exceed 100
Thermo Fisher Scientific filed notice that it will close its Franklin, Massachusetts facility and lay off more than 100 employees, according to a state filing. The company attributed the move to...
AbbVie bets on precision immunology: reverse translation to guide combos
In a perspective piece, Kori Wallace, AbbVie’s VP of Clinical Development for Immunology, outlines a strategic shift toward precision immunology built on reverse translation and rational...
Lentiviral vectors take center stage in next‑gen gene therapies
A recent study reviewed advances in lentiviral-vector technology that are reshaping gene-therapy delivery, highlighting improvements in tropism, payload capacity, and safety profiling. Authors...
In vivo CARs move closer to clinic – new reagents and protocols emerge
Researchers outlined progress in in vivo CAR therapeutic development, describing delivery strategies (viral vectors, nanoparticles), CRISPR editing needs, and assay frameworks for assessing CAR...
Brown uncovers molecular switch to sensitize glioblastoma to therapy
Brown University scientists published a Cell Reports study that decodes a molecular mechanism limiting glioblastoma response to existing therapies and identifies a targetable pathway to enhance...
FDA Halts Regenxbio Trials: Cancer Case Prompts Clinical Hold
The FDA placed clinical holds on two Regenxbio gene therapy studies after a participant in one study developed cancer, raising fresh safety and regulatory questions for viral-vector programs....
EU Overhauls Rules: Generics and Biosimilars Could Come Sooner
European regulators will implement new laws that tighten the pathways companies use to delay generic and biosimilar competition, forcing drugmakers to navigate additional regulatory steps to...
Thermo Fisher Shutters Mass. Site: 100+ Employees Affected
Thermo Fisher Scientific announced the closure of its Franklin, Massachusetts facility, triggering layoffs for more than 100 employees according to a state notice. The company cited site...
Neoadjuvant FOLFIRINOX–Nivolumab: Pilot Phase 1 Yields Promising Signals in PDAC
A pilot phase 1 trial evaluated neoadjuvant modified FOLFIRINOX combined with nivolumab in pancreatic ductal adenocarcinoma (PDAC) and reported encouraging safety and preliminary activity,...
Brown Identifies Pathway to Sensitize Glioblastoma to Therapy
Researchers at Brown University disclosed a molecular mechanism that could enhance therapeutic responses in glioblastoma, offering a potential pathway to overcome intratumoral resistance, the team...
Intranasal H5N1 Vaccine Prevents Infection in Rodents — WashU Study
Washington University researchers developed an intranasal adenoviral-vectored H5N1 vaccine that protected mice and hamsters from highly pathogenic avian influenza in preclinical testing, the team...