Tag

Biologics

All articles tagged with #biologics

GSK joins Chai Discovery’s AI drug pipeline after wet-lab validation

GSK has signed a deal with San Francisco-based AI startup Chai Discovery to access its protein-folding and design models for biologics development. This marks Chai’s sixth major pharmaceutical partnership in nine months, following agreements with Eli Lilly, Bristol Myers Squibb, Novartis, and Pfizer. GSK validated Chai’s technology through internal wet-lab testing, confirming that the AI-generated designs produced binders with strong affinities across diverse targets without requiring target-specific training. The collaboration aims to accelerate the discovery of new medicines by integrating Chai’s models with GSK’s internal data.

via Endpoints News|

#ai-drug-discovery #biologics #biotechnology

healthcare1 month ago•5 min saved

AstraZeneca's tozorakimab posts big COPD trial gains, eyeing multi-billion-dollar sales

AstraZeneca reported positive Phase 3 results for its COPD therapy tozorakimab, showing reductions in moderate and severe flare-ups across broad patient groups, including current and former smokers and across a range of eosinophil counts, with up to 43% reductions in some subsets. The IL-33–targeting antibody is under FDA priority review with potential approval in early 2027, and AZ has lifted its peak sales forecast above $5 billion as it eyes a larger COPD biologics market beyond current options like Dupixent and Nucala.

via CNBC|

#astrazeneca #biologics #copd

science2 months ago•9 min saved

Engineered biologics win FDA nod, opening doors across the blood–brain barrier

The first FDA-approved engineered biologic that can cross the blood–brain barrier marks a milestone in CNS drug delivery, as researchers accelerate brain-shuttle approaches to ferry large-molecule therapies into the brain for potential treatments of neurological diseases.

via Nature|

#biologics #blood-brain-barrier #cns

health3 months ago•2 min saved

CBER seeks steady footing under new FDA leadership

Under acting director Karim Mikhail, the FDA’s Center for Biologics Evaluation and Research is trying to move past a turbulent period by holding adviser meetings and showing flexibility in accepting drug submissions, signaling a return to a more normal operating stance after Vinay Prasad's controversial tenure.

via STAT|

#biologics #cber #fda

business7 months ago•3 min saved

Novo Nordisk bets $2.1B on next-gen oral biologics with Vivtex

Novo Nordisk plans to invest up to $2.1 billion in Vivtex to advance next-generation oral delivery systems for biologics, leveraging Vivtex’s GI tract screening platform developed in MIT labs. Novo will fund research and later development and commercialization, aiming to expand its lead in oral obesity and diabetes therapies after Wegovy’s pill launch, while Vivtex pursues broad partnership opportunities and potential standalone programs.

via Fierce Biotech|

#biologics #business #novo-nordisk

healthcare9 months ago•20 min saved

2025 FDA Approvals and Their Impact on Biopharma and Ophthalmology

In 2025, the FDA approved 46 new therapeutic agents, including a diverse range of modalities such as biologics, kinase inhibitors, and gene therapies, with cancer remaining the most common therapeutic area. The year was marked by policy changes, staffing challenges, and the launch of new approval pathways, reflecting a tumultuous but innovative period for drug development.

via Nature|

#2025 #biologics #cancer

health11 months ago•3 min saved

FDA Accelerates Approval of Generic Biologics to Cut Drug Costs

The FDA announced new measures to streamline the development and approval of biosimilar drugs, aiming to lower costs and increase access to affordable biologic treatments by simplifying testing requirements and promoting interchangeability, thereby fostering market competition and reducing healthcare expenses.

via fda.gov|

#biologics #biosimilars #drug-costs

health1 year ago•0 min saved

FDA Proposes New Guidelines to Accelerate Cell, Gene, and Rare Disease Therapies

The FDA's biologics center has released new draft guidances aimed at helping developers streamline the creation of innovative cell and gene therapies for small patient populations.

via Endpoints News|

#biologics #cell-therapy #fda

health1 year ago•1 min saved

Vinay Prasad Rejoins FDA Amidst Regulatory Turmoil

Vinay Prasad is returning to the FDA to resume his role overseeing biologics, including vaccines and gene therapy, after a brief departure amid tensions related to a Duchenne muscular dystrophy gene therapy and political criticisms.

via statnews.com|

#biologics #fda #gene-therapy

health1 year ago•0 min saved

FDA's Peter Marks Engages in Vaccine Dialogue with RFK Jr.

Peter Marks, the FDA's chief of vaccines and biologics, announced at the Jefferies London Healthcare Conference that he intends to remain in his position as long as he is welcome, despite any incoming changes.

via Endpoints News|

#biologics #fda #health

health-and-medicine2 years ago•19 min saved

"FDA's 2023 Surge in Drug Approvals Marks a Record Year for Pharmaceuticals"

The FDA approved 55 new drugs in 2023, marking a significant increase from the previous year and setting a 10-year rolling average high. Oncology led with 24% of the approvals, followed by neurology. Notable approvals included the first CRISPR–Cas9-based gene editing product, two RSV vaccines, and a burst of gene therapies. AstraZeneca's capivasertib became the first AKT inhibitor approved for breast cancer, and several first-in-class cancer therapies were greenlit. In neurology, Biogen and Ionis's tofersen received accelerated approval for SOD1-mutated ALS, and Eisai and Biogen's lecanemab was approved for Alzheimer's disease. The approvals spanned various modalities, including nucleotide-based therapeutics and T-cell engaging bispecific antibodies.

via Nature.com|

#biologics #drug-development #fda-approvals

biotechnology2 years ago•12 min saved

"Enhancing Targeted Biologic Delivery to T Cells through Genetically Encoded Extracellular Vesicles"

Scientists have developed a method to genetically encode multiple functionalities into extracellular vesicles (EVs) for targeted delivery of biologics to T cells. EVs, such as exosomes, have shown promise as vehicles for therapeutic cargo delivery, but their targeting capabilities have been limited. By engineering EVs to express specific ligands or antibodies on their surface, researchers were able to enhance their binding and uptake by T cells. This approach could potentially improve the efficacy of T cell-based therapies and expand their applications in treating various diseases.

via Nature.com|

#biologics #biotechnology #extracellular-vesicles

technology3 years ago•1 min saved

Biden administration designates multiple regions as biotech and tech hubs

The Kansas City area has been chosen by the Biden administration as one of 31 technology hubs in the United States, with the aim of promoting innovation and job creation. The Kansas City Inclusive Biologics and Biomanufacturing Tech Hub (KC BioHub) will focus on the development and manufacturing of vaccines and related technologies. Led by BioNexus KC, the nonprofit organization will have the opportunity to receive up to $75 million in federal funding, attract additional investments, and expand the development of cutting-edge medicines and vaccines. The tech hubs program was established through bipartisan legislation, allocating $10 billion over five years.

via KSHB 41 Kansas City News|

#biden-administration #biologics #biomanufacturing

health3 years ago•5 min saved

Revolutionary German Guidelines Transform Asthma Treatment

New German guidelines on the management of asthma aim to shift the paradigm from relying on inhalers to a symptom-prevention approach. The guidelines emphasize the use of anti-inflammatory therapy as the primary treatment option, with inhaled glucocorticoids being the cornerstone of therapy. Allergen immunotherapy and biologics are also effective anti-inflammatory treatments. The guidelines recommend the use of biomarkers, such as eosinophils, IgE levels, and the FeNO test, for diagnosis. Biologics are highlighted as highly effective for severe asthma cases, and a diagram is provided to help choose the most suitable biologic for each patient. The guidelines also address asthma management in children and adolescents, including advice on career choices and the interrelation between asthma and mental health.

via Medscape|

#anti-inflammatory-therapy #asthma #biologics

health3 years ago•9 min saved

Continuous Dosing with a Single Injection: The Future of Drug Delivery?

Researchers at Rice University have developed a drug-delivery system that uses microparticles to release medication in timed delays that can span days or even weeks. The system involves injecting hundreds of tiny microplastic particles, each encapsulating a small dose of a drug, into the body. By adjusting the molecular weight of the polymer used for each capsule, the scientists can control how fast they erode and release medication. The team envisions designing a library of these particles that can mimic different dosing schedules: daily, weekly, monthly, or something in between, depending on the patient.

via WIRED|

#biologics #chronic-illness #dosing-adherence