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FDA Animal Testing Phase-Out Targets Monoclonal Antibodies

XTalks

The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. On April 10, 2025, the FDA unveiled a new plan to phase out its animal testing requirements, refocusing the FDAs animal testing policy towards other methods.

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IONTAS and FairJourney Biologics discover COVID-19 neutralizing antibodies

BioPharma Reporter

Two leading clinical research organizations (CROs) say they have identified neutralizing antibodies with great potential for monoclonal antibody treatment.

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Mayo Clinic researchers develop new antibody test to diagnose MS

Scienmag

Mayo Clinic researchers have validated a new antibody test to diagnose multiple sclerosis (MS), a potentially disabling disease of the brain and spinal cord. An antibody typically consists of two immunoglobulin heavy chains and […]. ROCHESTER, Minn. Nearly 1 million people in the U.S.

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CytoDyn scores $12M in legal battle win: A huge breakthrough for its antibody drug trials

BioPharma Reporter

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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Covid vaccine booster raises antibody levels in fight against Omicron

pharmaphorum

Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5 Details of the study were published in The Lancet this week. times higher against Omicron after three doses compared to after two.”.

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China’s NMPA accepts IND for SinoMab BioScience’s SM17 to treat asthma

Pharmaceutical Technology

SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders. It can suppress Th2 immune responses by binding to IL-17RB on Type 2 innate lymphoid cells (ILC2s).

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AbbVie begins trials of COVID-19 antibody therapy

pharmaphorum

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.