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News and Trends 12 Oct 2022

Boston Cell Standards wins FDA $510K clearance for anatomic pathology controls

A company standardizing cancer diagnostic tissue testing with the first immunohistochemistry (IHC) laboratory reference standards has received $510,000 clearance from the U.S. Food and Drug Administration (FDA). The money will go towards Boston Cell Standards IHControls panel for evaluating breast cancers. The clearance represents regulatory approval. “IHControls represent a giant step forward in standardization in […]

October 12, 2022 - 2 minutesmins - By Liza Laws

News and Trends 12 Oct 2022

Novavax COVID-19 vaccine data supports homologous and heterologous boosting

Data in from adults and adolescents aged 12-17 collected in a phase 3 trial of a prototype Novavax COVID-19 vaccine showed it had achieved its pre-specified immunologic endpoint. Study 307 met its primary endpoint, showing three lots of the vaccine tested as a heterologous booster induced consistent immune responses in previously vaccinated adults aged 18-49. […]

October 12, 2022 - 3 minutesmins - By Liza Laws

News and Trends 12 Oct 2022

Amolyt Pharma publishes hypoparathyroidism treatment results

Amolyt Pharma has announced positive results from the second patient cohort in its phase 2a clinical proof of concept trial of AZP-3601, a PTH1 receptor agonist, which the company is developing as a potential treatment for hypoparathyroidism. Consistent with the findings from cohort 1, in the full data set from the phase 2a study, AZP-3601 […]

October 12, 2022 - 5 minutesmins - By Jim Cornall

News and Trends 12 Oct 2022

SiSaf takes steps with FDA for RNA therapeutic to treat rare genetic skeletal disorders

SiSaf Ltd, an RNA delivery and therapeutics company, is initiating the U.S. FDA Regulatory process to obtain orphan drug designation for SIS-101-ADO. SIS-101-ADO is a siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), a rare genetic skeletal disorder. The request for orphan drug designation and advancement through the regulatory process that SIS-101-ADO […]

October 12, 2022 - 3 minutesmins - By Jim Cornall

Mike Nally Generate Biomedicines ai drug discovery

Interview 12 Oct 2022

Boosting pharma’s falling productivity with AI in drug discovery

The pharmaceutical industry is struggling with mounting costs of drug development. Generate Biomedicines’ CEO, Michael Nally, outlines the firm’s mission to tackle the trend by making drug discovery scalable. Over the decades, the pharma and biopharma industry has suffered a growing stagnation in productivity. According to a report from University College London in 2018, for […]

October 12, 2022 - 5 minutesmins - By Jonathan Smith

News and Trends 12 Oct 2022

Agreement signed to advance therapy for autoimmune disease

HanAll Biopharma’s licensed partner, Harbour BioMed, has signed an exclusive sublicense agreement with CSPC NBP Pharmaceutical Co., Ltd for an advanced inhibitor. The agreement is for HanAll’s neonatal Fc receptor (FcRn) inhibitor batoclimab which is one of the most advanced being developed in Greater China. The companies say it has the potential to become a […]

October 12, 2022 - 3 minutesmins - By Liza Laws

News and Trends 12 Oct 2022

Ascidian Therapeutics launches with $50M to rewrite RNA

Ascidian Therapeutics, a biotechnology company focused on treating human diseases by rewriting RNA, has been launched. With an initial focus on replacing mutated exons at the RNA level, Ascidian’s technology enables therapeutic targeting of large genes and genes with high mutational variance while maintaining native gene expression patterns and levels. This approach is designed to […]

October 12, 2022 - 4 minutesmins - By Jim Cornall

News and Trends 12 Oct 2022

Malaysian Genomics signs research agreement with government

MGRC Therapeutics Sdn Bhd (MGRC-T), a wholly-owned subsidiary of Malaysian Genomics Resource Centre Berhad, has entered into a cooperation agreement with the National Institutes of Health, Malaysia (NIH). The agreement provides a framework for collaboration between the two parties in medical research pertaining to genomics and biopharmaceuticals. The National Institutes of Health (NIH), the research […]

October 12, 2022 - 2 minutesmins - By Jim Cornall

decentralized trial clinical trial digital technology

News and Trends 12 Oct 2022

Virtual trials growth leads to Cambridge Cognition acquiring eClinicalHealth

Cambridge Cognition is looking to accelerate its growth through the acquisition of eClinicalHealth Ltd (eCH). Cambridge Cognition is an active player in the central nervous system (CNS) market, supplying digital solutions to assess brain health. eCH is a full-service digital technology provider working on virtual clinical trials for three of the world’s top 10 largest […]

October 12, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 12 Oct 2022

Emergex looks to microneedle patches with Zosano Pharma acquisition

Emergex Vaccines Holding Limited has acquired the assets of California-based company Zosano Pharma Corporation. Emergex is a clinical stage biotechnology company addressing major global infectious diseases through the development of fully synthetic CD8+ T cell Adaptive Vaccines. The assets acquired include intellectual property, license agreements, and manufacturing equipment. They also include Zosano’s proprietary microneedle array […]

October 12, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 12 Oct 2022

WuXi Biologics and Toregem BioPharma to develop antibody for adentia treatment

WuXi Biologics and Toregem BioPharma, a biotech startup company from Kyoto University, have signed a memorandum of understanding to form a strategic partnership to develop TRG035. TRG035 is a monoclonal antibody targeting USAG-1 as a tooth regeneration treatment for congenital adentia. Within the partnership, Toregem BioPharma will have access to WuXi Biologics’ integrated CMC services […]

October 12, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 11 Oct 2022

Late-breaking data shows significant remission in children with EoE

Late-breaking positive results from a phase 3 trial have shown that children with eosinophilic esophagitis (EoE) given a higher dose of Dupixent showed histological disease remission and signs of weight gain. At week 16, 68% of children aged one to 11 years with active EoE on the higher dose displayed the positive results during the […]

October 11, 2022 - 3 minutesmins - By Liza Laws

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Boston Cell Standards wins FDA $510K clearance for anatomic pathology controls

Novavax COVID-19 vaccine data supports homologous and heterologous boosting

Amolyt Pharma publishes hypoparathyroidism treatment results

SiSaf takes steps with FDA for RNA therapeutic to treat rare genetic skeletal disorders

Boosting pharma’s falling productivity with AI in drug discovery

Agreement signed to advance therapy for autoimmune disease

Ascidian Therapeutics launches with $50M to rewrite RNA

Malaysian Genomics signs research agreement with government

Virtual trials growth leads to Cambridge Cognition acquiring eClinicalHealth

Emergex looks to microneedle patches with Zosano Pharma acquisition

WuXi Biologics and Toregem BioPharma to develop antibody for adentia treatment

Late-breaking data shows significant remission in children with EoE

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The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

The top biotech deals of March 2025

The biggest biotech funding rounds in March 2025

Join the webinar: AI in antibody discovery - from in silico analysis to AI-enabled data management

Beyond amyloid: The search for the next big thing in Alzheimer’s treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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