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News and Trends 19 Aug 2022

Treatment for patients with fragile skin disease accepted by FDA

The U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for B-VEC, a treatment for patients with dystrophic epidermolysis bullosa (DEB). Krystal Biotech Inc. works in redosable gene therapy and made the announcement today (August 18). The application has been granted Priority Review designation, and the Prescription Drug […]

August 19, 2022 - 3 minutesmins - By Liza Laws

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News and Trends 19 Aug 2022

Nuance Pharma receives clearance to begin clinical trials with Ensifentrine in China

Nuance Pharma and its partner Verona Pharma plc have received clearance from the Center of Drug Evaluation for the investigational new drug (IND) application for ensifentrine. The application means both phase 1 and phase 2 studies looking at the drug for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in mainland China. In 2021, […]

August 19, 2022 - 2 minutesmins - By Liza Laws

News and Trends 19 Aug 2022

Beyond Biotech podcast 10: Endpoint Health, Nevrargenics, Triastek

This week our guests on the podcast are Xianghao Zuo, deputy director of R&D at Triastek; Endpoint Health CEO Jason Springs; and Andy Whiting, CEO of Nevrargenics. Triastek and Lilly working together on 3D printing for drugs A new research collaboration between Chinese company Triastek, Inc. and Eli Lilly and Company will leverage 3D printing […]

August 19, 2022

News and Trends 19 Aug 2022

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

Aeglea BioTherapeutics, Inc. says its marketing authorization application (MAA) for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) has been validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that […]

August 19, 2022 - 3 minutesmins - By Jim Cornall

News and Trends 18 Aug 2022

First patient on Innovative Cellular Therapeutics’ study looking at treating colorectal cancer

The first patient has been enrolled on a study to trial a treatment for relapsed or refractory metastatic colorectal cancer (R/R mCRC) in the U.S. Innovative Cellular Therapeutics (ICT), Inc. a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies made the announcement today (August 18). Tolerability The study […]

August 18, 2022 - 2 minutesmins - By Liza Laws

News and Trends 18 Aug 2022

FDA lifts partial clinical hold on Curis lymphoma study

Curis, Inc., a biotech company focused on the development of innovative therapeutics for the treatment of cancer, says the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim lymphoma phase 1/2 study of emavusertib after reviewing the data package submitted by Curis. “We are excited to announce that FDA […]

August 18, 2022 - 4 minutesmins - By Jim Cornall

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News and Trends 18 Aug 2022

89bio completes enrollment in NASH phase 2b trial

U.S. clinical-stage biopharma company 89bio, Inc. has completed enrollment in ENLIVEN, the phase 2b trial of pegozafermin for the treatment of non-alcoholic steatohepatitis (NASH). “We are very pleased to have successfully completed enrollment of 219 total patients in ENLIVEN, a well-powered trial that builds on positive data demonstrating pegozafermin’s broad metabolic effects and favorable safety/tolerability […]

August 18, 2022 - 2 minutesmins - By Jim Cornall

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News and Trends 18 Aug 2022

Patients with beta-thalassemia able to access first approved gene therapy

A gene therapy drug approved by the U.S. Food and Drug Administration (FDA) has been made accessible for people with beta-thalassemia. Zynteglo, a betibeglogene autoemcel, also known as beti-cel, treats adults and pediatric patients with the disease who need regular red blood (RBC) transfusions. The condition is passed down from one or both parents through […]

August 18, 2022 - 3 minutesmins - By Liza Laws

News and Trends 18 Aug 2022

Carina Biotech raises funds for colorectal cancer research

Australia’s Carina Biotech has raised A$7.5 million (US$5.2 million) at first close of its current funding round. Venture capital business Tenmile was the cornerstone investor, with support from existing investors. The capital raise enables Carina Biotech to complete its Investigational New Drug (IND) enabling studies and initiate a CAR-T clinical trial of its LGR5 CAR-T […]

August 18, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 18 Aug 2022

CSL gets positive results for preventive treatment in patients with hereditary angioedema

Hereditary angioedema (HAE), a condition that causes recurrent attacks of severe swelling, could be prevented by a monoclonal antibody after positive top line phase 3 results were reported. Garadacimab, biotech company CSL’s investigational monoclonal antibody inhibiting factor XIIa, is being developed as a long-term preventive treatment for patients with HAE. Efficacy objectives The study met […]

August 18, 2022 - 3 minutesmins - By Liza Laws

PAN-TB collaboration: a new project for tuberculosis treatment

More News! 18 Aug 2022

Collaboration to advance investigational tuberculosis drug treatments

A collaboration called The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) was announced yesterday (August 17). The joint development agreement (JDA) will support the progression of two investigational tuberculosis (TB) combination treatment regimens into phase 2 clinical development. The collaboration is made up of organizations contributing five antimicrobial agents. Active pulmonary TB Together they […]

August 18, 2022 - 5 minutesmins - By Liza Laws

News and Trends 17 Aug 2022

TurtleTree produces first precision fermentation sustainable lactoferrin

Singapore biotech company TurtleTree has announced production of LF+, the world’s ﬁrst sustainable bovine lactoferrin created using precision fermentation technology. A key part of the company’s ongoing work with cultivated dairy, precision fermentation uses microbial hosts for the mass production of ingredients. Compared to traditional methods, precision fermentation offers far greater efficiency and volume, enabling […]

August 17, 2022 - 2 minutesmins - By Jim Cornall

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News and Trends

Treatment for patients with fragile skin disease accepted by FDA

Nuance Pharma receives clearance to begin clinical trials with Ensifentrine in China

Beyond Biotech podcast 10: Endpoint Health, Nevrargenics, Triastek

Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok

First patient on Innovative Cellular Therapeutics’ study looking at treating colorectal cancer

FDA lifts partial clinical hold on Curis lymphoma study

89bio completes enrollment in NASH phase 2b trial

Patients with beta-thalassemia able to access first approved gene therapy

Carina Biotech raises funds for colorectal cancer research

CSL gets positive results for preventive treatment in patients with hereditary angioedema

Collaboration to advance investigational tuberculosis drug treatments

TurtleTree produces first precision fermentation sustainable lactoferrin

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Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Catalonia: A biotech hub going from strength to strength, with Barcelona at its core

Top biotech deals of February 2025

Grab your free report on 3D organoids and explore their future potential

These 7 biotechs are shaping the next generation of endometriosis care

Connect with decision-makers and researchers worldwide for collaborative opportunities

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