The latest biotech news

News and Trends 19 Aug 2022

Emtora to use $16.9M grant to develop treatment for rare genetic disease

Emtora Biosciences, a Texas-based clinical-stage biopharmaceutical company, has been awarded a $16.9 million non-dilutive grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The funding will be used to advance the clinical and product development of its lead program, eRapa, an encapsulated form of rapamycin, for the treatment of familial adenomatous polyposis (FAP). […]

August 19, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 19 Aug 2022

World’s first CAR-T for treatment of inflammatory disorders of the central nervous system approved in China

China’s National Medical Products (NMPA) has approved an investigational new drug application from IASO Bio for the new extended indication of neuromyelitis optica spectrum disorder (NMOSD). Neuromyelitis optica spectrum disorders previously known as Devic disease or neuromyelitis optica are inflammatory disorders of the central nervous system characterized by severe, immune-mediated demyelination and axonal damage predominantly targeting […]

August 19, 2022 - 2 minutesmins - By Liza Laws

News and Trends 19 Aug 2022

Axsome Therapeutics’ MDD treatment gets green light from FDA

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics, Inc.’s Auvelity tablets for the treatment of major depressive disorder (MDD) in adults. Auvelity (dextromethorphan HBr -bupropion HCl) is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at […]

August 19, 2022 - 4 minutesmins - By Jim Cornall

Kintor Pharmaceutical drug gets positive results for breast cancer

News and Trends 19 Aug 2022

Gilead to acquire remaining worldwide rights of breast cancer drug, Trodelvy

All of Everest Medicine’s development and commercialization rights for a breast cancer drug called Trodelvy have been transferred to American biopharma Gilead Sciences Inc. The transfer of the antibody drug, sacituzumab govitecan treatment, will apply to Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. In China mainland and Singapore, Trodelvy is […]

August 19, 2022 - 3 minutesmins - By Liza Laws

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

coronavirus COVID 19 Europe biotech lungs

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

nash liver fibrosis genfit terns pharmaceuticals organ

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

beta-thalassemia blood APS antiphospholipid syndrome

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

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News and Trends

Emtora to use $16.9M grant to develop treatment for rare genetic disease

World’s first CAR-T for treatment of inflammatory disorders of the central nervous system approved in China

Axsome Therapeutics’ MDD treatment gets green light from FDA

Gilead to acquire remaining worldwide rights of breast cancer drug, Trodelvy

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

Subscribe to our newsletter to get the latest biotech news!

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

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Advertise with us

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