The latest biotech news

News and Trends 22 Aug 2022

Roche launches COVID-19 test to detect emerging variant of interest

Roche and its subsidiary TIB Molbiol have developed a COVID-19 test for researchers that detects and differentiates the latest sub-variant of interest BA.2.75. The test specifically targets two of the known unique mutations in BA.2.75, which allows clear differentiation against other notable subvariants. “Roche is pleased to have developed a test for researchers that provides […]

August 22, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 22 Aug 2022

Vaderis emerges from stealth to start HTT trial

Vaderis Therapeutics AG, a clinical stage biotech company focused on developing treatments for rare diseases associated with vascular malformations, has emerged from stealth. The company has also started its INSIGHT proof-of-concept clinical trial in patients suffering from hereditary hemorrhagic telangiectasia (HHT), also known as Osler-Weber-Rendu syndrome. About HHT HHT is a disorder where some blood […]

August 22, 2022 - 3 minutesmins - By Jim Cornall

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

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News and Trends

Roche launches COVID-19 test to detect emerging variant of interest

Vaderis emerges from stealth to start HTT trial

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

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Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Illuminating biotech in the City of Light: Inside Paris’s thriving ecosystem

ASCO 2025: key highlights in cancer therapeutics

New report: Artificial intelligence and the future of antibody discovery

Stem cell therapy: a potential cure for hearing loss?

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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