Clinical trial Archives

Alume Biosciences announces first patient dosed with ALM 488

News and Trends 23 Aug 2022

Alume Biosciences progressing with fluorescence study in patients undergoing head and neck surgery

Alume Biosciences, Inc. says the first patient has been dosed in a phase 3 pivotal study of ALM-488, a peptide-dye conjugate designed to highlight nerves with fluorescence in real time during surgery. “The successful initiation of this phase 3 pivotal study is another major milestone for Alume Biosciences. It marks the final phase of clinical […]

August 23, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 22 Aug 2022

Santhera and ReveraGen announce first patient with Becker muscular dystrophy dosed in FDA-funded pilot study

The first patient has been dosed in a phase 2 pilot study looking at a treatment for muscular dystrophy. Santhera Pharmaceuticals and ReveraGen BioPharma made the announcement that vamorolone is to be assessed in patients with Becker muscular dystrophy (BMD). The study is being funded by the U.S. Food and Drug Administration (FDA). Eric Hoffman, […]

August 22, 2022 - 3 minutesmins - By Liza Laws

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

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

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

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

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

News and Trends 17 Aug 2022

Sanofi drops amcenestrant clinical development program

Sanofi says it is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). The decision was based on the outcome of an interim analysis of the phase 3 AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive […]

August 17, 2022 - 2 minutesmins - By Jim Cornall

News and Trends 16 Aug 2022

Viridian reports positive news from ongoing trial for patients with Thyroid Eye Disease

Patients with active thyroid eye disease (TED) could benefit from rapid and significant improvements after positive data emerged from a clinical trial. Viridian Therapeutics made the announcement yesterday (August 15) that the 10mg/kg cohort in its ongoing phase 1/2 trial of VRDN-001, an anti-IGF-1R antibody TED – an autoimmune disease where the body’s own immune […]

August 16, 2022 - 3 minutesmins - By Liza Laws

Patient dosed in phase 1 trial evaluating ATG-018 treatment

News and Trends 16 Aug 2022

Patient dosed in phase 1 trial evaluating treatment for those with tumors and malignancies

The first patient has been dosed in a phase 1 trial evaluating a monotherapy treatment in people with advanced solid tumors and hematologic malignancies in Australia. Antengene Corporation Ltd., is running the ATRIUM trial, a phase 1 multi-center, open-label, dose-finding study of monotherapy ATG-018. Safety and tolerability of ATG-018 The primary objective of the study […]

August 16, 2022 - 3 minutesmins - By Liza Laws

PBC clinical trials: Gannex doses first patient

News and Trends 16 Aug 2022

Gannex’ first patient dosed in study for treatment of primary biliary cholangitis

A study looking at a treatment for primary biliary cholangitis (PBC) has this month (August) enrolled 12 patients and is expected to be completed by the start of this year’s fourth quarter. Gannex Pharma Co., Ltd., owned by Ascletis Pharma Inc., announced yesterday (August 15) that it had finished its first dosing in the […]

August 16, 2022 - 3 minutesmins - By Liza Laws

News and Trends 16 Aug 2022

Pneumagen embarks on phase 2 proof of concept influenza study

Biotech company Pneumagen says the first person has been dosed in its phase 2 controlled human infection challenge study. Its product, Neumifil, is an intranasal, broad-spectrum antiviral treatment to prevent or, if infected, reduce and manage, viral respiratory tract infections. The phase 2 trial is a single center, randomized, double-blinded, placebo-controlled study evaluating two dose […]

August 16, 2022 - 2 minutesmins - By Jim Cornall

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Clinical trial

Alume Biosciences progressing with fluorescence study in patients undergoing head and neck surgery

Santhera and ReveraGen announce first patient with Becker muscular dystrophy dosed in FDA-funded pilot study

Vaderis emerges from stealth to start HTT trial

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

Treatment for patients with fragile skin disease accepted by FDA

FDA lifts partial clinical hold on Curis lymphoma study

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

Sanofi drops amcenestrant clinical development program

Viridian reports positive news from ongoing trial for patients with Thyroid Eye Disease

Patient dosed in phase 1 trial evaluating treatment for those with tumors and malignancies

Gannex’ first patient dosed in study for treatment of primary biliary cholangitis

Pneumagen embarks on phase 2 proof of concept influenza study

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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