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Tag: clinical trials


Clinical Trials, Research and Development

Another amyloid miss in Alzheimer’s as Roche’s crenezumab fails trial

June 16, 2022

Via: Pharmaphorum

The result isn’t a big surprise – Roche terminated two phase 3 trials of crenezumab in people with prodromal to mild sporadic Alzheimer’s in early 2019 after interim analyses found it would be futile to continue – but is another […]


Clinical Trials, Research and Development

FDA’s treatment of China-developed drugs spurs demands for multiregional clinical trials

June 14, 2022

Via: Pharmaphorum

China’s emergence as an R&D powerhouse means that the country is quickly adding a number of drug candidates to the global pipeline. Despite more treatment options being a positive, Ben Hargreaves finds that this has raised issues over single-region clinical […]


Cell and Gene Therapy, Industry

Coave Therapeutics and ABL Enter Gene Therapy Collaboration

June 13, 2022

Via: Contract Pharma

Coave Therapeutics, a clinical-stage biotechnology company focused on developing life-changing gene therapies for CNS (Central Nervous System) and eye diseases, and ABL, a pure play contract development and manufacturing organization (CDMO) specialized in the development and manufacturing of viruses for […]


News

Roche gambles $125M on a sliding biotech’s cancer drug

June 2, 2022

Via: Biopharma Dive

The most immediate effect of the deal is a much-needed infusion of funds for Repare, which went public in 2020 at a price of $20 a share. The company’s stock soared above $42 in early 2021, only to plummet as […]


Cell and Gene Therapy, Industry

BioMarin’s hemophilia A gene therapy further delayed amid new FDA questions

June 1, 2022

Via: FierceBiotech

BioMarin’s commercial aspirations for its hemophilia gene therapy remain on ice after the FDA lobbed additional questions for the company to address, pushing back an expected approval submission to September. BioMarin was vague on what the FDA is asking for, […]


Cell and Gene Therapy, Industry

Novel cancer vaccines by Dana-Farber and Stanford look beyond T cells to better fight tumors

May 27, 2022

Via: FierceBiotech

Most cancer immunotherapies primarily rely on T cells to neutralize tumors. But in two new studies, scientists at Dana-Farber Cancer Institute and Stanford University have described novel immuno-oncology approaches, showing that leveraging other components of the immune system may achieve […]


Clinical Trials, Research and Development

Moleculin Commences Dosing in Healthy Volunteers in Phase 1a Clinical Trial of WP1122 for the Treatment of COVID-19

May 26, 2022

Via: Drugs.com

Moleculin Biotech, Inc., (“Moleculin” or the “Company”), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the commencement of dosing in its first-in-human Phase 1a study to evaluate the […]


Clinical Trials, Research and Development

FDA lifts hold on Ocugen’s COVID-19 vaccine trial. But is it too late for the shot?

May 23, 2022

Via: FiercePharma

Six weeks after slapping a clinical hold on a trial of Ocugen’s COVID-19 vaccine, the FDA has lifted it. That’s the good news for the Malvern, Pa. company, which has partnered with India’s Bharat Biotech on the shot known commercially […]


Cell and Gene Therapy, Industry

Bayer pulls plug on $670M CAR-T cell therapy pact with Atara in wake of patient death

May 20, 2022

Via: FierceBiotech

Bayer is pulling the plug on its $670 million CAR-T pact with Atara Biotherapeutics. Three months after a death paused a study of the lead candidate, the German drugmaker has decided to cut its ties to Atara’s two mesothelin-directed CAR-T […]


Clinical Trials, Research and Development

Death triggers FDA hold on Foghorn blood cancer clinical trial, shrouding timing of data drop

May 20, 2022

Via: FierceBiotech

The FDA has sounded a warning about Foghorn Therapeutics’ blood cancer candidate FHD-286, putting a phase 1 clinical trial on a partial hold in response to the death of a patient with potential differentiation syndrome. FHD-286 is an enzymatic inhibitor […]


Cell and Gene Therapy, Industry

With lead gene therapy nearing the clinic, SwanBio leans heavily on Syncona to close $56M series B

May 19, 2022

Via: FierceBiotech

Syncona is continuing to bet big on gene therapy. While setbacks at other biotechs have taken the sheen off the modality, the investor is keeping the faith in SwanBio Therapeutics, stepping up to provide the lion’s share of a $56 […]


Cell and Gene Therapy, Industry

Vertex Expands Cell and Gene Therapy Footprint

May 18, 2022

Via: Contract Pharma

At a dedication of the new Jeffrey Leiden Center for Cell and Genetic Therapies in Boston’s Seaport, Vertex Pharmaceuticals unveiled plans to build another 344,000 square foot facility in the Seaport to support the company’s growth of its cell and […]