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Research & Development

Set Alert for Research & Development

Ocular’s Dry Eye Drug Fails In Phase II, But It Isn’t Giving Up Yet

Company hopes a different formulation of its intracanicular insert of cyclosporin might provide longer duration of drug in the eye and better tear production with it.

Clinical Trials Drug Approval Standards

Agenus PD-1 Down But Not Out With Cervical Cancer BLA Withdrawal

The company announced it would withdraw the BLA for balstilimab monotherapy in cervical cancer following Keytruda’s full approval, but it plans to keep developing the drug.

FDA ImmunoOncology

Sanofi Scores Clinical Win In Sixth Disease For Dupixent

The French major and partner Regeneron expect to file Dupixent for the rare skin disease next year after a Phase III trial of the blockbuster hit its primary and secondary endpoints.

Inflammation Clinical Trials

Pipeline Watch: Phase III Readouts In Breast And Liver Cancer Plus COVID-19

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Leucid Bio Unveils ‘Parallel CAR-T’ Platform Targeting Solid Tumors

The King's College London spin-out has gained £11.5m backing to take its ‘parallel CAR-T’ into the clinic.

Commercial Clinical Trials

Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Clinical Trials Drug Approval Standards

Sage/Biogen Delay Zuralone Filing, Commercial Path Remains Unclear

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

FDA Neurology

Bluebird Spinoff 2seventy Bio Gets Its Own Wings

The formal split between the companies had been in the works since January, with 2seventy set to take over oncology operations while bluebird focuses on gene therapies.

Business Strategies Biologics

BI Bets On Gene Therapy To Treat All Cystic Fibrosis Patients

Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Oxford BioMedica aim to get their CFTR gene therapy into the clinic soon, confident it could offer a long-lasting option for patients with cystic fibrosis.

Gene Therapy Manufacturing

Biogen Seeking A Path Forward After Phase III Tofersen Study Fails In ALS

The drug showed favorable but not significant trends across secondary endpoints, and greater efficacy in slower-progressing patients and those treated earlier in the disease, in a small subpopulation.

Clinical Trials Neurology

EyeGene: EG-COVID Will Be Starting Point For Other mRNA Vaccines

EyeGene R&D head talks to Scrip at CPhI Korea about the development of its COVID-19 vaccine candidate EG-COVID, potential challenges in clinical trials and positioning and the over-riding importance of validating a viable mRNA platform.

South Korea Coronavirus COVID-19

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: US tax policies challenge pharma; J&J’s long-time R&D head to retire; Legend Biotech’s CEO talks about plans; BMS disappointment in ulcerative colitis; and another gene therapy partnership for Takeda.

Companies ImmunoOncology
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