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Home » Newsletters » BioWorld

BioWorld

Oct. 29, 2019

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Eye-chart

Iveric's positive top-line data for macular degeneration brings its stock into focus

Upbeat top-line data for New York-based Iveric Bio Inc.'s phase IIb trial testing Zimura in dry age-related macular degeneration propelled the company stock (NASDAQ:ISEE) 82.8% upward in Monday's trading, a big success in a company that rebranded itself earlier this year. Read More

Agile's Twirla struggles to impress ahead of FDA adcom date

The third time is proving not to be so charming for Agile Therapeutics Inc. as it prepares its lead candidate for a date Wednesday with the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee. Read More

What it's looking for: TG to find CLL victory in U2? Follicular win lifts case

As TG Therapeutics Inc.'s phase IIb win in the follicular lymphoma (FL) cohort of the Unity-NHL pivotal experiment testing umbralisib charmed Wall Street, CEO Michael Weiss told investors that the New York-based company is "completely committed to getting our marginal zone lymphoma [MZL] filing in on time and getting to the market" soon. Nobody's forgetting about the opportunity in chronic lymphocytic leukemia (CLL), either. Read More

Takeda reports positive phase III data for eosinophilic esophagitis candidate

A late-stage test of Takeda Pharmaceutical Co. Ltd.'s oral suspension of the steroid budesonide for the treatment of eosinophilic esophagitis (EoE) achieved both its co-primary endpoints, improving histologic and dysphagia symptom responses vs. placebo during the first pivotal phase III study of an EoE treatment ever to be reported in the U.S. The study, part of the largest EoE clinical program globally to date, also met secondary endpoints, including improvements from baseline to final treatment as measured by an established patient-reported outcome measurement. Read More

Bispecific matchmakers can improve antibodies, CARs

BOSTON – Researchers from Memorial Sloan-Kettering Cancer Center presented encouraging, though very early, data on Merus NV's bispecific antibody MCLA-128 for the treatment of patients with NRG-1 gene fusions at the AACR-NCI-EORTC Molecular Targets meeting on Sunday. Read More

Pfizer tracking lung cancer resistance profile using Inivata's liquid biopsy tool

LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC). Read More

Virocure's Australian branch launches operations with an oncolytic virus phase I trial

HONG KONG – South Korean biopharma Virocure Inc., based in Seoul, recently founded a local corporation in Brisbane, Australia. The new company, Virocure Australia Pty Ltd., will facilitate a phase I trial of cancer drug RC-402 in Australia. Read More

Financings for Oct. 29, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Oct. 29, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Oct. 29, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Oct. 29, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

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