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Home » Newsletters » BioWorld

BioWorld

June 24, 2019

View Archived Issues

Mixed results for REGN-3500's phase II asthma trial dent IL-33 rival Anaptysbio

Top-line data for Sanofi SA and Regeneron Pharmaceuticals Inc.'s phase II trial of the IL-33 antibody REGN-3500 show patients with moderate to severe asthma treated with Dupixent (dupilumab) monotherapy did numerically better than REGN-3500 across all endpoints. And combining REGN-3500 and Dupixent did not demonstrate increased benefit compared to Dupixent monotherapy. Read More

'Lyme' still standing as Valneva, GSK unwind legacy deal

DUBLIN – Vaccine maker Valneva SE and Glaxosmithkline plc have unwound the final strands of a longstanding alliance, leaving the smaller firm to go its own way with the two surviving assets from the agreement, a vaccine against Lyme disease, which is currently in phase II trials, and a vaccine against chikungunya virus, which has completed a phase I trial.  Read More

Contravir climbs as FDA appears supportive of early studies in NASH

A tumultuous stretch of active trading in Contravir Pharmaceuticals Inc. continued Friday as shares (NASDAQ:CTRV) climbed 21.2% to $5.20 on news of positive FDA feedback regarding a pre-IND package for CRV-431 in nonalcoholic steatohepatitis (NASH).  Read More

Beyond POLO, string of ponies running on large DDR field

One of the highlights of the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) earlier this month were results from the phase III POLO trial, demonstrating that treatment with Lynparza (olaparib, Astrazeneca plc/Merck & Co. Inc.) after platinum chemotherapy nearly doubled the progression-free interval (progression-free survival, PFS) in a group of 154 metastatic pancreatic cancer patients with germline BRCA mutations, from 3.8 months to 7.4 months. Read More

Razza-ma-taz(emetostat): Epizyme's FL phase II databode brisk approval path?

Attendees of the International Conference on Malignant Lymphoma in Lugano, Switzerland, got even more interim data than expected from Epizyme Inc.'s phase II trial with lead candidate tazemetostat for relapsed or refractory follicular lymphoma (FL) in patients who have undergone at least two prior lines of systemic therapy. Read More

Japan approval world-first for tumor-agnostic Rozlytrek in NTRK-positive solid tumors

Japan has become the first country to give approval for Rozlytrek (entrectinib), a drug targeting patients with NTRK fusion gene-positive solid tumors, regardless of the site of disease origin. The Japanese Ministry of Health, Labour and Welfare (MHLW) had granted the drug both orphan drug designation and Sakigake status, which allows the accelerated approval of drugs designated as breakthrough therapies. Read More

Regulatory front

Following discussions with industry and other stakeholders, the FDA last week withdrew a 2014 draft guidance on developing pain drugs.  Read More

Financings

Artelo Biosciences Inc., of La Jolla, Calif., which is developing therapeutics targeting the endocannabinoid system, priced a public offering of 1.3 million units at $6.15 per unit.  Read More

Other news to note

Wuxi Biologics Co. Ltd., of Shanghai, said it is planning to expand the new state-of-the-art integrated biologics conjugation solution center to include commercial manufacturing in Wuxi City. Read More

Clinical data for June 21, 2019

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Regulatory actions for June 21, 2019

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Bench Press: BioWorld looks at translational medicine

Two separate research groups, one at the Barcelona Institute of Science and Technology and one at Harvard Medical School, have discovered a way to predict 3D protein structures by focusing on mutated versions of the proteins that affected epistatic interactions.  Read More

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