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Home » Newsletters » BioWorld

BioWorld

June 6, 2018

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Regulatory actions for June 5, 2018

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Clinical data for June 5, 2018

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Financings

Optinose Inc., of Yardley, Pa., said it commenced a proposed underwritten public offering of 4.5 million shares of its common stock, which will consist of 2.25 million shares to be offered by the company and 2.25 million shares to be offered by certain selling stockholders.  Read More

Other news to note

Kxtbio Inc., of Chapel Hill, N.C., will receive a NIH $300,000 grant to develop a new screening platform with the goal of reducing costs of the early phases of drug development. The high-throughput platform will screen for compounds acting on G protein-coupled receptors, reduce off-target hits, increase successful leads and speed up drug discovery.  Read More

Open science equals progress through public-private partnerships

BOSTON - Pierre Meulien, executive director of the Innovative Medicines Initiative (IMI), described the difference between open innovation and open science on Tuesday at the Biotechnology Innovation Organization’s International Convention. Read More

Immutep's LAG-3 immunotherapy shows promise for boosting efficacy of Keytruda

PERTH, Australia – Sydney-based Immutep Ltd. unveiled new data for its phase I immunotherapy study that showed a long-lasting and durable response and an overall response rate of 61 percent in a melanoma study combining its lead immunotherapy with Merck's anti-PD-1 therapy Keytruda (pembrolizumab). Read More

New educational efforts seek to pave way for biopharma’s future workforce

BOSTON – U.S. bioscience firms directly employ 1.74 million people, according to a new report published by BIO, with average annual wages for a U.S. bioscience worker reaching $98,961, at least as of 2016. But despite the industry’s positive impact, there remains room to grow, and energy to be invested in broadening the industry’s reach, two new efforts show. Read More

Growing microbiome space maps out research, regulatory hurdles, ignores hype

BOSTON – Two survey questions at a Biotechnology Innovation Organization (BIO) International Convention panel determined that 44 percent of those attending were business professionals looking to switch to a microbiome company, and 28 percent were considering starting a microbiome company. Read More

Sterna mulls its options for first-in-class GATA-3 inhibitor in inflammatory disease

DUBLIN – Decision time is looming for Sterna Biologicals GmbH & Co. KG on the development trajectory of its first-in-class GATA-3 inhibition program, which has delivered promising, if preliminary, data in ulcerative colitis, asthma, atopic dermatitis, and chronic obstructive pulmonary disease. Read More

Nimbus looks beyond partners, lands $65M for its own account

Existing investors stepped up with enthusiasm to an oversubscribed $65 million internal round at Nimbus Therapeutics that will enable the Cambridge, Mass.-based company to accelerate pipeline programs and examine additional targets in metabolic, immuno-oncology (I-O) and autoimmune disease. Each of the company's current investors participated in the round, including Atlas Venture, SR One, Lilly Ventures, Bill Gates, Pfizer Venture Investments, Lightstone Ventures and Schrödinger. Read More

Mylan and the FDA score a first with approval of Neulasta biosimilar

Mylan NV Monday accomplished what others have failed to do – get FDA approval for a Neulasta biosimilar. The licensing of Fulphila (pegfilgrastim-jmbd), co-developed with Biocon Ltd., of Bangalore, India, also scores a first for the FDA, which has been playing catch-up with the EMA’s head start on the biosimilar path. Although the EMA has authorized 43 biosimilars since 2006, it has yet to approve a biosimilar to Amgen Inc.’s Neulasta, which is used to treat neutropenia in patients on chemotherapy in certain types of cancer. Read More

Conference data: American Society of Clinical Oncology (Chicago)

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