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4/24/2018

An early-stage study was launched by researchers at the University of Massachusetts to assess the safety of a potential vaccine for HIV. The clinical trial, which will take place at four sites, will include one group of patients that will receive the priming-booster regimen and another group that will get the DNA vaccine and the protein vaccine simultaneously.

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MD Magazine online
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HIV, University of Massachusetts
4/24/2018

A new-drug application was submitted to the FDA by Astellas Pharma for its Gilteritinib, which is being developed as a treatment for patients with FLT3MUT+ relapsed or refractory acute myeloid leukemia.

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Reuters
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FDA, Astellas Pharma, Astellas
4/24/2018

Autolus acquired worldwide rights to develop and commercialize UCL Business' AUTO1, a CD19 chimeric antigen receptor T-cell therapy to treat B-cell malignancies. The drug candidate is being evaluated in early-stage studies for acute lymphoblastic leukemia in children and adults.

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BioCentury
4/24/2018

Enlivex Therapeutics, which is working on a treatment for graft-versus-host disease, signed a nonbinding memorandum of understanding with Korea Investment Partners for a $2 million investment. Enlivex shareholder Hadasit Bio-Holdings will also invest $1.2 million as part of the agreement, and both parties will recruit other investors to complete a funding round of $6 million to $10 million.

4/24/2018

The Department of Agriculture and the FDA have differing definitions of biotech food. The USDA says using CRISPR-Cas9 to delete genes rather than inserting them creates a biosimilar product rather than a biotech one, while the FDA considers any genetic modification of an animal or crop -- regardless of whether a gene is added, deleted or edited -- to be not simply genetically modified but also a drug, subjecting the modified organism to the same regulatory process and testing as any other drug.

4/24/2018

An agreement was reached by Orion to sell its diagnostics business, Orion Diagnostica, to an Axcel Management-led investment fund for about $199 million plus up to approximately $73 million depending on Axcel's return on investment when it exits the business. The deal is expected to be completed this quarter.

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Orion Diagnostica, Axcel
4/24/2018

Terumo subsidiaries Vascutek and Bolton Medical will merge to become Terumo Aortic, a company that will offer surgical grafts, catheter-based stent graft systems and other advanced technologies for aortic disease treatment. Vascutek President and CEO Paul Holbrook will serve as president of the company, which will employ over 1,100 people globally.

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Insider (U.K.)
4/24/2018

The acquisition of Minnetonka, Minn.-based Cogentix Medical, valued at $214 million, was completed by Toronto-based Laborie Medical Technologies. Cogentix manufactures urology and gynecology devices, including solutions for overactive bladder syndrome and female stress urinary incontinence, which will allow Laborie to offer comprehensive solutions for urological applications from diagnosis through treatment.

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MassDevice (Boston)
4/24/2018

An initial public offering of 5 million shares was priced by Maple Grove, Minn.-based Inspire Medical Systems at a price range of $14 to $16 each in hopes of raising $75 million. The company markets its proprietary Inspire therapy for treating patients with sleep apnea.

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Renaissance Capital
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Inspire Medical Systems
4/24/2018

A round of Series A financing pulled in $11 million for Cambridge, Mass.-based NuProbe, an early-stage molecular diagnostics company that is developing a noninvasive blood test for early cancer and infectious disease detection. The proceeds will be used to build out the company's staff in Massachusetts and China, as well as for continued product development, trials and commercialization.

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FinSMEs