Histogenics to complete Phase 3 enrollment in Q2

Histogenics to complete Phase 3 enrollment in Q2

Histogenics (NASDAQ:HSGX) expects to complete enrollment by the end of the second quarter this year in a Phase 3 clinical trial of its NeoCart biologic cell therapy and tissue engineering solution for knee cartilage regeneration.

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Arch moving to regulatory stage this year

Arch moving to regulatory stage this year

Arch Therapeutics (OTCQB:ARTH) has multiple regulatory filings planned in the U.S. and Europe this year for its AC5 Topical Hemostatic Device as the biopharma company shifts to regulatory-stage footing ahead of commercialization.

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Jaguar, Napo merger set for transformative growth

Jaguar, Napo merger set for transformative growth

The proposed merger of Jaguar Animal Health (NASDAQ:JAGX) and closely-held Napo Pharmaceuticals is expected to create a combined company with prescription product revenue, potential line extensions and an expanded pipeline.

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Kalytera cannabidiol platform to target GvHD

Kalytera cannabidiol platform to target GvHD

Kalytera Therapeutics (TSX-V:KALY) has put its bone repair and osteoporosis research programs on the back burner in order to focus development of a new cannabidiol (CBD) therapeutic for the treatment of acute Graft versus Host Disease (GvHD).

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In conversation with Chiara Russo

In conversation with Chiara Russo

As a specialty pharmaceuticals analyst with Cantor Fitzgerald for the past 2 1/2 years, Chiara Russo covers developmental-stage companies that are on the cusp of changing the medical landscape as we know it. A philosophy major with an MBA from the Olin School of Business at Babson College, Ms. Russo was a R&D innovation consultant for Cubist Pharmaceuticals before becoming a sell-side equity research analyst. On the Street, she has been a research associate at ThinkEquity and VP and specialty pharmaceuticals analyst at Janney Montgomery Scott. In this interview with BioTuesdays.com, Ms. Russo discusses industry trends and some of the stocks she likes.

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BioTime leading advances in regenerative medicine

BioTime leading advances in regenerative medicine

BioTime (NYSE MKT, TASE:BTX) has multiple data milestones scheduled this year in its two lead regenerative medicine programs: OpRegen in dry AMD and Renevia in facial aesthetics.

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Clearside out front targeting back-of-the-eye diseases

Clearside out front targeting back-of-the-eye diseases

Using a novel ocular injection platform to deliver drug to the suprachroidal space (SCS) at the back of the eye, Clearside Biomedical (NASDAQ:CLSD) is relentless pursuing treatments for blinding diseases with a late-stage pipeline for macular edema associated with uveitis and retinal vein occulusion and DME, as well as an early development program for wet AMD.

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In conversation with Mohit Trikha

In conversation with Mohit Trikha

As chief scientific officer, EVP and head of closely held Triphase Accelerator, Mohit Trikha has parlayed a successful 20-year track record in oncology drug development into a home run, selling Triphase’s first asset, a proteasome inhibitor known as marizomib, to Celgene (NASDAQ:CELG). Prior to joining Triphase, Dr. Trikha was associate VP of clinical development at Ambit Biosciences; director of BioOncology and early development at Genentech; and assistant director of oncology research at J&J’s Centocor. 

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Athersys poised to launch pivotal stroke study next summer

Athersys poised to launch pivotal stroke study next summer

After receiving a Special Protocol Assessment (SPA) from the FDA at the end of September, Athersys (NASDAQ:ATHX) hopes to launch a pivotal trial next summer administering its intravenous MultiStem cell therapy in patients following an ischemic stroke.

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GeneNews aims to fix compliance gap in early cancer screening

GeneNews aims to fix compliance gap in early cancer screening

GeneNews (TSX:GEN) is addressing the major issue in earlycancer screening - patient reluctance with inconvenient and intrusive screening methods - with a suite of differentiated molecular diagnostic tests that rely on a convenient in-office blood draw to find cancers of the colon, lung, breast and prostate, early.

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In conversation with Jason Kolbert

In conversation with Jason Kolbert

As head of healthcare research and as the senior biotechnology analyst with Maxim Group, Jason Kolbert has worked extensively in the healthcare sector. This includes pharma experience with Schering-Plough in Japan, as a fund manager and as an equity analyst for the past 20 years. 

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In conversation with Dr. Chad Larson

In conversation with Dr. Chad Larson

As an advisor and consultant with Cyrex Laboratories, a clinical immunology lab, Dr. Chad Larson holds a Doctor of Naturopathic Medicine degree from Southwest College of Naturopathic Medicine and a Doctor of Chiropractic degree from Southern California University of Health Sciences. 

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NeuroproteXeon targets Q2 start of Phase 3 Xenex trial

NeuroproteXeon targets Q2 start of Phase 3 Xenex trial

Closely-held NeuroproteXeon has received agreement on a special protocol assessment from the FDA for a Phase 3 trial of its inhaled pharmaceutical grade product, XENEX, a xenon gas formulation, as a neuroprotecter against brain cell death following acute neurologic injury, such as cardiac arrest.

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