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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William Blair analyst discusses Hep B space

William Blair analyst discusses Hep B space

As a partner and biotechnology analyst with William Blair & Co., Y. Katherine Xu was recognized in 2010 by the Financial Times/StarMine “World’s Top Analysts” listing, ranking No. 7 overall for stock-picking in the U.S., and No. 2 for stock-picking in biotech in 2011. She also received the No. 2 ranking in The Wall Street Journal’s “Best on the Street” listing in 2011. Prior to joining William Blair in 2011, Ms. Xu was a SVP and senior biotech analyst at Wedbush Securities; VP and senior biotech analyst at Credit Suisse; and a senior biotech analyst at Pacific Growth Equities. Before her move into equity research, Ms. Xu worked in investment banking for two years. In this interview with BioTuesdays.com, Ms. Xu discusses her industry-leading research report entitled, Hepatitis B: The Next Frontier, and some of her best investment ideas in the Hep B space.

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Mesoblast developing multiple cell-based products

Mesoblast developing multiple cell-based products

Mesoblast (NASDAQ:MESO; ASX:MSB) has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells (MLCs), to establish a broad portfolio of late-stage product candidates.

“This technology has the potential to target advanced stages of diseases, with high, unmet medical needs, including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions,” CEO and managing director, Dr. Silviu Itescu, says in an interview with BioTuesdays.com.

Dr. Itescu explains Mesoblast’s MLCs are rare cells and central to blood vessel maintenance, repair and regeneration, largely via secretion of growth factors, which act on neighboring endothelial cells to promote blood vessel regeneration and function.

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COTI approaching critical inflection point

COTI approaching critical inflection point

As it transitions from a discovery and technology platform-focused organization to a clinical stage biotech company, Critical Outcome Technologies (OTCQB:COTQF; TSX-V:COT) is approaching a critical inflection point by mid-2017 with its lead program, COTI-2, in in gynaecological cancers.

COTI-2 is currently being evaluated in a Phase 1 clinical study at two premier cancer centers in the U.S.

“We’ve assembled an impressive amount of supportive preclinical data in the past for COTI-2, and are excited to be evaluating in the clinic this potentially significant therapeutic option for women suffering from debilitating gynecological cancers, such as ovarian cancer,” Alison Silva, president, says in an interview with BioTuesdays.com.

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Mateon taking VDAs in new direction against cancer

Mateon taking VDAs in new direction against cancer

Mateon Therapeutics (NASDAQ:MATN) is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal tumor blood vessels, which supply nutrients to cancer cells, with an initial clinical focus on platinum-resistant ovarian cancer and acute myeloid leukemia.

“VDAs have been around for a long time but we’re taking them in a new direction: in combination with anti-angiogenic (AA) therapies,” president and CEO, Dr. William Schwieterman, says in an interview with BioTuesdays.com.

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Lupus Foundation puzzled by negative reaction to Aurinia data

Lupus Foundation puzzled by negative reaction to Aurinia data

As president and CEO of The Lupus Foundation of America (LFA), a role she has held for 15 years, Sandra Raymond is an outspoken advocate for the plight of lupus patients. She has worked with the board of directors and the lupus research community to bring national attention and resources to lupus research and education. Ms. Raymond came to the LFA after serving as the founding CEO of the National Osteoporosis Foundation, beginning in 1986. She envisions great progress in lupus treatment and care over the next 10 years but recognizes the urgent need to elevate lupus on the national healthcare agenda by increasing federal and private investment in research on lupus and developing constructive public policies aimed at bringing support and services to all people affected by lupus. In this interview with BioTuesdays.com, Ms. Raymond discusses the state of the disease and results of a recent clinical study by Aurinia Pharmaceuticals (NASDAQ:AUPH; TSX:AUP).

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BioSyent to target international markets

BioSyent to target international markets

BioSyent (OTC:BIOYF; TSX-V:RX) is actively building its international pharmaceutical sales and marketing business, adding products licensed and sold internationally to products already being shipped from Canada.

“We’re working on a couple of international deals now,” René Goehrum, chairman, president and CEO, says in an interview with BioTuesdays.com.

Mr. Goehrum explains that BioSyent hopes to commercialize new product deals in the Middle East, Latin America and Southeast Asia. “These products may not be licensed for sale in Canada.”

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Oramed hopes to start Phase 3 oral insulin trial next year

Oramed hopes to start Phase 3 oral insulin trial next year

After posting positive Phase 2b results with its oral insulin drug candidate, ORMD-0801 in Type 2 diabetes, Oramed Pharmaceuticals (NASDAQ:ORMP) hopes to meet with the FDA before the end of 2016 to discuss proceeding with a Phase 3 clinical trial in 2017.

“We believe that our data set shows that oral insulin works, which is a first in history,” Josh Hexter, COO and VP of business development, says in an interview with BioTuesdays.com.

“While currently under development, our Phase 3 program will focus on safety and long-term HbA1c lowering efficacy, and will include both active comparator and placebo controlled trials,” he adds. HbA1c is an important three-month average of plasma glucose concentration in blood.

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