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416 Result: FDA

Pluristem Reports Second Quarter Fiscal 2017 Highlights & Provides Calendar 2017 Outlook

February 13th, 2017

HAIFA, Israel / CRWE PRESS RELEASE / February 13, 2017 - Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today reported financial update and corporate and clinical developments for . Read more

Kitov Provides Further Update on Formal Investigation by Israeli Securities Authority

February 09th, 2017

Tel Aviv, Israel / CRWE PRESS RELEASE / February 9, 2017 - Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, in response to requests made by the NASDAQ Stock Market, today provided a further upda. Read more

Pluristem Receives Clearance from Germany to Initiate its Multinational Phase III Trial in Critical Limb Ischemia Targeting Early Conditional Marketing Approval

January 17th, 2017

* PLX-PAD cells could potentially obtain early conditional marketing approval in Europe via the Adaptive Pathways pilot project based on positive interim efficacy data from first 125 patients * This approval joins those from the U.S. FDA and U.K. fo. Read more

EyeGate Receives Additional Milestone Payment from Valeant Pharmaceuticals for EGP-437

January 09th, 2017

WALTHAM, Mass. / CRWE PRESS RELEASE / January 9, 2017 - EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (“EyeGate” or the “Company”), a specialty pharmaceutical company that focuses on developing and commercializing pro. Read more

Ritter Pharmaceuticals Phase 2a Lactose Intolerance Clinical Trial Microbiome Data, Published in Proceedings of the National Academy of Science

January 03rd, 2017

LOS ANGELES, CA / CRWE PRESS RELEASE / January 3, 2017 - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a developer of novel therapeutic products that modulate the human gut micro. Read more

Pluristem and New York Blood Center to Collaborate in Evaluating PLX-R18 as an Adjuvant Therapy to Umbilical Cord Blood Transplantation, Winning $900,000 Funding From BIRD

December 27th, 2016

* Prior research has suggested that PLX-R18 helps cord blood cells to engraft more rapidly and effectively * Grant of $900,000 from Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) to fund the research * Constitutes a 3r. Read more

vTv Therapeutics Announces Positive Topline Results from Phase 2 Study of TTP273 in Type 2 Diabetes

December 14th, 2016

Oral small molecule GLP-1 receptor agonist met primary endpoint Company’s second successful Phase 2 diabetes trial in 2016 High Point, North Carolina / CRWE PRESS RELEASE / December 14, 2016 - vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) to. Read more

Pluristem's PLX-R18 Advances into Second Cohort of Dose Selection Study for Treatment of Acute Radiation Syndrome

December 06th, 2016

* NIH’s NIAID completes first cohort of dose selection study * Data from completed study expected in first half of 2017 * Upon determining the optimal dose, a pivotal trial could be conducted to support marketing authorization of PLX-R18 for . Read more

Aurinia Highlights Speed of Remission from Global Phase IIb AURA Study of Voclosporin in LN

November 16th, 2016

Late breaking abstract showcases first global study of active lupus nephritis to meet its primary endpoint, presented on November 15th Victoria, British Columbia / CRWE PRESS RELEASE / November 16, 2016 - Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH). Read more

Takeda to Present Broad Range of Clinical Data During 58th American Society of Hematology Annual Meeting

November 03rd, 2016

– Demonstrating Expertise and Leadership in Hematologic Oncology, Presentations Include Phase 3 Data on ADCETRIS® (brentuximab vedotin) in CD30-Positive Cutaneous T-Cell Lymphoma, NINLARO™ (ixazomib) in Relapsed/Refractory Multiple My. Read more

Aurinia Announces Plans for Single Phase III Clinical Trial for Voclosporin in the Treatment of Lupus Nephritis Following Successful Completion of End of Phase II Meeting With FDA

November 02nd, 2016

-Voclosporin 23.7mg BID to advance into double-blind placebo controlled Phase III study -AURORA Phase III study design consistent with AURA -Trial expected to commence in Q2 2017 -Conference Call and webcast at 8:30am ET tomorrow Victoria. Read more

Corindus Vascular Robotics Receives FDA Clearance for Next Generation Robotic System

October 27th, 2016

CorPath® GRX enhances procedural control and improves workflow, bringing added benefits to robotic-assisted coronary interventions Waltham, MA / CRWE PRESS RELEASE / October 27, 2016 - Corindus Vascular Robotics, Inc. (NYSE MKT: CVRS), a leadi. Read more

Patent Trial and Appeal Board Upholds the Validity of LIALDA(R) Patent

October 05th, 2016

Lexington, Mass. / CRWE PRESS RELEASE / October 5, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Patent & Trademark Office’s Patent Trial and Appeal Board (PTAB) has issued their decision upholding the validity o. Read more

GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for Epidiolex(R) (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

September 26th, 2016

- Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo - Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in March 2. Read more

DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk for the Treatment of Cow's Milk Protein Allergy

September 21st, 2016

DBV first to announce Fast Track designation for IgE-mediated CMPA; Viaskin Milk is currently being investigated in a Phase IIb study Second Fast Track designation for the Viaskin platform in food allergies reinforces DBV’s commitment to imp. Read more

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