R&D

CV Sciences, Inc. to Exhibit and Present at the American Association of Naturopathic Physicians 2017 National Conference

June 27, 2017

LAS VEGAS, NV–(Marketwired – June 27, 2017) – CV Sciences, Inc. (OTCQB: CVSI) (the “Company,” “CV Sciences,” “our” or “we”), today announced that its industry-dominating brand of hemp-derived cannabidiol oil finished products, PlusCBD Oil™, will be exhibiting at the American Association of Naturopathic Physicians (AANP) 2017 National Conference, held on July 12-15, 2017 at The […]

Neos Therapeutics Announces Pricing of Underwritten Public Offering of $32.4 Million of Common Stock

June 27, 2017

DALLAS and FORT WORTH, Texas, June 27, 2017 (GLOBE NEWSWIRE) — Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release (XR) products using its proprietary modified-release drug delivery and orally disintegrating tablet (ODT) technology platforms, today announced the pricing of an underwritten public offering of $32.4 million of shares […]

UCSF Enhances Cancer Assay with Interpretive Reporting Powered by GenomOncology’s GO Clinical Workbench

June 27, 2017

CLEVELAND, June 27, 2017 (GLOBE NEWSWIRE) — GenomOncology today announced that UC San Francisco (UCSF) is now utilizing the GO Clinical Workbench for rapid analysis and reporting of results from the “UCSF500,” an advanced next-generation sequencing panel used by researchers and physicians at the UCSF Helen Diller Family Comprehensive Cancer Center for precision cancer diagnosis […]

Lion Biotechnologies, Inc. Changes Name to Iovance Biotherapeutics, Inc.

June 27, 2017

SAN CARLOS, Calif., June 27, 2017 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that it changed its corporate name from Lion Biotechnologies, Inc. to Iovance Biotherapeutics, Inc. The company’s new NASDAQ ticker symbol “IOVA” will be effective at the open […]

FDA Tackles Drug Competition to Improve Patient Access

June 27, 2017

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review […]

Eye microbiome trains immune cells to fend off pathogens in mice

June 27, 2017

Bugs in your eyes may be a good thing. Resident microbes living on the eye are essential for immune responses that protect the eye from infection, new research shows. The study, which appears in the journal Immunity on June 27, demonstrates the existence of a resident ocular microbiome that trains the developing immune system to […]

Verastem Reports Phase 2 Long-Term Follow-Up Data for Duvelisib in Patients with Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma at the 22nd Congress of the European Hematology Association

June 27, 2017

BOSTON–(BUSINESS WIRE)–Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today announced the presentation of long-term follow-up data from the DYNAMO™ study, which met its primary endpoint of Overall Response Rate (ORR; p=0.0001) at the final analysis, at the 22nd Congress of the […]

Ra Pharmaceuticals Presents Data on Oral Small Molecule Complement Inhibitors at the 22nd Congress of the European Hematology Association

June 27, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Ra Pharmaceuticals, Inc. (NASDAQ:RARX), a clinical stage biopharmaceutical company focusing on the development of next-generation therapeutics for the treatment of complement mediated diseases, today announced the presentation of scientific data at the 22nd Congress of the European Hematology Association (EHA), June 22-25, 2017 in Madrid, Spain. “These findings demonstrate the feasibility of an […]

Agios Announces Updated Data from Fully Enrolled DRIVE PK Study Demonstrating AG-348’s Potential as the First Disease-modifying Treatment for Patients with Pyruvate Kinase Deficiency

June 27, 2017

MADRID, Spain, June 24, 2017 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq:AGIO) presented updated data from its wholly owned pyruvate kinase-R (PKR) activator demonstrating the potential for the first disease-modifying treatment for patients with pyruvate kinase (PK) deficiency at the 22nd Congress of the European Hematology Association (EHA). PK deficiency is a rare, potentially debilitating, […]

New Data from Phase 1/2 Trial of Oral IDHIFA® (enasidenib) Demonstrate Durable Complete Responses in Patients with IDH2 Mutant Relapsed or Refractory AML

June 27, 2017

MADRID, Spain, June 24, 2017 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) today announced new efficacy and safety data from the ongoing Phase 1/2 dose-escalation and expansion study evaluating investigational oral IDHIFA® (enasidenib) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-2 (IDH2) mutation. IDHIFA®, being developed in collaboration […]

Four-Year Follow-up with Empliciti (elotuzumab) Plus Lenalidomide/Dexamethasone (ELd) in Patients with Advanced Multiple Myeloma Shows Long-term Efficacy in ELOQUENT-2 Trial Combination therapy demonstrated a sustained reduction in risk of progression/death of 29% and relative improvement of 50% in progression-free survival rate of ELd (21%) compared to Ld alone (14%)

June 27, 2017

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) presented four-year follow-up data from the Phase 3 ELOQUENT-2 study in which Empliciti (elotuzumab) plus lenalidomide/dexamethasone (ELd) continued to demonstrate efficacy in patients with relapsed/refractory multiple myeloma (RRMM), compared to patients treated with lenalidomide/dexamethasone (Ld) alone. The data also showed a safety profile consistent with prior findings. The results […]

Technology selection identified as biggest hurdle in serialization race for compliance

June 27, 2017

New industry research explores the greatest barriers to serialization success as companies across the pharmaceutical supply chain prepare for new regulations in the US and Europe. The research, conducted by serialization system provider SEA Vision and life science technology specialist Zenith Technologies, highlights technology selection as the biggest challenge currently faced by the industry, cited […]

CISCRP Recognizes WIRB-Copernicus Group’s Support and Donation to Clinical Trial Awareness and Education

June 27, 2017

The Center for Information and Study on Clinical Research Participation (CISCRP) is honored to recognize WIRB-Copernicus Group’s generous support of its Chicago event and donation to its clinical research education and outreach programs.   The Center for Information and Study on Clinical Research Participation (CISCRP), an independent, non-profit organization dedicated to educating patients and the […]

Roche will remain oncology market leader to 2023, in an increasingly fragmented but growing therapy area, says GBI Research

June 27, 2017

None of the products due to enter the oncology market by 2023 are expected to reach the same levels of success as the highest revenue-generating drugs currently in the market – such as Revlimid, Opdivo and Avastin – according to business intelligence provider GBI Research. The company’s latest report states that the oncology landscape is […]

FDA Tackles Drug Competition to Improve Patient Access

June 27, 2017

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review […]

Esperion Announces FDA Confirmation of Regulatory Pathway to Approval for the Combination of Bempedoic Acid and Ezetimibe

June 27, 2017

ANN ARBOR, Mich., June 26, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed the regulatory pathway to […]

KemPharm Announces First Patent Grant for KP746, a Prodrug of Oxymorphone

June 27, 2017

CORALVILLE, Iowa, June 26, 2017 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced a further enhancement to KemPharm’s U.S. and global intellectual property estate governing its portfolio of prodrug product candidates with the addition of a patent for KP746, a prodrug […]

Clarus Re-submits JATENZO NDA Following Positive Results of inTUne Trial

June 27, 2017

NORTHBROOK, Ill – June 26, 2017 — Clarus Therapeutics, Inc., today announced the re-submission of its New Drug Application (NDA) for JATENZO™ (formerly Rextoro™), the Company’s oral testosterone (T) replacement product for the treatment of low testosterone in hypogonadal men, to the U.S. Food and Drug Administration (FDA).  The new submission addresses all points raised […]

FDA approves first subcutaneous C1 Esterase Inhibitor to treat rare genetic disease

June 27, 2017

The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received. HAE, which is […]

FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies

June 27, 2017

CARLSBAD, Calif., June 22, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing (NGS)-based test  that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC). Lung cancer is the leading cause of cancer-related […]

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