R&D

JDRF and IBM Collaborate to Research Risk Factors for Type 1 Diabetes in Children

August 18, 2017

–Global Data Analysis Is First Precision Medicine Effort to Identify T1D Risk and Onset– NEW YORK, Aug. 18, 2017 /PRNewswire/ — IBM (NYSE: IBM) and JDRF, the leading global organization funding type 1 diabetes (T1D) research, today announced a new collaboration to develop and apply machine learning methods to analyze years of global T1D research […]

Champions Oncology Announces Research Collaboration with The Addario Lung Cancer Medical Institute to Develop Unique Cohort of Patient-Derived Xenograft (PDX) Models

August 18, 2017

HACKENSACK, N.J., Aug. 18, 2017 /PRNewswire/ — Champions Oncology, Inc. (NASDAQ: CSBR), a company engaged in the development and sale of advanced technology solutions and products to personalize the development and use of oncology drugs, today announced a collaboration with The Addario Lung Cancer Medical Institute “ALCMI” to develop a novel cohort of PDX models […]

Cellectis’ UCART123 Administered to First Patient with BPDCN in Phase I Clinical Trial at MD Anderson Cancer Center

August 18, 2017

UCART123 is First U.S. Gene Edited, Off-the-Shelf CAR T-Cell Program August 17, 2017 04:30 PM Eastern Daylight Time NEW YORK–(BUSINESS WIRE)–Regulatory News:   Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), announced today that the first patient with Blastic Plasmacytoid Dendritic Cell […]

Medivir Initiates Clinical Study of Birinapant in Combination With KEYTRUDA® (Pembrolizumab) in Patients With Treatment-refractory Solid Tumours

August 18, 2017

STOCKHOLM, Aug 18, 2017 /PRNewswire/ — Medivir AB (Nasdaq Stockholm: MVIR) today announces that the first patient has been enrolled in the company’s phase I/II study of birinapant in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab), which is marketed by MSD (known as Merck & Co., Inc, Kenilworth, NJ, USA in the US and Canada). […]

Halloran Consulting Group Announces Role as US Regulatory Lead for Curtana Pharmaceuticals’ CT-179 Orphan Drug Designation for the Treatment of Gliomas

August 18, 2017

BOSTON, August 16, 2017 – Halloran Consulting Group, a national consultancy serving biotech, pharma, & medical device companies with clinical, quality and regulatory compliance projects, today announced their role as US regulatory consultants for Curtana Pharmaceuticals. The Food and Drug Administration (FDA) granted orphan drug designation to CT-179, Curtana Pharmaceuticals’ lead Olig2 inhibitor for the […]

Kite Highlights Publication from the National Cancer Institute Demonstrating Responses in Patients with Metastatic Solid Tumors Treated with T Cell Receptor (TCR) Therapy Targeting

August 17, 2017

SANTA MONICA, Calif.–(BUSINESS WIRE)–Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today highlighted the publication of results in the Journal of Clinical Oncology from a National Cancer Institute (NCI) study evaluating the safety and efficacy of a MAGE A3 T cell receptor (TCR) engineered T-cell therapy. The cancer testis antigen MAGE A3 is frequently […]

Protalex Awarded Grant from FDA Office of Orphan Products Development to Foster Clinical Development of PRTX-100 for the Treatment of Immune Thrombocytopenia

August 17, 2017

FLORHAM PARK, N.J.–(BUSINESS WIRE)–Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded the Company a $403,000 grant to support future clinical development activity of PRTX-100 as a treatment for Immune Thrombocytopenia (ITP). The goal of FDA’s OOPD Orphan Products […]

Every Health Executive Now Needs An Amazon Strategy

August 17, 2017

Amid reports that Amazon is getting into the pharmacy business, CNBC created a list of five companies that would care most about the move. All five were asked about Amazon in recent earnings calls or analyst meetings. Most acknowledged the potential threat. Amazon’s path to dominance in big industries, whether it’s retail or cloud computing, […]

NIH gives nod to Vibrent Health for precision medicine work

August 17, 2017

Vibrent Health’s cloud-based precision medicine platform has gained authority to operate from the National Institutes of Health, a certification that it meets federal privacy and security standards and paving the way for the company’s work on the landmark research cohort that will fuel the Precision Medicine Initiative   “This ATO certification marks a significant milestone […]

GlaxoSmithKline taps Baltimore’s Insilico for AI-based drug discovery

August 17, 2017

GlaxoSmithKline and Insilico Medicine are partnering to explore how the latter’s artificial intelligence technology can aid in the drug discovery process.   The duo kept mum on the details but said the agreement comes after Baltimore-based Insilico completed a series of pilot challenges. First, Glaxo will “evaluate Insilico’s technology in the identification of novel biological […]

MannKind and One Drop Partner to Launch the A-One Clinical Trial

August 17, 2017

NEW YORK and VALENCIA, Calif., Aug. 7, 2017 /PRNewswire/ — MannKind Corporation (NASDAQ: MNKD) (TASE: MNKD) and One Drop today announced the first step of their collaboration with the launch of the A-ONE study, a randomized controlled trial investigating the use of Afrezza® inhaled insulin and One Drop’s integrated digital diabetes care platform.   In […]

Biostage Announces the Use of Its Esophageal Implant Product Candidate in a Patient

August 17, 2017

HOLLISTON, Mass., Aug. 7, 2017 /PRNewswire/ — Biostage Inc., (Nasdaq: BSTG), (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat cancer, congenital abnormalities and other life-threatening conditions of the esophagus, bronchus and trachea, today announced the use of Biostage’s Cellspan Esophageal Implant product candidate in a patient at a major U.S. […]

Mylan Receives Tentative Approval for “TLD” Under PEPFAR

August 17, 2017

HERTFORDSHIRE, England and PITTSBURGH, Aug. 7, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, […]

Rebiotix Announces First Patient Enrolled in Phase 3 Clinical Trial of RBX2660 for the Prevention of Recurrent Clostridium difficile Infection

August 17, 2017

ROSEVILLE, Minn., Aug. 7, 2017 /PRNewswire/ — Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that it has enrolled the first patient in a Phase 3 clinical trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 is […]

Immune Pharmaceuticals, Inc. Issues Letter to Shareholders

August 17, 2017

ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–Immune Pharmaceuticals Inc. (NASDAQ; IMNP) a clinical stage biopharmaceutical company specializing in the development of novel targeted therapeutic agents in the fields of immuno-inflammation, dermatology and immuno-oncology, issued the following Letter to Shareholders.   Dear Immune Shareholder,   Set out below are a review of our asset portfolio for our new shareholders […]

FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of IgA Nephropathy

August 17, 2017

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. IgA nephropathy […]

Alamo Pharma Services launches Alamo Recruitment Services

August 17, 2017

DOYLESTOWN, Pa. (August 16, 2017) – Alamo Pharma Services, an established leader in attracting exceptional talent in the pharmaceutical and biotech industries, has formed a specialized division of the company that offers partner organizations recruiting services to place the right people with the right attitude and the right talent in the right position within the […]

FDA Accepts Supplemental Biologics License Application and Grants Priority Review for ADCETRIS® (Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma

August 17, 2017

BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) based on data from the phase 3 ALCANZA trial and two phase 2 investigator-sponsored trials of ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). In November […]

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