R&D

Connected Health Conference

October 17, 2017

The Connected Life Journey: Shaping Health and Wellness for Every Generation The 2017 Connected Health Conference (CHC17) is the most anticipated event in connected health, bringing together the industry’s two leading events and top thought leaders for three days of inspirational, provocative and forward-thinking discussion. Plus, it’s now in Boston  — learn more about the […]

Immune Design Announces Positive FDA Feedback on Phase 3 Clinical Trial Design for CMB305 in Synovial Sarcoma Patients

October 17, 2017

SEATTLE and SOUTH SAN FRANCISCO, Calif., Oct. 16, 2017 (GLOBE NEWSWIRE) — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced that based on productive discussions with the U.S. Food and Drug Administration (FDA), it plans to initiate a pivotal Phase 3 trial to support a Biologics License Application (BLA) for CMB305, […]

U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review

October 17, 2017

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo(nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy Designation […]

ARCEDI Biotech Announces Publication Highlighting Success Of Cutting-Edge Cell-Based Noninvasive Prenatal Testing To Detect Aneuploidy And Subchromosomal Abnormalities In First Trimester Pregnancies

October 17, 2017

VEJLE, Denmark, Oct. 17, 2017 /PRNewswire/ — ARCEDI Biotech ApS, a company developing technologies for rare fetal cell detection for use in prenatal diagnostic applications, today announced the publication of data suggesting the Company’s cell-based noninvasive prenatal testing (cbNIPT) technology provides a viable alternative to existing non-invasive as well as commonly used invasive prenatal testing […]

Plasticell and GSK sign collaboration agreement to produce hematopoietic cells from iPSCs.

October 17, 2017

17 October 2017, Stevenage UK: Plasticell, the biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK to use its combinatorial stem cell screening technology, CombiCult®, to optimise the directed differentiation of induced pluripotent stem cells (iPSCs) to specific blood cell lineages for use by GSK in […]

AntriaBio Announces Selection of Lead Oral Plasma Kallikrein Inhibitor Candidates for the Treatment of Diabetic Retinopathy, Diabetic Macular Edema and Hereditary Angioedema

October 17, 2017

LOUISVILLE, Colo., Oct. 17, 2017 (GLOBE NEWSWIRE) — AntriaBio, Inc. (“AntriaBio” or the “Company”) (OTCQB:ANTB), a biopharmaceutical company focused on developing therapies to address significant unmet medical needs, today announced that it is advancing the first development candidates from its oral plasma kallikrein inhibitor (PKI) portfolio. The two preclinical programs are AB402 for vision-threatening eye […]

Aduro Biotech Announces Presentation of Phase 1 Data for LADD-based Immunotherapy at World Conference on Lung Cancer

October 17, 2017

BERKELEY, Calif., Oct. 17, 2017 (GLOBE NEWSWIRE) — Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, today announced that its license partner, Janssen Biotech, Inc., presented a poster with initial data from an ongoing first-in-human Phase 1 dose finding trial to evaluate JNJ-64041757 (also known as ADU-214 ), a live, attenuated […]

Regeneron and Sanofi Announce Positive Phase 2 Study Results for Dupilumab in Patients With Active Moderate-to-Severe Eosinophilic Esophagitis

October 17, 2017

TARRYTOWN, N.Y. and PARIS, Oct. 16, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive results from a Phase 2 investigational study of dupilumab in adults with active moderate-to-severe eosinophilic esophagitis. The study showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo. […]

Halozyme Initiates Clinical Trial Of PEGPH20 With Anti-PDL1 Immunotherapy In Cholangiocarcinoma And Gallbladder Cancer Patients

October 17, 2017

SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced initiation of a clinical trial evaluating its investigational new drug PEGPH20 with atezolizumab (TECENTRIQ®), an anti-PDL1 cancer immunotherapy from Genentech, a member of the Roche Group, in patients with previously untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma and gallbladder adenocarcinoma.   […]

Regen BioPharma, Inc. Researchers Capitalize on Key Structure in Compounds that Activate Checkpoint NR2F6 for the Potential Treatment of Autoimmune Diseases

October 17, 2017

SAN DIEGO, October 16, 2017 /PRNewswire/ —   Regen BioPharma Inc. (OTCQB: RGBP) and (OTCQB: RGBPP) believes it has taken full advantage of its recent prior discovery in developing small molecule drugs that activate NR2F6. The Company recently reported that it identified key structural elements in small molecules that make them active and specific towards […]

New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Patients Taking Entyvio® (vedolizumab), Particularly in Biologic-Naïve Patients

October 17, 2017

OSAKA, Japan, Oct. 16, 2017 /PRNewswire/ — Takeda Pharmaceutical Company Limited (TSE: 4502), (“Takeda”) today announced the presentation of data suggesting early symptomatic improvement in specific symptoms with Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), particularly in biologic-naïve patients for whom other therapies have not worked […]

New Clinical Data and Microbiome Research from Rebiotix’s Phase 2 Program for RBX2660 Highlighted at the World Congress of Gastroenterology at ACG2017

October 17, 2017

ROSEVILLE, Minn., Oct. 16, 2017 /PRNewswire/ — Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced new clinical findings from the RBX2660 Phase 2 program that are being presented in three poster presentations at the World Congress of Gastroenterology at ACG2017 in Orlando, […]

Ardelyx Announces Tenapanor Reduces Pain Caused by IBS-C Through Inhibition of TRPV-1 Signaling

October 17, 2017

FREMONT, Calif., Oct. 16, 2017 /PRNewswire/ — Ardelyx, Inc. (NASDAQ: ARDX) today reported that data from preclinical studies have shown that tenapanor works to reduce abdominal pain caused by irritable bowel syndrome with constipation (IBS-C) through the inhibition of TRPV-1 dependent signaling. TRPV-1, better known as the “hot chili pepper receptor,” is a well-established pain […]

New Post-Hoc Analyses Report Early Symptomatic Improvement in Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease Patients Taking Entyvio® (vedolizumab), Particularly in Biologic-Naïve Patients

October 17, 2017

OSAKA, Japan, Oct. 16, 2017 /PRNewswire/ — Takeda Pharmaceutical Company Limited (TSE: 4502), (“Takeda”) today announced the presentation of data suggesting early symptomatic improvement in specific symptoms with Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), particularly in biologic-naïve patients for whom other therapies have not worked […]

Aprea Therapeutics Announces First Patients Enrolled in Phase Ib/II Clinical Study of APR-246 for the Treatment of Esophageal Cancer

October 17, 2017

BOSTON and STOCKHOLM, Oct. 16, 2017 /PRNewswire/ — Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor protein p53, announced today that the first patients were enrolled in a Phase Ib/II clinical study of APR-246 in esophageal cancer. The study is sponsored by the Peter MacCallum Cancer […]

Amgen And Boston Children’s Hospital Enter A Collaboration To Find New Genes And Drug Targets For Severe Pain Syndromes

October 17, 2017

CAMBRIDGE, Mass., Oct. 16, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Boston Children’s Hospital today announced that they have entered into a neuroscience research collaboration aimed at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity. Amgen will leverage its industry-leading expertise in […]

Forge & Evotec Expand Strategic Alliance With Launch Of BLACKSMITH Platform To Discover Novel Metalloenzyme Inhibitors Across Broad Therapeutic Areas

October 17, 2017

SAN DIEGO, Oct. 17, 2017 /PRNewswire/ — Forge Therapeutics, Inc. (Forge) announced today that the companies have expanded their existing strategic alliance and launched the BLACKSMITH platform to discover a broader range of therapeutics targeting metalloenzymes.   “Over the last two years, we have experienced the power of Forge’s discovery capabilities with the discovery of […]

Cadent Therapeutics Receives Milestone for the Initiation of Phase 1 Clinical Studies

October 17, 2017

CAMBRIDGE, Mass., Oct. 17, 2017 /PRNewswire/ — Precision neuroscience company Cadent Therapeutics has earned a milestone payment from Novartis for the initiation of a Phase 1 clinical study of a subtype selective NMDA receptor negative allosteric modulator (NAM) for the treatment of treatment-resistant depression.   Cadent Therapeutics exclusively licensed the intellectual property for compounds that […]

ProMIS Neurosciences Lead Product Candidate, PMN310, Shows Desired Target Binding

October 17, 2017

TORONTO and CAMBRIDGE, MA, Oct. 17, 2017 /PRNewswire/ – ProMIS Neurosciences, Inc., a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, today announced that its lead product candidate for Alzheimer’s disease, PMN310, showed the desired binding profile of selectively targeting amyloid beta oligomers in a preclinical study directly comparing […]

Dicerna Files Clinical Trial Application for DCR-PHXC, the Company’s Most Advanced GalXC™ Product Candidate, for Phase 1 Study in Primary Hyperoxaluria (PH)

October 17, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA), a leading developer of investigational RNA interference (RNAi) therapeutics, today announced the first submission of a clinical trial application (CTA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to initiate a Phase 1 clinical trial of DCR-PHXC, the company’s most advanced GalXCTM product […]

Aimmune Therapeutics Announces Clinical Collaboration to Study AR101 with Regeneron and Sanofi’s Dupilumab for Peanut Allergy

October 17, 2017

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (NASDAQ:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced a clinical collaboration with Regeneron and its strategic alliance collaborator Sanofi to study AR101 treatment with adjunctive dupilumab in peanut-allergic patients in a Phase 2 clinical trial. Regeneron will sponsor the trial, with Aimmune to provide clinical […]

ImmunoGen Announces Investigational New Drug Application for IMGN632 for Hematological Malignancies is Active

October 17, 2017

WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has completed the safety review of its investigational new drug (IND) application for IMGN632 in patients with CD123-positive hematological malignancies, including acute myeloid leukemia […]

Results from Phase 2 Studies of Oral Ozanimod in Crohn’s Disease and Ulcerative Colitis to Be Presented at World Congress of Gastroenterology at ACG2017

October 17, 2017

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that phase 2 data of investigational compound ozanimod in Crohn’s disease and ulcerative colitis will be presented at the World Congress of Gastroenterology at ACG2017 (WCOG at ACG2017) in Orlando. The studies include new data from the STEPSTONE study in patients with moderately to severely active Crohn’s disease […]

Flex Pharma Initiates CMT Phase 2 Trial with FLX-787 in US

October 17, 2017

BOSTON–(BUSINESS WIRE)–Click to Tweet this News   “FLX-787 promises to have significant clinical advantages because of its safety profile and the lack of systemic exposure.” Tweet this Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with severe neurological diseases such as amyotrophic […]

U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review

October 17, 2017

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy […]

AstraZeneca and Chi-Med’s Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification

October 17, 2017

CAMBRIDGE, England–(BUSINESS WIRE)–AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment […]

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