Clinical Development

NeuroVive and Yungjin Reports Positive KL1333 Phase I Clinical Study Results Paving the way for Further Clinical Development

May 21, 2018

LUND, Sweden and SEOUL, South Korea, May 21, 2018 /PRNewswire/ — NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) and Yungjin Pharm Corporation Ltd (South Korea Stock Market, KRX 003520) today jointly announced positive topline results after data base lock in the phase I single ascending dose (SAD) clinical study of KL1333, a novel treatment […]

Head-to-Head Trial Shows Refixia® Achieves Greater Total Factor IX Exposure in People With Haemophilia B Than Recombinant Factor IX-Fc Fusion Protein

May 21, 2018

GLASGOW, Scotland, May 21, 2018 /PRNewswire/ — Adults with haemophilia B who received a single dose Refixia® (nonacog beta pegol; N9-GP) achieved greater total factor IX exposure than those treated with rFIXFc (recombinant factor IX-Fc fusion protein). The head-to-head paradigm7 trial also observed a longer half-life for Refixia®. These pharmacokinetic findings were presented today at […]

Rocket Pharmaceuticals Presents Updated Data from Phase 1/2 Gene Therapy Trial of RP-L102 in Patients with Fanconi Anemia at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

May 21, 2018

– Continued Clinical Evidence Demonstrates RP-L102 Can Restore Bone Marrow Function of Fanconi Anemia Patients Without Conditioning – – Increases in Gene-Corrected Leukocytes Demonstrate Bone Marrow Rescue Leading to Hematologic Stabilization – – All Four Patients Followed for Six Months or Longer Demonstrate Mixed Chimerism; Two Patients with Higher Product Doses Exhibit Sustained Mosaic Phenotype […]

Bioverativ Presents Preliminary Phase 1/2a Data on BIVV001, the First Factor VIII Therapy to Break Through the VWF Half-Life Ceiling in Hemophilia A

May 21, 2018

BIVV001 demonstrates unprecedented half-life of 37 hours with high factor VIII activity of 5.6% at seven days following a single low dose in late-breaking presentation at WFH 2018 World Congress Bioverativ is now exploring twice-a-month dosing with BIVV001, which could transform the treatment paradigm in hemophilia A WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ Inc., a Sanofi company dedicated […]

F-star Announces First Patient Dosed in Phase I Clinical Trial of FS118, a First-in-Class Immuno-oncology Bispecific Antibody

May 21, 2018

Lead programme FS118 to be investigated in cancer patients relapsing after PD-1/PD-L1 therapy Clinical validation of F-star’s proprietary Modular Antibody Technology™ platform and bispecific format, mAb²™ CAMBRIDGE, England–(BUSINESS WIRE)–F-star, a clinical-stage biopharmaceutical company developing novel bispecific antibodies, today announced successful dosing of the first patient with FS118 in a Phase I clinical trial. “FS118 has […]

MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM Immunotherapy for the Treatment of Newly Diagnosed Glioblastoma

May 21, 2018

Interim analysis shows significant survival benefit compared to historical standard of care; Combination of SurVaxM and standard therapy was well-tolerated, with few serious side effects; MimiVax to share findings at ASCO annual meeting. BUFFALO, N.Y., May 21, 2018 (GLOBE NEWSWIRE) — MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, […]

Inovio Opens Phase 2 Trial for VGX-3100 in Third Indication To Treat HPV – The No. 1 Sexually Transmitted Disease

May 21, 2018

Inovio initiates Phase 2 trial for HPV-related anal precancer; already advancing treatment for HPV-caused cervical precancers (Phase 3), and vulvar precancers (Phase 2) PLYMOUTH MEETING, Pa., May 21, 2018 (GLOBE NEWSWIRE) — Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has commenced a Phase 2 clinical trial to evaluate the efficacy of VGX-3100 in adult […]

MANF Therapeutics Announces Publication in Society for Neuroscience eNeuro Journal of Human Ocular Distribution and Animal Photoreceptor Protection Data for MANF

May 21, 2018

NEW YORK, May 21, 2018 (GLOBE NEWSWIRE) — Via OTC PR Wire — MANF Therapeutics, Inc., a wholly-owned subsidiary of Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS) in pre-clinical development advancing the orphan-drug designated therapeutic protein mesencephalic astrocyte-derived neurotrophic factor (MANF) as a disease-modifying treatment for orphan ophthalmological conditions, Glaucoma and Parkinson’s disease, today announced the publication […]

Dendreon Initiates Large-Scale Clinical Trial to Investigate PROVENGE® (sipuleucel-T) in Men with Early-Stage Prostate Cancer on Active Surveillance

May 18, 2018

ProVent Trial Aims to Halt Disease Progression, Reduce Need for Aggressive Intervention SEAL BEACH, Calif.–(BUSINESS WIRE)–Dendreon Pharmaceuticals LLC, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, today announced it will conduct a large-scale, placebo-controlled clinical trial evaluating the effectiveness of PROVENGE® (sipuleucel-T) in reducing disease progression in men with prostate cancer on […]

RXi Pharmaceuticals Announces Positive Results from Phase 2 Trial with Samcyprone™ for the Treatment of Common Warts

May 18, 2018

– Study successfully meets its primary effectiveness objectives and its secondary safety and tolerability objectives. – Samcyprone™ is a proprietary topical formulation of the small molecule diphenylcyclopropenone (DPCP), a topical immunomodulator that works by initiating a T-cell response. – Currently, there are no prescription drugs approved by the FDA for the treatment of common warts. […]

LIXIANA® ▼ (edoxaban) Shows Reduced Rate of a Variety of Types of Intracranial Haemorrhage Compared to Warfarin in New Sub-analysis Presented at the European Stroke Organisation Conference 2018

May 18, 2018

MUNICH, May 18, 2018 /PRNewswire/ — Sub-analysis presented from ENGAGE AF-TIMI 48, the longest single comparative global trial of a non-vitamin K oral anticoagulant (NOAC) in patients with non-valvular atrial fibrillation (NVAF) to date Results showed a reduction in both spontaneous and traumatic intracranial haemorrhage (ICH) in patients who took edoxaban, compared to warfarin[1] The data […]

Internationalisation and regulatory reform driving growth and investment at CPhI China

May 18, 2018

Amsterdam, 17 May 2018: CPhI & P-MEC China (#CPhIChina) – organized by UBM and UBM SINEXPO – takes place at the Shanghai New International Expo Center (SNIEC) on 20-22nd June 2018. Asia’s largest pharmaceutical event returns with recent regulatory reforms stimulating international interest in the region, as the CFDA is harmonising China’s regulatory environment with the rest […]

Glenmark Pharmaceuticals Announces Oral Presentation of New Data on GBR 830, an Investigational, Anti-OX40 Monoclonal Antibody, at the International Investigative Dermatology Meeting

May 18, 2018

PARAMUS, New Jersey, May 17, 2018 /PRNewswire/ — Glenmark Pharmaceuticals, a global pharmaceutical company, today announced data from a Phase 2a, proof-of-concept study of GBR 830, an investigational, anti-OX40 monoclonal antibody being studied for the treatment of moderate-to-severe atopic dermatitis (AD), that were presented at the International Investigative Dermatology Meeting (IID) in Orlando, Florida. The exploratory […]

LYRICA® (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

May 18, 2018

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted […]

Syntimmune Announces Positive Preliminary Results from Clinical Proof-of-Concept Trial of SYNT001 in Pemphigus Vulgaris and Foliaceus

May 18, 2018

Favorable safety and tolerability profile consistent with Phase 1a data SYNT001 treatment resulted in clinical improvement as measured by Pemphigus Disease Area Index (PDAI) score, with clinical effect persisting beyond the treatment period Rapid reductions in total IgG and circulating immune complex (CIC) levels BOSTON–(BUSINESS WIRE)–Syntimmune, Inc., a clinical-stage biotechnology company developing antibody therapeutics targeting […]

Genosco/Yuhan Announce Results from Phase 1/2 Study of YH25448, a 3rd- Generation EGFR-TKI, in Advanced NSCLC to be Presented at ASCO 2018

May 18, 2018

CAMBRIDGE, MA, May 16, 2018 (BusinessWire) – Genosco, a clinical-stage biotechnology company focused in immunology and oncology, today announced that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) Annual […]

Abeona Therapeutics Provides Clinical Update on MPS IIIA Gene Therapy Trial at the 21st Annual ASGCT Meeting

May 18, 2018

ABO-102 18-month efficacy and safety data continue to demonstrate time- and dose-dependent reductions in underlying disease pathology, including decreased CSF and urine GAGs and improved liver volumes 11 subjects enrolled through > 4,200 days cumulative follow up NEW YORK and CLEVELAND, May 18, 2018 — Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused […]

Eurocine Vaccines has Completed Dosing of its Quadrivalent Influenza Vaccine Candidate, Immunose™ FLU, in the Second Clinical Study

May 18, 2018

  STOCKHOLM, May 18. 2018 /PRNewswire/ — This week, dosing was completed according to plan in the second clinical study with Immunose™ FLU, developed with the aim to become a modern and effective nasal influenza vaccine. – In the perspective of this year’s severe influenza outburst we are pleased to have chosen the broader quadrivalent, […]

MD Anderson, BMS tout successes of researcher-led clinical trial model

May 17, 2018

by Conor Hale MD Anderson Cancer Center detailed the successes of their collaborative clinical research model launched in 2014, which directly connects academic experts to big pharma studies through a leukemia pilot program allowing for multiple, simultaneous immunotherapy studies. By partnering with Bristol-Myers Squibb, MD Anderson leukemia researchers were able to explore BMS’ immuno-oncology pipeline […]

Sunovion Announces Data Presentations Highlighting Broad Portfolio of Treatments for COPD at the American Thoracic Society International Conference 2018

May 16, 2018

– Poster presentations focus on clinical studies of a range of nebulized and handheld therapies for chronic obstructive pulmonary disease (COPD)  – New data analyses highlight effects on lung function and patient-reported outcomes for Seebri ® Neohaler ® (glycopyrrolate) Inhalation Powder and Utibron ® Neohaler ® (indacaterol/glycopyrrolate) Inhalation Powder – Sunovion Pharmaceuticals Inc. (Sunovion) will present […]

Sanofi: Dupixent® (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis

May 16, 2018

Dupixent® (dupilumab) showed positive Phase 3 results in adolescents with inadequately controlled moderate-to-severe atopic dermatitis   U.S. regulatory submission for patients ages 12-17 planned for third quarter 2018 Paris and Tarrytown, NY – May 16, 2018 – A pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents (ages 12-17) met […]

At the Meet Novartis Management investor event, Novartis highlights strategy to focus the company and drive sustainable growth

May 16, 2018

Basel, May 16, 2018 – Today Novartis holds its annual Meet Novartis Management event at its global headquarters in Basel, Switzerland, giving investors and analysts the opportunity to meet with key executives across the company in six separate breakout sessions. The meeting provides a deeper view into the company’s strategy for sustainable value creation, and […]

Emulate, Inc. and AstraZeneca Form Strategic Agreement to Work Side-by-Side on Organs-on-Chips Technology to Improve Prediction of Human Safety and Efficacy of Drug Candidates

May 16, 2018

BOSTON–(BUSINESS WIRE)–Emulate, Inc. has formed a collaborative partnership with AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit to embed its Organs-on-Chips technology within the laboratories of the IMED Drug Safety organization. As part of the agreement, Emulate plans to co-locate scientists within AstraZeneca’s laboratories. The aim of this agreement is to accelerate the development […]

Bellerophon to Present Positive Results from Phase 2 Study of INOpulse® for Treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease at the American Thoracic Society 114th International Conference

May 16, 2018

WARREN, N.J., May 16, 2018 (GLOBE NEWSWIRE) — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company, today announced that it will present the previously reported top-line results from its Phase 2 study evaluating the use of INOpulse® in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) at the […]

Albireo Enrolls First Patient in Phase 3 PFIC Trial of A4250

May 16, 2018

BOSTON, May 16, 2018 (GLOBE NEWSWIRE) — Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the first patient has been enrolled in PEDFIC-1, a Phase 3 clinical trial of lead product candidate A4250, an ileal bile acid transporter (IBAT) inhibitor being studied for the treatment […]

FEEDBACK