R&D

The Lancet publishes results demonstrating adjuvanted quadrivalent influenza vaccine provides significantly greater efficacy in children 6 through 23 months

April 20, 2018

CAMBRIDGE, Mass., April 19, 2018 /PRNewswire/ — Seqirus, a CSL company (ASX: CSL) and a leading innovator in influenza vaccines, today announced that The Lancet Respiratory Medicine published results from a Phase 3, randomized, head-to-head efficacy study that found an MF59® adjuvanted, quadrivalent influenza vaccine (aQIV) 31 percent more efficacious in preventing influenza than a […]

NovaDigm Therapeutics Announces Initiation of Phase 2a Clinical Trial of NDV-3A in Staphylococcus aureus

April 20, 2018

BOSTON–(BUSINESS WIRE)–NovaDigm Therapeutics, a company developing innovative immuno-therapeutics and preventative vaccines for fungal and bacterial infections, today announced the initiation of a Phase 2a study evaluating NDV-3A for the reduction of Staphylococcus aureus (S. aureus) colonization in a high-risk population of military trainees. The study is being conducted with the Uniformed Services University of the […]

GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences Announces the Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy

April 20, 2018

LONDON and CARLSBAD, Calif., April 19, 2018 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (“GW”, “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced that the Peripheral and Central Nervous System Drugs Advisory […]

New Novartis analyses at AAN show siponimod’s efficacy on disability and cognition in secondary progressive MS patients

April 20, 2018

Basel, April 20, 2018 – Novartis today announced new analyses from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in patients with secondary progressive multiple sclerosis (SPMS). In pre-specified statistical analyses, treatment with siponimod consistently reduced the risk of confirmed disability progression in SPMS patients, with and without relapses[1]. In addition, new post-hoc […]

Clementia Initiates Phase 2 MO-Ped Trial for Palovarotene in Patients with Multiple Osteochondromas

April 20, 2018

MONTREAL, April 20, 2018 (GLOBE NEWSWIRE) — Clementia Pharmaceuticals Inc. (NASDAQ:CMTA), a clinical-stage company innovating new treatments for people with ultra-rare bone disorders and other diseases, today announced the start of the MO-Ped Trial, its Phase 2 study evaluating the safety and efficacy of palovarotene for the treatment of pediatric patients with multiple osteochondromas (MO), […]

Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases

April 20, 2018

CAMBRIDGE, Mass. & CARLSBAD, Calif.–(BUSINESS WIRE)–Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership […]

Asembia Expands Collaboration with Pfizer Oncology

April 20, 2018

FLORHAM PARK, N.J., April 19, 2018 /PRNewswire/ — Asembia members can now gain expanded access to Pfizer Oncology defined distribution oncology products for qualified hospital and health system clients. The new agreement includes Pfizer oncology products: Ibrance® (palbociclib), Bosulif® (bosutinib), Sutent® (sunitinib), Inlyta® (axitinib) and Xalkori® (crizotinib).   “Asembia continues to work closely with Pfizer […]

Theravance Biopharma Highlights Landmark IMPACT Study Published in NEJM Showing Significant Benefits of Trelegy Ellipta for COPD Patients

April 20, 2018

DUBLIN, April 19, 2018 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today highlighted the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study of Trelegy Ellipta in patients with chronic obstructive pulmonary disease (COPD). The IMPACT study is one of the largest trials ever conducted in COPD patients […]

NeuroVive Presents NVP025 Mitochondrial Myopathy Project Progress at Mitochondrial Medicine Conference

April 20, 2018

LUND, Sweden, April 20, 2018 /PRNewswire/ — NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that its mitochondrial myopathy project, NVP025, has been selected for an oral presentation at the prestigious Mitochondrial Medicine 2018 conference held on 9-11 May in Cambridge, UK.   The detailed results from an experimental study conducted in collaboration […]

Data from Multiple Celldex Programs Presented at American Association for Cancer Research (AACR) Annual Meeting 2018

April 20, 2018

HAMPTON, N.J., April 20, 2018 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced promising early data from an investigator-initiated pilot study evaluating the combination of CDX-301 and stereotactic body radiotherapy (SBRT) in patients with advanced non-small cell lung cancer (NSCLC). CDX‑301 (recombinant human Flt3 ligand) is a potent hematopoietic cytokine that uniquely expands dendritic […]

Sterling invests £6m in pilot plant facility

April 20, 2018

Contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions is investing £6m into its pilot plant facility at its UK site to enhance its scale-up and small to midscale commercial API manufacturing capabilities. The expansion will increase the pilot plant’s capacity by 33% and enhance the site’s production capabilities and flexibility for small to mid-scale […]

FDA Plans to Ramp Up Disease-Focused Guidance

April 19, 2018

FDA Commissioner Scott Gottlieb on Tuesday told a House Appropriations subcommittee that the agency plans to “sharply increase” its release of disease-focused guidance documents to help drugmakers develop new treatments. “Among some of the many areas we’re working on right now are new guidance to lay out modern criteria for the development of drugs targeted […]

Citing Opioid Crisis, Feds Seek Rule Change For Drugmakers

April 19, 2018

ASSOCIATED PRESS CHARLESTON, W.Va. — Apr 17, 2018, 5:19 PM ET.  Drugmakers would be required to identify a legitimate need for controlled substances to justify their production under a proposed rule change intended to rein in the diversion of drugs for illicit purposes, the Drug Enforcement Administration announced Tuesday. According to the DEA, current regulations […]

Boehringer Ingelheim and Lilly announce an academic collaboration with University of Oxford to investigate the effects of Jardiance in adults with chronic kidney disease

April 19, 2018

– University of Oxford, in partnership with the Duke Clinical Research Institute, to assess effect of Jardiance (empagliflozin) on heart and kidney disease in adults with chronic kidney disease   – EMPA-KIDNEY will be part of the empagliflozin clinical development program which explores the efficacy and safety of Jardiance across a broad spectrum of patients […]

Phoenix Molecular Designs Announces Manufacturing Collaboration with WuXi STA to advance PMD-026 toward IND

April 19, 2018

VANCOUVER, British Columbia and SAN DIEGO, April 19, 2018: Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designing precise cancer therapeutics by targeting essential kinases, announced that it has entered into a collaboration with STA Pharmaceutical Co., Ltd (STA), a WuXi AppTec group company, to manufacture the PMD-026 needed for IND-enabling toxicology studies and a […]

Lycera Presents Clinical Safety and Dose Selection Results for First-in-class RORgamma Agonist Candidate LYC-55716 at the 2018 AACR Annual Meeting

April 18, 2018

NEW YORK and ANN ARBOR, Mich., April 17, 2018 /PRNewswire/ — Lycera Corp., a privately held biopharmaceutical company developing breakthrough immune modulatory medicines, today announced new clinical findings from the Phase 1 portion of its Phase 1/2a ARGON study of the company’s novel immuno-oncology therapeutic candidate, LYC-55716, at the 2018 American Association of Cancer Research […]

Clinical Trial Begins For Promising New Post-Menopausal Therapy Treating Vasomotor Symptoms

April 18, 2018

GREENVILLE, N.C., April 17, 2018 /PRNewswire/ — Fervent Pharmaceuticals has announced the launch of clinical trials for their promising new post-menopausal drug therapy, FP-101. This two-month Phase 2a clinical trial, which involves 112 patients from across the Southeast, will assess the therapeutic potential of FP-101 in treating vasomotor symptoms, such as hot flashes, night sweats […]

Eiger Announces Sub-Analysis of Phase 2 Results Demonstrating High Response Rates to “All-Oral” Lonafarnib-Ritonavir Regimen in Low Viral Load HDV-Infected Patients at The International Liver Congress™ 2018

April 18, 2018

PALO ALTO, Calif., April 17, 2018 /PRNewswire/ — Eiger BioPharmaceuticals, Inc., (NASDAQ: EIGR) today announced additional positive lonafarnib (LNF) data from the LOWR HDV (LOnafarnib With Ritonavir in Hepatitis Delta Virus) Program presented at The International Liver Congress™ 2018, in Paris, France. A subanalysis of the LOWR-2 study reveals high response rates to LNF all-oral […]

Preclinical Data Highlighting ADXS-Hot as Immunotherapy with Potential to Target Hotspot Cancer Mutations across Multiple Cancer Types Presented in Poster Discussion at The AACR Annual Meeting

April 18, 2018

PRINCETON, N.J.–(BUSINESS WIRE)– Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, announces the presentation of ADXS-HOT preclinical data in a poster discussion entitled “Targeting Shared Hotspot Cancer Mutations with a Listeria monocytogenes Immunotherapy Induce Potent Anti-Tumor Immunity” at the American Association for Cancer Research (AACR) […]

Obsidian Therapeutics Presents Preclinical Data from Regulated Cytokine Programs that Enable CAR-T Therapies with Controllable Functions

April 18, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, today announced the presentation of preclinical data on its regulated cytokine programs at the Annual Meeting of the American Association for Cancer Research in Chicago, IL.   Obsidian Therapeutics presents preclinical data at […]

Merck Announces First Phase Three Studies for PCV-15 (V114) Its Investigational Pneumococcal Disease Vaccine

April 18, 2018

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the company is beginning two Phase 3 studies of PCV-15 (V114), its investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. The first study (ClinicalTrials.gov, NCT03480763) will evaluate the safety, tolerability and immunogenicity of PCV-15 followed by […]

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