Biopharma Archives - Page 11 of 16

HCB Health Structures Firm, Invests in Talent to Meet Client & Growth Needs

Appointments, Biopharma, Digital, Expansion, Health & Wellness, Healthcare Communications Agencies, Marketing & Advertising, Medical Technology, New Hires, New Offerings, People on the Move

HCB Health, one of the leading independent healthcare communications agencies in the United States, announced the creation of three internal business units to best serve an increasingly diverse set of clients and to help manage the firm’s rapid growth.

March 1, 2019/by Administrator

Top 10 Pipelines To Watch: 2019 Annual Report

Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare Diseases

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

February 13, 2019/by Andrew Humphreys

Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar Candidate Accepted for U.S. FDA Review

Australia's Therapeutic Goods Administration, Biologics License Application (BLA), Biopharma, Biosimilars, Blockbusters, Clinical Trials, European Commission, FDA, FDA/Regulatory, Health Canada

Samsung Bioepis Co. Ltd. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application under the 351(k) pathway for SB5, a biosimilar candidate referencing Humira (adalimumab).

September 26, 2018/by Business Wire

FDA Lifts Partial Clinical Hold for Mersana’s XMT-1522

Biopharma, Breast Cancer, Clinical Hold, Clinical Trials, FDA/Regulatory, Gastric Cancer, Immunoconjugates, Non-Small Cell Lung Cancer, Ovarian Cancer, Tumors

Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.

September 17, 2018/by GlobeNewswire

Imbruvica Plus Gazyva Phase 3 iLLUMINATE Trial for First-Line Therapy of Chronic Lymphocytic Leukemia Patients Met Primary Endpoint

Biopharma, Bruton's Tyrosine Kinase (BTK) Inhibitors, Chronic Lymphocytic Leukemia (CLL), Clinical Studies, Progression-Free Survival (PFS), Small Lymphocytic Lymphoma (SLL)

AbbVie, a research-based global biopharmaceutical company, announced that the Phase 3 iLLUMINATE (PCYC-1130) trial met its primary endpoint of improvement in progression-free survival.

May 24, 2018/by PR Newswire

Syneos Health Names Lisa van Capelle Chief Human Resources Officer

Appointments, Biopharma, Business, Contract Commercial Organization (CCO), Contract Research Organization (CRO), People on the Move

Syneos Health, the only fully integrated biopharmaceutical solutions organization, announced the appointment of Lisa van Capelle as Chief Human Resources Officer (CHRO).

February 8, 2018/by Administrator

Celgene Announces Positive Results from Pivotal Phase III Study of Pomalyst/Imnovid for Treatment of Relapsed or Refractory Multiple Myeloma

Biopharma, Clinical Trials, Multiple Myeloma

Celgene Corporation announced that the Phase III, randomized, open-label, international clinical study OPTIMISMM achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival for the pomalidomide arm versus the comparator arm.

February 6, 2018/by Business Wire

Soliris Receives Approval in Japan for gMG

Approvals, Biopharma, FDA/Regulatory, First-In-Class, Generalized Myasthenia Gravis (gMG), Japanese Ministry of Health, Neuromuscular Disorders

Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.

December 26, 2017/by Business Wire

Gilead, Kite to acquire Cell Design Labs

Biopharma, Biotherapeutics, Business, Cell Therapy, Hepatocellular Carcinoma, M&A, Prostate Cancer, Shares, Technology

Gilead Sciences and its cell therapy subsidiary Kite Pharma agreed to acquire Cell Design Labs.

December 7, 2017/by Business Wire

Sumitomo Dainippon, Poxel Strike Diabetes Deal

Asia, Biopharma, China, Clinical Trials, Deals, Japan, Metabolic Disorders, Product Pipelines, Taiwan, Type 2 Diabetes, WHO

Sumitomo Dainippon Pharma Co. Ltd. and Poxel SA announced the signing of a strategic partnership for the development and commercialization of Imeglimin – an investigational therapeutic agent for type 2 diabetes – in Japan, China, South Korea, Taiwan and nine other Southeast Asian countries. Poxel is a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders.

October 30, 2017/by Business Wire