BRCA mutation Archives - Page 2 of 2

European Commission Approves Talzenna for Patients with Inherited BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Approvals, BRCA mutation, European Commission, FDA/Regulatory, Metastatic Breast Cancer, PARP Inhibitors, Therapeutics

The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.

June 21, 2019/by Business Wire

AstraZeneca’s Lynparza gets EU nod as first-line ovarian cancer maintenance treatment

Advanced pancreatic cancer, Analysts, Approvals, BRCA Gene, BRCA mutation, BRCA-Mutated Ovarian Cancer, European Commission, FDA/Regulatory, Future Blockbusters, Ovarian Cancer, PARP Inhibitors

Lynparza was approved as a first-line maintenance treatment for a type of advanced ovarian cancer by the European Commission.

June 18, 2019/by Reuters Health

Lynparza stalls pancreatic cancer in patients with BRCA mutations: study

Advanced pancreatic cancer, BRCA mutation, Gene Mutations, R&D

AstraZeneca and Merck & Co.’s Lynparza helped patients with advanced pancreatic cancer who carry BRCA gene mutations go nearly twice as long without their disease worsening than those who received a placebo, according to data from a late-stage clinical trial.

June 2, 2019/by Reuters Health

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

Clovis Oncology Announces European Commission Authorization of Rubraca for Women with Recurrent Ovarian Cancer

Approvals, BRCA mutation, Chemotherapy, European Commission, FDA/Regulatory, First-In-Class, Ovarian Cancer, PARP Inhibitors

Clovis Oncology Inc. today announced that the European Commission authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.

May 29, 2018/by Business Wire

Lynparza Receives Positive EU CHMP Opinion in Platinum-Sensitive Relapsed Ovarian Cancer

BRCA mutation, Committee for Medicinal Products for Human Use, European Medicines Agency, Ovarian Cancer, PARP Inhibitors, Recommended For Approval

AstraZeneca and Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending a marketing authorization of Lynparza (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

February 23, 2018/by Business Wire

Lynparza Receives Approval in Japan for Treating Advanced Ovarian Cancer

Approvals, BRCA mutation, Chemotherapy, DNA, FDA/Regulatory, Japan, Japanese Ministry of Health, Ovarian Cancer, PARP Inhibitors

AstraZeneca and Merck announced that the Japanese Ministry of Health, Labour and Welfare approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.

January 19, 2018/by Business Wire

Clovis Oncology Presents Comprehensive Dataset from Successful Phase 3 ARIEL3 Maintenance Treatment Trial of Rucaparib in Advanced Ovarian Cancer at ESMO 2017

BRCA mutation, Genetics, NDA/MAA, Ovarian Cancer, PARP Inhibitors, Product Pipelines, Tumors

Clovis Oncology Inc. announced the first presentation of a comprehensive dataset from the company’s Phase 3 ARIEL3 study of rucaparib at the 2017 European Society for Medical Oncology (ESMO) Congress in Madrid.

September 7, 2017/by Business Wire