Genentech Press Release
|06/19/2020 - 08:24||
Breaking the monopoly of imported anti-HER2 monoclonal antibody drugs Approval obtained for Inetetamab, the first innovative anti-HER2 monoclonal antibody independently developed in China
The first approved indication of Cipterbin® is for the treatment of HER2-positive metastatic breast cancer combining with chemotherapy.
|06/02/2020 - 08:22||
COVID-19 Drug Development Could Benefit from Approach Used Against Flu
AUSTIN, Texas — A new study from researchers at The University of Texas at Austin has found that some antivirals are useful for more than helping sick people get better — they also can prevent thousands of deaths and hundreds of thousands of virus cases if used in the early stages of infection.
|University of Texas|
|05/22/2020 - 00:14||
Enhertu granted Orphan Drug Designation in the US for gastric cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Orphan Drug Designation (ODD) in the US for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.
|05/18/2020 - 06:58||
Enhertu granted Breakthrough Therapy Designation in the US for HER2-mutant metastatic non-small cell lung cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)?s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.
|05/18/2020 - 02:40||
ENHERTU Granted Breakthrough Therapy Designation in the U.S. for HER2 Mutant Metastatic Non-Small Cell Lung Cancer
Tokyo, Basking Ridge, NJ and Munich - (May 18, 2020) ? Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca?s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.
|05/13/2020 - 16:03||
New treatment extends lives of people with most common type of liver cancer
For the first time in over a decade, scientists have identified a first-line treatment that significantly improves survival for people with hepatocellular carcinoma, the most common type of liver cancer.
|05/11/2020 - 03:28||
ENHERTU Granted Breakthrough Therapy Designation in the U.S. for HER2 Positive Metastatic Gastric Cancer
Tokyo, Basking Ridge, NJ and Munich – (May 11, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
|05/10/2020 - 22:10||
Enhertu granted Breakthrough Therapy Designation in the US for HER2-positive metastatic gastric cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
|05/07/2020 - 21:34||
LYNPARZA (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab.
|05/07/2020 - 00:58||
Results from pivotal phase 2/3 study of emapalumab in patients with primary HLH published in New England Journal of Medicine
Sobi™ announced today that the results from the pivotal phase 2/3 study evaluating the efficacy and safety of emapalumab in patients with primary haemophagocytic lymphohistiocytosis (HLH) were published in the New England Journal of Medicine on 7 May 2020. Emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH and is under review by the European Medicines Agency (EMA).
|Swedish Orphan ...|
|05/05/2020 - 00:54||
Abstract Book highlights new data from Cidara accepted for presentation at ECCMID 2020
Seven abstracts highlight new data on influenza antiviral conjugates (AVCs) from Cloudbreak® antiviral platform
|05/01/2020 - 14:07||
Novel Immunotherapy/Targeted Therapy Combination Extended Survival in Some Patients With Lethal Biliary Tract Cancers
A randomized, multicenter study of a combination of immunotherapy with a targeted therapy improved cancer control for some patients with a rare and lethal type of gastrointestinal cancer known as biliary tract cancers (BTCs). This is an aggressive cancer for which the standard treatment for the majority of patients has not changed significantly in more than a decade.
|Johns Hopkins H...|
|04/21/2020 - 15:02||
U.S. FDA Approves IMBRUVICA (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
|04/21/2020 - 00:36||
Outlook Therapeutics Bolsters Clinical and Commercial Expertise with Two Key Appointments to Board of Directors
Internationally renowned ophthalmologist, Gerd Auffarth, MD, ranked as one of the “100 most influential personalities in ophthalmology worldwide" in the 2020 Power List published by The Ophthalmologist magazine Julian Gangolli, former President of the North American Pharmaceutical division of Allergan, Inc., brings distinguished track record of successfully overseeing product commercialization launches.
|04/20/2020 - 11:36||
TUKYSA (tucatinib), FDA Approved for Treatment of Advanced Unresectable or Metastatic HER2 Positive Breast Cancer, Available at Biologics by McKesson
CARY, N.C., April 20, 2020—Biologics by McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, has been selected by Seattle Genetics as a specialty pharmacy provider for TUKYSATM (tucatinib) for the treatment of HER2 positive breast cancer.
|04/20/2020 - 05:50||
Seattle Genetics Announces U.S. FDA Approval of TUKYSA (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to TUKYSA™ (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.
|04/17/2020 - 15:46||
FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer
Today, as part of Project Orbis, the U.S. Food and Drug Administration approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments.
|04/15/2020 - 09:34||
Merck Announces US Launch of ONTRUZANT (trastuzumab-dttb), a Biosimilar of Herceptin (trastuzumab)
KENILWORTH, N.J.--( )--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. launch of ONTRUZANT (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. ONTRUZANT is available in both 150 mg single-dose vials and 420 mg multiple-dose vials.
|04/15/2020 - 00:22||
Outlook Therapeutics to Present at the April 2020 Virtual Investor Summit
Presentation with live audio webcast on Wednesday, April 22 at 10:30 AM ET, immediately followed by an interactive Q&A session.
|04/14/2020 - 00:17||
Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2
Company reports no anticipated COVID-19 impact on NORSE 1, its first registration clinical trial evaluating ONS-5010, an investigational ophthalmic formulation of bevacizumab, to treat wet AMD Risk mitigation strategies being developed for possible one- to three-month delay related to COVID-19 for NORSE 2, the Company’s second registration clinical trial for ONS-5010 to treat wet AMD, depending on local emergency conditions
|04/08/2020 - 19:03||
U.S. FDA Approves BRAFTOVI (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation.
|04/07/2020 - 23:44||
Magellan Rx Management Medical Pharmacy Trend Report Delivers Industry Insights and Forecasting in Notable 10th Edition
For 10 years, Magellan Rx has produced the industry’s only detailed trend report that analyzes medical benefit drug claims for trends, data benchmarking, forecasting for significant categories, as well as current medical benefit drug management approaches.
|04/03/2020 - 10:42||
Case Study: Treating COVID-19 in a Patient with Multiple Myeloma
A case study of a patient in Wuhan, China, suggests that the immunosuppressant tocilizumab may be an effective COVID-19 treatment for very ill patients who also have multiple myeloma and other blood cancers.
|04/02/2020 - 09:25||
Susan Desmond-Hellmann Elected to Pfizers Board of Directors
With Dr. Desmond-Hellmann's election, we have further bolstered Pfizer’s already strong, diverse Board with additional clinical expertise, scientific insights and respected business leadership."
|03/31/2020 - 14:27||
- Switzerlands First Approval Under FDA Initiative Project Orbis -
The application for TUKYSA approval was reviewed by Swissmedic as part of Project Orbis, an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international regulatory agencies in Canada, Australia and Singapore. On April 17, the FDA approved TUKYSA in the U.S. under the FDA’s Real-Time Oncology Review (RTOR) pilot program, four months prior to its action date, and represented the first new drug approved under Project Orbis.