Search Results for “EC” – Page 553 – media

Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
- Source: Novartis
- 625
- March 29, 2018
FDA New Approvals Ph+ CML-CP Tasigna®
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review

Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
- Source: drugdu
- 582
- March 29, 2018
FDA MBS New Approvals Opdivo
Bluebird Bio and Celgene Corporation Enter into Agreement to Co-Develop and Co-Promote Anti-BCMA CAR T Cell Therapy bb2121 in the United States

Bluebird Bio, Inc. (Nasdaq: BLUE) and Celgene Corporation (Nasdaq: CELG) today announced that the companies have entered into an agreement to co-develop and co-promote bb2121, an investigational anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cell therapy for the potential treatment of patients with relapsed/refractory multiple myeloma in the United States.
- Source: investor.bluebirdbio
- 459
- March 29, 2018
bb2121 Celgene multiple myeloma T cell therapy
Conservative estimates of EHR safety incidents belie bigger industry concerns

Researchers and patient safety advocates have often warned about the association between EHR usability and patient harm, but hard numbers have been difficult to pin down.
- Source: FierceHealthcare
- 524
- March 29, 2018
digital health EHR Researches
ViiV Healthcare gains CHMP Positive Opinion for Juluca (dolutegravir/rilpivirine) in Europe

ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection in adults
- Source: Viivhealthcare
- 452
- March 28, 2018
HIV Juluca New Approvals
Astellas and Seattle Genetics Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting -Pivotal Monotherapy Phase 2 Trial Initiation Planned for 2017-

Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
- Source: newsroom.astellas.us
- 541
- March 28, 2018
Astellas monotherapy mUC Seattle Genetics
Novartis sells stake in joint venture to GSK for $13bn

Novartis has sold its stake in its consumer health joint venture with GlaxoSmithKline to its British rival for $13bn in an early move by Vas Narasimhan, the Swiss pharmaceuticals group's new boss, to focus on its core business.
- Source: Financial Times
- 512
- March 28, 2018
Company Insights healthcare pharmaceutical company
Improving health literacy is in pharma’s interests

Patients who understand the information provided about their health are more likely to adhere to a medicine regime and feel empowered to take steps towards healthier lifestyles. To what extent are pharma companies taking the initiative? Amanda Barrell reports.
- Source: PharmaPhorum
- 702
- March 28, 2018
Consumer Healthcare Market Views
Vanderbilt researcher says hospital data breaches are tied to patient deaths

The research compared patient care metrics at hospitals that had experienced a data breach and those that had not. For instance, the study examined the proportion of heart attack patients that die within 30 days of being admitted to a health system.
- Source: MedCityNews
- 577
- March 28, 2018
cybersecurity digital health Policies
Lokelma approved in the EU for the treatment of adults with hyperkalaemia

AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases.
- Source: Worldpharmanews
- 573
- March 27, 2018
hyperkalaemia Lokelma New Approvals

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