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Mylan Introduces Symfi™ Triple Combo Once-Daily HIV Treatment in the U.S.

Global pharmaceutical company Mylan N.V. (MYL) today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfi™ (efavirenz, lamivudine and tenofovir disoproxil fumarate) 600 mg/300 mg/300 mg tablets, a once-daily, single-tablet regimen (STR), indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
- Source: finance.yahoo
- 560
- March 29, 2018
HIV-1 New Approvals Symfi™
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
- 653
- 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
- 604
- 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
- 477
- March 29, 2018
bb2121 Celgene multiple myeloma T cell therapy
Charity launches biometrics wristband project for autistic people

The North-West charity aims to build the world’s first autism assessment and diagnostic centre in Wirral, where biometric technology will be used to measure physiological properties of people with autism.
- Source: MedicalPlasticsNews
- 623
- March 29, 2018
autism digital health Researches wearables
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
- 541
- March 29, 2018
digital health EHR Researches
FDA clears new Dexcom CGM that requires no patient calibration earlier than expected

Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
- Source: MedCityNews
- 730
- March 29, 2018
diabetes FDA insulin New Approvals
Amgen And Allergan Receive Positive CHMP Opinion For ABP 980 (Biosimilar Herceptin®) For The Treatment Of Three Types Of Cancer

Recommended for Approval for the Same Indications as Herceptin® (Trastuzumab) Positive Opinion for ABP 980 is Supported by Phase 3 Data in Patients With HER2-Postive Early Breast Cancer
- Source: finance.yahoo
- 625
- March 28, 2018
Allergan Amgen biosimilar herceptin New Approvals
Bayer announces completion of rolling submission of New Drug Application in the U.S. for larotrectinib for the treatment of TRK fusion cancer

Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
- Source: investor.bayer.de
- 607
- March 28, 2018
FDA larotrectinib New Approvals NTRK
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
- 470
- March 28, 2018
HIV Juluca New Approvals

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