Search Results for “FDA” – Page 171 – media

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
- 590
- March 28, 2018
FDA larotrectinib New Approvals NTRK
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
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
Phase III data in The Lancet show Novartis siponimod significantly improves outcomes in patients with secondary progressive MS

Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet.
- Source: Novartis
- 532
- March 26, 2018
Clinical Trials SPMS
Big Events on Pharmaceuticals during NPC & CPPCC

The two sessions (NPC & CPPCC) this year have received much attention from China and outside China, wherein, the most-watched theme is “reform”. Regarding pharmaceuticals, the event that attracts the highest attention is CFDA reform, followed by policy moves of the TCM issue and bio-medicine, etc. that China has been strongly supporting in recent years.
- Source: EN-CPhI
- 1,104
- March 26, 2018
CFDA China CPhI pharmaceutical Policies
AbbVie shares tank on Rova-T flop, sudden retreat from accelerated approval pitch

AbbVies stock $ABBV is getting hammered this morning after its $10 billion Rova-T program posted poor mid-stage results for third-line small cell lung cancer, forcing the company to scuttle any plans to seek an accelerated approval for the closely-watched drug after talks with skeptical regulators.
- Source: 4-traders
- 600
- March 26, 2018
AbbVies Clinical Trials Company Insights small cell lung cancer
EMA starts review of Xtandi in non-metastatic prostate cancer

The EU medicines regulator has started its review of Astellas and Pfizer’s prostate cancer drug Xtandi in what looks likely to become a hotly contested indication - non-metastatic castration-resistant prostate cancer (nmCRPC).
- Source: pmlive
- 806
- March 23, 2018
Astellas Company Insights nmCRPC Pfizer Xtandi
Phase III IMpower131 Study Showed Genentechs TECENTRIQ (Atezolizumab) Plus Chemotherapy (Carboplatin and ABRAXANE) Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People with a Type of Advanced Squamous Lung Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.
- Source: cleveland19
- 723
- March 22, 2018
Chemotherapy Clinical Trials Genentech NSCLC oncology
Oxford Performance Materials targets Asia after 3D printed medical devices approved in Japan

Oxford Performance Materials, a company whose materials have been used in everything from medical implants to Boeing airplanes, has been given the green light to distribute its 3D printed medical devices in Japan, paving the way for major expansion within Asia.
- Source: 3Ders
- 533
- March 22, 2018
3D printing Japan medical device products New Approvals
Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter Klein To Board Of Directors;

Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that it has commenced dosing of its small molecule inhibitor of RIPK1 in a Phase 1 clinical trial in healthy volunteers and achieved proof of concept of its large molecule blood-brain barrier delivery platform technology in nonhuman primates.
- Source: Nasdaq
- 551
- March 21, 2018
Clinical Trial neurodegenerative disease RIPK1

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