Search Results for “CFDA” – Page 2 – media

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
- 1,121
- March 26, 2018
CFDA China CPhI pharmaceutical Policies
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer (for specialized target groups only)

Bayer reported that the Chinese Food and Drug Administration (CFDA) approved Stivarga (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar (sorafenib) (Press release, Bayer, DEC 13, 2017, View Source [SID1234522618]).
- Source: 1stoncology
- 533
- March 20, 2018
HCC New Approvals Nexavar® Stivarga®
FDA Grants Breakthrough Device Designation to Polyganics’ Liver and Pancreas Sealant Patch

Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
- Source: polyganics
- 656
- March 15, 2018
bioresorbable medical devices FDA New Approvals Polyganics
Medtec China 2018 scale will grow by 10% to feed the rapidly growing needs of the medical device industry in China

Medtec China 2018 is taking place on September 26–28 in Shanghai China. This year the scale of the show will grow by 10% reaching a new height since 2015; it is now at a scale making utilization of an entire hall possible to hold the show.
- Source: Ddu
- 1,548
- March 8, 2018
Exhibitions & Activities Medtec China
Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.
- Source: Emergo
- 804
- January 10, 2018
CFDA Clinical Trials medical device polices
Illumina and KingMed to develop oncology diagnostics in China

US-based gene sequencing firm Illumina has signed an agreement with Guangzhou KingMed Diagnostics Group to co-develop new oncology and hereditary disease testing applications in China.
- Source: Verdict Medical Devices
- 640
- January 9, 2018
cancer CFDA Company Insight digital health
Ultragenyx Sells Priority Review Voucher for $130 million

“The sale of the PRV provides us with an important source of non-dilutive capital to help advance our pipeline of rare and ultra-rare therapies, and accelerates the availability of these potential therapies to patients,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.
- Source: finance.yahoo
- 716
- December 20, 2017
FDA Market Views Novartis PRV
Surgical Device Company Virtual Incision Raises $18 Million in Series B

Virtual Incision’s RASD weighs just two pounds and is designed to perform the procedure through a smaller incision, potentially reducing recovery time and mitigating the risk of surgical complications.
- Source: xtalks
- 568
- December 18, 2017
FDA medical device RASD Series
Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
- Source: chi-med
- 669
- December 18, 2017
cancer Clinical Trials Fruquintinib
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)
- Source: investor.bayer
- 700
- December 14, 2017
Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®

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