Novartis Joins Call Asking FDA To Stop Biosimilar Trash-Talkers (BioCentury)
Mundipharma name GSK veteran as new Senior Vice President & CFO (Pharmafile)
Scientists Discover A Way To Get Drugs To The Brain Faster And More Efficiently (Forbes)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
ArQule to Present Clinical Data for its BTK Inhibitor, ARQ 531, at the 2018 American Society of Hematology (ASH) Annual Meeting (Press)
CStone initiates a bridging Phase I clinical trial for PD-1 antibody CS1003 with first patient dosed in China (Press)
Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Pulmonary Hypertension Clinical Trial (Press)
DURECT Announces Amendment to Accelerate Ongoing Phase 2a Trial of DUR-928 in Alcoholic Hepatitis (AH) by Allowing Dosing of Severe AH Patients in Parallel to Moderate AH Patients (Press)
Blue Earth Diagnostics Announces Results of Investigational Phase 3 Blinded Image Evaluation Study of 18F-Fluciclovine PET Imaging in Glioma (Press)
GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia (Press)
Medical Devices
Roche Diagnostics to Replace CoaguChek® XS PT Test Strips (FDA)
Is Progress on MDR and IVDR Happening Fast Enough? (MDDI)
FDA clears Thermi in “vaginal rejuvenation” product inquiry (MassDevice)
Intracranial Hemorrhage Detection Software Receives FDA Clearance (MDDI)
Innovative skin cancer drug available on Cancer Drugs Fund (NICE)
Reclassification of therapeutic products in dispensing category C: Evaluation concluded (Swissmedic)
NICE publishes draft scope for new guideline on cannabis-based products for medicinal use (Pharmaceutical Journal)
Asia
Fuji Pharma to sell Alvotech biosimilars in Japan (PharmaLetter-$)
Innovent Biologics applies for adalimumab biosimilar in China (Biosimilar News)
India
Aurobindo Pharma to launch oncology, respiratory products in US by 2021 (Economic Times)
Superbugs kill more in India than globally, mortality rate is 13% (Times of India)
Pharma cos to make big ticket investments as Gujarat FDCA approves layout designs of 185 drug units post GST (PharmaBiz)
Karnataka sharply increases fees for non-statutory services for 11 certificates like GMP, CoPP & WHO-GMP (PharmaBiz)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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