Startup Tiburio nabs Avrobio executive Kreher as chief medical officer (Fierce)
AstraZeneca lines up a $20M installment plan to launch a new oncology collaboration with microbiome player Seres (Endpoints)
Zafgen’s second try at Prader-Willi syndrome triggers another safety alarm in preclinical tox study (Endpoints)
FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination (IPQ)
Biomarkup: creating or promoting medical tests to drive revenue (STAT)
Esketamine Faces Challenges In Its Quest To Be A Breakthrough Drug Against Suicidal Ideation (Forbes)
FDA Pulls Fast-Track Designation for Tonix’s PTSD Treatment (FDANews-$)
Real-Time Oncology Review Quickly Grows Popular; Venclexta Is Latest To Join Pilot (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
Allergan files anti-CGRP migraine drug in the US (PharmaTimes)
GeNeuro touts a mixed set of extension data in a shot at salvaging their failed mid-stage MS drug (Endpoints)
New Phase 3 STELARA® (ustekinumab) Data Show Positive Results As Maintenance Therapy In Adults With Moderate To Severe Ulcerative Colitis (Press)
Akebia Therapeutics Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of Vadadustat in Japanese Patients with Anemia Due to Chronic Kidney Disease (Press)
Rocket Pharmaceuticals Announces First Patient Dosed in Phase 1 Clinical Trial of RP-L102 in the U.S. (Press)
Medical Devices
CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility (Focus)
Smith & Nephew puts up $660m for Osiris Therapeutics (MassDevice)
Provisional NICE nod for Ilumetri (PharmaLetter-$)
Public unaware of how to verify legitimacy of online pharmacies, survey finds (PharmaTimes)
Asia
Japan eyes India for tech transfer, business collaboration & maximise manpower expertise in lifesciences-healthcare (PharmaBiz)
India
Pharma SMEs seek year-long deadline extension for implementation of new labelling norms (PharmaBiz)
General Health & Other Interesting Articles
Evaluation of Journal Registration Policies and Prospective Registration of Randomized Clinical Trials of Nonregulated Health Care Interventions (JAMA)
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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