With the drug industry as its partner, an addiction policy group invites tough questions (STAT)
Drug makers still have a bad reputation among patient groups (STAT-$)
Trump administration is urged to override patents on pricey muscular dystrophy drug (STAT-$)
Creative Minds: Optimizing Radio-Immunotherapy for Cancer (NIH)
ImmunoRestoration, Inc. Selects Premier Research for Pre-Trial Services (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Novartis-backed Conatus highlights a silver lining, but PhIIb NASH setback causes whiplash in share price (Endpoints)
RA Capital jumps into the melee on TTR amyloidosis, backing a $91M development plan for a BridgeBio drug (Endpoints)
Nordic Nanovector further delays pivotal lymphoma readout, parts company with CEO (Fierce)
Pfizer, Acadia fund Fox Foundation’s new tool for Parkinson’s clinical studies (Fierce) (Press)
Unnecessary exclusions shut patients out of clinical trials (STAT)
Clinical Trials in Medical Center Advertising (JAMA)
High prevalence of S. pyogenes Cas9-specific T cell sensitization within the adult human population - A balanced effector/regulatory T cell response (bioRxiv)
First Patient Dosed In Pivotal Biomarker-Guided Phase 3 Study Of First Line Therapy With DB102 + R-CHOP In Patients With High-Risk Diffuse Large B-Cell Lymphoma (Press)
Medical Devices
Repro-Med defeats an appeal from EMed in needle-stick patent case (MassDevice)
Axonics executes $40M financing to commercialize neuromodulation device (Fierce)
RefleXion Medical reaps $100M in series C round (Fierce)
Ascensia looks to expand access to blood glucose monitoring tech for UnitedHealthcare enrollees (Drug Delivery Business News)
Apple launches Health Records with 39 health systems. How soon will it reach clinical studies? (Fierce)
Six organizations ask HHS Secretary Azar to take title of 5 patents on Exondys 51, as remedy to failure by inventors to disclose NIH funding (Knowledge Ecology International)
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting (FDA)
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (FDA)
Updating an existing Class 1-3 in-house IVD notification (TGA)
Canada
Before voting, understand these facts about health care (Toronto Star)
General Health & Other Interesting Articles
The stark disparities in how infectious diseases kill Americans (Axios)
Monkey study suggests Zika infection in infancy could cause brain damage (STAT)
Poll: Most Americans wary of those suffering from addiction, despite recognition of medical condition (STAT)
Fall prevention gets harder when elderly leave hospital (Reuters)
Taxing Soda and Booze Can Spark Healthy Spiral, Experts Say (Bloomberg)
Fur-covered robots are the new therapy animal (CNET)
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. Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.