Recon: NGM's NASH drug fails; Alzheimer's breakthrough?
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
U.S. Covid cases hit lowest level since June (CNBC ) (NPR )
Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down (CNBC )
Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog )
Covid vaccine passports: Everything we know so far (CNBC )
White House says no plans to require vaccines for foreign visitors (Reuters )
New York to open vaccination pop-ups at airports for visitors, locals (The Hill )
FDA Seizes 37,500 Tons of Kratom in Florida (Pain News Network )
Biden’s ‘Advanced Research’ Agency May Have Pros And Cons, Congressional Research Service Concludes (Pink Sheet )
Improving federal R&D policy: My long-read Q&A with Matt Hourihan (AEI )
Biden administration moves toward making the pandemic work-from-home experiment permanent for many federal workers (WaPo )
Virtual Reality – FDA and AdComms (Eye on FDA )
In Focus: International
IMF plan seeks to vaccinate 40% of world’s population this year (Biocentury )
TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine (TGA )
Worst of COVID may be yet to come in Africa (AHCJ )
Israel to end COVID-19 restrictions after vaccine success (Reuters )
Factbox: Countries weigh 'mix and match' COVID-19 vaccines (Reuters )
WHO sets new targets for vaccinating world's poorest to end 'scandalous inequity' (Reuters )
Mass vaccine centers opening in Japan ahead of Olympics (The Hill )
Moderna, Novavax to produce more COVID-19 vaccines in S.Korea (Reuters )
Singapore provisionally approves 60-second COVID-19 breathalyser test (Reuters )
Coronavirus Pandemic
G-20 Health Accord Shows Split On Waiving COVID IP (Law360 )
WHO: COVID-19 deaths likely two to three times higher than reported (The Hill )
First Vaccine Data Against Indian Variant (MPT )
Scientists play catch-up with Covid therapies (Politico )
In the Race for a Covid-19 Pill, a Little Lab Plays a Big Role (NYT )
Pfizer begins testing use of pneumococcal vaccine along with COVID-19 booster shot (Reuters )
He’s a Stanford professor and a Nobel laureate. Critics say he was dangerously misleading on Covid (STAT )
Good news: Mild COVID-19 induces lasting antibody protection (EurekAlert )
CDC looking into heart inflammation in some young vaccine recipients (Reuters ) (NYT )
AstraZeneca chief hits back at ‘armchair generals’ after criticism (Guardian )
Are the Allergic Reactions of COVID-19 Vaccines Caused by mRNA Constructs or Nanocarriers? (PubMed )
Instead of Vaccine Passports, Let’s Push for Global Justice in Vaccine Access (Hastings Center )
Pharma & Biotech
Signs of a possible breakthrough in Alzheimer's and Parkinson's (Pharmaletter )
Russian Clinical Trials Weather The COVID-19 Storm (Pink Sheet )
Stock Watch: Pandemic Lessons For Smaller Commercial Biotechs (Scrip )
Gamma Biosiences takes majority stake in Mirus Bio (Biopharma )
After Haven dissolves, JPM goes it alone (MedCity News )
Eliem raises $60M to take neuro programs to series of data drops (Fierce )
Boehringer embarks on a PhIII odyssey for a failed Alzheimer's drug — now refocused on schizophrenia (Endpoints )
BMS follow-up data sees long-term survival for melanoma patients (Pharmafile )
GlaxoSmithKline's ViiV preps doctors ahead of Cabenuva's patient marketing push (Fierce )
Fresh Data Pushes Microbiome Pioneer Ferring Closer To Approval Line (Scrip )
Takeda outlines longterm followup data that it says keep it out of Dengvaxia's shadow (Endpoints )
New paths for a bispecific road less traveled (Biocentury )
European Medicines Agency Grants PRIME Designation to Larimar’s Treatment for Friedreich’s Ataxia (Global Genes )
NGM concedes key failure for their lead NASH drug, closing the door on a pivotal followup (Endpoints )
Freenome, high-profile liquid biopsy company, quietly replaces its CEO (STAT )
Genentech oncology exec moves to Guardant to address cancer even earlier through diagnostics (Fierce )
Almirall Aims To Disrupt Actinic Keratosis Space With Klisyri (Pink Sheet )
CVS joins the decentralized clinical trials movement with launch of new biz unit (MedCity News )
Pharmacological treatments for Ehlers-Danlos syndrome (EDS) (Pharmaletter )
A Hidden Opportunity — Medicaid’s Role in Supporting Equitable Access to Clinical Trials (NEJM )
Medtech
Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA (MedTech Dive )
Latest Release of IBM iConnect Access® Provides Foundation for Planned Future 3D Printing Solution (IBM )
Samsung Biologics to provide fill-finish manufacturing for Moderna’s COVID-19 vaccine (Biopharma )
VitalConnect Adds Mobile Cardiac Telemetry to its Arsenal (MD+DI )
Docbot CEO highlights how AI can be applied to gastrointestinal image analysis ( MedCity News )
Retinal prostheses: Where to from here? (PubMed )
Implantable piezoelectric polymer improves controlled release of drugs (EurekAlert )
Government & Regulatory
Shkreli, Vyera Rip FTC Sanction Bid Over Alleged Phone Wipe (Law360 )
Jurors in Elizabeth Holmes trial can hear some evidence about extravagant lifestyle as Theranos CEO (CNBC )
ITC To Probe Apple Watches In Portable EKG Patent Row (Law360 )
Zantac Chronicles IV – The Preponderance of Preemption (Drug & Device Law )
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.