Regulatory Focus™ > News Articles > 2021 > 5 > Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

Posted 24 May 2021 | By Kari Oakes 

Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

2888 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)
  • 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.


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