Regulatory Focus™ > News Articles > 2021 > 3 > Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

Posted 19 March 2021 | By Kari Oakes 

Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies (Pink Sheet)
  • Experts Warn U.S. Could See New Coronavirus Hot Spots (NPR)
  • Biden says 65% of people 65 or older have received at least one COVID vaccine shot (Reuters)
  • Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary (Endpoints)
  • New HHS Secretary Becerra urged to expand digital health access (Healthcare IT News)
  • J&J’s MS drug ponesimod receives approval in the US (PMLive)
  • When states should reopen, briefly explained (Vox)
  • FDA spells out how the Covid-19 variants impact the effectiveness of Regeneron, Eli Lilly mAb treatments (Endpoints)
  • Fauci Denounces Sen. Paul’s ‘Dead Wrong’ Anti-Mask Message As Studies Show Variants Still Pose A Threat (Forbes)
In Focus: International
  • Not Enough Vaccine Doses In Europe To Stop A 3rd Wave, German Health Minister Says (NPR)
  • Charts show that Europe’s third coronavirus wave has begun (CNBC)
  • The EU Vaccine Bungling (Marginal Revolution)
  • Europe aims to get vaccinations back on track after clearing AstraZeneca shot (Reuters)
  • Oxford vaccine chief says reassuring that safety monitoring systems are working (Reuters)
  • Australia relieved after EU drug regulator backs AstraZeneca vaccine (Reuters)
  • France limits AstraZeneca Covid jab to over-55s as Europe treads cautiously (Guardian)
  • Health Canada follows European regulators in backing AstraZeneca's COVID-19 vaccine (Reuters)
  • RDIF & Stelis Biopharma to supply 200 million doses of the Sputnik V vaccine (Pharmafile)
  • EU to back vaccine export checks when leaders meet next week: draft decision (Reuters)
  • Pelmeg developed with aid of regulatory reform (GaBI)
  • Plans For Mandatory EU Joint Clinical Assessments Watered Down (Pink Sheet)
Coronavirus Pandemic
  • Will try to supply more doses of COVID-19 vaccine to UK later: Serum Institute (Economic Times)
  • U.S. Will Send 4 Million AstraZeneca Vaccine Doses to Canada and Mexico (FDA News)
  • The 'Tamiflu' Approach to Treating COVID-19 (MedPage Today)
  • Germany could imagine signing deal for Sputnik V shot, minister says (Reuters)
  • Keep using AstraZeneca vaccine, WHO urges world (Reuters)
  • Providing Cancer Care in the Age of COVID-19 (Harvard Law)
  • The Case for Donating US Covid Vaccines Overseas (KHN)
Pharma & Biotech
  • SEC charges co-founders of shuttered microbiome startup uBiome with $60 million fraud (STAT)
  • Merck, Eisai detail Keytruda and Lenvima's endometrial cancer win in confirmatory study (Fierce Pharma)
  • Sanofi parts ways with Oxford BioMedica on hemophilia tie-up inked by Bioverativ (Fierce Pharma)
  • NICE recommends new triple therapy for multiple myeloma patients (Pharmafile)
  • Merck breathes a sigh of relief as Keytruda-Lenvima combo aces confirmatory study in endometrial cancer (Endpoints)
  • Three drugmakers nab $639M as biotech's IPO pace eclipses a record year (BioPharma Dive)
  • Microbiome biotherapeutic shows promise in acute graft-versus-host disease (EPR)
  • Jakafi failed the primary endpoint in a Covid-19 study. But Incyte is still going to FDA with a compassionate use pitch (Endpoints)
  • Two Rare Disease Biotechs Rake in $170 Million in Public Equity Offerings (Global Genes)
  • How Five Prime suitor Amgen battled multiple companies for the biotech—and won (Fierce Biotech)
  • NICE approves Lynparza plus Avastin via Cancer Drugs Fund (PharmaTimes)
  • Idera's TLR9 drug flunks melanoma phase 3, tanking stock (Fierce Biotech)
  • IVM releases toolbox on how to switch patients to insulin biosimilars (GaBI)
  • Antibiotic stewardship may be improving at U.S. hospitals, but new targets are still needed (STAT)
  • Academia/Industry Collaboration Intensifies on Addressing the Pressing Needs in Biopharma Workforce Development (IPQ)
  • How Amgen spent $2 billion on a biotech that had been on the brink (Endpoints)
  • Gilead and Novo Nordisk advance NASH collaboration to larger clinical study (MedCity News)
  • Knowledge and perceptions about naming biosimilars in the US (GaBI)
  • The state of play for copy biologicals in China (GaBI)
  • Takeda bags mRNA translation modulators in $120M Anima deal (Fierce Biotech)
  • Starving tumors to slow melanoma and pancreatic cancer (Fierce Biotech)
  • FDA approves first treatment for recurrent pericarditis (PharmaLetter)
  • Cancer immunotherapy may also treat certain autoimmune diseases (EurekAlert)
  • How RNA editing affects the immune system (EurekAlert)
  • Novel blood cleansing device to enter first-in-human trial (EPR)
  • New Image Sensor Aims to Make a Difference in Surgical and Diagnostic Endoscopy (MD+DI)
  • Like an artificial nervous system (EurekAlert)
  • More stroke patients receiving mechanical clot removal, yet racial disparities persist (EurekAlert)
  • Medline Expands UV Disinfection Portfolio (PR Newswire)
  • Scientists identify genetic pathway that suppresses Lou Gehrig's Disease (EurekAlert)
Government & Regulatory
  • What Will “Modernizing” Regulatory Review Look Like? (AAF)
  • Democrats unveil bill to prevent Sackler family from evading lawsuits through bankruptcy (The Hill)
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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