Regulatory Focus™ > News Articles > 2021 > 9 > Recon: FDA declines EUA for Humanigen's COVID drug; CRISPR startup Mammoth raises $200M

Recon: FDA declines EUA for Humanigen's COVID drug; CRISPR startup Mammoth raises $200M

Posted 09 September 2021 | By Michael Mezher 

Recon: FDA declines EUA for Humanigen's COVID drug; CRISPR startup Mammoth raises $200M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden to call for global summit on Covid response (Politico)
  • FDA declines emergency use approval for Humanigen's COVID-19 drug (Reuters) (STAT)
  • Biden Administration Unveils Plan to Cut Prescription-Drug Prices (WSJ) (STAT) (Politico)
  • 'Failure is not a crime,' defense says in trial of Theranos founder Holmes (Reuters) (NYTimes)
  • Theranos was running out of money — so Elizabeth Holmes 'lied,' prosecution says at trial (NBC)
  • Moderna developing single-dose booster shot for COVID-19 and flu (Reuters)
  • Biogen admits Aduhelm launch ‘slower than we anticipated’ (STAT)
  • Lilly joins RNA editing race with ProQR deal (BioPharmaDive) (Fierce)
  • Amazon-backed biotech Mammoth raises $200m for diseases push (FT)
In Focus: International
  • WHO seeks COVID-19 vaccines for poor nations, 'not empty promises' (Reuters)
  • Biden to order all federal workers to be vaccinated against Covid (Politico)
  • EU lists rare nerve disorder as possible side-effect of AstraZeneca COVID-19 vaccine (Reuters)
  • UK approves COVID-19 boosters but final decision on programme still pending (Reuters)
Coronavirus Pandemic
  • Covid-19 testing system struggles to keep up with Delta demand (Politico)
  • When Was the First U.S. Covid Death? C.D.C. Investigates 4 Early Cases (NYTimes)
  • Sinovac to trial COVID-19 vaccine in South African children as part of global study (Reuters)
Pharma & Biotech
  • Medical cannabis unlikely to benefit most chronic pain patients, international researchers say (STAT)
  • Early data suggest monthly hemophilia drug could contend with gene therapy (STAT)
  • FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids (FDA)
  • Project Orbis Nears 30 Approvals In Oncology; Could China Be Added? (Pink Sheet)
  • Boehringer Ingelheim, Twist Bioscience team up for $710M+ antibody discovery collab (Fierce)
  • Sanofi’s BTK inhibitor flunks phase 3 autoimmune trial, delivering blow to $3.7B biotech bet (Fierce)
  • Obsidian bags $115M to untether cell therapy from toxic sidekick (Fierce)
  • Genome of South Korea gains CDMO capability and drug material insurance with $27M purchase of List Labs (Fierce)
  • WCLC: AstraZeneca's detailed Imfinzi, tremelimumab data in metastatic NSCLC are far from a clear-cut win (Fierce)
  • WCLC: Jazz charts new path for small cell lung cancer drug Zepzelca after late-stage flop (Fierce)
  • ResMed touts CPAP survival benefits for sleep apnea after HHS doubts therapy efficacy (MedtechDive)
  • Smiths shuns previous medtech deal, instead opting for $2.4B from ICU Medical (Fierce)
  • Stryker buys Gauss Surgical for its AI tech that tracks blood loss during childbirth (Fierce)
Government, Regulatory & Legal
  • FDA to Seek More Time to Decide Fate of Juul (WSJ)
  • No dice: Court tells AbbVie it can't force Takeda to supply a drug that's in shortage worldwide (Fierce)
  • Mallinckrodt Pushes Back Ch. 11 Plan Vote After $583M Deal (Law360)
  • CPAP Maker Sued Over Recall For Chemical Inhalation Risk (Law360)
  • PTAB Wipes Out BASF Patent On Fatty Acid (Law360)
  • Massachusetts devicemaker SpineFrontier faces federal bribery, money laundering charges (Fierce)
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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