Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

ReconRecon | 01 September 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • When Will the Delta Surge End? (NYT)
  • Why can’t America fix its Covid-19 testing problems? (VOX)
  • Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant (NPR)
  • First vaccination doses up 17 percent since Pfizer approval: analysis (The Hill)
  • Companies eye financial penalties for unvaccinated workers (The Hill)
  • America has wasted at least 15 million Covid vaccine doses since March, new data shows (CNBC)
  • Health Care Providers Are Warned Not To Give COVID Vaccines Beyond Recommendations (NPR)
  • Biden pledged to ‘follow the science.’ But experts say he’s sometimes fallen short (STAT)
  • Sneaky boosters: how Americans are finding unofficial third jabs (FT)
In Focus: International
  • NICE approves inclisiran for LDL cholesterol reduction (EPR)
  • NICE, Cochrane to collaborate on delivery of ‘living’ recommendations (EPR)
  • Africa has a chance to help the world end polio for good. It needs to seize it now (STAT)
  • NIH launches study into COVID-19 vaccine booster among people with autoimmune disease (BioPharma Reporter)
  • Fourth contaminated Moderna vial found in Japan (Pharmafile)
  • North Korea rejects offer of nearly 3 million Sinovac COVID-19 shots (Reuters)
  • Falsified Covishield vaccine identified in Africa and Asia (EPR)
Coronavirus Pandemic
  • WHO says it is monitoring a new Covid variant called ‘mu’ (CNBC)
  • Pfizer, Merck launch large new trials of oral COVID-19 drugs (Biopharma Dive)
  • Israel’s COVID-19 boosters are preventing infections, new studies suggest (Science)
  • Pfizer Vax Safe, Even Among the Highly Allergic (MPT)
Pharma & Biotech
  • Biden still lacks FDA chief more than 7 months into presidency (Fox)
  • Astellas Voluntarily Halts X-linked Myotubular Myopathy Gene Therapy Trial (Rare Daily)
  • Asher Bio’s encouraging early data against rival cancer drug sparks $108M financing (MedCity News)
  • VectivBio Acquires Comet, Expanding Rare Metabolic Disease Pipeline (Rare Daily)
  • HebeCell lands $53M, Chinese collaborator to make a splash in busy CAR-NK space (Fierce)
  • A next-gen IL-2 challenger bags a megaround with RA Capital on board to accelerate 'modular' drug platform (Endpoints)
  • Atara Biotherapeutics: Developing an off-the-shelf therapy for MS with EBV T-cells (BioPharma Reporter)
  • Maximizing the potency of autologous cell lines: Orgenesis in tie-up with Israeli technology provider (BioPharma Reporter)
  • What to expect at the FDA's two-day meeting on gene therapy safety (Biopharma Dive)
  • Psychopharmacologic Drugs Advisory Committee; Notice of Meeting (FDA)
  • Blockbuster Shingrix schedule back on track after COVID jabs (Pharmaletter)
  • Bavarian Nordic Seeks Partner After RSV Jab Generates Glowing Phase II Data (Scrip)
  • FDA accepts NDA for Teva and MedinCell’s schizophrenia candidate (Pharmaletter)
  • Pharmaceutical membrane filtration market to value $10 billion by 2025 (EPR)
  • Recognizing National Immunization Awareness Month (PhRMA)
  • Patient equations will help us work out of the current pandemic and address the next (MedCity News)
  • Zolgensma Provides No Proven Benefit Over Spinraza In SMA, Says German HTA (Pink Sheet)
  • Current druggable targets for therapeutic control of Alzheimer's disease (PubMed)
  • Alpharetta-based firm reopens nation’s sole producer of penicillin-like antibiotic (Saporta Report)
  • Telehealth marketplace Sesame launches digital pharmacy (Mobihealth News)
  • Cancer diagnoses stayed low even as initial COVID-19 crisis eased: Quest (MedTech Dive)
  • COVID-19: OTC Rapid COVID-19 Tests — Are They Even Worth It? (MD+DI)
  • A Wake-Up Call for Sustainable Healthcare (MD+DI)
  • Surgical training tool Osso VR adds assessment, more language support (Mobi Health News)
  • New AI Allows Physicians to Obtain Better Images of the Heart (MD+DI)
Government, Regulatory & Legal
  • The 10 power players to watch on Democrats’ drug pricing push (STAT)
  • Is Facebook Ghosting Pharma? (FDA Law Blog)
  • Earlier Start Likely For Europe’s Unified Patent Court (Pink Sheet)
  • Sanofi pulls Epilim website after U.K. regulator points out consumer complaint (Fierce)
  • OxyContin-Maker Purdue Pharma Launched A Stealth Campaign To Sway U.S. Officials (NPR)
  • Bankruptcy Judge Is Set To Rule On Purdue Pharma's Opioid Settlement Plan (NPR)
  • Jury Selection Begins In The Fraud Trial Of Theranos Founder Elizabeth Holmes (NPR)
  • Rx vs. OTC (Part Two): Costs and Benefits (Incidental Economist)
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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