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July 12, 2021
by Michael Mezher

Recon: Pfizer discussing boosters with US officials; WHO calls for sharing gene editing tools with developing nations

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer to discuss vaccine booster with US officials Monday (STAT) (Washington Post)
  • Pfizer/BioNTech bid for booster doses premature, more data needed -experts (Reuters)
  • BioBonds Would Use Wall St. Tools to Fund Medical Research (NYTimes)
  • Drug Prices Are One Focus of Biden’s Push to Boost Competition (WSJ) (BioPharmaDive) (Endpoints)
  • Astellas and Seagen's Padcev wins full FDA approval, notching expanded label in tough-to-crack urothelial cancer (Endpoints) (FDA)
  • Bayer's Farxiga rival Kerendia scores long-awaited kidney and heart disease nod for Type 2 diabetes patients (Fierce) (FDA)
  • The Rationing of a Last-Resort Covid Treatment (NYTimes)
In Focus: International
  • WHO committee calls for sharing of gene editing tools with poorer nations (Reuters) (STAT)
  • Sputnik V second dose shortage to delay India's full rollout -Dr Reddy's (Reuters)
  • Chinese drugmakers agree to supply more than half a billion vaccines to COVAX (Reuters)
  • Novo, in rare deal, buys rights to Prothena amyloidosis treatment (BioPharmaDive) (Endpoints)
  • German lab Eluthia says suspends use of BGI prenatal tests for privacy probe (Reuters)
Coronavirus Pandemic
  • Few options for Biden as vaccination pace hits a wall (Politico)
  • EU reaches 70 percent vaccine delivery goal for adults (The Hill)
  • Decision on emergency use listing of Covaxin likely in 4-6 weeks: WHO (Economic Times)
  • Unvaccinated Belgian woman contracted two COVID variants simultaneously (Reuters)
  • Vaccines will get full FDA approval, Fauci predicts (Politico)
  • Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy (STAT)
  • Israel offers third shot of Pfizer COVID-19 vaccine to adults at risk (Reuters)
  • Covid-19 vaccine: Moderna offered legal indemnity, but with riders (Economic Times)
  • Bipartisan lawmakers press NIH for info on deleted coronavirus data (The Hill)
  • Taiwan finally getting BioNTech COVID vaccines in $350 mln deal (Reuters)
  • Politics, health collided in Taiwan's tortured BioNTech vaccine talks (Reuters)
Pharma & Biotech
  • Landmark gene therapy trial points to a wider window to alter course of rare disease (STAT)
  • As 5 more biotechs file their IPOs, one Nasdaq official doesn't see momentum slowing down anytime soon (Endpoints)
  • Dying patients with rare diseases struggle to get experimental therapies (NBC)
  • bluebird bio to restart marketing of Zynteglo in EU after previous suspension (PMLive)
  • NICE ‘no’ for Orchard Therapeutics’ gene therapy Libmeldy (PharmaTimes)
  • Fierce)
  • Union official says Viatris severance package provides former Mylan workers ‘sustainability’ (MetroNews)
  • Bayer takes SGLT2 hopefuls head on with FDA approval for new kidney disease drug (Endpoints)
  • Poxel pivots to different programs, but questions abound over imeglimin (Fierce)
  • Switching focus in the brain, researchers herald a possible gene therapy breakthrough in treating an ultra rare disease (Endpoints)
  • Aiming to rebound from blunders years ago, Celldex touts a Phase Ib win with sights set on Xolair (Endpoints)
Medtech
  • Medtech pay to doctors plunged in 2020 as COVID-19 pummeled electives, in-person services fell (MedtechDive)
  • Biden order takes aim at high cost of hearing aids, calls for OTC sales (MedtechDive)
  • Abbott lays off 400 workers amid drop in demand for COVID-19 tests (MedtechDive)
  • Merck KGaA taps Spanish graphene start-up for ultrafine, smart neuromodulation therapies (Fierce)
  • In rare double-SPAC deal, Hyperfine picks up brain-sensing tech company as it goes public (Fierce)
Government, Regulatory & Legal
  •  Plugging Obamacare’s biggest hole poses dilemma for Democrats (Politico)
  • Bayer, Janssen Duck Louisiana Blue Cross' Xarelto Claims (Law360)
  • Generics, Retailers Escape Zantac MDL With Preemption (Law360)
  • Gov't Can't Ditch Akebia's Suit Over Kidney Drug Coverage (Law360)
  • 9th Circ. Won't Revive Ex-Merck Worker's Drug Kickback Suit (Law360)
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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