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)
- 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)
- 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)
- 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 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)
- 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)
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