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April 23, 2021
by Michael Mezher

Recon: US pulls funding for Inovio COVID vaccine study; EU seeks 1.8 billion more doses of Pfizer-BioNTech vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • With Few New Clotting Cases, J&J Pause Could Be Lifted Soon (NYTimes) (WSJ) (Reuters) (FT)
  • White House writes off Johnson & Johnson vaccine after string of production failures (Politico)
  • US CDC probes new death, hospitalization after J&J vaccine shots – officials (Reuters)
  • US stops funding for late-stage study of Inovio's COVID-19 vaccine (Reuters) (Endpoints)
  • CDC reassigns official who drew spotlight for pandemic warning (Politico)
  • New data point to benefits of Bristol’s novel psoriasis pill, but safety issues will be scrutinized (STAT)
  • FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients (FDA)
  • ‘There are no alternatives’: As Pfizer discontinues an old glaucoma drug, a small group of patients struggles to cope (STAT)
In Focus: International
  • EU to strike world's largest vaccine deal with Pfizer (Reuters)
  • EU approves ramp-up of Pfizer vaccine manufacturing site in Belgium (Reuters)
  • EU Commission sees potential in protein-based COVID-19 vaccines (Reuters)
  • Moderna CEO says world faces 2022 COVID vaccine production surplus (Reuters)
  • WHO, Macron denounce vaccine inequity as COVAX scheme marks first year (Reuters)
  • India's Cadila Healthcare starts producing COVID-19 vaccine candidate (Reuters)
  • MHRA authorises Amarin’s heart drug Vazkepa (PharmaTimes)
  • Malaria vaccine trial raises hopes of beating disease (FT)
  • Final Opinion On The Safety Of Breast Implants In Relation To ALCL (EC)
  • ACT-Accelerator one year on (WHO)
Coronavirus Pandemic
  • As At-Home Coronavirus Tests Hit Pharmacies, What Role Can They Play In The Pandemic? (NPR)
  • Patients With Long Covid Face Lingering Worrisome Health Risks, Study Finds (NYTimes)
  • Vaccines Are Effective Against the New York Variant, Studies Find (NYTimes)
  • British regulator says AstraZeneca COVID shot clots rise to 168 (Reuters)
  • Brazil's COVID-19 vaccination program at risk due to 2nd dose no-shows (Reuters)
  • Norway offers mRNA COVID-19 vaccines to those who first got AstraZeneca's (Reuters)
  • Swedish health agency extends pause on J&J vaccine (Reuters)
  • Germany sets no limits on use of J&J COVID-19 shot (Reuters)
  • Olumiant Snags Japan Approval for COVID-19 (PharmaJapan)
  • J&J COVID-19 vaccine expected to be imported to India by July – report (Economic Times)
Pharma & Biotech
  • J&J shareholders approve CEO Gorsky's near-$30 mln pay plan (Reuters)
  • Vertex eyes controllable genetic drugs with $1.3bn Obsidian alliance (PharmaPhorum)
  • Why GSK will struggle to mount AstraZeneca-style revival (FT)
  • With new PhI­II da­ta in hand, Der­ma­vant lines up top­i­cal pso­ri­a­sis con­tender for a sprint to the fin­ish line (Endpoints)
  • Regeneron looks to inject another $330M into long-running manufacturing expansion plan: report (Fierce)
  • With 7 PD-1s on the mar­ket, price com­pe­ti­tion has­n't been a fac­tor. Will Re­gen­eron be the first to ask for less? (Endpoints)
  • Lonza to invest over £150 million on new molecule complex (Pharmafile)
  • China Cancer Drug Off-Label Use: A Crossed Line? (Pink Sheet)
  • Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be? (Endpoints)
  • April show­ers bring more biotechs to Nas­daq, as Rain and Im­pel bump 2021's to­tal raise above $6B (Endpoints)
  • Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies (Endpoints)
  • A pair of Bayer execs land promotions in the US; Energized by lenzilumab data, Humanigen taps AstraZeneca alum as CMO (Endpoints)
  • The ICH Q3C(R8) Guideline reaches Step 4 of the ICH Process (ICH)
  • Pricing Reform in Japan: How Must Life Science Companies Evolve? (PharmaJapan)
  • Takeda Teams Up with IT Startup for AI-Driven Early HAE Detection (PharmaJapan)
Medtech
  • Medtech earnings show early signs of electives return, lingering testing uncertainty (MedtechDive)
  • Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes (MedtechDive)
  • Roche nets companion diagnostic approval for GlaxoSmithKline's Jemperli in MMR-deficient endometrial cancer (Fierce)
  • UK Device Regulatory System Off To Good Start Under ‘Supportive’ MHRA (MedtechInsight)
  • Endeavour Vision raises $375M to fund post-COVID medtech ambitions (Fierce)
  • FDA Presses Domestic Manufacturers To Engage In Remote Regulatory Assessments In Lieu Of Inspections (MedtechInsight)
  • Can real-world remote monitoring help doctors treat heart failure? Amgen and Datos aim to find out (Fierce)
Government, Regulatory & Legal
  • Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence (Endpoints)
  • GenMark Sued by Holder Eyeing $1.8 Billion Roche Deal Challenge (Bloomberg)
  • How the SCO­TUS de­ci­sion to gut the FTC could help bio­phar­ma com­pa­nies (Endpoints)
  • Amgen Petitions Federal Circuit to Reconsider Decision Invalidating Praluent Patents (Big Molecule Watch)
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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