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Regulatory Focus™ > News Articles > 2020 > 10 > Recon: Exact Sciences nabs rival Thrive for $2B+; Lilly's COVID antibody flops

Recon: Exact Sciences nabs rival Thrive for $2B+; Lilly's COVID antibody flops

Posted 27 October 2020 | By Kari Oakes 

Recon: Exact Sciences nabs rival Thrive for $2B+; Lilly's COVID antibody flops

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Third wave of coronavirus infections in the U.S.? More like 'wildfire,' epidemiologist says (NBC)
  • U.S. Coronavirus Cases Surpass Summer Peak And Are Climbing Higher Fast (NPR)
  • Covid hospitalizations rising in 36 states as U.S. hits another record for average new cases (CNBC)
  • Fauci on latest surge: 'No matter how you look at it, it's not good news' (The Hill)
  • Report: Covid-19 Vaccine Will Be Covered By Medicaid, Medicare (Forbes) (Politico)
  • US FDA Drug Review Hiring Doing Well Despite Pandemic (Pink Sheet)
  • Crucial Covid vaccine data expected from Pfizer this week now unlikely to come before U.S. election (CNBC) (Reuters) (Endpoints)
  • Novavax delays U.S. trial of COVID-19 vaccine candidate to November (Reuters)
  • Trump claims the worsening U.S. coronavirus outbreak is a ‘Fake News Media Conspiracy’ even as hospitalizations rise (CNBC)
  • In a Battered New York Office Market, Life Science Is Flourishing (NYT)
In Focus: International
  • Europe focuses on new curbs as COVID surges in absence of proven vaccine (Reuters)
  • EU warns not enough COVID vaccines for all in Europe until 2022 (Reuters)
  • EU weighs buying Roche, Abbott rapid COVID tests amid limited supplies (Reuters)
  • Digital divide remains, despite big COVID-19 tech innovation (Healthcare IT News)
  • Indian drugmaker Cadila looks for outside production boost for COVID-19 vaccine: report (Fierce Pharma)
  • Pharma urged to review anti-counterfeiting strategies ahead of no-deal Brexit (EPR)
  • Boots to offer 12-minute Covid testing service within weeks (Guardian)
  • Sensyne Health signs new NHS research agreement (PharmaTimes)
  • Bayer’s Nubeqa wins NICE prostate cancer backing (PharmaTimes)
  • Death rates among people with severe COVID-19 drop by a half in England (AAAS)
  • Russian government eases labelling requirements for domestic drugmakers (Pharmaletter)
  • EU Framework For Patient Preference Studies Under Review (Pink Sheet)
Coronavirus Pandemic
  • Lilly antibody drug fails in study of hospitalized Covid patients, other trials go on (NBC) (NPR) (Fierce Biotech) (Forbes) (BIoPharma Dive)
  • Eli Lilly still confident in benefits of Covid antibody treatment despite end to hospital study (CNBC)
  • The coronavirus vaccine trials: Which companies are in the lead? (Imarc Research)
  • What Are the Most Popular COVID-19 Tests? (MedPage Today)
  • Coronavirus antibodies decline after infection, study finds, raising questions about herd immunity (CNBC) (Slate)
  • Merck says early data from COVID-19 vaccines expected this year (Reuters)
  • Covid vaccine race: Oxford stays near front despite delay in US trial (Mint)
  • Oxford Covid vaccine works in all ages, trials suggest (Guardian)
  • Pfizer’s late-stage coronavirus vaccine trial is near complete enrollment with 42,000 volunteers (CNBC)
  • US experts urge caution on giving Covid vaccine to children (FT)
  • A Flu Shot Might Reduce Coronavirus Infections, Early Research Suggests (SciAm)
  • New study shows link between Covid-19 and heart damage (NBC)
  • Protein Mapping Study Reveals Valuable Clues for COVID-19 Drug Development (NIH Director’s Blog)
  • Are Trials That Deliberately Infect People With The Covid-19 Virus Really Necessary? (Forbes)
  • Trial to evaluate oral nitric oxide therapy in COVID-19 patients (EPR)
  • Roche, Atea Pharmaceuticals partner on COVID-19 oral treatment (Outsourcing Pharma)
  • Italy, Spain Tighten Restrictions After Coronavirus Cases Spike (NPR)
  • GSK tunes in to Pandora and Facebook to raise vaccine awareness among older adults (Fierce Pharma)
  • Coronavirus (COVID-19) Update: Daily Roundup October 26, 2020 (FDA)
Pharma & Biotech
  • Ultragenyx pauses antisense trial after patients lose ability to walk (Fierce Biotech)
  • With $1.8B valuation within reach, Sommadossi’s Atea readies ‘mega-IPO’ (Biocentury)
  • Catabasis DMD effort fails again as it cuts drug from pipeline, considers 'strategic options' (Fierce Biotech)
  • Saama introduces ASAP pharmacovigilance platform (Outsourcing Pharma)
  • Care Access Research, Lilly join on mobile COVID-19 trials (Outsourcing Pharma)
  • Mirati impresses with KRAS inhibitor response rates, potential biomarker (Biocentury)
  • Sanofi presents Dupixent eosinophilic esophagitis data at scientific meetings (Sanofi) (Pharmafile)
  • A record number of biotechs are going public. Here's how they're performing. (BIoPharma Dive)
  • First-in-human trial to study remestemcel-L as Crohn’s disease therapy launched (EPR)
  • Novartis’ rare renal disease candidate shows promise in phase II (PharmaTimes)
  • ‘Dying waiting’: Advocates urge Vertex to widen global access to cystic fibrosis drugs (STAT)
Medtech
  • Exact Sciences to buy cancer screening rival Thrive for up to $2.15B (MedTech Dive) (MD+DI) (Endpoints)
  • FoundationOne CDx Wins Approval as Companion Diagnostic to Vitrakvi (MD+DI)
  • ‘New’ Medtronic Wins FDA Approval for Venous Self-Expanding Stent System (MD+DI)
  • Merck Is Piloting A Drone Delivery Program For Medications (Forbes)
  • FDA, Philips warn of data bias in AI, machine learning devices (MedTech Dive)
  • Stryker buyout of Wright poised to pass 1-year mark without closing (MedTech Dive)
Government & Regulatory
  • J&J, 3M Urge Congress To Back PTAB Discretionary Denials (Law360)
  • Federal Circuit Affirms PTAB Finding that Dupixent Immunex Patent is Obvious (Big Molecule Watch)
  • Rare Disease Drug Developer Group Blasts New Canadian Price Controls (Global Genes)
  • Post-Albrecht Preemption Pervasively Pummels Pradaxa Plaintiffs (Drug & Device Law)
 
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.
 

Tags: coronavirus, EMA, EU, FDA, US

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