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.