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July 29, 2020
by Michael Mezher

Recon: Moderna eyes $50-60 price for COVID-19 vaccine; UK signs deal for Sanofi, GSK coronavirus vaccine

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna pitches virus vaccine at about $50-$60 per course (Financial Times) (STAT)
  • Moderna Vaccine Test in Monkeys Shows Promise (NYTimes)
  • Most voters say they'd rather wait for an effective coronavirus vaccine (Politico)
  • Public Health Experts Fear a Hasty FDA Signoff on Vaccine (KHN)
  • ‘Nobody Likes Me,’ Trump Complains, Renewing Defense of Dubious Science (NYTimes)
  • Trump says he still thinks hydroxychloroquine works in treating early stage coronavirus (CNBC) (AP)
  • ‘This is health care moonshot time’: Pandemic pulls Biden, Dems further left (Politico)
  • Pfizer chief says Trump price threats distract from vaccine progress (Financial Times)
  • Lawmakers urge congressional watchdog to probe US government’s role in discovering remdesivir (STAT)
  • Genentech to cut 474 Bay Area-based jobs (SF Chronicle)
  • Amgen Reports Second Quarter 2020 Financial Results (Press)
In Focus: International
  • Roche bid to retool arthritis drug for COVID-19 fails (Reuters) (BioPharmaDive) (Press)
  • UK 'must ensure medicines stockpile replenished' for Covid-19 second wave (The Guardian)
  • UK strikes deal for 60m Covid-19 vaccine doses with Sanofi and GSK (Financial Times) (Press)
  • ‘Silver bullet’ to beat Covid-19 unlikely, warns UK vaccine chief (Financial Times)
  • Covid-19 hastens French push to bring home medicines manufacture (Financial Times)
  • Indian API makers benefit as global buyers ditch China (Economic Times)
  • Europe secures supply of Gilead's COVID-19 drug remdesivir (BioPharmaDive)
  • Cepheid is accused of overcharging and undersupplying its Covid-19 test to poor countries (STAT)
  • WHO, WIPO, WTO launch updated study on access to medical technologies and innovation (WHO)
  • Sanofi lifts earnings view as Regeneron stake sale boosts Q2 (CNBC) (Press)
  • GSK profit misses as vaccine sales disappoint, stockpiling eases (Reuters) (Press)
Coronavirus Pandemic
  • The Coronavirus Could Dodge Some Treatments, Study Suggests (NYTimes)
  • Harvested Antibodies Now Being Tested As A Prevention Tool Against COVID-19 (NPR)
  • Remdesivir Could Be in Short Supply. Here’s a Fix. (NYTimes)
  • US FDA’s Coronavirus Workload Shifting Beyond Idea Stage (Pink Sheet)
  • Color targets supply, staffing bottlenecks with updated coronavirus test EUA (MedtechDive)
  • Hologic wins HHS-DOD contract to boost COVID-19 test supplies production (MedtechDive)
  • Sorrento picks up color-changing COVID-19 saliva test built by Columbia University fertility clinic (Fierce)
  • Coronavirus (COVID-19) Update: Daily Roundup July 28, 2020 (FDA)
Pharma & Biotech
  • Harry Reid and Alex Trebek tried Patrick Soon-Shiong’s experimental cancer therapy. Can their results be duplicated in a clinical trial? (STAT)
  • Cancer drug is the first potential therapy to emerge from 23andMe and GlaxoSmithKline collaboration (STAT)
  • GSK’s latest pipeline review includes a slate of COPD programs headed to the scrap heap (Endpoints) (Fierce)
  • Sanofi prunes its pipeline, taking the ax to a lineup of drug, vaccine programs (Endpoints) (Fierce)
  • Roche/Genentech doubles down on tau, fronting $120M cash to ally on a 2-pronged strategy to fight Alzheimer’s (Endpoints)
  • Amgen tosses back unwanted bispecific to Xencor as KRAS data on track for 2020 readout (Fierce)
  • Takeda poised to cut sales jobs in Japan as restructuring continues (Pharmafile)
  • DSCSA Pilot Used Blockchain To Trace Drug Through 'Last Mile' of Supply Chain (Pink Sheet)
  • Three years after leaving Biogen, Alpna Seth takes the spotlight with $73M for her neuro startup (Endpoints)
  •  'Exquisite control': Flagship pulls off $85M rally around Omega Therapeutics' clinical push for epigenetic programming tech (Endpoints)
  • Codiak gets a competitor, as Mantra Bio leaves stealth and enters growing exosome space (Endpoints)
  • Which pharma advertising did President Trump lambaste on Twitter? Good question (Fierce)
  • EC approves subcutaneous version of Remsima (PharmaTimes)
  • Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation (Press)
  • Opaque Pricing Could Protect Europe From US Policy (Pink Sheet)
  • Industry Laments UK Change To SPC Waiver Approach (Pink Sheet)
  • The secret life of excipients (Nature)
  • Recursion Pharma acquires digital vivarium outfit Vium (Fierce)
  • AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention (Press)
Medtech
  • Robot redux: Pandemic scrambles competitive timelines for Intuitive, J&J, Medtronic (MedtechDive)
  • Dexcom nixes plan to begin G7 launch this year (MedtechDive)
  • Medical devices provide another window for hospital hackers (Modern Healthcare)
  • ‘Amazing, Isn’t It?’ Long-Sought Blood Test for Alzheimer’s in Reach (NYTimes)
  • Framework for the evaluation of new tests for tuberculosis infection (WHO)
  • Thrive flourishes, raises $257M to carry forward its cancer-seeking blood test (Fierce)
  • LabCorp says COVID-19 testing 'more than' offsets still-recovering base business (MedtechDive)
  • Smith+Nephew misses expectations in Q2 (MassDevice)
  • Boston Scientific rises on Street-beating Q2 (MassDevice)
  • LivaNova slides despite forecast-topping Q2 results (MassDevice)
  • Dexcom up after hours on Street-beating Q2 (MassDevice)
  • Baxter and Ayogo Announce Partnership for Unique Digital Health Solutions for Home Dialysis (Press)
Government & Regulatory
  • Genentech v. JHL case schedule extended (Big Molecule Watch)
  • Up, Up and But Not Away: DEA Raises Registration Fees (FDA Law Blog)
  • 6th Circ. Questions Opioid Negotiation Class 'Inventiveness’ (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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