Recon: Purdue pleads guilty to criminal charges over opioid sales; EU signs deal for J&J COVID vaccine

• Purdue Pharma Pleads Guilty to Criminal Charges for Opioid Sales (NYTimes)
• AstraZeneca close to restarting Covid-19 vaccine trial in US (Politico) (Reuters)
• Covid-19 vaccine researchers left in the dark as trials remain on hold (NBC)
• Lilly hires external adviser for COVID-19 drug plant problems (Reuters) (Bloomberg)
• States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA (Politico)
• How the FDA Stood Up to the President (NYTimes)
• Trump’s Antibody ‘Cure’ Will Be in Short Supply (NYTimes)
• What do patients think about AI in the clinic? The FDA wants to find out (STAT)
• Lawmakers press HHS for documents on Trump’s drug-card plan (Politico)

• EU signs supply deal with J&J on potential COVID-19 vaccine (Reuters)
• EU leaders to hold COVID-19 video-conference October 29: officials (Reuters)
• Lack of antidotes adds to ethical dilemmas for UK COVID-19 challenge trials (Reuters)
• No Skipping of Japanese Translation for COVID-19 Vaccine Dossiers: PMDA Official (PharmaJapan)
• France's AP-HP says Roche's Actemra limits need for ICU in COVID-19 patients (Reuters)
• Brazil's Bolsonaro says his government will not buy China's Sinovac vaccine (Reuters)
• Chinese city to offer COVID-19 vaccine candidate as emergency use expands (Reuters)
• Deaths after flu shots in South Korea fan fears, but authorities find no link (Reuters)
• GSK to launch late-stage testing of syncytial virus vaccine (Reuters)
• Novartis to pursue SMA drug branaplam in Huntington's disease (Reuters) (Endpoints)

• COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA (Pink Sheet)
• Rheumatoid arthritis drug tocilizumab advances as a COVID treatment, as other regimens fall back, studies show (USA Today)
• NIH chief: Trump has not met with White House COVID-19 task force in 'quite some time' (The Hill)
• Public health experts push vaccine makers, HHS to release Covid-19 trial protocols (STAT)
• Pfizer could haul in $3.5B in 2021 from COVID-19 vaccine: analyst (Fierce) (Endpoints)
• The FDA’s Evolving COVID-19 Emergency Use Authorizations: How The Convalescent Plasma Authorization Can Inform Future Vaccine And Therapeutic EUAs (Health Affairs)
• Upcoming COVID Vaccines Cmte. May Be More For Public Education Than Advising US FDA (Pink Sheet)
• Venezuela plans to use Russian and Chinese coronavirus vaccines (Reuters)
• The Good, The Bad And The Ugly Of COVID-19 Vaccine Manufacturing Technology Platforms (Pink Sheet)

• A pivotal FDA meeting on Biogen’s Alzheimer’s treatment is near. Here’s what you need to know (STAT)
• Biogen spotlights a pair of painful pipeline setbacks as aducanumab showdown looms at the FDA (Endpoints)
• Biden looks to Germany for answers on how to tackle high US drug prices: analyst (Fierce)
• Digital Pharma Is a Major Cultural Change (GEN)
• Inspection Interviews: Dutch Official Addresses Frustrations And Misconceptions (Pink Sheet)
• CRISPR Therapeutics’ CAR-T treatment shows encouraging results, but one death is tied to therapy (STAT)
• Americans Took Prevagen for Years—as the FDA Questioned Its Safety (Wired)
• Little Zosano takes another beating as the FDA slaps down their application for a migraine patch (Endpoints)
• GlaxoSmithKline's vaccines group aims for a first as it kicks off PhIII RSV studies (Endpoints)
• Unfazed by PhII miss, Roche ushers Prothena's Parkinson's drug into late-stage trial — a $60M move (Endpoints)
• UC San Diego spinout awarded up to $15M for nanosponge designed to soak up sepsis-causing toxins (Endpoints)
• SparingVision raises $52M to kick off long journey for a next-gen gene therapy that goes much, much broader than Luxturna (Endpoints)
• Looking to repurpose an old drug to treat irregular heartbeats, InCarda raises $30M in first Series C close (Endpoints)

• AdvaMed seeks regulatory clarity on FDA's new digital health center (MedtechDive)
• Medtronic's Intellis spinal cord stimulator shows back pain relief at one-year mark (Fierce)
• FDA floats framework to message cybersecurity threats to patients (MedtechDive)
• One pandemic, $2 billion, 3 months: Top COVID-19 player Thermo Fisher posts hefty Q3 revenue (Fierce)
• Robotic surgery startups help drive Q3 medical device funding over $5B, an all-time high (MedtechDive)
• CMS coverage draft shuns 1st-to-market colorectal cancer blood test, outlines path for Exact, Guardant (MedtechDive)
• Siemens Healthineers To Spend €160M Building R&D And Manufacturing Hub In India (MedtechInsight)

• Questions Raised By FDA's New Lab Test Policy (Law360)
• Sanofi Wants Antitrust Claims Over Insulin Pen Pared Down (Law360)
• Daiichi Faces Patent Suit Over New Breast Cancer Drug (Law360)
• DC Circ. Won't Rethink HHS Cuts To Medicare Drug Program (Law360)