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20th April 2020
by Michael Mezher

Recon: Novartis plans phase 3 trial of hydroxychloroquine; FDA approves Incyte’s Pemazyre for cholangiocarcinoma

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Congress, Trump administration close to deal on new aid package (Politico) (Reuters) (CNBC)
  • White House still scrambling to cover virus treatment for the uninsured (Politico)
  • A watchdog out of Trump's grasp unleashes wave of coronavirus audits (Politico)
  • Poll: Majority fear coronavirus restrictions will be lifted too soon (Politico)
  • Trump’s Wild West approach to virus cure-alls is a game-changer for drugmakers (Politico)
  • US Coronavirus Cases Near 760,000 as New York Plans to Start Antibody Tests (WSJ) (Reuters)
  • Antibody Test, Seen as Key to Reopening Country, Does Not Yet Deliver (NYTimes) (Axios)
  • CDC Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say (NYTimes) (Washington Post)
  • Coronavirus Testing Hampered by Disarray, Shortages, Backlogs (WSJ)
  • An FDA tool for hastening approvals is not very useful for breast cancer drugs (STAT)
  • Bristol Myers Says Opdivo Performs Well in Kidney, Lung Cancer Trials (NYTimes) (STAT) (Press)
  • Novartis steps up to study of hydroxychloroquine in Covid-19 (STAT) (Reuters) (Press)
  • FDA OKs Incyte’s Pemazyre as first targeted drug for cholangiocarcinoma (PMLive) (Endpoints) (FDA)
  • Amid Pandemic, FDA Seizes Cheaper Drugs From Canada (KHN)
In Focus: International
  • Rift opens over European coronavirus contact tracing apps (Reuters)
  • Europe reaches grim milestone, surpasses 100,000 coronavirus deaths (NBC)
  • G20 health ministers acknowledge health systems' vulnerability to pandemics: statement (Reuters)
  • UK to trial use of COVID-19 survivors' blood plasma for treatment (Reuters)
  • Exclusive: In Russia, a black market for HIV drug to try on coronavirus (Reuters)
  • Novartis buys digital ‘lazy eye’ treatment company Amblyotech (PMLive) (Endpoints) (Press)
  • Africa can still contain COVID-19 outbreak: WHO (Reuters)
  • Escape of Ebola patient in Congo sparks fear of further infection (Reuters)
  • WHO advisory body releases malaria eradication report (WHO)
Coronavirus Pandemic
  • The Coronavirus in America: The Year Ahead (NYTimes)
  • An Overlooked, Possibly Fatal Coronavirus Crisis: A Dire Need for Kidney Dialysis (NYTimes)
  • Hydroxychloroquine and Other Autoimmune Drugs Don’t Fully Protect Against Coronavirus, Early Data Suggest (WSJ)
  • Former FDA commissioner: China may get to a vaccine first (The Hill)
  • GM dispatches first batch of ventilators for COVID-19 patients (Reuters)
  • ITU-WHO Joint Statement: Unleashing information technology to defeat COVID-19 (WHO)
  • Everything we know about coronavirus immunity and antibodies — and plenty we still don’t (STAT)
  • Internal Documents Show Federal Agencies Supported the WHO Before Trump Was Against It (ProPublica)
  • Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020 (FDA)
  • Alexion to study rare blood-disorder drug in severe COVID-19 patients (Reuters)
  • Trump invokes DPA for testing swabs, weeks after reported shortages (Politico) (CNBC)
  • Elon Musk says he sent ventilators to California hospitals, they say they got something else instead (CNN) (The Hill)
  • Good News on the Coronavirus/Angiotensin Connection (In The Pipeline)
  • Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 (FDA)
  • US to start antibody testing of sailors on coronavirus-hit aircraft carrier (Reuters)
  • New York Governor sounds optimistic note as coronavirus numbers improve (Reuters)
  • French coronavirus deaths top 19,000, though increase slows (Reuters)
  • South Korea relaxes some social distancing rules as new virus cases fall (Reuters)
  • Canadian coronavirus data trending in right direction, shutdowns to continue: PM (Reuters)
Pharma & Biotech
  • After declining for years, anxiety and insomnia prescriptions start to climb (STAT)
  • Managing a pharma company during three crises: lessons learned for Covid-19 (STAT)
  • Esperion strikes Japan deal for 'goldilocks' cholestrol drug, bags $60M cash as pandemic forces virtual US rollout (Endpoints)
  • It’s not the money: The latest Fortune list of the top 10 biopharmas to work for includes a few surprise players (Endpoints)
  • AbbVie Announces Extension of Expiration Date for Exchange Offers for Allergan Notes (Press)
  • Pivotal data suggest clean safety profile, potency could set Idorsia's sleeping pill apart (Endpoints)
  • Sofinnova Telethon Fund backs Naldini's gene therapy biotech; ORIC prices $75M IPO (Endpoints)
  • Boosting delivery of rare disease therapies: the IRDiRC Orphan Drug Development Guidebook (Nature)
  • US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time (Press)
Medtech
  • Fears of Ventilator Shortage Unleash a Wave of Innovations (NYTimes)
  • AdvaMed CEO Says Some Top Agenda Items For the Year Are ‘Taking A Back Seat’ To Address COVID-19 (MedtechInsight)
  • Pandemic drives US da Vinci robot use down 65% (MedtechDive)
  • Despite FDA Guidance, CDx Providers Still Have Challenges in Seeking 'Therapeutic Group' Indication (Precision Oncology News)
Government & Regulatory
  • Opioid MDL Needs New Pharmacy Bellwether, Judge Says (Law360)
  • A New Breed Of Antitrust Challenges To FDA's Orange Book (Law360)
  • FBI agents raid Ocean Springs pharmaceutical company (Sun Herald)
  • Class 4 Medicines Defect Information: Glaxosmithkline Consumer Healthcare (UK) Trading Limited, various products, EL(20)A/22 (MHRA)
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.