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)
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.
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