Recon: FDA approves Neurocrine’s add-on Parkinson’s drug; Trial of Sanofi’s Kevzara narrowed to critical COVID-19 patients

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

• Trial of Gilead's remdesivir running ahead of schedule, researcher says (Reuters)
• Regeneron, Sanofi to treat only 'critical' COVID-19 patients with arthritis drug (Reuters) (STAT) (Press)
• Regeneron and Sanofi immunotherapy extends survival in non-small cell lung cancer (STAT) (Press)
• Neurocrine gets US nod for Parkinson's therapy; COVID-19 delays launch (Reuters)
• FDA pushed through scores of inaccurate antibody tests without agency review (Politico) (NPR)
• Ousting vaccine chief ‘is going to set us back,’ former FDA head says (Politico)
• Supreme Court rules government must pay billions to Obamacare insurers (Politico) (Reuters)
• Prescriptions Surged as Trump Praised Drugs in Coronavirus Fight (NYTimes)
• Woodcock on authorizing emergency use for hydroxychloroquine: ‘We did the best we could’ (STAT)
• Congressional Watchdog To Review Federal Coronavirus Response (NPR)
• Gilead sues U.S., claiming it ‘secretly’ obtained patents on HIV research that led to Truvada (STAT)
• Custom cell therapy shrinks lung tumors, seeding hope for a new cancer treatment (STAT)

In Focus: International

• Countries, companies risk billions in race for coronavirus vaccine (Reuters)
• Drugmakers urged to collaborate on coronavirus vaccine (Financial Times)
• Global coronavirus death toll hits 200,000 (Reuters)
• Japan to approve remdesivir for coronavirus patients in May (Kyodo) (Fierce)
• G20 launches initiative for health tools needed to combat the coronavirus (Reuters)
• "No evidence" that recovered COVID-19 patients cannot be reinfected: WHO (Reuters)
• China eases restrictions on exports of some coronavirus equipment (Reuters)
• Novacyt signs coronavirus test supply contract with UK government (Reuters)
• Health Canada cautions on use of malaria drugs to treat COVID-19 (Reuters)
• US, China researchers collaborate despite government battles (Financial Times)
• Italy picks U.S. firm Abbott Laboratories to supply coronavirus blood tests (Reuters)
• Chile to push ahead with coronavirus 'release certificates' despite WHO warning (Reuters)

Coronavirus Pandemic

• Gottlieb: America Needs to Win the Coronavirus Vaccine Race (WSJ)
• CDC Adds 6 Symptoms To Its COVID-19 List (NPR)
• Young and middle-aged people, barely sick with covid-19, are dying of strokes (Washington Post)
• Tracking the hunt for coronavirus drugs and vaccines (Politico)
• France limits nicotine sales after coronavirus study (Financial Times)
• UK will host a global vaccines summit on June 4: UK foreign minister Raab (Reuters)
• How overly optimistic modeling distorted Trump team’s coronavirus response (Politico)
• Can Antibody Tests Help End the Coronavirus Pandemic? (NYTimes)
• New York clinical trial quietly tests heartburn remedy against coronavirus (Science)
• Can Estrogen and Other Sex Hormones Help Men Survive Covid-19? (NYTimes)
• UK to start trials on whether plasma could help COVID-19 patients (Reuters)
• US FDA Preparing For Less-Than-Ideal COVID-19 Vaccine Studies (Pink Sheet)
• Indian medical body asks states to stop using COVID-19 test kits from two Chinese firms (Reuters)
• China's Sinovac amps up COVID-19 vaccine work with new facility backed by Chinese government (Fierce)
• HHS Prepares To Procure Hard-To-Find Ventilator-Associated Medicines For COVID-19 Patients (Pink Sheet)
• Canada notifies WTO on Bill C-13 to facilitate compulsory licensing in the COVID-19 response (KEO)
• CVS and UPS will use drones to deliver prescriptions in a retirement community amid coronavirus outbreak (CNBC)
• New Zealand Claims a Victory Over Coronavirus, But Doubts Persist (WSJ)
• China to keep coronavirus tests focused, stops short of wider testing (Reuters)
• Britain passes 'terrible' milestone of 20,000 coronavirus deaths (Reuters)
• UK to trial drones to deliver medical supplies (Reuters)
• Infectious Diseases Society of America Guidelines on Infection Prevention in Patients with Suspected or Known COVID-19 (IDSA)
• Coronavirus (COVID-19) Update: Daily Roundup April 24, 2020 (FDA)

Pharma & Biotech

• FDA clears label update for AZ' Lokelma (PharmaTimes)
• RNA therapeutics on the rise (Nature)
• The Covid-19 pandemic could mark the beginning of the ‘biotech century’ (STAT)
• New type of checkpoint inhibitor offers early promise against tumors, but will it last? (STAT)
• Compugen sees 'encouraging signals' from early-stage cancer trial (Reuters)
• Experts Concerned Over U.S. Dependence On Foreign Drug Manufacturers (NPR)
• Boehringer Ingelheim VC backs plan to send GMO bacteria after tumors (Endpoints)
• Axsome shares rocket up on a surprise win for late-stage Alzheimer’s agitation study — but this is no easy layup (Endpoints)
• #AACR20: Early data suggest Novartis' Incyte-discovered MET inhibitor helps lung cancer patients with brain lesions (Endpoints)
• #AACR20 roundup: Tecentriq/Xtandi combo fails to show OS benefit, halting Roche's PD-L1 push into prostate cancer (Endpoints)
• #AACR20: Iovance revels in promising lung cancer data out of Moffitt as TIL therapy triggers 2 complete responses (Endpoints)
• Nimbus founder Rosana Kapeller has a new company, with $50M and an eye on the ‘repeatome’ (Endpoints)
• Mushroom magic draws $80M injection for London-based mental health startup (Endpoints)
• US approves Chinese drug maker Shanghai Green Valley’s Alzheimer’s therapy for large-scale clinical trials (SCMP)
• Running Rehab: Managing Talent In A Pandemic (LifeSciVC)
• ‘GI tract outside the body’ tests how well oral drugs are absorbed (STAT)
• ICER Enhanced Patient Engagement Program Will Be Led By Former Biopharma Exec (Pink Sheet)
• Drug Makers Should Join in “Concerted National Effort” to Propel Regulatory Harmonization in Asia: Ex-PMDA Chair (PharmaJapan)
• Prospective Grant of an Exclusive Patent License: Development, Production, and Commercialization of a Seasonal Influenza Vaccine (FDA)
• Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations (Press)

Medtech

• Edwards sees 14% sales bump in Q1, but near-term TAVR prospects grim (MedtechDive)
• Essure: FDA Grants Bayer Variance From MDR Reporting For Certain Adverse Events Found On Social Media (MedtechInsight)
• AACR: Grail substudy shows its cancer blood test could help focus oncologists' diagnostic workups (Fierce)

Government & Regulatory

• Ethicon Escapes Covidien Patent Claims In Device Case (Law360)
• Fed. Circ. Affirms Illumina's $27M Patent Win Over Ariosa (Law360)
• Indivior Gets Amicus Cut From 3rd Circ. Suboxone Appeal (Law360)
• No FDCA-Based Negligence Per Se in Texas (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.