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March 12, 2020
by Michael Mezher

Recon: House to Vote on Coronavirus Bill; Qiagen Boosts Production of Coronavirus Test Materials

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House slow downs coronavirus bill to consider Trump administration proposals (Reuters) (NYTimes)
  • Trump stops Europe flights, China says coronavirus outbreak may end by June (Reuters) (CNN)
  • Pence defends coronavirus travel ban, says US cases to rise (Reuters)
  • Trump says trade will not be affected by US travel restrictions on Europe (Reuters)
  • Trump’s Payroll Tax Cut Would Dwarf the 2008 Bank Bailout (NYTimes)
  • White House told federal health agency to classify coronavirus deliberations – sources (Reuters)
  • Kymera announces $102 million in new funding to develop treatments for diseases such as blood cancers (STAT) (Endpoints)
  • A biotech tests Wall Street's roiled waters and comes away with a $75M IPO haul (Endpoints)
  • Lilly, Boehringer's Jardiance nabs speedy FDA review in kidney disease (Fierce) (Press)
  • Lilly joins new Medicare scheme to reduce insulin prices (PMLive)
  • How Coronavirus Is Affecting The US Pharmaceutical Supply (NPR)
In Focus: International
  • WHO's Tedros urges world to 'double down' against virus pandemic (Reuters 1, 2)
  • Qiagen boosting production of chemical needed to test for coronavirus (Reuters)
  • Danish regulator eyes sanctions against trial sponsors that fail to post results (STAT)
  • AZ’s comeback drug cediranib stumbles in phase 3 trial  (PMLive) (Endpoints) (Press)
  • Teva's Ajovy scores backing from England's cost watchdogs (Fierce)
  • Keytruda rejected for NHS use for kidney cancer, will be removed from the Cancer Drugs Fund (Pharmafile)
  • UK Research and development investment to rise to record £22bn (Financial Times)
  • Key EU notified body meeting goes on, virtually (MedtechDive)
Coronavirus Outbreak
  • Human trials testing coronavirus vaccine could begin ‘within a few weeks,’ top US health official says (CNBC) (STAT)
  • Here’s the Biggest Thing to Worry About With Coronavirus (NYTimes)
  • 'Dr Tedros', the WHO chief leading the fight against the pandemic (Reuters)
  • Coronavirus probe at California nursing home slowed by shortage of test kits (Reuters)
  • California bans mass gatherings to slow spread of coronavirus (Reuters)
  • Many private labs want to do coronavirus tests. But they're still facing obstacles and delays. (NBC)
  • UK scientists not recommending U.S.-style travel ban: PM's spokesman (Reuters)
  • Confirmed Dutch coronavirus infections rise 22% to 614: health authorities (Reuters)
  • Italy toughens coronavirus lockdown after death toll soars (Reuters)
  • Three Britons have coronavirus on cruise on Cambodia's Mekong (Reuters)
  • Spain's coronavirus outbreak death toll rises to 84 from vs 47 on Wednesday (Reuters)
  • Iran asks IMF for $5 billion emergency funding to fight coronavirus (Reuters)
  • Death toll in Iran from coronavirus reaches 429: health official (Reuters)
  • Number of coronavirus deaths in Britain rises to eight (Reuters)
  • Ireland reports first coronavirus death, nine more cases (Reuters)
  • South Korea tries to contain smaller outbreaks as new coronavirus cases slow (Reuters)
  • France's coronavirus death toll close to 50, new restrictions imposed (Reuters)
  • Cuba confirms first coronavirus cases, urges citizens to make own masks (Reuters)
  • Guyana confirms first case of coronavirus in woman who returned from US (Reuters)
  • Germany reports more than 2,000 coronavirus cases: Johns Hopkins University (Reuters)
  • Bolivia coronavirus patient turned away from hospitals; election rallies suspended (Reuters)
  • Egypt's confirmed coronavirus cases increase to 67 (Reuters)
  • Austria reports first coronavirus death, a 69-year-old who visited Italy (Reuters)
  • Costa Rica reports 22 coronavirus cases, nearly double prior tally (Reuters)
  • As the coronavirus pandemic continues to rattle the world, biopharma braces for a few new shocks to the system (Endpoints)
  • House Oversight committee continues hearing on coronavirus preparedness and response (CNBC)
  • Congress shuts down Capitol to the public, White House cancels tours amid coronavirus pandemic (CNBC)
  • ECB surprises markets by not cutting rates, but announces stimulus to fight coronavirus impact (CNBC)
  • Second US senator closes Washington office amid coronavirus outbreak (Reuters)
  • First US hospital chain to treat coronavirus considers treating patients in ‘tents outside’ (CNBC)
  • Senators Warren and Murray Urge NIH and FDA to Incorporate the Needs of Pregnant People and Other Underrepresented Populations as Companies Develop Vaccines and Therapeutics for COVID-19 (Warren)
  • Coronavirus Test From GenMark Diagnostics Submitted to FDA for Emergency Use Authorization (GenomeWeb)
  • Should I Quarantine Because of Coronavirus? It Depends on Who You Ask. (ProPublica)
  • Coronavirus on the high seas: Why the U.S. can't touch cruise lines (Politico  )
Pharmaceuticals & Biotechnology
  • How Big Pharma Grew Addicted to Big Profits (NYTimes)
  • $1.3 billion per drug? (Nature)
  • Priority review vouchers miss the policy mark (Nature)
  • Interchangeable Insulins — New Pathways for Safe, Effective, Affordable Diabetes Therapy (NEJM)
  • Newer anti-HIV drugs safest, most effective during pregnancy (NIH)
  • New drugs are costly and unmet need is growing (The Economist)
  • Pharmacogenomics can show what your body makes of a drug (The Economist)
  • Microbial signatures in the blood could offer new avenue for liquid biopsies to detect cancer (STAT)
  • A one-time biotech unicorn gets slaughtered as lead program is scrapped, highlighting lingering trouble (Endpoints)
  • CureVac founder back at the helm; Merck extends immunomodulatory drug discovery program with Sutro (Endpoints)
  • After a year of big advances, AstraZeneca CEO Pascal Soriot takes home a major-league pay package (Endpoints)
  • How Gilead's blood cancer med Zydelig might also address triple-negative breast cancer (Fierce)
  • Vir’s George Scangos teams up with his former colleagues at Biogen to press fast-forward on antibody programs for coronavirus (Endpoints)
  • Was it something he said? Biotech CEO who met Trump this month exits without a word (Fierce)
  • Harbour BioMed nets $75M in Series B+ as first global trial gets underway (Endpoints)
  • Flagship merges two startups to build a $220M Repertoire of T cell tech, therapies (Endpoints)
  • Stanford stem cell pioneer nets $194M from Gilead-Forty Seven buyout (Endpoints)
  • Back to the drawing board for triple-negative breast cancer targets, researchers propose new combo approach (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections (Press)
  • New Clinical Study Data for Gilead’s Investigational HIV-1 Capsid Inhibitor GS-6207 Presented at CROI 2020 (Press)
  • Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial (Press)
  • PharmaCyte Biotech Addresses Submission of IND and Recent FDA-Required Testing (Press)
  • Virometix Announces Initiation of Phase 1 Clinical Trial With Its V-306 Vaccine Candidate (Press)
Medical Devices
  • Patient Engagement Forum Postponed (MDIC)
  • FDA issues Class I recall for Medtronic's HeartWare HVAD after patient death (MedtechDive)
  • ANVISA will implement new rules for medical device modifications in Brazil (Emergo)
  • OSSIO Receives FDA 510(k) Clearance for OSSIOfiber® Hammertoe Fixation System (Press)
  • Proov gets FDA nod for its at-home ovulation testing kit (mobihealthnews)
US: Assorted & Government
  • Hospitals turn to big tech companies to store and analyze their data — leaving patients in the dark on privacy protections (STAT) (NYTimes)
  • The FTC’s Teami Case: “All [the FTC] really wanna see is the money.” (FDA Law Blog)
  • A Couple of Things (Drug & Device Law)
  • District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases (Big Molecule Watch)
  • 21 Related Teva Price-Fixing Suits Consolidated (Law360-$)
  • Taro Escapes Off-Label Use Claims For Heart Drug (Law360-$)
  • “Compound King” Convicted in $21 Million Health Care Fraud Scheme (DOJ)
  • Fired cancer scientist says ‘good people are being crushed’ by overzealous probes into possible Chinese ties (Science Mag)
Europe
  • NICE, Health Technology Wales announce new partnership (PharmaTimes)
  • UK MHRA: COVID-19 To Spark Rise In Clinical Trial-Related Deviations (Pink Sheet-$)
  • UK Assesses Firms’ Coronavirus Resilience (Pink Sheet-$)
  • European Commission approves Venclyxto plus Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia (Press)
  • Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation (MHRA)
India
  • Covid-19: India needs to get into vaccine production in a big way, says Kiran Mazumdar-Shaw (Economic Times)
  • ICMR’s 30 influenza sites to test for Covid-19 cases (Economic Times)
  • Covid-19: No near-term threat to pharma cos' credit profile (Economic Times)
Canada
  • CF Canada pleads with Ottawa to pave way for access to life-saving drugs (CTVNews)
General Health & Other Interesting Articles
  • Omega-3s Show No Overall Benefits for Heart Health or Cancer Prevention (NYTimes)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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