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Regulatory Focus™ > News Articles > 2020 > 3 > Recon: House Passes $2T Stimulus, Heads to Trump for Signature; Vertex Joins List of Drugmakers Halt

Recon: House Passes $2T Stimulus, Heads to Trump for Signature; Vertex Joins List of Drugmakers Halting New Studies

Posted 27 March 2020 | By Michael Mezher 

Recon: House Passes $2T Stimulus, Heads to Trump for Signature; Vertex Joins List of Drugmakers Halting New Studies

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House passes historic $2 trillion stimulus despite objections from GOP lawmaker (CNN) (WSJ)
  • Irate House lawmakers scramble back to DC amid fears of coronavirus vote delay (Politico) (Reuters)
  • The US Now Leads the World in Confirmed Coronavirus Cases (NYTimes)
  • After Considering $1 Billion Price Tag for Ventilators, White House Has Second Thoughts (NYTimes)
  • Could Obamacare save jobless Americans from coronavirus? (Politico)
  • Internal Emails Show How Chaos at the CDC Slowed the Early Response to Coronavirus (ProPublica)
  • Trump allies fear a premature victory lap against coronavirus (Politico)
  • Orphan status for coronavirus drug caught health officials off guard (Axios)
  • Sanofi, Translate Bio to work on COVID-19 vaccine (Reuters) (Endpoints) (Press)
  • A Spur to the Biotech Century Ahead (WSJ)
  • Ex-FDA commissioner says US coronavirus epidemic likely to be national (The Hill)
  • FDA moots virtual AdComms but delays GSK, Intercept meetings (Fierce)
  • Despite another delay, Intercept says its NASH drug remains on track (BioPharmaDive) (Fierce)
  • Drugmaker Vertex to delay new clinical studies due to coronavirus (Reuters) (Endpoints)
  • US government has 1.5 million expired N95 masks sitting in an Indiana warehouse (Washington Post)
In Focus: International
  • Study sees 'severe and acute' emergency for world in coronavirus pandemic (Reuters)
  • Mapping the Coronavirus (Bloomberg)
  • WHO chief urges G20 to boost production of protective gear against virus (Reuters)
  • Italy’s coronavirus death toll tops 8,000 as EU leaders fail to present new stimulus (CNBC)
  • COVID-19: Parliament approves crucial EU support measures (European Parliament)
  • Italy suffers setback to hopes its coronavirus epidemic might be in retreat (Reuters)
  • Roche urged to share info with Dutch corona test labs: FTM (DutchNews)
  • Patents on new products could result in high prices and keep medicines and vaccines out of reach for people everywhere (MSF)
  • South Korean test kit makers swamped as coronavirus cases explode in US, Europe (Reuters)
  • A Singapore VC raises $200M for a new round, but will Covid-19 prevent it from raising the rest? (Endpoints)
  • UK pledges 210 million pounds to global push for coronavirus vaccine (Reuters) (Fierce)
  • Roche strikes a deal with Britain to increase coronavirus testing: Channel 4 news (Reuters)
  • With U.S. hit by virus, China courts Latin America with medical diplomacy (Reuters)
  • China to suspend entry of foreigners with visas, residence permits due to coronavirus (Reuters 1, 2)
  • Email mix-up causes Britain to miss EU ventilator buying scheme (Reuters 1, 2)
  • Boris Johnson, U.K. Prime Minister, Tests Positive for Coronavirus (NYTimes)
Coronavirus Outbreak
  • 'It’s a razor’s edge we’re walking': inside the race to develop a coronavirus vaccine (The Guardian)
  • Italian scientists investigate possible earlier emergence of coronavirus (Reuters)
  • Mystery In Wuhan: Recovered Coronavirus Patients Test Negative ... Then Positive (NPR)
  • Coronavirus Pandemic Delays Testing of New Drugs (WSJ)
  • Known Drugs Against the Coronovirus: Runner-Up Candidates (In the Pipeline)
  • Emory-discovered antiviral is poised for COVID-19 clinical trials (C&EN)
  • A.I. Versus the Coronavirus (NYTimes)
  • ‘Drug development is a long, long process’: pharma CEO in Italy sounds a note of caution on Covid-19 (STAT)
  • AGs Ask Feds To Allow Fetal Tissue Research For COVID-19 (Law360)
  • The Drug Trials of the Century (WSJ)
  • In Defense Of Coronavirus Testing Strategy, Administration Cited Retracted Study (NPR)
  • How Monoclonal Antibodies Might Prove Useful Against The Coronavirus (NPR)
  • How many Americans have coronavirus? New Reuters poll might offer a hint (Reuters)
  • The next frontier in coronavirus testing: Identifying the full scope of the pandemic, not just individual infections (STAT)
  • Blood Plasma From Survivors Will Be Given to Coronavirus Patients (NYTimes)
  • New Orleans Faces a Virus Nightmare, and Mardi Gras May Be Why (NYTimes)
  • Trump downplays need for ventilators as New York begs to differ (Politico)
  • ‘The Other Option Is Death’: New York Starts Sharing of Ventilators (NYTimes)
  • Not So Fast Using CPAPs In Place Of Ventilators. They Could Spread The Coronavirus. (KHN)
  • Coronavirus could kill 81,000 in U.S., subside in June - Washington University analysis (Reuters)
  • Significance of Pangolin Viruses in Human Pandemic Remains Murky (NYTimes)
  • Trump says he will not cancel August Republican Convention (Reuters)
  • What if hydroxychloroquine doesn’t work? What if it does? Right now, we don’t know (STAT)
  • Prisma Health develops FDA-authorized 3D-printed device that lets a single ventilator treat four patients (TechCrunch)
  • Congress pumps up NSF program to fast-track COVID-19 research (Science)
  • Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines (FDA)
  • Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020 (FDA)
  • Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions (FDA)
  • Turkey struggles to ramp up tests as outbreak reaches critical phase (Reuters)
  • Paris hospitals near coronavirus breaking point (Reuters)
  • Chinese firm to replace exported coronavirus test kits deemed defective by Spain (Reuters)
  • Spain reports 769 new coronavirus deaths but says daily rise stabilizing (Reuters)
  • Iran's death toll from coronavirus rises to 2,378: Health Ministry (Reuters)
  • Fresh From Iran’s Coronavirus Zone, Now Moving Across Afghanistan (NYTimes)
  • Japan PM says lockdown of Tokyo would have severe impact on economy (Reuters)
  • Russian PM urges all citizens to stay at home, calls for tougher measures: Interfax (Reuters)
  • Russia says coronavirus cases surpass 1,000 in biggest daily rise (Reuters)
  • Number of coronavirus cases in Germany rises to 42,288: RKI (Reuters)
  • Germany takes in 47 coronavirus patients from Italy (Reuters)
  • Germany looks at tracking patients to rein in coronavirus – reports (Reuters)
  • UK to use firefighters to deliver food, collect bodies in coronavirus crisis (Reuters)
Pharmaceuticals & Biotechnology
  • Strategic Planning In Biotech During A Pandemic Crisis (LifeSciVC)
  • Biotech in the time of the coronavirus: With China returning to work, preclinical companies ramping back up (STAT)
  • Biotech’s balancing act amid Covid-19 delays (Evaluate)
  • Allergenic Products Advisory Committee; Cancellation of Meeting - DBV Technologies (FDA)
  • Could real-world evidence help shape the future of drug development? (STAT)
  • After 'initial shock,' generics supply chain likely to weather COVID-19 blows: analyst (Fierce)
  • Should Biogen's Spinraza for SMA be delayed amid COVID-19? No, say these parents (Fierce)
  • Bluebird bio pushes back commercial launch of Zynteglo due to COVID-19 (PMLive)
  • Struggling Unum execs are ready to consider a sale, merger or any deal that comes its way (Endpoints)
  • Scientific Wave Pushes CBER Into Brighter Light (Pink Sheet-$)
  • As share buybacks come under scrutiny, what's in store for the biopharma industry? (Endpoints)
  • Jim Robinson takes over the reins at Urovant; Carlos Campoy moves to CytomX (Endpoints)
  • VBL and its “gene therapy” cancer treatment are back — with a peek at PhIII potential (Endpoints)
  • Call for Submissions: Journal of Law and Biosciences, “Law and Ethics in the Time of a Global Pandemic” (Harvard Bill of Health)
  • Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children (Press)
  • CStone submits new drug application for the targeted therapy avapritinib in Taiwan for the treatment of adults with advanced PDGFRA exon 18 mutant gastrointestinal stromal tumor (Press)
Medical Devices
  • Modifications to the List of Recognized Standards (FDA)
  • What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19 (FDA Law Blog)
  • In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia (MedtechDive)
  • Small PAMA victory in aid package, but labs remain in 'untenable situation' (MedtechDive)
  • UnitedHealth says self-swabbing study spurred FDA coronavirus policy change (MedtechDive)
  • Continuing to make progress on human factors work during the COVID-19 pandemic (Emergo)
US: Assorted & Government
  • Inside The COVID-19 Bill: Breaking Down The Pharma Policy Provisions (Pink Sheet-$)
  • Drug Industry Perks Mostly Dropped From COVID-19 Bill, But A Big One Remains (Pink Sheet-$)
  • Senate stimulus plan includes $155 million for HIV care (NBC)
  • Genentech Says It Shouldn't Lose Patent Rights Over Error (Law360-$)
  • Ariad Exec's Spouse Can't Shake Insider Trading Conviction (Law360-$)
  • Abbott Wins Test Strip Suit After Supplier's Discovery Fraud (Law360-$)
  • Guest Post – Is Artificial Intelligence a “Product”? The Third Circuit Says, “No.” (Drug & Device Law)
  • Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 26 UPDATE (Patent Docs)
  • Grantee Institutions' Actions To Strengthen Policies in Response to Concerns Regarding Potential Foreign Influence on NIH-Funded Research (HHS OIG)
Europe
  • Antitrust: Joint statement by the European Competition Network (ECN) on application of competition law during the Corona crisis (ECN)
  • UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD (Pink Sheet-$)
  • EMA accepts Arvelle’s cenobamate MAA (PharmaTimes)
  • Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA (GenomeWeb)
Asia
  • Alvotech Enters Partnership for Commercializing Adalimumab Biosimilar in Asia-Pacific Markets (Big Molecule Watch)
  • Fosun Long March Gets Chinese Regulatory Approval for Coronavirus MDx Kit (GenomeWeb)
India
  • DGFT allows export of 13 restricted APIs & their formulations under advance licences (PharmaBiz)
  • COVID-19: NPPA asks states, UTs to ensure unobstructed movement of stock, manpower (Economic Times)
  • Lockdown will soon hit medicine supplies in the country: Chemists and Druggists lobby (Economic Times)
  • COVID-19 lockdown: Health Ministry allows doorstep delivery of essential medicines (Economic Times)
Canada
  • Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs (Health Canada)
Australia
  • Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines (TGA)
  • Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities (TGA)
  • Regulation of cleaners and disinfectants: Information for sponsors and manufacturers (TGA)
  • COVID-19 testing in Australia - information for health professionals (TGA)
  • Oxymed Australia Pty Ltd fined $63,000 for alleged advertising breaches (TGA)
Other International
  • Israel's Generic COVID-19 Drug Licensing Lacks Due Process (Law360)
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.
 
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