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March 10, 2020
by Michael Mezher

Recon: Trump Administration Eyes COVID-19 Stimulus; FDA Approves Boehringer’s Ofev for Interstitial Lung Diseases

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump seeks 'big' stimulus steps but aides are skeptical (Politico) (Reuters)
  • Trump has not been tested for coronavirus - White House (Reuters)
  • Coronavirus Containment Chance Missed, US Aims to Blunt Impact (Bloomberg) (Reuters) (STAT)
  • Number of Congressional Lawmakers in Self-Quarantine Due to Coronavirus Climbs to Six (WSJ) (Reuters)
  • Biden and Sanders far apart on drug pricing (Politico)
  • Acceleron ditches midstage drug after flop (Fierce) (Endpoints) (Press)
  • FDA clears wider use for Boehringer’s Ofev in lung disease (PMLive) (Fierce) (FDA)
  • Days after wielding the ax, Unum hit with clinical hold, again (Fierce) (Endpoints)
  • New brand-name HIV-prevention pill not worth the added cost: study (Reuters) (STAT)
  • Pelosi, Seeking to Insulate House Majority, Presses Plan to Lower Health Costs (NYTimes)
  • Debates over biosimilar uptake notwithstanding, sales growth should accelerate by 2024 (STAT)
  • Clinical research company sued over stolen trade secrets after employee filmed dogs used in experiments (STAT) (Law360-$)
In Focus: International
  • Threat of coronavirus pandemic 'has become very real': WHO's Tedros (Reuters)
  • Japan announces $4 billion coronavirus package, not yet eyeing extra budget (Reuters)
  • Italy wakes up to deserted streets in unprecedented coronavirus lockdown (Reuters)
  • Italy's coronavirus lockdown likely unsustainable, ineffective (Reuters)
  • Italy to boost coronavirus measures to help households, small firms (Reuters)
  • Celltrion applies for European approval of Humira biosimilar (The Korea Herald)
  • Japan’s 2020 Price Revision Hits Major Drugs with Double-Digit Slashes: Top 5 Product Survey (PharmaJapan)
  • Bristol Myers backs a European VC's record-setting biotech venture fund, which tops out at $600M (Endpoints)
  • CMA Sent Back To The Drawing Board In £89M Pfizer Case (Law360-$) (CMA)
  • GSK consumer hiving off Canada plant with 400 workers to Taiwan CDMO (Fierce)
  • Gene Therapy For Severe Retinitis Pigmentosa Secures EMA PRIME Status (Pink Sheet-$)
  • Shionogi launches thrombocytopenia treatment Mulpleo in the UK (PMLive)
  • Poor countries struggle to get the insulin they need (Financial Times)
  • EFPIA response to the publication of the EU Industrial Strategy (EFPIA)
  • Epidemic response group ups coronavirus vaccine funding to $23.7 million (Reuters)
Coronavirus Outbreak
  • Some Hospitals Are Close to Running Out of Crucial Masks for Coronavirus (NYTimes)
  • Seattle-area nursing home unable to test 65 workers with COVID-19 symptoms (Reuters)
  • Head of EU parliament Sassoli in self-isolation as precaution (Reuters)
  • It begins: California county bans mass gatherings as coronavirus spreads (Politico)
  • Oregon’s supply of coronavirus tests could run out Wednesday without infusion of kits from feds (The Oregonian)
  • How Biogen’s Strategy Meeting Spread Coronavirus in Massachusetts and Beyond (WSJ) (Endpoints)
  • $125M effort to find coronavirus drugs started by Gates Foundation, Wellcome, and Mastercard (STAT)
  • The coronavirus outbreak has left medical supplies in short supply. Is the nation’s emergency stockpile ready to help? (STAT)
  • You could get paid $1,100 to test the first potential coronavirus vaccine (Business Insider)
  • If Covid-19 gets bad, triage will be needed. Are we ready for that? (STAT)
  • Iran coronavirus deaths reach 291, cases at more than 8,000: health ministry (Reuters)
  • Xi visits Wuhan, signaling tide turning in China's coronavirus battle (Reuters)
  • Covid-19: Pharma companies ask Indian Govt to lift API's export restrictions (Economic Times)
  • Lower trend in new coronavirus cases raises glimmer of hope in South Korea (Reuters)
  • Canada reports first coronavirus death as number of infected climbs (Reuters)
  • Germany, with over 1,100 cases, reports first two coronavirus deaths (Reuters)
  • French coronavirus death toll jumps by five to total of 30 (Reuters)
  • Ireland announces 3 billion euro package to fight coronavirus (Reuters)
  • Sixth person dies in United Kingdom from coronavirus (Reuters)
  • Indonesia confirms eight new coronavirus cases, taking total to 27 (Reuters)
  • Lebanon records first death from coronavirus: local media (Reuters)
  • Cyprus' largest hospital suspends admissions after heart surgeon diagnosed with coronavirus (Reuters)
  • Mongolia confirms its first coronavirus case in French worker (Reuters)
  • Brunei reports first coronavirus cases (Reuters)
  • Burkina Faso confirms first cases of coronavirus (Reuters)
  • Morocco reports first coronavirus death: health ministry (Reuters)
  • Democratic Republic of Congo confirms first coronavirus case (Reuters)
  • Saudi Arabia detects another five cases of new coronavirus: state TV (Reuters)
  • CVS Health offers free home delivery of prescription drugs amid virus outbreak (Reuters)
  • Pence to meet Tuesday with health insurance representatives (Reuters)
  • Two passengers tested for suspected coronavirus on Marseille cruise ship (Reuters)
  • Cheering cruise passengers return to California; now comes coronavirus quarantine (Reuters)
  • PharmaMar Group's GENOMICA diagnostic kits for COVID-19 coronavirus receive CE conformity marking (Press)
  • Hologic gets US funding for coronavirus test kit (Reuters) (GenomeWeb)
Pharmaceuticals & Biotechnology
  • A Call to Arms: Under Attack, Pro-Vaccine Doctors Fight Back (NYTimes)
  • More choice means higher prices for American diabetics (Financial Times)
  • Members of congress urge FDA to improve clinical trials process for ALS patients (Letter)
  • Kala to Take Another Shot at FDA Approval With New Dry Eye Drug Data (Xconomy)
  • PhRMA submits comments on FDA’s proposed rule on drug importation (PhRMA)
  • Global biopharma supply chain holding together for now: Vertex, Lilly, Recipharm and others update patients (Fierce)
  • Tapping the therapeutic potential of the innate immune system (Nature)
  • Bias and stereotyping may limit minority participation in clinical trials (Reuters)
  • Exclusive: Syneos Health exploring a sale: sources (Reuters)
  • Alzheimer’s Drug Coverage Issues Move To Forefront With Biogen’s Plan To Seek Approval (Pink Sheet-$)
  • NIH study finds lower concentration of PrEP drug in pregnant teens & young women (NIH)
  • Drug-delivery technology leads to sustained HIV antibody production in NIH study (NIH)
  • Alzheimer’s Biomarker Development Hampered By ‘Limited’ Commercial Incentives (Pink Sheet-$)
  • Versant plots Basel expansion as incubator hits full capacity (Fierce)
  • Israel’s Arkin Holdings launches second biotech fund, worth $140 million (Endpoints)
  • Targeting CAR T cells to glioblastoma (Nature)
  • NEW: The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers (Drug Channels)
  • J&J's favorite CAR-T developer, currently owned by a Chinese CRO, is laying the groundwork for US IPO (Endpoints)
  • I thought I understood the Sacklers’ opioid empire. Startling documents I found showed I was wrong (STAT)
  • To arm the immune system for sustained attack against HIV, NIH scientists take to viral vectors (Endpoints)
  • Versant woos MorphoSys' ex-CSO to its booming discovery engine, with big plans for new startups (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Takeda Provides Update on TOURMALINE-MM2 Phase 3 Trial (Press)
Medical Devices
  • Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (FDA)
  • Insightec nets up to $150M for incisionless brain surgery tech (MedtechDive)
  • LivaNova lands CE Mark for depression neurostimulation treatment (MassDevice)
  • Kinepict Health wins FDA nod for imaging tech (MassDevice)
  • Cadent Therapeutics Announces FDA Clearance of IND Application and Dosing of Subjects of CAD-9303 for Schizophrenia (Press)
  • Class 1 Device Recall HeartWare HVAD System Battery Charger AC Adapter (FDA)
US: Assorted & Government
  • Coronavirus Brings a New Legislative Push for Paid Sick Leave (Reuters)
  • FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market (FDA)
  • ‘Unleash that data’: Medicare chief promotes freer exchange of medical records, highlights efforts to protect privacy (STAT)
  • Seventh Circuit Finds Albrecht Did Not Create a New Rule of Preemption Law (Drug & Device Law)
  • Top Blockchain Considerations For Health, Life Sciences Cos. (Law360-$)
  • Surescripts Wants DC Circ. To Review FTC Antitrust Suit (Law360-$)
  • United Opens New Front In Celgene Monopoly Fight (Law360-$)
  • FDA Defends Approval Of Genetically Engineered Salmon (Law360-$)
Upcoming Meetings & Events Europe
  • Myovant seeks EMA approval in uterine fibroids (PharmaLetter-$)
Australia
  • Update to listed medicine ingredients in March 2020 (TGA)
  • TGA response to coronavirus (COVID-19) (TGA)
Other International
  • South Africa Explains How To Evaluate Samples Collected In Clinical Trials (Pink Sheet-$)
General Health & Other Interesting Articles 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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