The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
Regulatory Focus™ > News Articles > 2020 > 3 > Recon: Senate Aims to Pass House Coronavirus Package; US Clinical Trial Delays Start Piling up

Recon: Senate Aims to Pass House Coronavirus Package; US Clinical Trial Delays Start Piling up

Posted 18 March 2020 | By Michael Mezher 

Recon: Senate Aims to Pass House Coronavirus Package; US Clinical Trial Delays Start Piling up

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Senate to pass coronavirus package as Treasury proposes emergency checks starting April 6 (Politico 1, 2)
  • Scoop: Bayer to donate potential coronavirus drug to US (Axios)
  • Coronavirus has now spread to all 50 states and DC, US death toll passes 100 (CNBC) (CNN)
  • US companies begin delaying clinical trials due to coronavirus outbreak (Reuters) (STAT) (Endpoints) (BioPharmaDive)
  • US Should Buy Coronavirus Vaccines Before They’re Invented (Bloomebrg)
  • Trump Sought to Expand Virus Drug Tests Over FDA Objections (WSJ)
  • New FDA Virus-Test Policy Could Boost Availability, But Reduce Reliability (WSJ)
  • US Mergers Face Antitrust Delays Amid Virus Disruptions (Bloomberg)
  • Covid-19 could throw final hurdle into AbbVie and Allergan’s massive merger (Endpoints) (Press)
  • Sage has a backup plan for its depression drug: Three new studies aiming for 2022 approval (STAT)
  • Coronavirus: Ventilator rush faces regulatory and logistical obstacles (NBC)
  • Coronavirus restrictions could lead to US blood shortage in two weeks (Reuters) (CRS Report)
  • Big pharma shied away from gene therapy for years. Academia picked up the slack (BioPharmaDive)
In Focus: International
  • Stunned world grapples with 'once-in-100-year' coronavirus battle (Reuters)
  • Coronavirus Infections Pass 200,000 Globally (WSJ)
  • 99% of Those Who Died From Virus Had Other Illness, Italy Says (Bloomberg)
  • China says coronavirus pandemic exposed global health system's shortcomings (Reuters)
  • Europe grapples with 'socio-economic tsunami' of coronavirus crisis (Reuters)
  • EU agrees to close external borders, but fast tracks for goods (Reuters)
  • Japan uses just a fraction of its coronavirus testing capacity (Reuters)
  • Mideast states not communicating enough about virus: WHO (Reuters 1, 2)
  • France limits paracetamol sales as hoarding threatens availability (Reuters)
  • Spain unveils 'unprecedented' 200 billion euros coronavirus package (Reuters)
  • Japanese Researchers to Test Blood Thinner For Virus Treatment (Bloomberg)
  • Japanese flu drug could be effective in treating coronavirus, report says (CNBC)
  • UK biotech Synairgen to begin COVID-19 trial of lead candidate (PMLive)
  • Armed with lessons from Ebola, Africa braces for coronavirus surge (Reuters)
  • Having Brushed Off Coronavirus Threat, Southeast Asia Begins to Confront It (NYTimes)
  • The dealmakers, dollars & diseases that transformed the Chinese biopharma market (Endpoints)
  • The MDCG MDR joint implementation plan (Medical Devices Legal)
Coronavirus Outbreak
  • Are Hospitals Near Me Ready for Coronavirus? Here Are Nine Different Scenarios. (ProPublica) (NYTimes)
  • Coronavirus will infect half the global population, EIU predicts (CNBC)
  • Drug Companies Will Make a Killing From Coronavirus (NYTimes)
  • As Coronavirus Testing Gears Up, Specialized Swabs Running Out (KHN)
  • Near Trump’s Florida Home, Drive-Thru COVID-19 Testing Gets Off To Rocky Start (KHN)
  • Here are some of the existing drugs that may be repurposed to treat coronavirus (CNBC)
  • US plan warns coronavirus pandemic could last 18 months: report (The Hill)
  • Children and Coronavirus: Research Finds Some Become Seriously Ill (NYTimes)
  • Transcript Of NPR's Full Interview With Vice President Pence (NPR)
  • The Trump Administration Drove Him Back to China, Where He Invented a Fast Coronavirus Test (ProPublica)
  • Hundreds of Scientists Scramble to Find a Coronavirus Treatment (NYTimes)
  • Pentagon to free up one million respirator masks immediately for coronavirus (Reuters)
  • Italy PM says coronavirus 'tsunami' won't leave any EU state untouched (Reuters)
  • Fortress Offers IP Rights To Fight COVID-19 After Backlash (Law360) (Ars Technica)
  • Medical company threatens to sue volunteers that 3D-printed valves for life-saving coronavirus treatments (The Verge)
  • Frustrated and afraid about protective gear shortages, health workers are scouring for masks on their own (STAT)
  • Europe’s COVID-19 battle: supply, support and the search for diagnostics, vaccines, treatments and cures (EFPIA)
  • Co-Diagnostics says new FDA policy to help expand use of COVID-19 test (Reuters)
  • Qiagen to beef up capacity to produce coronavirus test kits (Reuters)
  • Beijing reports 11 new imported coronavirus cases as China's local infections fall (Reuters)
  • Israel's confirmed coronavirus cases jump by 40 percent in 24 hours (Reuters)
  • India says 276 citizens have tested positive for coronavirus overseas (Reuters)
  • Coronavirus Disease 2019 (COVID-19) in Italy (JAMA)
  • UK confirmed coronavirus cases rise 26% to 1,950 in past 24 hours (Reuters)
  • UK aiming for under 20,000 deaths from virus: government chief scientist (Reuters)
  • Greece says confirmed coronavirus infections rise to 387 (Reuters)
  • Singapore reports 47 new virus cases, to impose self-quarantine on all entering city-state (Reuters)
  • Thailand reports 35 new coronavirus infections for total of 212 (Reuters)
  • Poland to receive protective gear, tests from China to fight coronavirus (Reuters)
  • Malaysia starts two-week isolation to rein in coronavirus (Reuters)
  • Cambodia reports 21 new cases of coronavirus, bringing total to 33 (Reuters)
  • Swiss hospitals face collapse in 10 days if virus keeps spreading (Reuters)
  • Employee at Sing Sing prison tests positive for coronavirus, triggering broader fears (NBC)
  • Hospital in Boston sets up new Covid-19 treatment center (STAT)
  • EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy announce initiation of an observational case-control study of siltuximab in patients with Covid-19 who have developed serious respiratory complications (Press)
  • COVID-19 Molecular Test From XCR Diagnostics Delivers Results in Half the Time of Existing Coronavirus Tests (Press)
Pharmaceuticals & Biotechnology
  • Despite coronavirus disruption, major microbiome companies are cautiously optimistic about upcoming data (STAT)
  • Iveric bio the latest to be hit by COVID-19 as it delays a key trial (Fierce)
  • Coronavirus Hasn’t Sparked CURE ID Physician Social Network Interest (Pink Sheet-$)
  • Swiss bio Addex halts Parkinson's test as trial delays tick up on COVID-19 disruption (Fierce)
  • Lilly CEO Ricks scores big pay bump to $21.3M, beating out other Big Pharma CEOs (Fierce)
  • FDA Overseas Inspection Policy Is Concerning, Says Biosimilars Patent Attorney (Center for Biosimilars)
  • Oxford Biomedica to license LentiVector to Juno (PharmaTimes)
  • TCR player Immatics combines with Perceptive’s blank check operator, scooping $252M and gaining a listing on Nasdaq (Endpoints)
  • Former Shire execs set up shop to take a shot at 'under the radar' cancer target (Endpoints) (Fierce)
  • Insilico inks another deal with Sino Biopharma unit; Ramaswamy's Datavant to invest in the "patient journey" (Endpoints)
  • Bristol Myers CEO Caforio hires a top investment banker from Barclays for his next BD/strategy chief  (Endpoints) (Press)
  • Gifu University and Astellas establish a Research Course on Phage Biologics, aimed at creating new treatments for bacterial infections (Press)
  • Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period (FDA)
  • List of hard-surface disinfectants for use against coronavirus (COVID-19) (Health Canada)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Alpine Immune Sciences’ ALPN-101 Receives FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease (Press)
  • Aurinia Announces AURORA Phase 3 Clinical Data for Voclosporin in Lupus Nephritis to be Presented at National Kidney Foundation 2020 Spring Clinical Meetings (Press)
  • The Lancet publishes papers from two studies of Takeda’s dengue vaccine candidate (Press)
Medical Devices
  • FDA clears new Conformis VHP sterilizers (MassDevice)
  • C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem (Press)
  • Nemaura To Prepare for Launch of sugarBEAT® CGM In the US Following FDA Feedback (Press)
  • Canon Medical’s 3T MR System Receives FDA Clearance for Artificial Intelligence-Based Image Reconstruction Technology (Press)
US: Assorted & Government
  • Grassley-Wyden drug price bill attacks rebates, includes inflation caps (BioCentury)
  • FTC Outlines Agency’s Response to Coronavirus Challenges (FTC)
  • Pallone, Nadler, Schakowsky & Cicilline Call On FTC To Protect Americans From Price Gouging During Covid-19 Health Crisis (House Energy & Commerce)
  • Grassley: Congress Must Act Decisively to Combat Coronavirus (Senate Finance)
  • Pfizer Moves to Dismiss Amgen’s Suit Over Proposed Neulasta Biosimilar (Big Molecule Watch)
  • We Finally Have Something To Say About COVID-19 (Drug & Device Law)
  • NY County Fights Mallinckrodt Bid For Separate Opioid Trial (Law360-$)
  • Split Fed. Circ. Revives Sequenom Fetal DNA Test Patents (Law360-$)
  • Makin’ It: How Does the Safe Harbor Apply to Biosimilar Manufacturing? (FDA Law Blog)
  • Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 17 (Patent Docs)
  • Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020) (Patent Docs)
  • Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements (FDA)
Europe
  • Readiness to supply ventilators and ventilator components (GOV.UK)
  • MedTech Europe sounds alarm over 'inconsistent' enforcement amid flurry of MDR updates (MedtechDive)
  • Responding to COVID-19 (ABPI)
  • UK Pharmacy inspections stopped as GPhC inspectors switch to 'supportive role' (Pharmaceutical Journal)
  • MHRA makes scientific advice meetings virtual in light of coronavirus (MHRA)
  • UK health service to cancel all routine surgery (Reuters)
  • New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements (Medical Devices Legal)
  • Class 2 Medicines Recall: Esmya 5mg tablets, EU/1/12/750/001-5, (EL(20)A/16) (MHRA)
India
  • Regulation of the European Parliament and of the Council amending Regulation (EU) No 1303/2013, Regulation (EU) No 1301/2013 and Regulation (EU) No 508/2014 as regards specific measures to mobilise investments in the health care systems of the Member States and in other sectors of their economies in response to the COVID-19 outbreak (EC)
  • Covid-19: Export curbs on imported API drugs under review (Economic Times)
  • Covid-19 in India: Cautious government involves private sector in treating patients (Economic Times)
  • DCGI mandates testing of all categories of new drugs for approval under New Drugs & Clinical Trials Rules, 2019 (Pharmabiz)
  • Indian Pharma Market registers 12.1% growth in February 2020 (Pharmabiz)
  • Provide information on masks, hand sanitisers, NPPA asks manufacturers (Economic Times)
  • Roche Diagnostics India first private firm to get COVID-19 test approval (Economic Times)
Australia
  • Australia Curbs GMP Inspections As Coronavirus Bites (Pink Sheet-$)
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 news@raps.org.
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe