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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)
  • 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)
  • 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 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.
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