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March 20, 2020
by Michael Mezher

Recon: US Negotiations Kick Off for $1T Coronavirus Stimulus; UK Bans Parallel Exports of Key Drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • The trillion-dollar coronavirus negotiation kicks off (Politico) (CNN)
  • States still waiting on coronavirus tests as Trump tells them to do more (Politico)
  • Roche CEO says coronavirus test capacity too limited to screen all (Reuters)
  • California issues 'stay home' order; US death toll hits 200 (Reuters) (NYTimes) (LA Times) (NBC)
  • Schumer urges Trump to invoke Defense Production Act to rush medical equipment to providers  (Politico) (The Hill)
  • With Minimal Evidence, Trump Asks FDA to Study Malaria Drugs for Coronavirus (NYTimes) (STAT) (CNN) (BioCentury)
  • A drug maker recently doubled the price of chloroquine — but in response to the coronavirus pandemic, it’s cutting it in half (STAT) (Endpoints) (Financial Times)
  • Novartis, Mylan and Teva to supply tens of millions of chloroquine tablets to fight COVID-19 (Fierce)
  • Potential coronavirus treatment touted by Trump already in shortage, pharmacists say (Reuters)
  • Pfizer’s top-selling vaccine won’t prevent Covid-19, but could get a boost because of it (STAT)
  • Navarro slams Big Pharma’s lobbying against possible ‘Buy America’ order (STAT)
  • J&J aims for US approval of MS drug ponesimod (PMLive) (Endpoints)
  • FDA OKs Gilead’s paediatric hep C drug (PharmaTimes) (FDA)
  • Four senators sold stocks before coronavirus threat crashed market (The Hill) (ProPublica)
  • FDA to relax hand sanitizer rules amid coronavirus outbreak (Reuters) (Bloomberg Law) (FDA)
  • NPR Interview with FDA Commissioner Stephen Hahn (NPR) (Transcript)
In Focus: International
  • Search for Coronavirus Vaccine Becomes a Global Competition (NYTimes)
  • World's governments draft manufacturers for virus treatment arsenal (Reuters)
  • UK bans parallel exports of key drugs to protect supplies (Reuters)
  • EU opens probe into fake coronavirus-related products (Reuters)
  • WHO working to ensure supplies of diagnostics, protective gear – Tedros (Reuters)
  • Coronavirus: 100,000 More People Worldwide Got Infected In Less Than 2 Weeks (NPR)
  • UK government scientists publish evidence on COVID-19 evolution (Reuters)
  • Israel approves generic HIV drug to treat COVID-19 despite doubts (Reuters)
  • Coronavirus Death Rate in Wuhan Is Lower than Previously Thought, Study Finds (NYTimes) (WSJ)
  • China's new imported coronavirus cases at record; no domestic transfers for second day (Reuters)
  • WHO: Africa seeing 'extremely rapid evolution' of coronavirus outbreak (The Hill)
  • Filing Error Slices Nearly Two Years Off Roche’s UK Lucentis Protection (Pink Sheet-$)
  • Health Canada okays GSK unit's monthly HIV injection (Reuters) (Fierce)
Coronavirus Outbreak
  • At-home tests for coronavirus are here. Should you take them? (STAT)
  • Why the Coronavirus Has Been So Successful (The Atlantic)
  • CDC, Emory University set up sites to check coronavirus symptoms online (Reuters)
  • Study: Nearly half of COVID-19 patients experience digestive issues (The Hill)
  • Coronavirus Tests Are Now Free, but Treatment Could Still Cost You (NYTimes)
  • CVS announces first drive-thru coronavirus testing site in Massachusetts (Reuters)
  • DARPA’s gambles might have created the best hopes for stopping COVID-19 (BioCentury)
  • How to Donate Blood as Coronavirus Threatens the US Supply (NYTimes) (FDA)
  • New blood tests for antibodies could show true scale of coronavirus pandemic (Science Mag)
  • They Fled Coronavirus in Europe. Border Agents Asked if They’d Visited China or Iran. (NYTimes)
  • Governor Expects More Than Half Of Californians To Become Infected With Coronavirus (NPR)
  • N.Y. Gov. Cuomo Says '100% Of Workforce Must Stay Home' Due To Coronavirus (NPR)
  • Millions Of Older Americans Live In Counties With No ICU Beds As Pandemic Intensifies (KHN)
  • Fetal tissue ban blocks study of potential coronavirus therapies (Science Mag)
  • Companies are rushing to introduce coronavirus testing kits — and so are scam artists (NBC)
  • Faced with a shortage of face masks, some US doctors make their own (Reuters)
  • Mask Shortage Straps Pharmacists Who Need Them To Keep Medicines Pure (KHN)
  • Come back to fight coronavirus, UK begs 65,000 former nurses and doctors (Reuters)
  • Sharp increase in Moscow pneumonia cases fuels fears over coronavirus statistics (Reuters)
  • Russia starts testing coronavirus vaccine prototypes on animals (Reuters)
  • The biotech start-ups racing to create quicker coronavirus tests (Financial Times)
  • Why lifesaving ventilators will be in short supply for the foreseeable future (Vox)
  • UK hopes newly-made ventilators will be ready for coronavirus fight next week (Reuters)
  • Ferrari and Fiat look at helping Italy make ventilators in coronavirus crisis (Reuters)
  • Merck KGaA donates multiple sclerosis med Rebif to French COVID-19 trial (Fierce)
  • NBC News employee dies after testing positive for coronavirus (NBC)
  • Spain's coronavirus death toll surpasses 1,000 (Reuters)
  • Brazil coronavirus cases top 600, diplomatic spat with China bubbles (Reuters)
  • Thailand reports 50 new coronavirus infections for total of 322 (Reuters)
  • Greece has registered 464 coronavirus cases, six deaths: health min official (Reuters)
  • Cambodia reports 10 new cases of coronavirus, bringing total to 47 (Reuters)
  • Dutch coronavirus cases up by 534 to 2,994, deaths up 30 to 106 (Reuters)
  • Delayed by sanctions, border checks, first medical aid trickles into North Korea (Reuters)
  • Mexico coronavirus tally rises to 164 from 118 a day earlier (Reuters)
  • Why India may be about to discover "tens of thousands" more coronavirus cases (CBS)
  • Tesla suspends production at U.S. vehicle factory due to coronavirus (Reuters)
  • Supply-chain recovery in coronavirus times—plan for now and the future (McKinsey)
  • 3M Outlines Actions to Support Healthcare Effort to Combat COVID-19 (3M)
  • Feinstein Institutes begins enrolling patients in multiple COVID-19 clinical trials (Press)
  • Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (FDA)
Pharmaceuticals & Biotechnology
  • The Covid-19 crisis is the right time to adopt decentralized clinical trials (MedCity)
  • IPO market sealed shut for the foreseeable future: report (Fierce)
  • ‘Organ-on-a-chip’ maker Emulate names new CEO, announces new funding (STAT)
  • In hard-hit Seattle, coronavirus pushes biotechs to a new normal (BioPharmaDive)
  • TV Drug Advertising Spend Rising, But Few Brands Provide Pricing Info (Pink Sheet-$)
  • Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions (JABFM)
  • Biogen fires staffer who fled to China after she was infected in the biotech’s coronavirus outbreak (Endpoints)
  • A key player behind 2 multibillion-dollar biotech M&A deals is back in the startup business (Endpoints)
  • Epizyme hires Kutok as CSO to find new uses for Tazverik (Fierce)
  • Charles Bancroft makes quick leap from Bristol Myers exec team to GSK; Medicxi adds two new partners to its team (Endpoints)
  • InnoCare IPO oversubscribed 300x as Hong Kong investors turned to biotech amid runoff (Endpoints)
  • Three Things to Look for in a Patient Assistance Program (Drug Channels)
  • Blood Products Advisory Committee; Postponed (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for the Treatment of Multiple Sclerosis (Press)
Medical Devices
  • Direct-to-consumer companies wade into coronavirus testing to fill gap (MedtechDive)
  • Exact Sciences pulls 2020 sales guidance amid coronavirus uncertainty (MedtechDive)
  • Co-Diagnostics, Inc Completes Successful Clinical Evaluation Required for FDA Emergency Use Authorization (Press)
US: Assorted & Government
  • NIH shifts non-mission-critical laboratory operations to minimal maintenance phase (NIH)
  • No, Seriously, Don't Try To 'Trademark' Coronavirus (Law360-$)
  • Ruling In HHS Case May Mean More Drug Trial Reporting (Law360-$)
  • Mylan, Pfizer Want EpiPen Row Paused For Class Cert. Appeal (Law360-$)
  • Japanese Device Co. Must Face FCA Suit Over Medicare Fraud (Law360-$)
  • PTAB To Review Allergen Juvederm Patent At Heart Of IP Suit (Law360-$)
  • Mallinckrodt Files Certiorari Petition in iNO v. Praxair (Patent Docs)
  • The Supreme Court Addresses Purposes and Objectives Preemption in a Surprising New Context (Drug & Device Law)
  • Preventing other Shkreli-like debacles may not save the government much money (STAT)
  • FDA suspends U.S. vape shop inspections as coronavirus spreads (Reuters)
Europe
  • EMA Management Board – highlights of March 2020 meeting (EMA)
  • COVID-19: research package welcomed, EU needs to be better equipped in future (European Parliament)
  • Targeted stakeholders' consultation on Annex 21: Importation of medicinal products, of the Eudralex volume 4 (EC)
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-18 March 2020 (EMA)
  • What Might Whistleblower Protections Look Like For UK Pharma Post-Brexit? (Pink Sheet-$)
  • The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck (MedicalDevicesLegal)
  • MHRA guidance on Coronavirus (COVID-19) (MHRA)
  • New arrangements for MHRA Good Practice (GxP) inspections due to coronavirus (COVID-19) (MHRA)
  • MHRA services during the Coronavirus (COVID-19) response (MHRA)
  • Advertising investigations: February 2020 (MHRA)
  • Advertising investigations: January 2020 (MHRA)
Asia
  • China’s NMPA Steps Up To The Plate In COVID-19 Fight But Much Is Left To Do (MedtechInsight)
India
  • Department of Pharma proposes Rs 10,000-crore incentive scheme for promoting domestic API units (Economic Times)
  • Prices of raw materials of hand sanitizers surge 200% due to huge demand since coronavirus outbreak (Pharmabiz)
  • Biocon gets EIR from USFDA for manufacturing facility in Bengaluru (Economic Times)
  • 14 firms get license to evaluate COVID-19 tests kits (Economic Times)
  • A Mumbai company is working on a potential coronavirus medicine (Economic Times)
  • ICMR may cap price of each coronavirus test at Rs 4,500-Rs 5,000 for private labs: Official (Economic Times)
Canada
  • Pricing Reforms Prompt Canadian Business Rethink (Pink Sheet-$)
  • Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 (Health Canada)
Australia
  • Supplying COVID-19 tests (TGA)
  • Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19 (TGA)
General Health & Other Interesting Articles
  • NIH study provides genetic insights into osteosarcoma in children (HIN)
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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