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Regulatory Focus™ > News Articles > 2020 > 3 > Recon: Congress, White House Reach Deal on $2T Stimulus; Merck KGaA’s MET Inhibitor Approved in Japa

Recon: Congress, White House Reach Deal on $2T Stimulus; Merck KGaA’s MET Inhibitor Approved in Japan

Posted 25 March 2020 | By Michael Mezher 

Recon: Congress, White House Reach Deal on $2T Stimulus; Merck KGaA’s MET Inhibitor Approved in Japan

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Congress and White House Strike Deal for $2 Trillion Stimulus Package (NYTimes) (Politico)
  • 5 Key Things in the $2 Trillion Coronavirus Stimulus Package (NYTimes)
  • Oracle Providing White House With Software to Study Unproven Coronavirus Drugs (NYTimes) (The Hill)
  • Trump seeks South Korea's help for medical equipment to tackle coronavirus (Reuters)
  • Malfunctioning EpiPens could harm patients, companies say (AP) (FDA)
  • Novartis wins dismissal of MS drug kickback lawsuit (Reuters)
  • Roche forges deal with San Diego biotech, betting on new antibiotic class (Endpoints)
  • US Lifts Ban on Malaysian Medical Glove Maker Amid Shortage (Reuters)
  • US antitrust agencies pledge quick action for anti-COVID-19 efforts (Reuters) (DOJ)
In Focus: International
  • EU states need 10 times more coronavirus equipment - internal document (Reuters)
  • Virus fight at risk as world's medical glove capital struggles with lockdown (Reuters) (AP)
  • WHO is asked to create a voluntary intellectual property pool to develop Covid-19 products (STAT)
  • Will the Coronavirus Ever Go Away? Here's What One of the WHO's Top Experts Thinks (TIME)
  • China's symptom-free coronavirus carriers raise fears of new wave of infections (Reuters)
  • Italian coronavirus deaths jump, dashing hopes that worst was over (Reuters)
  • India bans exports of drug touted by Trump as potential Covid-19 treatment (STAT) (Reuters)
  • Merck gets first okay for MET inhibitor tepotinib in Japan (PMLive) (Fierce) (Endpoints)
  • China suspends BMS cancer drug sales over findings at US plant (Reuters) (Endpoints) (Press)
  • Coronavirus: Parliament to vote on €37 billion crisis response (European Parliament)
Coronavirus Outbreak
  • Can We Put a Price Tag on a Life? The Shutdown Forces a New Look (NYTimes)
  • Three legislative proposals to help the FDA confront COVID-19 (AgencyIQ)
  • Malaria Drug Chloroquine No Better Than Regular Coronavirus Care, Study Finds (Bloomberg               )
  • Explainer: Why are malaria pills being used against coronavirus? (Reuters)
  • Over 100 drugs are in testing in the race to treat coronavirus (Axios) (NBC)
  • Coronavirus Drugs, Vaccine Are Many Months Away, Health Experts Say (WSJ)
  • U.S. Communities Struggle to Deal With Coronavirus Testing Backlogs (WSJ)
  • Bill Gates says the US missed its chance to avoid coronavirus shutdown and businesses should stay closed (CNBC)
  • We need smart coronavirus testing, not just more testing (STAT)
  • CVS CEO Larry Merlo: Lack of protective gear for workers has slowed rollout of drive-thru testing (CNBC)
  • Some States Are Reporting Incomplete COVID-19 Results, Blurring The Full Picture (KHN)
  • Quest Diagnostics has capacity to run 25,000 coronavirus tests a day: CEO (ABC)
  • U.S. companies, labs rush to produce blood test for coronavirus immunity (Reuters)
  • U.S. hospitals brace for another challenge — an unprecedented shortage of nurses (NBC)
  • The coronavirus isn’t mutating quickly, suggesting a vaccine would offer lasting protection (Washington Post)
  • Vir Biotechnology reports early progress in antibody treatment for Covid-19 (STAT)
  • Hospital orders for old malaria drugs have spiked amid coronavirus pandemic (STAT)
  • The Toughest Triage — Allocating Ventilators in a Pandemic (NEJM)
  • New York is experimenting with splitting one ventilator between two patients (CBS)
  • FDA issues another safety alert related to fecal transplants, as data suggest coronavirus lingers in poop (Endpoints)
  • Results released from first clinical trial using Danoprevir to treat COVID-19 (Pharmafile)
  • FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing (Press)
  • Novacyt and Yourgene Health to produce coronavirus test products in UK (Reuters)
  • Amid mounting shortage, 5 facts about the nation's stockpile of emergency medical supplies (Healthcare Dive)
  • Italy sees self-sufficiency in mask production against coronavirus in two months (Reuters)
  • COVID-19 in Europe: the Italian lesson (The Lancet)
  • Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy (JAMA)
  • Iran fears second wave of coronavirus as death toll rises to 2,077 (Reuters)
  • Number of coronavirus cases in Germany rises to 31,554: RKI (Reuters)
  • French coronavirus death tally much higher than official data: hospitals chief (Reuters)
  • French coronavirus death toll tops 1,000, lockdown likely to be extended (Reuters)
  • Spain's coronavirus death toll surpasses that of China (Reuters)
  • Spain asks NATO for coronavirus testing kits, ventilators, protective gear (Reuters)
  • Moscow's coronavirus outbreak much worse than it looks, Putin ally says (Reuters)
  • Coronavirus cases in Russia reach 658 after biggest daily rise: government (Reuters)
  • Mainland China reports drop in new imported coronavirus cases, no local transmissions (Reuters)
  • Tokyo governor asks residents to stay home to avoid sharp coronavirus rise (Reuters)
  • 10 dead, over 800 test positive in coronavirus outbreaks on Princess cruises, CDC says (NBC)
  • Coronavirus death toll in UK jumps by 87 to 422 (Reuters)
  • UK has bought 3.5 million coronairus antibody tests: health minister (Reuters)
  • UK to open temporary London hospital to tackle coronavirus outbreak (Reuters)
  • More than 170,000 volunteer to help UK fight coronavirus (Reuters)
  • At-Home Covid-19 Test Kit Makers Come Under Lawmaker Scrutiny (Bloomberg Law)
  • Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry (FDA)
  • The National Library of Medicine expands access to coronavirus literature through PubMed Central (NIH)
Pharmaceuticals & Biotechnology
  • As US FDA Settles Into Teleworking, Will Application Reviews Be Affected? (Pink Sheet-$)
  • The first big hurdle on the Celgene CVR arrives today. Can Bristol Myers clear a low bar in the middle of a pandemic? (Endpoints)
  • Coronavirus forces ASCO, cancer research's top meeting, to move online (BioPharmaDive)
  • Obalon Therapeutics explores strategic alternatives as coronavirus hits (Reuters)
  • Bellus Health hopes to be one of biotech’s more improbable turnarounds (STAT)
  • China biotech Laekna snaps up Novartis PD-L1 cancer therapy (Fierce)
  • Redpin bags A round to advance Chantix-controlled gene therapies (Fierce)
  • Kallyope lands $112 million Series C to ride the gut-brain axis for another 3 years (Endpoints)
  • Joining Novartis in siRNA space, AstraZeneca hands Silence $80M upfront for discovery deal (Endpoints) (Pharmafile)
  • Oprah day in biotech: Regenacy gets $30M, Abbisko gets $70M, Castle Creek gets $75M (Endpoints)
  • Turn on, tune in: New York biotech scores $15M+ in chemogenetics bet (Endpoints)
  • BMS Investor Fact Sheet related to COVID-19 (SEC)
  • Warning Letter: California IVF Fertility Center (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Infinity Receives Fast Track Designation for IPI-549 in Combination with the Checkpoint Inhibitor Opdivo for the Treatment of Advanced Urothelial Cancer (Press)
  • Astra, Daiichi's Enhertu shows early promise in HER2 lung cancer (Fierce)
  • ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer (Press)
  • Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma (Press)
Medical Devices
  • CDRH lays out filing extensions, shift from in-person amid coronavirus response (MedtechDive)
  • Conformis Faced with Tough Decision to Furlough One-Third of Its Workforce (MDDI)
US: Assorted & Government
  • Walmart Was Almost Charged Criminally Over Opioids. Trump Appointees Killed the Indictment. (ProPublica)
  • Drug Pricing Reform In 2020 Gets Harder Due To Third Coronavirus Bill (Pink Sheet-$)
  • Medicare Is Updating Coverage to Help in the Coronavirus Crisis (NYTimes)
  • Why Silicon Valley's virus-era D.C. glow may not last (Politico)
  • Edwards' Patent Suit Over Heart Valve Device Set For July Trial (Law360-$)
  • EpiPen Buyers Tear Into Mylan, Pfizer Bid For Cert. Review (Law360-$)
  • Express Scripts Off The Hook For $50M Prescription Drug Bill (Law360-$)
  • M.D. Fla. Holds Breast Implant Claims Preempted (Drug & Device Law)
  • Critical Juncture In Zolgensma EU Market Quest (Pink Sheet-$)
  • EU Filings For Orphan Status On The Decline (Pink Sheet-$)
  • Hep C cases down around 70% in HIV positive men in London and Brighton (PharmaTimes)
  • How to place a Coronavirus (COVID-19) test kit on the market (MHRA)
  • MHRA guidance on Coronavirus (COVID-19) (MHRA)
  • Ten years of MUMS: 22 new veterinary medicines authorised for minor uses and minor species (EMA)
  • Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules, PL 46302/0149 (EL (20)A/18) (MHRA)
  • Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak (MHRA)
  • Placing essential ventilators on the market (Swissmedic)
  • Lockdown resulting in drugs, medical devices supply disruption: Industry (Economic Times)
  • Pharma companies in panic mode as lockdown hits supply chain (Economic Times)
  • Serum Institute to test if TB vaccine VPM1002 is effective against Covid-19 (Economic Times)
  • Consultation: Scope of Regulated Software based products (TGA)
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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