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April 21, 2020
by Michael Mezher

Recon: Drugmakers call for billions upfront for coronavirus; Switzerland reaches reimbursement deal for Vertex CF drugs

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump tones down the hydroxychloroquine hype (Politico)
  • US revs up ventilator production for coronavirus patients as need wanes (Reuters)
  • US coronavirus deaths top 42,000 as protesters demand restrictions end (Reuters)
  • Study Raises Questions About False Negatives From Quick COVID-19 Test (NPR)
  • Drug Cos. Say Foreign Status Outs Them From Opioid Case (Law360)
  • Merck KGaA adds to gene therapy manufacturing boom with €100M facility in California (Endpoints)
  • Coronavirus Is Forcing Medical Research to Speed Up (NYTimes Magazine)
  • Tracking the virus may require 300,000 workers. We're nowhere close. (Politico)
  • Trump Plans to Suspend Immigration to US amid pandemic (NYTimes)
  • 'The silver lining': Biotech IPOs in the time of coronavirus (Fierce)
In Focus: International
  • UN presses for scale-up of coronavirus medicines, vaccines worldwide (The Hill) (UNGA)
  • UN agencies issue urgent call to fund the global emergency supply system to fight COVID-19 (WHO)
  • Coronavirus very likely of animal origin, no sign of lab manipulation: WHO (Reuters)
  • WHO chief warns the worst of the coronavirus is still ahead (NBC)
  • Big Pharma calls for ‘billions’ in upfront coronavirus funding (Financial Times)
  • Coronavirus puts Big Pharma’s IP regime to the test (Financial Times)
  • Grifols says anti-coronavirus hyperimmune immunoglobins may be ready mid-July (Reuters)
  • Korea bans local sales of Medytox’s BTX drug Meditoxin (The Korea Herald)
  • Swiss deal on cystic fibrosis drugs could change price negotiations (SwissInfo) (Press)
  • Otsuka Grabs Japan Rights to Esperion’s Cholesterol Drug (PharmaJapan)
  • Japanese biotech seeks to turn ‘brown gem’ into gold (Financial Times)
Coronavirus Pandemic
  • WHO warns lifting of coronavirus lockdowns must be gradual (Reuters)
  • Exporting coronavirus? Infections among US deportees reach Haiti, Mexico (Reuters)
  • The Pandemic’s Hidden Victims: Sick or Dying, but Not From the Virus (NYTimes)
  • These Are the Drugs and Vaccines That Might End the Coronavirus Pandemic (Bloomberg)
  • Op-Ed: We need more covid-19 tests. We propose a ‘shark tank’ to get us there. (Washington Post)
  • Americans Are Poisoning Themselves in Their Rush to Fight Virus (Bloomberg)
  • Datavant boots up a big Covid-19 registry — looking to shine a light on virus spread, impact and most effective therapies (Endpoints)
  • The Path Forward: Coronavirus Treatment Acceleration Program (FDA Voice)
  • Justice Department Issues Business Review Letter to AmerisourceBergen Supporting Distribution of Critical Medicines Under Expedited Procedure for COVID-19 Pandemic Response (DOJ)
  • Trump administration to require nursing homes report coronavirus cases (The Hill)
  • California researchers test everybody in one town for coronavirus (Reuters)
  • Los Angeles coronavirus infections 40 times greater than known cases, antibody tests suggest (Reuters)
  • 73% Of Inmates At An Ohio Prison Test Positive For Coronavirus (NPR)
  • Japan waiting for Golden Week to decide on extending coronavirus emergency: sources (Reuters)
  • France becomes fourth country with more than 20,000 coronavirus deaths (Reuters)
  • Spain coronavirus cases top 200,000 but infection rate falling 'a lot' (Reuters)
  • Russia's confirmed coronavirus cases surge past 52,000 (Reuters)
  • Singapore reports 1,111 new coronavirus cases (Reuters)
  • Coronavirus (COVID-19) Update: Daily Roundup April 20, 2020 (FDA)
Pharma & Biotech
  • If pharma helps quench the Covid-19 pandemic, what will it want in return? (STAT)
  • The journey from scientific breakthrough to a life-changing cystic fibrosis drug (Washington Post)
  • HTA: Scotland Says Yes To Stelara For Ulcerative Colitis (Pink Sheet)
  • Bayer's Vitrakvi becomes first tumour-agnostic therapy approved by NICE for NHS patients with NTRK fusion+ cancer (Pharmafile)
  • Sangamo taps Mogrify for off-the-shelf CAR-Treg project (Fierce)
  • Daily Aspirin Tied to Lower Risk of Various Digestive Cancers (NYTimes)
  • Novartis Says New Mayzent Data Shows Sustained Effect In Delaying Disability (Reuters)
  • European Commission approves nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) (AP)
  • NIH Director Francis Collins on Tony Fauci, the WHO, and running a $39 billion research agency from home (STAT)
  • General Motors, 3M, and pharma companies beef up lobbying firepower amid coronavirus pandemic (STAT)
  • Another PhIII win in hand, Cara aims straight for priority review of 'breakthrough' pruritus drug (Endpoints)
  • Short attack targets one of the favorites now sharing the lead in the popular KRAS drug development race (Endpoints)
  • Despite pricing controversies, pharma’s reputation is improving among patient groups (STAT)
  • Biogen execs have been quiet since Covid-19 spread through the biotech. The silence ends Wednesday (STAT)
  • Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data (Pink Sheet 1, 2)
  • Sumitomo Dainippon Chair Sees No Need for Further Consolidation among Japan Drug Makers (PharmaJapan)
  • Avet recalls tetracycline antibiotic capsules on low-potency fears (Fierce)
  • Pharma search ads shift to 'savings' and 'coverage' amid COVID-19 pandemic (Fierce)
Medtech
  • Roche Gets FDA Approval for HPV Test Used With Cobas 6800/8800 Platforms (GenomeWeb)
  • COVID-19: Dialysis Machine Makers Respond To Surge In Demand (MedtechInsight)
  • The European MDR and human factors engineering: Use-related risks (Emergo)
  • Philips to invest $109M as COVID-19 drives connected care order growth (MedtechDive)
Government & Regulatory
  • Epogen IP Fight Ends With Hospira Paying More Than $70M (Law360)
  • Akebia Gets FibroGen Anemia Drug Patents Invalidated In UK (Law360)
  • Opioid Cos. Hold To Drug Data Pursuit In Chicago Case (Law360)
  • Generic Warning Case Barred by Learned Intermediary Doctrine (Drug & Device Law)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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