Recon: Drugmakers counter Trump's pricing plan; Teva indicted by US DOJ on price-fixing charges

ReconRecon | 26 August 2020 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Drugmakers deliver counteroffer to Trump international pricing plan (Politico)
  • Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide (Pink Sheet)
  • Eric Topol Criticizes FDA's Exaggeration Of Plasma's Efficacy In COVID-19 Treatment (NPR)
  • Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy (KHN)
  • Opinion: The FDA must stand up for itself and for science, not politics (Washington Post)
  • Acadia Pharma Acquires CerSci, Potential Pain Meds in $52.5M Buyout (Xconomy)
  • Ipsen Plans to Move Forward with Filing for FOP Drug (Global Genes)
  • Novartis' asciminib bests Pfizer's Bosulif in phase 3 leukemia trial (Fierce Biotech)
In Focus: International
  • 73,000 Scientists collaborate over new COVID-19 Data Portal to speed up vaccine development (PharmaNews)
  • COVID-19 vaccine deals with the EU hindered by strict liability rules (PMLive)
  • Kura hires Tagrisso lead to take cancer drugs deeper into clinic (Fierce Biotech)
  • Bavarian Nordic’s freeze-dried smallpox vaccine clears clinical test (BioPharma Reporter)
  • Amid deepening desperation, the story of those who won't wait for superpowers’ Covid vaccines (Economic Times)
  • Russia seeks collaboration with India for manufacturing Covid vaccine Sputnik V: Report (Economic Times)
Coronavirus Pandemic
  • CDC says asymptomatic people don't need testing, draws criticism from experts (NYT) (The Hill) (CNBC) (NBC)
  • When FDA Might Approve A Coronavirus Vaccine (NPR)
  • Moderna's COVID-19 vaccine shows similar immune response in old and young (Reuters) (Moderna)
  • Convalescent Plasma: The Unanswered Questions (MedPage Today)
  • Biogen conference likely linked to 'tens of thousands' of COVID-19 cases, researchers say (Fierce Pharma) (MedCity News)
  • EU eyes initial COVID-19 vaccination for at least 40% of population (Reuters)
  • Trump Administration Orders Hospitals to Report Data or Risk Losing Funding (NYT)
  • Can China Convince World With Its Fast, Cheap COVID Vaccines? (Pink Sheet)
  • Thousands of coronavirus cases recorded in hospital were caught on site, new research suggests (Pharmafile)
  • Dr. Scott Gottlieb: ‘This is really a 2020 event’ provided U.S. stays vigilant on coronavirus (CNBC)
  • Inside Pence's coronavirus task force (Politico)
  • Coronavirus (COVID-19) Update: Daily Roundup August 25, 2020 (FDA)
  • COVID-19 exposes a critical shortage of oxygen in developing countries (McKinsey)
Pharma & Biotech
  • Catalyst takes its fight over a rare disease drug to Canada, suing the country’s regulator (STAT)
  • Bristol/Agios AML Drug Idhifa Fails In Phase III (Scrip)
  • Convalescent Plasma EUA Will Not Complicate Hyperimmune Globulin Product Development, Sponsors Say (Pink Sheet)
  • New CF Patient Subset For Vertex With Kaftrio's EU Approval (Scrip) (European Pharmaceutical Review)
  • Takeda/Ovid Plan Phase III For Soticlestat In Dravet Syndrome, But Pull Back On LGS (Scrip) (BioPharma Dive)
  • Strengthening the sting of immunotherapy (Nature)
  • Thread Research lands $50m infusion for decentralized trial tech (
  • AbbVie Exercises Option to License Morphic’s Program for IPF and Other Fibrotic Diseases (Global Genes)
  • As Elon Musk’s Neuralink prepares to draw back the curtain, ex-employees describe rushed timelines clashing with science’s slow pace (STAT)
  • Fitbit launches smartwatch as EKG feature awaits FDA's OK (MedTech Dive)
  • Measuring the sensitivity of COVID tests with new material from NIST (AAAS)
  • Freenome raises $270M to run pivotal trial of colorectal cancer liquid biopsy (MedTech Dive)
  • Insulin pumps among millions of devices facing risk from newly disclosed cyber vulnerability, IBM says (MedTech Dive)
  • Covid-19 Is Fueling A Digital Therapeutics Revolution, But The Road To Maturity Travels Through The Four Healthcare ‘Ps’ (Forbes)
Government & Regulatory
  • Teva Pharmaceutical’s U.S. Unit Indicted on Price-Fixing Charges (WSJ) (Forbes) (Fox Business)
  • 2 Become 1: MAPP on Consolidation of ANDAs (FDA Law Blog)
  • Senate bill would give FDA authority to recall drugs (Law 360)
  • Sequence Comparisons Illustrate Susceptibility to Coronavirus Infection (Patent Docs)
  • FDA and Lab-Developed Tests: The Saga Continues (MedPage Today)
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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