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May 6, 2020
by Michael Mezher

Recon: FTC clears AbbVie, Allergan merger; FDA extends review of BMS’ CAR-T drug by three months

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump Says Coronavirus Task Force to Shift Focus to Safety and Reopening Economy (WSJ)
  • US regulator clears AbbVie’s $63bn deal for Allergan (Financial Times) (STAT) (Press)
  • AstraZeneca diabetes drug gets US nod to treat heart failure (Reuters) (Endpoints) (FDA)
  • FDA extends review of Bristol Myers' cancer therapy acquired in Celgene deal (Reuters) (Endpoints)
  • Gilead Seeks Deals With Other Drugmakers to Boost Supply of Covid-19 Drug (WSJ) (Reuters) (STAT)
  • Who can make Gilead's coronavirus drug, licence free? (Reuters)
  • Ousted vaccine expert accuses HHS of political pressure in formal complaint (Politico) (NYTimes)
  • Trump’s Virus Drug Whim Costs Millions, Even as the Mania Wanes (Bloomberg)
  • Most Americans would take coronavirus vaccine if deemed safe: Reuters/Ipsos poll (Reuters)
In Focus: International
  • Sanofi to enroll thousands for its coronavirus vaccine trials (Reuters)
  • Coronavirus: Prostate-cancer men swap chemo for precision drugs (BBC)
  • Novo Nordisk's drug sales boosted by virus-related stockpiling (Reuters)
  • Roche Actemra studies against COVID-19 could be done this month: NZZ (Reuters)
  • Ferring's therapy curbs recurrent superbug infection: study (Reuters)
  • Remdesivir Likely to Get Japan Nod on May 7 (PharmaJapan) (Reuters)
  • Top Australian biotech firm CSL joins virus treatment race (Reuters)
  • France's BioMerieux launches product to identify coronavirus antibodies (Reuters)
  • India to send nearly 1,000 tonnes of paracetamol raw material to Europe (Reuters)
  • Millions of people are expected to fall ill with tuberculosis due to coronavirus lockdown (CNBC)
  • Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 (EMA)
Coronavirus Pandemic
  • Study suggests coronavirus spread swiftly around world in late 2019 (Reuters)
  • With New Hot Spots Emerging, No Sign of a Respite (NYTimes)
  • Scientists say a now-dominant strain of the coronavirus could be more contagious than original (LA Times)
  • Beware Overblown Claims of Dangerous Coronavirus Strains (The Atlantic)
  • Woodcock Said To Have Guided Hydroxychloroquine EUA In ‘Brokered Compromise’ To Limit Use (Pink Sheet)
  • New reagent available to support global diagnostic testing of coronavirus (COVID-19) (MHRA)
  • US, UK officials warn of cyberattacks on hospitals, research facilities on coronavirus front lines (NBC)
  • How Kushner’s volunteer force led a fumbling hunt for medical supplies (NYTimes)
  • Increased Irish testing shows slowing coronavirus spread (Reuters)
  • Herd Immunity, or Big 2nd Wave? Israel Antibody Testing Hopes to Find Out (NYTimes)
  • Details of a New Anti-Coronovirus Neutralizing Antibody (In the Pipeline)
  • U.S. sends Mexico planeload of ventilators to fight coronavirus (Reuters)
  • The race is on for antibodies that stop the new coronavirus (Science)
  • US coronavirus deaths exceed 70,000 as forecasting models predict grim summer (Reuters)
  • Asia coronavirus cases hit 250,000 but pace much slower than U.S., Europe (Reuters)
  • Russia's coronavirus cases rise by more than 10,000 for fourth straight day (Reuters)
  • Sweden, UK and three other European nations are not seeing a drop in coronavirus cases, EU agency says (CNBC)
  • NICE publishes rapid COVID-19 guideline for acute kidney injury (PharmaTimes)
  • Coronavirus (COVID-19) Update: Daily Roundup May 5, 2020 (FDA)
Pharma & Biotech
  • National Lab Taps AI Machine With Massive Chip to Fight Coronavirus (WSJ)
  • Another sparse round of NASH data; TG raises $60M after PhIII success (Endpoints)
  • PhRMA And AAM Urge New Approaches In Dealing With COVID-19 Supply Chain Disruptions (Pink Sheet)
  • Roche flashes new 16-week bispecific AMD data, setting eyes on pair of PhIII trials (Endpoints)
  • Amgen Announces Positive Top-Line Results From Otezla® Phase 3 Advance Study In Mild-To-Moderate Plaque Psoriasis (Reuters) (Press)
  • Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water (Fierce)
  • Boehringer Ingelheim adds second AI partner in a month (Endpoints)
  • J&J R&D exec Najat Khan — and data science — are getting an elevated role at the pharma giant (Endpoints)
  • After big 2016 setback, field of microbiome-based drugs gets injection of promise with positive signal from Rebiotix pivotal study (Endpoints)
  • 'It's pure art': Versant, GV reveal $60M bet that a clearer look at inflammasomes can lead to better drugs (Endpoints)
  • William Haddad, Crusader for Generic Drugs, Dies at 91 (NYTimes)
Medtech
  • Fitbit launches study to test irregular heartbeat detection of devices (Reuters)
  • Apple Heart Study researchers find success in recruitment, struggle with engagement (MobiHealthNews)
  • Guardant offers 'encouraging' colorectal cancer screening update, as analysts await further data (MedtechDive)
  • Smith+Nephew April sales halve as elective surgeries take backseat (MassDevice)
  • AHA, societies share new roadmap amid restarts to TAVR, other postponed procedures (MedtechDive)
  • Inspire Medical up on Q1 mixed bag (MassDevice)
  • Baxter Announces Results of Clinical Trial on Benefits of Dynamic Fluid Management in Septic Shock Patients (Press)
Government & Regulatory
  • US Supreme Court hears Obamacare contraception Case; Ginsburg takes part (Reuters)
  • Animal Health International Sentenced on Federal Misbranding Charge (FDA)
  • USPTO Extends Certain Deadlines to June 1 Due to COVID-19 Pandemic (Big Molecule Watch)
  • Rep. Neal Calls For 90-Day Hold On Medical Product Duties (Law360)
  • New HIV Antitrust Complaint, Same Problems, Gilead Says (Law360)
  • Manufacturer Can't Claim Hand Sanitizer Stops Diseases (Law360)
  • Pfizer Inc. v. Chugai Pharmaceuticals Co. (Fed. Cir. 2020) (Patent Docs)
  • Post-Albrecht Preemption Persistently Pummels Pradaxa Plaintiffs (Drug & Device Law)
  • Exemption to enable timely access to radiopharmaceuticals and RAI (TGA)
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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