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.