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Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep
Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Trump Plans Order Seeking to Return Drug Production to US (Bloomberg ) (Politico ) (STAT ) (Endpoints ) (Reuters )
FDA commissioner: No matter what, only a safe, effective vaccine will get our approval (Washington Post )
FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 (NPR )
Trump says coronavirus vaccine possible before Nov. 3 (Reuters )
Fauci says regulators promise politics will not guide vaccine timing (Reuters 1 , 2 )
Pandemic Lays Bare US Reliance on China for Drugs (WSJ )
FDA approves GlaxoSmithKline's blood cancer drug (Reuters ) (Endpoints ) (FDA )
Eight Charged in Scheme to Defraud FDA and Falsify Records Used in Clinical Research Trials (FDA )
Bristol Myers Squibb Reports Second Quarter 2020 Financial Results (Press )
In Focus: International
Global recovery will come faster if COVID vaccine available to all - WHO chief (Reuters )
AstraZeneca in first COVID-19 vaccine deal with Chinese company (Reuters )
Israel institute to start COVID-19 vaccine trials in humans soon (Reuters )
Novavax signs COVID-19 vaccine supply deal with India's Serum Institute (Reuters )
Human trials of coronavirus vaccine set to begin in Indonesia (Reuters )
Bausch Health to Spin Off Eye-Care Business (WSJ ) (FT )
Novo axes experimental obesity drugs after success with later-stage meds (Fierce ) (Endpoints )
Fair Prices Call Prompts EU Industry To Insist On Innovation Incentives (Pink Sheet )
Malaria in Africa: Parasite 'resistant to artemisinin' (BBC )
Coronavirus Pandemic
Health Experts to F.D.A.: Make Your Vaccine Deliberations Public (NYTimes )
Covid-19 Vaccine Trials Have a Problem: Minority Groups Don’t Trust Them (WSJ )
It's not for me: speed of COVID-19 vaccine race raises safety concerns (Reuters )
America’s Obesity Epidemic Threatens Effectiveness of Any COVID Vaccine (KHN )
BARDA responds to KEI, Public Citizen Letter Asking BARDA to Enforce Moderna Contract (KEI )
The Many Symptoms of Covid-19 (NYTimes )
FDA lets NeuroRx, Relief Therapeutics test RLF-100 in COVID-19 patients (Reuters )
This California company has a better version of a simpler, faster Covid-19 test (STAT )
Major U.S. Health Insurers Report Big Profits, Benefiting From the Pandemic (NYTimes )
Coronavirus (COVID-19) Update: Daily Roundup August 5, 2020 (FDA )
Pharma & Biotech
Biogen strikes $1 billion deal with Denali to advance Parkinson’s drug based on approach that was nearly abandoned (STAT ) (Endpoints )
IQVIA: US Out-Of-Pocket Drug Costs Stable, But Overall Spending Is Higher (Scrip )
Pfizer's Lorbrena bests Xalkori in PhIII readout — is it a potential successor? (Endpoints ) (PMLive )
Alvotech and Teva Announce Strategic Partnership to Collaborate in the US Biosimilar Market (Big Molecule Watch )
Bayer's struggle to find Vitravki patients highlights broader diagnostics hurdles in pharma, likely exacerbated by COVID-19 (Fierce )
Takeda hustles to prevent cancer drug shortage after FDA warning letter (Fierce )
Novartis builds its case for novel MS treatment ofatumumab (PMLive )
Novartis' Xolair scores European approval to treat chronic rhinosinusitis with nasal polyps (Pharmafile )
UCB’s Cimzia bags EU label extension (PharmaTimes )
European Commission approves first drug for hepatitis D (Pharmafile )
Roche-backed Dicerna pushes into the pack racing toward the blockbuster hep B goal line, armed with PhI data (Endpoints )
Alnylam president Barry Greene leaves after 17 years, handing position over to Yvonne Greenstreet as biotech looks toward profitability (Endpoints )
Lundbeck sounds taps on another CNS drug, retreating from a mine field still occupied by a Merck team (Endpoints )
Versant funds TCR therapy biotech T-knife's $78M+ Series A to boost humanized T cell mice platform (Endpoints )
Regeneron adds more positive PhIII data for its NGF program — but safety is still a big concern (Endpoints )
Levo Therapeutics misses primary endpoint in PhIII trial of Prader-Willi drug — the latest setback in a disaster-prone field (Endpoints )
Blackstone agrees to buy Ancestry in $4.7 billion deal (STAT )
Subgroups & Missing Data: The Problems Facing HTAs In Europe (Pink Sheet )
UK MHRA Acts To Improve Quality Of GCP Serious Breach Reports (Pink Sheet )
Medtech
NuVasive's spine robot sees delay, again (MedtechDive )
BD sales slide below expectations, as COVID-19 antigen test gains momentum (MedtechDive )
ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing (MedtechDive )
Nevro blasts past analyst consensus on rebound in pain procedures (MedtechDive )
AstraZeneca taps digital stethoscope maker Eko to support its heart failure research (Fierce )
Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year's end (MedtechDive )
Government & Regulatory
Missouri Voters Approve Medicaid Expansion Despite Resistance From Republican Leaders (NPR )
Bristol Myers, Pfizer fend off a key challenge to their top-selling heart drug (BioPharmaDive )
Lessons From Novartis' $678M Speaker Program Settlement (Law360 )
EpiPen Buyers Lose Bid For Class Status In ERISA Suit (Law360 )
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.