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Regulatory Focus™ > News Articles > 2020 > 8 > Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer

Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

Posted 06 August 2020 | By Michael Mezher 

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.

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