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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: AstraZeneca resumes COVID vaccine trials in South Africa, Brazil, US study still on hold

Recon: AstraZeneca resumes COVID vaccine trials in South Africa, Brazil, US study still on hold

Posted 15 September 2020 | By Michael Mezher 

Recon: AstraZeneca resumes COVID vaccine trials in South Africa, Brazil, US study still on hold

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Trump says not pressing US government for coronavirus vaccine for political reasons (Reuters)
  • AstraZeneca COVID-19 vaccine trial in US on hold until at least midweek – sources (Reuters) (KHN)
  • Bill Gates Wonders Whether FDA Can Be Trusted on a Covid Vaccine (Bloomberg)
  • Axios-Ipsos poll: Distrusting Big Pharma and the FDA (Axios)
  • Compass Pathways set to become the first psychedelic biotech IPO (STAT)
  • Pfizer says no new serious adverse events in DMD gene therapy trial (Reuters)
  • Court rules NY can collect taxes from drugmakers, wholesalers to address opioid crisis (STAT)
  • Trump Health Aide Pushes Bizarre Conspiracies and Warns of Armed Revolt (NYTimes)
  • Dem probe: Trump administration ignored NIH evidence on fetal tissue (Politico)
  • White House blocks Navarro from testifying to House panel about ventilator deal (Politico)
In Focus: International
  • AstraZeneca resumes COVID-19 vaccine trials in South Africa, health dept says (Reuters)
  • AstraZeneca COVID-19 vaccine trials resume in Brazil (Reuters)
  • Some volunteers quit J&J COVID-19 trial in Spain after AstraZeneca scare, investigator says (Reuters)
  • First vaccine approvals could come at end of 2020: German vaccine regulator (Reuters 1, 2)
  • China coronavirus vaccine may be ready for public in November: official (Reuters)
  • Germany grants BioNTech, CureVac $745 million to speed up COVID-19 vaccine work (Reuters)
  • Novavax aims for 2 billion COVID-19 vaccine doses with expanded India deal (Reuters)
  • Bayer in deal with Systems Oncology over novel breast cancer drug (Reuters)
  • Sanofi backs Escient's $77.5M round as it kick-starts first clinical test (Fierce)
Coronavirus Pandemic
  • Becton Dickinson probes false-positive COVID-19 test results in US nursing homes (Reuters)
  • Ethical or exploitative—should prisoners participate in COVID-19 vaccine trials? (Science)
  • Lonza works with Humanigen on COVID-19 drug candidate lenzilumab (Reuters)
  • Coronavirus Q&A: Venable's FDA Co-Chair (Law360)
  • CDC: Testing for STDs plummeted during pandemic (Politico)
  • 9th Circ. Doubts Drugmakers' Bid To Revive Free Speech Suit (Law360)
  • Coronavirus (COVID-19) Update: Daily Roundup September 14, 2020 (FDA)
Pharma & Biotech
  • User Fee Renewal Negotiations Beginning This Week (Pink Sheet)
  • A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions (Pink Sheet)
  • China Regulatory Express: 12 Months Exclusivity Proposed For First Generics (Pink Sheet)
  • Italy To Consult On Pricing Transparency Requirements (Pink Sheet)
  • EU Fast-Track Review In Store For Takeda’s Dengue Vaccine (Pink Sheet)
  • A fresh look at an old topic: Investigations in the GMDP environment (MHRA blog)
  • Shionogi launches novel antibiotic Fetcroja in the UK (PharmaTimes)
  • Crown jewel in big Gilead buyout lands breakthrough designation for MDS (Endpoints)
  • Ex-Moderna CFO Lorence Kim joins a new class of venture partners jumping on board Third Rock (Endpoints)
  • Takeda opens cell therapy manufacturing facility — tucked right in its Boston R&D hub (Endpoints)
  • The central figure in Nestlé's $2.6B Aimmune buyout? Covid-19 (Endpoints)
  • Following job cuts and R&D restructuring, microcap microRNA player miRagen brings in new CEO to right the ship (Endpoints)
  • Akcea’s board managed to get Ionis to boost its buyout bid a bit, but never got close to a 2019 acquisition offer (Endpoints)
  • Attempting to bounce back after mid-stage flop, Novus pivots to immunology with CD40L-focused acquisition of Anelixis (Endpoints)
  • ImCheck adds $7.1M to Series B, boosting development of gamma delta T cell programs (Endpoints)
  • Marinus execs herald the rebirth of the one-drug biotech as a positive PhIII readout arrives for a rare disease (Endpoints)
  • GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ® Gene Therapy to Treat Vision Loss Due to Leber Hereditary Optic Neuropathy (LHON) (Press)
  • European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma (Press)
  • US FDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack (Press)
Medtech
  • US FDA updates final guidance on ISO 10993 for medical device biocompatibility (Emergo)
  • After uneven start to 2020, Hologic becomes Wall Street darling (MedtechDive)
  • FDA Approves Two New Indications For Edwards’ Sapien 3 TAVR System (MedtechInsight)
  • Spurred On By HHS Policy Shift, AdvaMed Chief Wants LDT Reform In User-Fee Negotiations (MedtechInsight)
  • BD has a serious recall of some Alaris System infusino pumps with stuck keys (MassDevice)
  • Fibralign wins CE mark for BioBridge tissue repair device (MassDevice)
  • B-Temia wins FDA clearance for mobility exoskeleton (MassDevice)
Government, Regulatory & Legal
  • Actavis $19M Deal In ADHD Drug Antitrust Suit Gets Initial OK (Law360)
  • Introduction To Biosimilars And Labeling Issues (For The Defense) (Big Molecule Watch)
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.

Tags: US, worldwide

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