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

• 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)

• 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)

• 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)

• 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)

• 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)

• Actavis $19M Deal In ADHD Drug Antitrust Suit Gets Initial OK (Law360)
• Introduction To Biosimilars And Labeling Issues (For The Defense) (Big Molecule Watch)