Recon: Gilead to begin trials of inhaled version of remdesivir; FDA rejects Nabriva’s antibiotic for the second time

• Gilead to Begin Human Testing of Inhaled Version of Covid-19 Drug Remdesivir (WSJ)
• FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions (Endpoints)
• Rules for Clinical Trials in a Pandemic (WSJ)
• CDC coronavirus test kits were likely contaminated, federal review confirms (Washington Post)
• Efforts for Coronavirus Vaccine Focus on Vulnerable Group: Older Adults (WSJ)
• Evoke Pharma finally lands approval for lead and only drug (Endpoints)
• Federal Agency Halts Studies of Hydroxychloroquine, Drug Trump Promoted (NYTimes)
• As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire (KHN)
• Inside the Trump Administration’s Decision to Leave the World Health Organization (ProPublica)

• Two In Running For Top Job At EMA (Pink Sheet)
• UK to tighten takeover rules for groups vital to virus response (Financial Times) (The Guardian)
• Second deadliest Ebola outbreak on record is days from being declared over (STAT)
• A Chinese drug maker scores a big clinical trial win with a novel diabetes therapy (STAT)
• Trans-Atlantic VC banks $126M to scout startup ideas out of 'underventured' areas in the UK (Endpoints) (PMLive)
• Perrigo Inks $195M Sale Of UK Generics Manufacturer (Law360)
• German generic drugmaker warns against EU protectionism (Financial Times)
• GSK and Clover’s COVID-19 vaccine starts clinical trials (PMLive) (Press)

• Drug recently shown to reduce coronavirus death risk could run out, experts warn (Science)
• How the U.S. and Italy traded places on coronavirus (Politico)
• Coronavirus: recovered Chinese patients may be defenceless against foreign mutation, study says (SCMP)
• New UK consortium established to monitor COVID-19 vaccine efficacy once they hit market (Pharmafile)
• Cipla, Hetero receive drug controller's emergency approval for Remdesivir for severe Covid-19 patients (Economic Times)
• Glenmark launches COVID-19 drug after DCGI nod; MRP at Rs 103 per tablet (Economic Times)
• Novartis discontinues hydroxychloroquine clinical trial based on slow enrollment, remains committed to pandemic research efforts (Press)
• Coronavirus (COVID-19) Update: Daily Roundup June 19, 2020 (FDA)

• FDA May Make Pre-Recorded Virtual Adcom Presentations Available Before Meeting (Pink Sheet)
• Pfizer's blockbuster-to-be Vyndaqel is too costly for heart patients, study suggests (Fierce)
• What's the hard cost of a pivotal drug trial? A lot less than you might expect (Endpoints)
• UniQure gets out the gate first in race for Huntington's gene therapy (BioPharmaDive)
• Cell and gene therapy 2.0 dominates latest round of biotech IPOs in scramble for a $300M-plus Nasdaq windfall (Endpoints)
• A crucial study of Bellus Health’s chronic cough drug reads out soon. Here’s what you need to know (STAT)
• Merck's next-gen pneumococcal vaccine scores in phase 3 amid race with Pfizer (Fierce)
• Sarepta expands gene therapy toolkit, bets $72.5M to hitch a ride on Codiak's exosome tech (Endpoints)
• FDA approves new Dupixent® (dupilumab) pre-filled pen designed to support more convenient self-administration (Press)
• January - March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) (FDA)
• New China Approvals Include Amgen, Sanofi, Hengrui Drugs, Innovent Biosimilar (Pink Sheet)
• Steep rise in prices of Chinese APIs hits Indian drug makers (PharmaBiz)
• Unichem, Lupin recall hypertension drugs in US (Economic Times)
• Roche’s anti-TIGIT drug shows zero response as monotherapy — but data back effect for lung cancer subset (Endpoints)
• Roche, BioNTech post 'low' response rate in cancer vaccine trial (Fierce)
• Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy (MHRA)
• What’s this? A rival bidder heads back to the table with a better offer for Tetraphase. Antibiotics show faint signs of life (Endpoints)
• Merck advances along a broad PhIII front, aimed at carving up Pfizer’s top-selling vaccine franchise. Could an ambush lay in wait? (Endpoints)
• Looking at a groundbreaking advance, Myovant gets a priority review at FDA; Agenus, G1 forge new China deals (Endpoints)

• Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says (MedtechDive)
• The quest for a COVID-19 digital warning system taps smartwatches, rings and more (Fierce)
• Conformis gains 510(k) for personalized knee tech (MassDevice)
• Standardisation request for MDR and IVDR refused; now what? (MedicalDevicesLegal)
• New Notified Body's Timelines Raise Hopes For Challenged French Medtech Market (MedtechInsight)

• Transition to new GMP requirements for medicinal products (TGA)
• Essure Negligence Suit Shouldn't Be In Pa. Court, Bayer Says (Law360)
• Diagnostics Co. Sued After COVID-19 Test Revoked By FDA (Law360)