Recon: US recruits scientists abroad for COVID vaccine trials; FDA places Passage Bio gene therapy trial on hold

• US recruits scientists abroad for COVID-19 vaccine trials, pledges access to supply (Reuters)
• The next unprecedented vaccine hurdle: Making hundreds of millions of doses (Politico)
• Flu season prep, complicated by COVID-19, starts early this year (Reuters)
• Passage Bio slapped with gene therapy clinical hold (Fierce) (Endpoints)
• Deaths from the most common lung cancer are falling fast, hinting at the impact of improved treatment (STAT) (Endpoints) (NEJM)
• The FDA just approved the third Duchenne MD drug. And regulators still don’t know if any of them work (Endpoints)
• Novo Nordisk’s concizumab trials can resume after safety trial halt (Fierce) (Endpoints)
• Scholar Rock’s experimental SMA therapy nabs speedy review voucher (Fierce)

• EU wraps up talks with J&J for 200 million doses of potential COVID-19 vaccine (Reuters)
• German institute withdraws report saying COVID-19 vaccine could be available (Reuters)
• Argentina, Mexico to produce AstraZeneca COVID-19 vaccine (Reuters)
• Zydus Cadila launches India's cheapest remdesivir version at $37 per vial (Reuters)
• AstraZeneca says could begin COVID-19 vaccine production early in 2021 (Reuters)
• Novartis’ CAR-T partner in China wraps $383M take-private deal engineered by CEO (Endpoints)
• CanSino reaps $748M from Shanghai IPO, says Covid vaccine won't be huge money maker (Endpoints)
• Thermo Fisher-Qiagen deal falls apart after failing to secure shareholder support (MedtechDIve) (Endpoints)

• US records deadliest COVID-19 day of summer with over 1,500 deaths (The Hill)
• Putting Together a Search Party for Better Covid-19 Treatments (Bloomberg)
• Accuracy of US coronavirus data in question as decline in testing skews drop in new cases (CNBC)
• A Deadly Coronavirus Was Inevitable. Why Was No One Ready? (WSJ)
• Why Is It Hard to Get a Rapid Covid-19 Test? The Machines Are in Short Supply (WSJ)
• Indian drugmaker Biological E. to make substance used in J&J's potential COVID-19 vaccine (Reuters)
• Novavax says SK bioscience to supply antigen for coronavirus vaccine (Reuters)
• The Trump administration haphazardly gave away millions of Covid-19 masks — to schools, broadcasters, and large corporations (STAT)
• The Challenges of Warp Speed: FDA, Administration Not Always On Same Page (Pink Sheet)
• Israeli hospital trials super-quick saliva test for COVID-19 (Reuters)
• Hologic jumps into COVID-19 pool testing, aimed at boosting lab capacity (MedtechDive)
• Coronavirus (COVID-19) Update: Daily Roundup August 12, 2020 (FDA)

• 21 biotech startups that are set to take off, according to top VCs (Business Insider)
• Galaxy Life Sciences lands $50 million deal to build in central Massachusetts biomanufacturing park (Endpoints)
• ‘We’re going to keep going’: A new clinical trial for ALS gives patients hope (STAT)
• AbbVie, Roche’s Venclyxto combo reduces risk of death in first-line AML (PMLive)
• Gilead’s Truvada becomes first China-approved drug to prevent HIV-1 (Pharmafile)
• FDA accepts application for self-administered Xolair use (PharmaTimes)
• Celleron picks up discarded cancer drug from Roche (PharmaTimes)
• VBL announces positive PhIII data for ovarian cancer drug; GeneCentric partners with Janssen on bladder cancer (Endpoints)
• Strides Hits Pause On Investments In Stelis’s Injectables (Scrip)

• FDA posts Essure adverse events pulled from social media (MedtechDive)
• NICE Updates Neurostim Guidance For Depression, Epilepsy (MedtechInsight)
• FDA clears RapidAI blood clot detector (MassDevice)

• Pfizer Gets PTAB To Wipe Out Rest Of Sanofi's Lantus Patent (Law360)
• How Orange Book Listings Affect Patent Density, Exclusivity (Law360)
• Resellers Say Drug Makers Erred In MDL Bellwether Claim (Law360)
• Opioid Hearings In NY AG's Suit Will Be Made Public (Law360)
• J&J, Bayer, Teva Sued Over Eye Damage From Cyst Meds (Law360)
• Fresh Twist: India Stays Revocation Order On Novartis Ceritinib Patent (Scrip)