Recon: FDA approves Gilead’s Veklury for young children; Nektar to lay off 70% of its staff after key drug failure

• US to widen COVID antiviral pill distribution (Reuters) (STAT)
• US FDA approves Gilead's COVID-19 drug for young children (Reuters) (FDA)
• Nektar to cut over 500 jobs following cancer drug failure (Reuters)
• Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies (STAT)
• Experts fear US may default to annual Covid boosters without sufficient data (STAT)
• One in four pharma status reports on follow-up trials are late or aren’t filed (STAT)
• Walgreens, Teva accused of fueling opioid addiction in quest for new markets (Reuters)
• Congress Has to Ask How Much McKinsey Hurt the FDA (NYTimes)
• Trevena's COVID-19 drug trial halted for inferiority as NIH continues ACTIV house cleaning (Fierce)

• Pharma R&D payments to European researchers are like ‘dark money’ (STAT)
• Novartis income edges higher on strong Sandoz, Entresto (Reuters)
• Europe’s push to rival US biotech hubs faces hit from market slump (FT)
• Streamlined EU process promises faster access to breakthrough drugs (FT)
• Pandemic bolsters EU’s role in health policy (FT)
• Explainer: Scientists investigate hepatitis outbreak in children in Europe and US (Reuters)
• Almost 200 cases of unexplained acute hepatitis reported in children -ECDC (Reuters)
• Second Ebola patient dies in northwestern Congo, WHO says (Reuters)

• Global fight against Covid hitting a snag (Politico)
• Veklury performs better the sooner it's given, Gilead says in new study and real-world analysis (Endpoints)
• Mexico to enable COVID vaccination of all children aged 12 and above (Reuters)

• Biden is urged to pursue march-in rights for a pricey cancer drug after NIH delays a petition review (STAT) (Endpoints)
• Califf: More Learning Necessary During Generic Drug Lifecycle (Pink Sheet)
• FDA plans study into how patients and physicians make prescription decisions (Fierce)
• The Endpoints R&D 15: How many blockbusters does $124B buy the biggest spenders in drug research? (Not enough) (Endpoints)
• Roche delays Polivy's blockbuster lymphoma filing as FDA asks for more data (Fierce)
• CRL appeal lands Ardelyx an FDA adcomm meeting for embattled CKD drug (Endpoints)
• In a surprise move, Novartis CEO Vas Narasimhan recruits top analyst Ronny Gal as new strategy, BD chief (Endpoints) (Fierce)
• Deerfield-backed biotech emerges from stealth with gene therapy delivery platforms from Harvard and MIT (Endpoints)
• Daiichi Sankyo and ViGeneron re-up eye disease deal (Endpoints)
• Sol-Gel gets FDA approval for encapsulated skin disease drug (Fierce)
• Sanofi offloads rights to prolonged-release antipsychotic drug (Fierce)
• Protagonist reports a PhII fail in ulcerative colitis, but execs are pushing forward anyway (Endpoints)
• Vivo Capital pitches $60M to bring Arrowhead's RNAi meds to China via joint venture (Endpoints)
• Undeterred by gene therapy’s struggles, a startup launches into a downturn (BioPharmaDive)
• Sanofi taps McLaren to apply racing know-how to pharma manufacturing (Fierce)

• Labcorp beefs up at-home testing options with Getlabs’ on-demand blood draw service (Fierce)
• Medtronic finds new medical, scientific chief in current research and regulatory leader Mauri (Fierce)
• Philips commits more cash to recall as DOJ issues subpoena (MedtechDive)
• Will early trends reported by J&J, Abbott and Intuitive hold in week 2 of earnings? (MedtechDive)

• HHS inspector general rules physician-owned device company poses a low risk of fraud and abuse (MedtechDive)