Recon: Gilead warns of counterfeit HIV medicines in US; Novavax delays seeking approval for its COVID vaccine

• FDA Covid-19 Vaccine Booster Plan Could Be Ready Within Weeks (WSJ)
• Novavax again delays seeking U.S. approval for COVID-19 vaccine (Reuters)
• Novavax Says U.S. Will Pause Funding for Production of Its Vaccine (NYTimes)
• Medtronic to buy Intersect ENT in $1.1B deal targeting chronic rhinosinusitis market (MedtechDive)
• Gilead says aware of counterfeit HIV medicines being distributed in U.S. (Reuters)
• FDA Approves New Treatment for Pompe Disease (FDA)
• U.S. plans to give extra COVID-19 shots to at-risk Americans, Fauci says (Reuters)
• FDA shoots down Spectrum's neutropenia drug, citing manufacturing issues (Endpoints)
• FDA Med Conference Study Raises Pharma Enforcement Risks (Law360)
• Court decision pushes FDA to make historical shift and regulate borderline drug/device products as devices (Endpoints)
• Federal circuit upholds Teva-GlaxoSmithKline decision, landing another blow to 'skinny' labels (Endpoints) (Law360)

• Interoperability of track and trace systems: key to public health protection (EMA)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 August 2021 (EMA)
• EU: too early to say if COVID booster needed as Germany, France press ahead (Reuters)
• CanSinoBIO COVID-19 says booster shot can reverse drop in antibodies (Reuters)
• J&J seeks emergency use nod for COVID-19 vaccine in India (Reuters)

• White House Makes Back-to-School Push for Student Vaccinations (NYTimes)
• A giant trial of COVID-19 treatments is restarting. Here are the drugs it’s betting on (Science)
• South African study shows high COVID protection from J&J shot (Reuters)
• Early signs COVID-19 vaccines may not stop Delta transmission, England says (Reuters)
• SII won't seek special marketing nod from EU body for vax (Economic Times)
• DHS watchdog to blame data management for rocky PPE distribution: report (The Hill)

• Early Access to Medicines Scheme (EAMS) Consultation (MHRA)
• Biden plan backfires as court tells AstraZeneca: No requirement to provide discounted drugs to unlimited contract pharmacies (Endpoints)
• A Texas-based pharma has enlisted Catalent for oral solid manufacturing; Cytiva drops massive manufacturing investment in home state (Endpoints)
• Q&A: BeiGene exec reflects on path that led them to select NJ for a major manufacturing/R&D campus (Endpoints)
• FDA orders clinical hold on Aprea's p53 reactivator as struggling biotech pledges to address safety concerns (Endpoints)
• Drug pricing disruptor EQRx makes the big leagues with $1.8B SPAC deal and a new CEO at the helm (Endpoints)
• With an assist from AstraZeneca, the salvage crew at Sierra bets another $216M they can resurrect an old Gilead JAK drug (Endpoints)
• Dicerna's RNAi drug shows 'inconsistent' results in rare kidney disease, tanking shares despite trial win (Endpoints)
• Chinese startup with Merck vet at the helm acquires rights to Oyster Point's eye disease nasal spray (Endpoints)
• mGx M&A? Moderna execs are leveraging their Covid cash on gene editing, gene therapy deals (Endpoints)

• ResMed pegs Philips recall to add up to $350M in sales as it struggles to meet surging demand (MedtechDive)
• TriGUARD 3 Data Does Not Pass Muster: FDA Experts (MedtechInsight)
• BD results called mixed amid bullish COVID-19 testing outlook (MedtechDive)
• Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum (FDA)
• Zoll scores FDA approval for updated sleep apnea implant acquired in Respicardia buyout (Fierce)
• Illumina posts 78% revenue growth as cancer, DNA testing ramp back up (Fierce)
• iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.' (MedtechDive)

• Federal Court Orders California Company and Owner to Stop Distribution of Unapproved, Misbranded and Adulterated ‘Poly-MVA’ Products (DOJ)
• Actavis Marketed Testosterone Drug Off-Label, Ill. Jury Told (Law360)
• 8th Circ. Backs 3M In Nixing Suit Over Warming Device (Law360)
• Teva Piles Onto Strong-Arm Tactic Accusations Against DOJ (Law360)