Recon: FDA and Biogen’s Aduhelm back channel; FDA rejects MediWound burn treatment

• Inside ‘Project Onyx’: How Biogen used an FDA back channel to win approval of its polarizing Alzheimer’s drug (STAT) (Endpoints)
• 'Biased and misleading': No holds barred in FDA's statistical review of Biogen's Aduhelm (Endpoints)
• New York takes Teva, McKesson, others to trial over opioids (Reuters) (NYTimes)
• MediWound shares tumble as FDA declines to approve treatment for burns (Reuters)
• Walmart launches low-priced private label analog insulin (Reuters) (STAT) (CNBC)
• Moderna's COVID-19 vaccine shows promise against Delta variant in lab study (Reuters)

• EU picks antibody treatments, arthritis drug as preferred COVID-19 therapies (Reuters)
• Sanofi to invest in mRNA vaccines development (Reuters) (Boston Globe) (FT)
• India's Cipla gets nod to distribute partner Moderna's COVID vaccine (Reuters)
• Russia's Sputnik V shot around 90% effective against Delta variant, developers say (Reuters)
• Five Indian drugmakers to jointly start trial of Merck & Co's COVID-19 drug (Reuters)
• African Union wants Covishield approved for EU COVID-19 certificate (Reuters)
• China's CanSino cuts ties with Brazil firm, halting vaccine licensing (Reuters)

• Vietnam approves Moderna's COVID-19 vaccine for emergency use (Reuters)
• Ireland allows AstraZeneca vaccine for all adults, cuts dose gap (Reuters)
• Covishield: India seeks EU travel approval for its main vaccine (BBC) (Economic Times)
• J&J explores ways to speed up delivery of its COVID-19 vaccine in India (Reuters) (Economic Times)
• Moderna SE Asia partner says regional vaccine supplies booked until year-end (Reuters)
• Biden administration to send COVID vaccines to Peru and Pakistan (Reuters)

• Ranitidine Did Not Convert to Carcinogen in Two Small FDA Studies (Medpage)
• Gilead, Foresite take an unknown pandemic antiviral public in $250M SPAC deal (Endpoints)
• BioMarin resubmits haemophilia A gene therapy to the EMA (PharmaTimes)
• ABPI launches updated Code of Practice (PharmaTimes)
• Cel-Sci's 11-year cancer drug odyssey ends in failure, sinking stock, but plots FDA filing anyway (Fierce)
• Amgen adds 400 jobs in central Ohio as part of an expansion of its packaging operations (Endpoints) (Fierce)
• WuXi's STA to build massive manufacturing facility in Delaware, adding 500 jobs (Fierce)
• Lonza Invests in Facility in China (GEN)
• MHLW to Start Study on US, European Schemes on ADR Evaluation (PharmaJapan)
• Alzheimer's gold rush inspires $565M deal between Chinese pharma powerhouse and little German biotech (Endpoints)
• Can a small band of biopharma players succeed where Eli Lilly failed? They’re taking a shot (Endpoints)
• Goldman Sachs backs clinical trial services in the cloud with $230M equity play amid decentralized study craze (Endpoints)
• At biotech's smallest companies, female executives make up only a fraction of C-suite leaders — report (Endpoints)
• Promises of a next-gen sequencing approach earn Element Biosciences a hefty Series C. Is an IPO next? (Endpoints)
• Petra Dörr: EDQM Appoints First New Director In 14 Years (Pink Sheet)
• Novartis, GBT sickle cell drugs face coverage hurdles as gene therapy threats loom: survey (Fierce)

• A Chat With Jeff Shuren: FDA Device Center Chief Worries About Agency Staffing; Talks MDUFA V, Pandemic, More (MedtechInsight)
• Abiomed scores FDA approval for upgraded, dual-sensor Impella heart pump (Fierce)
• Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast (MedtechDive)
• Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe (MedtechDive)
• ADA 2021: Senseonics shows off accuracy of its 6-month implanted glucose sensor (Fierce)
• ADA 2021: Medtronic's smart insulin pen helps control blood sugar levels in study (Fierce)

• 3rd Circ. Asks Pa. Justices To Take Up Device Liability Row (Law360)
• Pharma Co. Says Contract Fight Can't Be Painted As Fraud (Law360)
• Takeda Hit With Antitrust Suit Over IBS Drug Amitiza (Law360)