Recon: FDA and Biogen’s Aduhelm back channel; FDA rejects MediWound burn treatment
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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