Regulatory Focus™ > News Articles > 2021 > 6 > Recon: FDA and Biogen’s Aduhelm back channel; FDA rejects MediWound burn treatment

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

Posted 29 June 2021 | By Michael Mezher 

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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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