Recon: Sanofi expects EU decision on COVID booster within weeks; FDA reviewers unconvinced ahead of second Amylyx adcomm

ReconRecon | 06 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Lifts Hold on Sarepta’s DMD Trial Following Protocol Adjustments (Biospace) (Fierce) (Pharma Letter)
  • Updated COVID boosters ready in U.S. this week, White House says (Reuters)
  • FDA approves durvalumab for locally advanced or metastatic biliary tract cancer (FDA) (Biospace)
  • FDA expands approval for Vertex's CF drug Orkambi to infants under two years of age (Endpoints) (The Pharma Letter)
  • FDA again finds Amylyx's ALS data lacking ahead of unusual second adcomm, while stressing dire need for treatments (Endpoints) (Pink Sheet) (Washington Post)
  • Two years after a refuse-to-file, Y-mAbs lands an FDA adcomm for its 2nd neuroblastoma treatment (Endpoints) (MedWatch)
  • Alvotech fails pre-approval inspection for its proposed Humira interchangeable biosimilar (Endpoints)
  • COVID-19 Vaccine Manufacturers Urged To Make Labeling Changes To Avoid Administration Errors (Pink Sheet)
  • BARDA Proposes New Consortia For Rapid Pandemic Response (MedTech Insight)
  • How Abbott Kept Sick Babies From Becoming a Scandal (NYT)
In Focus: International
  • EU Regulator Eyes Mid-September For Decision On Comirnaty BA.4/BA.5 Booster Approval (Pink Sheet)
  • Sanofi sees EU regulatory decision on its COVID booster in weeks (Reuters)
  • Boost high-risk people with Omicron-tailored shots first - EU officials (Reuters)
  • EU swats down Illumina's $8B Grail acquisition days after FTC lost antitrust case (Endpoints)
  • EU blocks Illumina acquisition of Grail (MedWatch)
  • Use of Gynecological Drugs Restricted In EU; ‘Urgent’ Safety Review Starts For Pholcodine (Pink Sheet)
  • Britain approves Pfizer/BioNTech's updated COVID-19 booster vaccine (Reuters)
  • Global Coalition Develops Consistent Terminology To Support Decentralized Trials (Pink Sheet)
  • Trial Sponsors Seek New Countries As Russian Market ‘Falls Into The Abyss’ (The Pink Sheet)
Pharma & Biotech
  • Biosimilar giant Biocon gets hit with 483 for issues at sites in Malaysia and India (Endpoints)
  • RWE On The Runway: Trio Of Upcoming Approval Decisions Will Test US FDA’s Thinking On RWE For Efficacy (Pink Sheet)
  • Lonza, Touchlight partner on ‘doggybone DNA’ development (Fierce)
  • BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies (Fierce)
  • Iveric hits again in pivotal eye disease program, keeping it on Apellis’ tail in race to market (Fierce)
  • Synaffix rustles up another ADC deal, allying with Emergence in $360M biobuck pact (Fierce)
  • Aurobindo plugs $37M into biologics expansion as its vaccine arm looks to get in on the contract manufacturing action (Fierce)
  • Five Potential Blockbuster Oncology Approvals To Look Out For In 2023 (Scrip)
  • Why India Pharma Failed To Impress In 2020-22 Bull Run (Scrip)
  • Federal jury convicts medtech executive in $77M blood testing kickback case (MedTech Dive) (MedTech Insight)
  • Owkin AI for identifying breast, colorectal cancer types score EU approval (Fierce)
  • DEKRA Accredited To Audit Against UKCA Marking, But More UK Capacity Needed (MedTech Insight)
Government, Regulatory & Legal
  • Philips settles with DOJ for $29M in 2 alleged False Claims Act violations (Bloomberg) (Fierce)
  • Bayer to Pay $40 Million Over Whistle-Blower’s Bribe Claims (Bloomberg) (STAT)
  • Otsuka and H. Lundbeck Sue Viatris Over Abilify Maintena Again (FDAnews)
  • Court win for United Therapeutics will restrain looming competition for its soon-to-be blockbuster (Endpoints)
  • J&J coughs up $40.5M in New Hampshire opioid settlement, evading upcoming trial (Endpoints)
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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