Recon: FDA staff indicates support for Bluebird gene therapy; FDA expert panel reviews Novavax vaccine

ReconRecon | 07 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Bluebird bio's blood disorder therapy effective - FDA staff (Reuters) (Endpoints)
  • FDA expert panel weighs Novavax COVID vaccine (Reuters) (WSJ)
  • FDA advisers recommend authorization of Novavax’s Covid-19 vaccine (STAT)
  • Former Lilly manager files whistleblower lawsuit over manufacturing failures at production plant (STAT) (Fierce)
  • Seres Therapeutics, armed with new safety data, eyes first FDA approval for a microbiome drug (Fierce) (Endpoints)
  • FDA slams small pharma for misleading ad with a dearth of safety info and dubious stat calculations (Endpoints)
  • Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval (The Pink Sheet)
  • How Biogen’s Aduhelm Bet Became A Commercial Bust (The Pink Sheet)
In Focus: International
  • UK designates monkeypox as a notifiable disease (Reuters)
  • Factbox: Countries offering vaccine for monkeypox (Reuters)
  • Bavarian Nordic expects to sign more contracts for monkeypox vaccine (Reuters)
  • Canada places USD 56m monkeypox vaccine order at Bavarian Nordic (MedWatch)
  • EMA grants orphan medicinal product designation to Applied’s AT-007 (Pharmaceutical Technology)
  • China’s NMPA accepts Innovent and IASO Bio’s multiple myeloma therapy NDA (Pharmaceutical Technology)
  • Arcutis Enjoys Seborrheic Dermatitis Win But Experts Itching For Psoriasis Approval (Scrip)
  • Guinea reports first H5N1 bird flu outbreaks on farms (Reuters)
Pharma & Biotech
  • Novartis is latest victim of cyberattack, but claims no confidential data compromised — report (Endpoints) (MedWatch)
  • Eli Lilly squares up to Novo Nordisk on obesity market (MedWatch)
  • Following deep cuts, Yumanity strikes a deal to sell drugs to J&J, hands the keys to Genentech-partnered Kineta (Endpoints)
  • Tough markets take a double hit on Vincerx’s workforce, clinical program (Fierce)
  • Code Bio launches with $75M to reinvent genetic medicine for rare and not-so-rare diseases (Fierce)
  • Racing Sanofi, ImmunOs bags $74M for myeloid checkpoint trials in cancer patients (Fierce)
  • Aurobindo Expects To Be In Top Three For Immunology Biosimilar - Is It Xolair? (Scrip)
  • A former Merck director's Pfizer-backed biotech will take on his old bosses in nascent LILRB field (Endpoints)
  • Sanofi moves into big Cambridge HQ, where 2,500 will work (Fierce)
  • ASCO: Black breast cancer patients want to participate in trials but adequate information is hard to come by (Fierce) (STAT)
  • AbbVie unveils diversity, climate and accessibility strategies in new report (Endpoints)
  • How to Solve The Advanced Therapies Skills Shortage (Scrip)
  • Type 2 diabetes may accelerate brain function decline (Washington Post)
  • Expert: Granting More Than 1 Year To Comply With QMSR Rule Puts FDA In A Pickle (MedTech Insight)
  • Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics (MedTech Dive)
  • Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans (MedTech Dive)
  • Ambu recalls single-use product one year after launch (MedWatch)
  • Apple Watch’s ‘AFib History’ feature ripens with new FDA clearance (Fierce)
Government, Regulatory & Legal
  • DC appeals court quashes Nostrum's suit against FDA, explaining CRLs are not final rejections (Endpoints)
  • Bristol-Myers Gets First Nod for $11 Million HIV Drug Settlement (Bloomberg)
  • Connecticut Law Requires Medical Device Makers to Report to FDA  (Bloomberg)
  • CEO Faces Fraud Charges Over False COVID-19 Test Sale Claims (MedTech Insight)
  • Moderna Shield Argument on Vaccine Royalties Rejected by Rivals (Bloomberg)
  • Mask Ruling Appeal Gets Backing From Former CDC Directors (Bloomberg)
  • Sackler Criminal Case Sought by Connecticut AG Over Opioids (Bloomberg)
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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