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