Recon: Biden admin embarks on effort to develop next-gen COVID-19 vaccines; EU approves Bavarian Nordic’s Monkeypox vaccine

| 25 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • White House to launch effort to develop next generation of Covid vaccines (STAT) (Barrons)
  • FDA puts the microscope on 2 more cancer approvals without voluntary withdrawals (Fierce)
  • Biden administration weighs declaring monkeypox a health emergency (Washington Post) (Reuters)
  • Monkeypox ‘Can Be Contained” in US, White House Doctor Says (Bloomberg)
  • Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply (Endpoints) (The Pink Sheet)
  • Takeda is heading to the FDA with positive PhIII results for HyQvia in rare autoimmune disease (Endpoints)
  • Medexus resubmits NDA as it still looks to repurpose a decades-old drug (Endpoints)
  • Unlikely duo leads bipartisan Senate bill to expand Right to Try into MDMA and psilocybin (Endpoints)
  • Exclusive: Turnover tsunami at FDA's pharma inspections office puts the backlog in sharp focus (Endpoints)
  • Biden covid symptoms continue to improve, White House says (Washington Post)
  • As new variant spreads, a crucial drug to protect the most vulnerable goes vastly underused (STAT)
  • UnitedHealthcare Announces Zero Cost Sharing For Insulin As Legislative Relief Faces Challenges (The Pink Sheet)
In Focus: International
  • WHO declares global health emergency over monkeypox outbreak (Reuters) (Bloomberg) (STAT) (Biospace) (Washington Post)
  • Bavarian Nordic nabs EU approval for monkeypox vaccine as WHO declares global health emergency (Endpoints)
  • Japan detects first monkeypox case (Reuters)
  • Hite Wins EMA Recommendation To Market Tescartes For Leukemia Patients (The Pink Sheet)
  • Payer Wish List For EU Pharma Legislation – Is The European Commission Listening? (The Pink Sheet)
  • Janssen’s Multiple Myeloma Drug Among 11 Products To Get EMA Thumbs Up (The Pink Sheet)
  • EMA joins regulatory coalition in calling for RWE to be integrated into regulatory decisions (Endpoints)
  • EU states should act now before winter COVID waves strike, official says (Reuters)
  • Pfizer and Flynn Under Fire Again for Alleged Overpricing of Anti-Epilepsy Drug (Biospace)
  • Roche Disappointed By English Funding Rejection For Gavreto But Will Not Appeal (The Pink Sheet)
  • After A Bumper 2021, How French Biotech Is Surviving Market Doldrums (Scrip)
  • What to Know About the Marburg Virus Disease (NYT)
Pharma & Biotech
  • On a roll, AstraZeneca flags looming approvals for three big drug franchises (Endpoints)
  • China’s Rona raises stake in the siRNA game by buying platform, 4 preclinical liver drugs from Sanofi (Fierce)
  • Lonza posts double-digit growth in H1 thanks to strong pharma demand (Endpoints)
  • Roche, Biogen temper Alzheimer’s expectations in Q2 calls. Will Lilly follow suit in August? (Fierce)
  • After failed Alzheimer’s launch, Biogen writes off the remaining value of its Aduhelm inventory (Fierce)
  • 7 months after announcing a pivot to drug discovery, Zymergen is acquired by Gingko  (Fierce)
  • Study Supports Opposing Role of T-Cells in Promoting and Preventing Colorectal Cancers (Biospace)
  • US FDA Delays UDI Database Enforcement For Low-Risk Devices To December (MedTech Insight)
  • FDA Clears iRhythm’s Afib-Detecting Wearable Running Software Co-Developed By Verily (MedTech Insight)
  • New Blood Test Detects Neurogenerative Disease; Offers Hope For Earlier Treatment (MedTech Insight)
  • That’s a wrap: BioCircuit seals up FDA clearance for surgical nerve-repairing tape (Fierce)
  • Roche Diagnostics Names Diagnostics Leader Schinecker As New CEO (MedTech Insight)
Government, Regulatory & Legal
  • Axsome Hid Problems Affecting Migraine Drug Approvals, Suit Says (Bloomberg)
  • Biogen Directors Hatched Schemes to Its Detriment, Suit Says (Bloomberg)
  • Demanding more impact from impact litigation: lessons to be learned from multi-state opioid settlements (STAT)
  • Metric, Spectrum Diagnostics Settle False Claims Act Allegations (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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