Recon: Sanofi wins first FDA approval for ASMD drug; Novo Nordisk lays out $1.1B for Forma’s blood disorder drug

ReconRecon | 01 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Sanofi Wins FDA Approval for First ASMD Drug (BioSpace) (Fierce) (Endpoints) (MedPage Today)
  • U.S. FDA green lights Omicron-targeted COVID boosters ahead of revaccination campaign (Reuters)
  • U.S. CDC advisers expected to recommend Omicron specific vaccine boosters (Reuters)
  • Proposal to Harmonize Research Protection Rules Clears Review (Bloomberg)
  • Biden administration weighs saving monkeypox doses for potential smallpox outbreak (Politico)
  • US House Republicans Launch Oversight Of Medicare Price ‘Negotiation’ Program (Pink Sheet)
  • ICER reaffirms Qsymia as most cost-effective obesity treatment in final report (Endpoints)
  • US expects to soon run out of government Covid-19 funds for vaccines, treatments (Endpoints)
  • No more free COVID vaccines: USA plots move to private market in 2023, setting up market clash between Pfizer and Moderna (Fierce)
In Focus: International
  • EU regulator backs use of Novavax COVID shot as a booster (Reuters)
  • Canada authorizes Moderna's Omicron-adapted COVID vaccine for adults (Reuters)
  • Biosimilar Lucentis Sponsors Had To Navigate Different FDA, EMA Requirements (Pink Sheet)
  • First-Of-Kind Treatments Win Funding in England & Wales (Pink Sheet)
  • India develops its first cervical cancer vaccine (Reuters)
  • Pakistan Updates Pharmacovigilance Guidance To Factor In New Rules (Pink Sheet)
  • S.Africa's Aspen, India's Serum Institute sign vaccines deal for Africa (Reuters)
  • A Q&A with WHO’s Maria Van Kerkhove on Covid — and fatigue over the pandemic (STAT)
Pharma & Biotech
  • As Novo Nordisk begins PhII sickle cell trial, it snags a later-stage blood disorder drug in $1.1B Forma buy (Endpoints) (BioSpace)
  • Once valued at more than $5B, Intarcia Therapeutics sees all of its execs depart and its final shot at FDA denied (Endpoints)
  • As activist investor ratchets up pressure, Mereo makes more cuts to extend cash runway into 2025 (Fierce) (Endpoints)
  • After disappointing Wall Street last year, Denali touts new biomarker data hoping to forge clear path to FDA (Endpoints)
  • Novartis taps Merck executive Marshall to replace Bradner as research head (Reuters)
  • Sanofi spinoff EUROAPI hits the ground running with double-digit growth in first half (Fierce)
  • Annual brand planning underway, but it’s about time for a disruption, says former Big Pharma commercial leader (Endpoints)
  • One protein, many cancers: Immatics finds a multi-tumor target for adoptive T-cell therapies (Fierce)
  • Seeking to accelerate R&D response, philanthropist puts up $171M to create pandemic antiviral center (Fierce)
  • EU MDR and IVDR Cybersecurity Measures Not Enough To Prevent Attacks, Warns ENISA (MedTech Insight)
  • Malfunctioning Integra intracranial monitor was used on patient who died: FDA (MedTech Dive)
  • Baxter gets 510(k) clearance for syringe pump, spurring optimism of faster FDA review process (MedTech Dive)
  • European Regulatory Roundup, August 2022: EU On Cusp Of Big Implementation Push
  • (MedTech Insight)
  • Medtronic’s Extravascular ICD Hits Targets In Trial; Will Soon Compete With Boston Scientific’s S-ICD (MedTech Insight)
  • Illumina opens first manufacturing facility in China to supply gene sequencing products (MedTech Dive)
  • Medtronic picks up BioIntelliSense’s round-the-clock vital sign monitor in distribution deal (Fierce)
  • JenaValve nabs $100M to clear a path toward FDA approval of dual-use TAVR system (Fierce)
  • Guardant, Merck KGaA expand precision therapeutics collab, focusing on hard-to-treat cancer (Fierce)
Government, Regulatory & Legal
  • AstraZeneca scores injunction to temporarily halt former exec’s start at crosstown rival GSK (Fierce) (Endpoints)
  • Bard $3.3 Million Verdict Upheld in Blood-Clot Filter Case (Bloomberg)
  • Hyloris Faces Trade-Secret Claims Over New Heart Arrhythmia Drug (Bloomberg)
  • Liquidia, UTC Each Scores Partial Win in Lund-Drug Patents Case(Bloomberg)
  • J&J to pay $40.5 million to settle New Hampshire opioid lawsuit (Reuters)
  • Federal judge rules against FDA in major stem cell oversight case (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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