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