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June 5, 2023
by Michael Mezher

Recon: Merck, Moderna vaccine cut spread of skin cancer 65% in midstage trial; FDA allows imports of unapproved Chinese chemo drugs amid shortage

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data (Reuters) (Endpoints)
  • Analysis: Stelara patent deal puts J&J back on path to $57 bln 2025 revenue forecast (Reuters)
  • US FDA delays decision on SpringWorks Therapeutics' tumor treatment (Reuters)
  • FDA rejects Clovis' long-shot bid for approval of Rubraca (Fierce)
  • Cancer drugmakers rise as industry meet fuels investor interest (Reuters)
  • Grail says about 400 patients incorrectly informed they may have cancer (Reuters)
  • FDA oncology head wants advisory panels to keep voting on new drugs (STAT)
  • FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage (CNBC) (FT)
In Focus: International
  • AstraZeneca's Tagrisso slashes death risk in certain post-surgery lung cancer patients (Reuters) (STAT)
  • Novartis drug cuts recurrence risk by 25% in early-stage breast cancer (Reuters) (STAT)
  • Novo Nordisk in talks buy controlling stake in Biocorp (Reuters) (MedtechDive)
  • Report finds NHS may miss out on new drugs due to rising costs (Pharmafile)
  • Nigeria Forex Shortage Hurt Drug and Vaccine Supplies, Firm Says (Bloomberg)
  • AstraZeneca defies geopolitics to bet on China (FT)
  • Pharma Industry On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics (Pink Sheet)
  • Digital Health: Commission and WHO launch landmark digital health initiative to strengthen global health security (European Commission)
Pharma & Biotech
  • Akero says NASH drug shown to reduce liver fat by 65% in some patients (Reuters) (STAT)
  • ImmunoGen drug prolongs survival of women with advanced ovarian cancer (STAT)
  • Drug developer Servier's brain cancer drug slows tumor progession considerably (Reuters)
  • Gilead’s CAR-T therapy prolongs survival in key blood cancer trial (STAT)
  • AstraZeneca, Daiichi Sankyo’s Enhertu impresses in 'game-changing' study with many cancers: #ASCO23 (Endpoints)
  • Bristol Myers' Opdivo keeps cancer at bay in more lymphoma patients than Seagen's Adcetris in PhIII: #ASCO23 (Endpoints)
  • ASCO: Merck bills Keytruda, used around surgery, as new standard in 'messy' early lung cancer realm (Fierce)
  • Bellerophon Therapeutics trial fails despite innovative digital endpoint (STAT)
  • To push antibiotic makers to be more green, a new system will certify manufacturing practices (STAT)
  • ASCO: Johnson & Johnson's Balversa tops chemotherapy in bladder cancer trial (Fierce)
  • J&J takes victory lap on its Carvykti data. But how many patients will take it — and when? #ASCO23 (Endpoints)
  • AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval (Fierce)
  • Biogen scraps late-stage study for Parkinson’s drug (BioPharmaDive)
  • Early data show Bicara’s bispecific helps shrink head and neck cancers when combined with Keytruda: #ASCO23 (Endpoints)
  • FDA pulls paid Eisai consultant from temporary role on adcomm reviewing Eisai's new Alzheimer's drug (Endpoints)
  • FDA lifts clinical hold on Foghorn’s study for blood and bone marrow cancer treatment (Endpoints)
Medtech
  • Exclusive: Musk's Neuralink valued at about $5 bln despite long road to market (Reuters)
  • Medtronic Creates Chief Technology And Innovation Officer Role (MedtechInsight)
  • FDA collects another 6,000 complaints—including 40 deaths—linked to Philips’ CPAP recall (Fierce) (MedtechDive)
Government, Regulatory & Legal
  • US drugmaker Indivior to pay $102.5 million to settle Suboxone monopoly claims (Reuters)
  • Ted Love, BIO’s first Black board chair, aims to rehab biotech’s image in Washington (STAT)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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