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June 6, 2024
by Jason Scott

Recon: Novartis, Roche face Italian antitrust probe, Novo braces for generic Ozempic in China

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Psychedelics companies see FDA panel’s vote as a growth opportunity, not a roadblock (STAT)
  • Novavax will be able to supply Covid-19 vaccines this fall (STAT)
  • Appeals court overturns Sutter Health’s victory in $400 million antitrust case (STAT)
  • 100,000 models show that not much was learned about stopping the Covid-19 pandemic (STAT)
  • Exclusive: Walmart shut down its healthcare clinics after losses reached nearly a quarter of a billion dollars (Endpoints)
  • Moderna’s mRNA candidate picked for FDA’s Operation Warp Speed for rare diseases (Endpoints)
  • US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug (Reuters)
  • COVID-19 Vaccines: Novavax Gets Reprieve With US FDA Panel Supporting JN.1 Formulation (Pink Sheet)
  • Democratic contraception access bill fails in US Senate (Reuters)
  • BIO Notebook: Amgen CEO Blasts IRA, Novo Nordisk Stays Cautious On BD, And More (Pink Sheet)
  • Medicare Negotiation: Therapeutic Alternatives Selection Will Become More Predictable, CMS Says (Pink Sheet)
  • Cows infected with bird flu have died in five US states (Reuters)
In Focus: International
  • Novartis, Roche unit and others face Italy antitrust probe over eye drug (Reuters)
  • Japan Nods Include Torii's Vtama, Skyrizi In New Uses (Pink Sheet)
  • Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China (Reuters)
  • EU HTA Regulation: Draft Conflicts Of Interest Rules Fail To Consider Orphan Drugs (Pink Sheet)
  • EMA Advises On Shift From Quadrivalent To Trivalent Flu Vaccines (Pink Sheet)
  • Staff at drugmaker under U.S. scrutiny worked with Chinese military scientists (Reuters)
Pharma & Biotech
  • Biohaven’s autoimmune drug disappoints, and other biotech news updates from the week (STAT)
  • GSK acquires tiny RNA startup Elsie, boosting its grand plans for developing RNA drugs (Endpoints)
  • AbbVie's ovarian cancer therapy succeeds in mid-stage trial (Reuters)
  • Who are the women making a mark in biopharma R&D? Nominate them for Endpoints’ 2024 special report (Endpoints)
  • Replimune aims for accelerated approval of melanoma therapy; Structure's upsized $476M offering (Endpoints)
  • Boehringer Ingelheim, Zealand’s positive Phase 2 MASH fibrosis data ‘unintentionally’ released (Endpoints)
  • To pay off debt and stay open, Seres will sell microbiome pill to partner Nestlé (Endpoints)
Medtech
  • Do digital physical therapy solutions work? New report has some insights (STAT)
  • Saliva test identifies men at high risk of prostate cancer (MedTech Dive)
  • Moon Surgical secures FDA nod for commercial soft tissue robot (MedTech Dive)
  • Stronger oversight of AI needed in medical devices, ECRI CEO says (MedTech Dive)
  • Dexcom connects G7 CGM directly to Apple Watch in US (MedTech Dive)
Government, Regulatory & Legal
  • FTC loses its bid to block Novant’s hospital merger in North Carolina (STAT)
  • US FDA rescinds market denial order for Juul products (Reuters)
  • Federal officials and physician groups express outrage over revelations of recent coercive sterilizations (STAT)
  • A new initiative will help governors and local leaders fight the next pandemic (STAT)
  • Withdrawal symptoms hit one in six patients stopping antidepressants, review finds (STAT)
  • Close a regulatory loophole in the ACA to provide vaccine access for all Americans (STAT)
  • How Accumulus’s ‘Dossier In The Cloud’ Platform Is Modernizing ‘Inefficient’ Drug Regulation (Pink Sheet
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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