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)
- 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)
- 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)
- 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)
- 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)
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