Recon: US makes $1.7 billion deal with Moderna for updated Covid booster; Sarepta plans to seek accelerated approval for Duchenne gene therapy

• U.S. Reaches $1.74 Billion Deal With Moderna for Updated Covid-19 Shots (Wall Street Journal) (The Pink Sheet) (Reuters)
• Sarepta to seek early FDA approval for gene therapy to treat Duchenne muscular dystrophy (STAT) (Fierce)
• FDA’s Califf backs limited use of single-arm trials, but says regulatory pathways for some cancers should ‘move into a new phase’ (Fierce)
• FDA Action Alert: Coherus, Sanofi and Regeneron, Acadia, Myovant and Pfizer (Biospace)
• ALS Drugs: Second US FDA Meeting On AMX0035 Gives Amylyx A Chance To Capitalize On Recent Events
• Which drugs may be hit with negotiations if the reconciliation bill passes? Wall St. analysts explain (Endpoints) (Fierce)
• Democrats Face Tough Messaging War on Prescription Drug Bill (Bloomberg)
• JAMA study finds cancer drug data is still largely unavailable to qualified researchers (Endpoints)
• New York Governor Hochul declares state emergency over monkeypox (Reuters)

• Accelerated Assessment Requests Fall Flat At EMA (The Pink Sheet)
• RWE Studies To Hit 100+ Per Year In Europe By 2025 (The Pink Sheet)
• AstraZeneca US Arm to Sell Rare Disease Drugs in More Countries (Bloomberg)
• AbbVie hit for marketing breaches, but PMCA slaps down Vifor, Britannia for repeated failings (Fierce)
• UK CMA Issues £70m Fines To Pfizer And Flynn Over Phenytoin (The Pink Sheet)
• Korea’s Regulatory Innovation Steps Focus On Investment, New Technologies (The Pink Sheet)
• 'The government didn't do anything': Mexican, Brazilian monkeypox responses draw concern (Reuters) (Reuters)

• The Company Behind the World’s Only Monkeypox Vaccine (The Journal [podcast])
• Bristol Myers' combo hits a roadblock in PhIII kidney test as the search to rival Keytruda continues (Endpoints) (Reuters)
• Onwards! Novo Nordisk’s once-weekly insulin marches on after hitting goals in pair of phase 3 trials (Fierce)
• Ipsen invests potential $1.6B to Turbo Charge Marengo’s Path to the Clinic (Biospace)
• After Roe, startups seek to fill Big Pharma’s male contraception gap (Endpoints)
• AstraZeneca’s novel checkpoint inhibitor flunks first phase 3, denting partner’s share price (Fierce)
• AstraZeneca axes Moderna-partnered, phase 2 heart disease drug plus a Wee inhibitor  (Fierce) (Endpoints)
• AstraZeneca lifts revenue guidance on COVID treatment (Reuters)
• Arcutis pulls in a win for its topical version of an old AstraZeneca drug in plaque psoriasis (Endpoints)
• Gilead pads case for top-seller Biktarvy in HIV, hepatitis B co-infection (Fierce)
• J&J is not the first name in Alzheimer’s these days, but Janssen is charting the ‘sweet spot’ behind the scenes (Fierce)

• US Federal Enforcement Priorities Include Clinical Trials, Data Security (MedTech Insight)
• MDUFA V: US FDA Staff Could See September Lay-Off Notices (MedTech Insight)
• US FDA Slaps another Class I Recall On Medtronic (MedTech Insight)
• Dexcom to resubmit G7 glucose monitor for FDA review, pushing back US launch (Fierce)
• FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection (MedTech Dive)
• Medtech’s Role In The Carbon Neutral Challenge To Counter Climate Change – The UK View (MedTech Insight)
• Zimmer Biomet plans AI center to smarten up its hip, knee replacement robots (Fierce)

• AbbVie to pay up to $2.37 billion to settle U.S. opioid claims (Reuters) (Law360)
• Mylan Beats Sanofi on Appeal in Antitrust Case Over EpiPen (Bloomberg)