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

ReconRecon
| 01 August 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
 
  • 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)
 
In Focus: International
  • 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)
 
Pharma & Biotech
 
  • 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)
 
Medtech
 
  • 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)
 
Government, Regulatory & Legal
  • 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)
 
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
 

 

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