Recon: Moderna to seek EUA for COVID-19 vaccine in children under 6; Pfizer’s ulcerative colitis drug hits goals in late-stage trial
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years (STAT) (Bloomberg) (Reuters)
- Ahead of FDA committee to discuss new ALS drug, the jury remains out on how much benefit is enough for approval (Endpoints)
- Ophthalmic Drug Dispensers Being Reclassified As Combo Products Get Some Regulatory Leeway (The Pink Sheet) (Bloomberg)
- Kids’ Cancer Research Bill Draws Wariness From Drug Industry (Bloomberg)
- What Congress Could Do About Remote US FDA Inspections That Are Not Inspections (The Pink Sheet)
- Bipartisan Duo Tapped to Build Support for Insulin Cap Plan (Bloomberg)
- Abbott Infant Formula Plant Found Unsanitary Before Recall (Bloomberg) (Reuters)
- AstraZeneca's preventative COVID shot set to win EU clearance this week-sources (Reuters)
- EMA’s New Emergency Task Force Gets ‘Balanced’ COVID-19 Expertise (The Pink Sheet)
- As branded drug sales surge, analysts predict China market will remain 'very attractive' (Endpoints)
- UK watchdog slaps AZ, Allergan, GSK, Sanofi and Brittania for marketing breaches (Fierce)
- Orphazyme Teeters On The Brink As Arimoclomol File Is Pulled (Scrip)
- Novartis’ Bouchard On Delivering Personalized Cancer Medicine In Asia Pacific, Middle East, Africa (Scrip)
- Fauci does not expect major surge in COVID cases in US (Reuters)
- Novavax says its COVID vaccine gets India authorisation for teens (Reuters)
- Trying to Solve a Covid Mystery: Africa’s Low Death Rates (NYT)
- Mexico sticking to plan to package Russian COVID-19 vaccine (Reuters)
- S.Korea gives emergency approval for adult use of Merck's COVID pills – Yonhap (Reuters)
- Pfizer’s $7B bet delivers phase 3 success, advancing bid to establish new drug in ulcerative colitis Arena (Fierce) (Reuters)
- Teva suffers setback on in-house asthma program as a PhII study is halted early due to futility (Endpoints)
- COVID vaccine maker Moderna flags Japan ambition with sumo sponsorship (Reuters)
- Moderna trains its mRNA tech on the common cold and a triple whammy against 3 respiratory diseases (Fierce)
- Aurobindo, major generic drug maker, will close a key U.S. production plant (STAT)
- Aligos hacks off 2nd hep B med since January after ‘unexpected’ reaction in 4 weeks (Fierce)
- LifeMine locks down $70M ‘dream scenario’ fungi partnership with GSK—and a fundraising too (Fierce)
- Catalent completes $30m expansion to biologics network (BioPharma Reporter)
- Sanofi CEO Paul Hudson continues hunt for new tech, spearing a deal with organoid startup (Endpoints)
- Merck development chief Roy Baynes is stepping out and reuniting with Roger Perlmutter at a biotech startup (Endpoints)
- FDA Releases Draft Device User Fee Agreement (MedTech Insight)
- Medtech’s top 10 money raisers of 2021 (Fierce)
- Another Philips ventilator recall gets Class I label from the FDA (MedTech Dive)
- FDA clears Quantum Surgical’s liver-cancer-focused ablation robot (Fierce)
- Bidding War As China Opens Up $2bn COVID-19 Antigen Test Market (MedTech Insight)
- Brain Implant Allows Fully Paralyzed Patient to Communicate (NYT)
- Novo Nordisk, Novartis Settle on Eve of Victoza Patent Trial (Bloomberg)
- Biotech founders sent to jail for stealing trade secrets (BioPharma Reporter)
- Generic drug industry calls on FTC to dig into monopsony power among buyers, PBMs (Endpoints)
- Purdue Pharma Opioid Settlement Appeal to Proceed in Late April (Bloomberg)
- A look into the 340B explosion of growth as Gilead and J&J join more than a dozen peers setting their own terms (Endpoints)
- Balwani Blames Holmes As 2nd Theranos Fraud Trial Opens (Law360)
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