Recon: FDA clears Pfizer booster for 12- to 15-year-olds; Teva found liable in New York opioid trial

ReconRecon | 03 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • The FDA clears booster shots for 12- to 15-year olds (NYTimes) (STAT) (Reuters) (WashingtonPost)
  • FDA authorizes new Merck Covid-19 pill despite scientists' concerns on its mechanism of action (Endpoints)
  • FDA authorizes the first at-home pills from Pfizer to treat Covid-19 (Endpoints)
  • Interval between Moderna COVID-19 vaccine second shot and booster still six months -FDA (Reuters)
  • FDA approves drug to treat, help prevent types of blood clots in certain pediatric populations (FDA)
  • FDA adds another drug OK to cap a record win list for 2021 (Endpoints)
  • US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18 (Pink Sheet)
  • Roche nets U.S. green light for rapid, home-based COVID test (Fierce)
  • It's a year late, but Novartis has finally steered inclisiran to FDA approval. Will it sell? (Endpoints) (FDA)
  • Hitting a new record on drug approvals, the FDA offers a thumbs-up to another atopic dermatitis contender (Endpoints)
  • On the heels of Tezspire approval in US, Amgen will add filling line in Ireland (Endpoints)
  • Months after missing its PDUFA date, FDA slaps down Takeda's old Shire drug for eosinophilic esophagitis (Endpoints)
  • New York jury holds Teva Pharmaceuticals liable in opioid crisis (STAT) (NYTimes
In Focus: International
  • Emer Cooke’s end-of-year message (EMA)
  • EMA recommends Nuvaxovid for authorization in the EU (EMA)
  • COVID-19: EMA recommends authorisation of antibody medicine Xevudy (EMA)
  • EFPIA Unimpressed By Proposals For Tackling EU Medicines Shortages (Pink Sheet)
  • Omicron evades immunity better than Delta, Danish study finds (Reuters)
  • Omicron 'plainly milder'; new measures not needed, UK's Johnson says (Reuters)
  • Israel now offering fourth covid shot to anyone 60 and older (Washington Post)
  • India vaccines 3.8 million teens in new COVID-19 inoculation push (Reuters)
  • UAE requires coronavirus booster shots for citizens seeking to travel abroad (Washington Post
Coronavirus Pandemic
  • Studies Suggest Why Omicron Is Less Severe: It Spares the Lungs (NYTimes)
  • As Omicron Spreads, Officials Ponder What It Means to Be ‘Fully Vaccinated’ (NYTimes)
  • As At-Home Tests Surge, Doubts Rise About Accuracy of Public Covid Counts (NYTimes)
  • J&J’s booster shot provides strong protection against severe disease from Omicron, a study says (NYTimes)
  • Novavax breaks another pledge for its Covid-19 vaccine. And the US is reportedly fretting about global goals now (Endpoints)
  • A WHO official weighs in on Covid, vaccines, and mistakes that were made (STAT)
  • Beyond case counts: What Omicron is teaching us (STAT)
  • Forecasting the Omicron winter: Experts envision various scenarios, from bad to worse (STAT
Pharma & Biotech
  • Novartis unwraps $1.5B gene therapy buyout — beefing up arsenal against retinal diseases (Endpoints)
  • Not everybody is buying it, but everybody is definitely talking about a new Biogen buyout report (Endpoints)
  • AstraZeneca taps Ionis to join crowd of companies gunning for rare heart disease in deal worth billions in biobucks (Fierce)
  • In a ‘baffling’ disappointment, BridgeBio’s heart drug misses primary goal in pivotal study (STAT)
  • Low-profile RNAi player lands on HKEX following modest $50M IPO (Endpoints) 
Medtech
  • FDA Issues Draft Guidance For Physiologic Closed-Loop Control Devices (MedtechInsight)
  • FDA Final Guidance On BPH Device Studies Suggests Swift Patient Follow-Up (MedtechInsight)
  • FDA Offers Framework For Assessing Credibility Of Devices Designed With Computational Modeling And Simulation (MedtechInsight)
  • More Pre-Development Medtech Work Must Be In Singapore’s Sights (MedtechInsight)
  • MTI 2022 Outlook: The Post-COVID Mantra For Medtechs: Prioritize, Optimize And Modernize (MedtechInsight)
  • Minute Insight: Quidel And Labcorp Finish Big Year For IVD Deals With Major Acquisitions (MedtechInsight)
  • Omicron Variant: Tide Labs Resolves False-Negative Problem With COVID-19 Tests (MedtechInsight)
  • A possible cervical cancer screening tool? A menstrual pad (Washington Post)
  • Three missing pieces the digital therapeutics sector needs to succeed in 2022 (STAT)
Government, Regulatory & Legal
  • 2022 Trials To Watch: Opioids, Oracle And Theranos Redux (Law360)
  • Holmes Jury Asks To Rehear Ex-CEO's 2013 Investor Call (Law360)
  • 5th Circ. Won’t Revive Walmart’s Opioid Suit Against Feds (Law360)
  • Will the Biden administration use ‘march-in’ to protect prostate cancer patients from excessive drug prices? (STAT)
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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