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