Recon: FDA clears Pfizer recall for 12-15 year olds; Teva found responsible in opioid lawsuit in New York


Posted on January 03, 2022 | Through Joanne S. Eglovich

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

Focus: United States

  • FDA clears booster shots for 12-15 year olds (NYTimes) (STAT) (Reuters) (WashingtonPost)
  • FDA clears new Merck Covid-19 pill despite scientists’ concerns over mechanism of action (Endpoints)
  • FDA clears Pfizer’s first at-home pills to treat Covid-19 (Endpoints)
  • Interval between second injection and booster of Moderna COVID-19 vaccine another six months -FDA (Reuters)
  • FDA approves drug to treat and help prevent types of blood clots in certain pediatric populations (FDA)
  • FDA adds another OK drug to cap record-breaking 2021 win list (endpoints)
  • US FDA new novel approvals jumped to 60 in 2021; CDER authorized 50 new agents, refused 18 (pink sheet)
  • Roche gets US green light for rapid home COVID test (Fierce)
  • A year overdue, but Novartis finally steered inclisiran towards FDA approval. will it sell? (End points)
  • Reaching new drug approval record, FDA gives green light to yet another atopic dermatitis candidate (Endpoints)
  • Following Tezspire US Approval, Amgen To Add Filler Line In Ireland (Endpoints)
  • Months after missing PDUFA date, FDA slaps Takeda’s old drug Shire for eosinophilic esophagitis (endpoints)
  • New York Jury Holds Teva Pharmaceuticals Accountable in Opioid Crisis (STAT) (NYTimes)

Focus: international

  • End of year message from Emer Cooke (EMA)
  • EMA recommends authorization of Nuvaxovid in the EU (EMA)
  • COVID-19: the EMA recommends the authorization of the antibody drug Xevudy (EMA
  • EFPIA not impressed with proposals to tackle drug shortages in the EU (pink sheet)
  • Omicron evades immunity better than Delta, Danish study finds (Reuters)
  • Omicron “clearly softer”; new measures not necessary, according to Britain’s Johnson (Reuters)
  • Israel now offers fourth covid snapshot to anyone 60 and over (Washington Post)
  • India vaccinates 3.8 million adolescents in new COVID-19 vaccination campaign (Reuters
  • UAE demands coronavirus booster injections for citizens wishing to travel abroad (Washington Post)

Coronavirus pandemic

  • Studies suggest why Omicron is less severe: it spares the lungs (NYTimes)
  • As Omicron spreads, officials wonder what it means to be ‘fully vaccinated’ (NYTimes)
  • As home testing rises, doubts rise over the accuracy of public Covid counts (NYTimes)
  • J&J Recall Offers Strong Protection Against Critical Illnesses From Omicron, Study Finds (NYTimes)
  • Novavax breaks another commitment for its Covid-19 vaccine. And the United States would now worry about Global Goals (Endpoints)
  • WHO official looks at Covid, vaccines and mistakes (STAT)
  • Beyond the number of cases: what Omicron teaches us (STAT)
  • Omicron winter forecast: experts consider various scenarios, worse and worse (STAT)

Pharma & Biotech

  • Novartis Unlocks $ 1.5 Billion Buyout for Gene Therapy – Boosts Arsenal Against Retinal Disease (Endpoints)
  • Not everyone is buying it, but everyone is definitely talking about a new Biogen buyout report (Endpoints)
  • AstraZeneca appeals to Ionis to join host of companies battling rare heart disease in billion-dollar deal worth biobucks (Fierce)
  • In ‘baffling’ disappointment, BridgeBio’s heart drug misses the primary focus of the pivotal study (STAT)
  • Low-key RNAi player lands on HKEX after modest $ 50 million IPO (End points)

Medtech

  • FDA Releases Draft Guidelines for Closed-Loop Physiological Monitoring Devices (MedtechInsight)
  • Final FDA Guidelines for BPH Device Studies Suggest Rapid Patient Follow-up (MedtechInsight)
  • FDA proposes framework to assess credibility of devices designed with computer modeling and simulation (MedtechInsight)
  • More pre-development Medtech work must be in Singapore’s sights
  • MTI Outlook 2022: The Post-COVID Mantra for Medical Technologies: Prioritize, Optimize and Modernize (MedtechInsight)
  • Minute Insight: Quidel and Labcorp end a great year for IVD agreements with major acquisitions (MedtechInsight)
  • Omicron Variant: Tide Labs Solves False Negative Problem With COVID-19 Testing (MedtechInsight)
  • A possible screening tool for cervical cancer? A menstrual pad (Washington Post)
  • Three missing pieces that the digital therapeutic sector needs to succeed in 2022 (STAT)

Government, Regulation and Legal

  • 2022 trials to watch: Opioids, Oracle and Theranos Redux (Law360)
  • Holmes Jury Asks to Rehear Former CEO’s 2013 Investor Appeal (Law360)
  • 5e Circ. Will Not Revive Walmart’s Opioid Lawsuit Against Federal Government (Law360)
  • Will the Biden administration use the “walk” to protect prostate cancer patients from excessive drug prices? (STAT)

Regulatory Recon is a daily intelligence briefing for the regulatory affairs space, bringing you the best regulatory, biopharmaceutical and medical news from around the world.

Inclusion of a story in the Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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