Regulatory Focus™ > News Articles > 2022 > 5 > Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing de

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Posted 17 May 2022 | By Michael Mezher 

Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio

2859 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA clears Covid booster shot for healthy kids ages 5 to 11 (STAT) (Reuters) (FDA)
  • U.S. to allow baby formula imports amid nationwide shortage (Reuters) (FDA)
  • Abbott, FDA reach agreement to reopen baby formula facility in Michigan (Reuters) (FDA)
  • Baby formula makers ramp up U.S. supplies to tackle shortage (Reuters)
  • U.S. Democrats unveil bill to address baby formula shortage (Reuters)
  • FDA declines to authorize common antidepressant as COVID treatment (Reuters) (Endpoints)
  • A CRL later, Gilead clears clinical hold on next-gen HIV drug — after finding a new glass vial for it (Endpoints)
  • Cerebral Says It Will Stop Prescribing Most Controlled Substances (WSJ)
  • Google taps FDA’s former digital health chief for global strategy role (STAT)
  •  
  • Labcorp's combo COVID, flu, RSV test nabs first green light for direct-to-consumer sales by FDA (Fierce) (FDA)
  • New Documents Show How Drug Companies Targeted Doctors to Increase Opioid Prescriptions (ProPublica)
  • Why So Slow? Legislators Take on Insurers’ Delays in Approving Prescribed Treatments (KHN)
In Focus: International
  • AstraZeneca boosts COVID portfolio with RQ Bio deal (Reuters)
  • International regulators and WHO: support healthcare professionals to enhance public confidence in COVID-19 vaccines (EMA)
  • US-China Fight May Spoil Global Deal for a Covid Vaccine-Patent Waiver (Bloomberg)
  • NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer (PMLive)
  • Novartis looks to grow global CDMO unit after pandemic pacts put its strengths on display (Fierce)
  • UK MHRA Specifies Eligibility For Consultancy Firms To Monitor GMP, GDP Compliance (Pink Sheet)
  • Novartis faces Greek bribery lawsuit as government prepares to seek compensation (Fierce)
  • MHRA approves faricimab through international work-sharing initiative (MHRA)
Pharma & Biotech
  • Pfizer-partnered Zentalis woos new CEO, cobbles together $200M (Endpoints)
  • Aldevron and Inscripta ink manufacturing deal for CRISPR Type-V nuclease (Endpoints)
  • Pfizer, Merck and AstraZeneca led Big Pharma's growth in Q1 but they couldn't match mRNA hotshots (Fierce)
  • Aiming to be biggest biotech in Boston, Vertex plots 500-person cell, gene therapy R&D center (Fierce)
  • FDA has change of heart, plans to convene advisory meeting for Cytokinetics' cardiac med (Fierce)
  • Roche lays out access ambitions in its ESG strategies, including innovation and value goals (Endpoints)
  • Scholar Rock in a hard place as biotech lays off 25% of staff, narrows pipeline and loses CMO (Fierce)
  • Cell and gene therapy consulting firm submits draft AAV purity guidance to FDA (Endpoints)
  • 3rd time lucky? ScPharmaceuticals gets decision date for twice-rejected on-body drug delivery product (Fierce)
  • Following potential billion-dollar J&J deal, RNA processing biotech Remix returns with fresh financing (Endpoints)
  • Emergent boosts countermeasures repertoire with $325M deal for smallpox newcomer Tembexa (Fierce)
  • Ultragenyx strikes deal with struggling Abeona for rare disease gene therapy (BioPharmaDive)
  • Agios to cut jobs as it moves away from exploratory research (BioPharmaDive)
  • Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization (Pink Sheet)
  • End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials (Pink Sheet)
Medtech
  • FDA smiles on 2nd cavity-spotting AI in a month with clearance for Overjet's tech (Fierce)
  • Avanos Medical recall gets Class I label from FDA following patient injury, death reports (MedtechDive)
  • Pear more than doubles revenue from last quarter, shares new economic data (MedtechDive)
  • Sernova taps Evotec’s insulin-producing cells to fill its pouch implant for diabetes (Fierce)
  • Third round of free Covid-19 tests now available (NBC)
Government, Regulatory & Legal
  • Two dozen states side with HHS in its raucous dispute with pharma over a drug discount program (STAT)
  • French court rules against Sanofi in landmark Depakine case (Endpoints)
  • Indian drugmaker seeks to toss 'bloated' billion-dollar lawsuit over Covid vaccine candidate (Endpoints)
  • As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms (STAT)
  • High Court Won't Hear 3M's Appeal In Surgical Blanket Case (Law360)
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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