Recon: J&J temporarily halts production of its COVID vaccine; Pfizer scraps Paxlovid’s intravenous sibling

ReconRecon | 08 February 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer, in a rare COVID-19 setback, dumps Paxlovid’s intravenous sibling to leave ACTIV-3 future in doubt (Fierce)
  • Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine pill (BioPharma Dive)
  • US funding to now cover study of Novavax's COVID-19 shot in adolescents (Reuters)
  • Eric Lander resigns — potentially imperiling the rest of Biden’s scientific agenda (STAT)
  • US FDA’s Reclassification Of Certain Drugs As Devices May Be 'Seismic Event' For Some (The Pink Sheet)
  • 'Regulatory flexibility is not warranted': FDA balks at allowing China-only data for Eli Lilly's anti-PD-1 antibody (Endpoints)
  • Despite Few Actions On Rx Drug Promos, US FDA Increased Engagement With Stakeholders Last Year (Pink Sheet)
  • Overdose epidemic costs US $1T per year: research (The Hill)
In Focus: International
  • J&J Pauses Production of Its Covid Vaccine Despite Persistent Need (NYT)
  • EU regulator reviews extending Pfizer COVID booster for kids aged 12-15 (Reuters)
  • Novavax underdelivers on COVID vaccine promises (Reuters)
  • Wuxi stock plummets, wiping nearly $10B off market value as US adds it to ‘unverified’ list (Endpoints)
  • AstraZeneca CEO Rues Reality Of Vaccine Inequity (Scrip)
Coronavirus Pandemic
  • US CDC urges Americans to avoid travel to Japan, Cuba, Armenia over COVID cases (Reuters)
  • Hong Kong Expands Vaccine Mandate Amid Record Covid-19 Outbreak (WSJ)
  • Good, not great’: Some long Covid patients see their symptoms improve, but full recovery is elusive (STAT)
Pharma & Biotech
  • New OrbiMed-backed biotech aims to replicate Vertex's wildly successful cystic fibrosis pills in other diseases (Endpoints)
  • Ovid pens deal to offload twice-failed former lead program, positioning Healx to write new chapter in fragile X (Fierce)
  • Synaffix Aims For Top ADC Tech Provider Spot After Inking MacroGenics Deal (Scrip)
  • Bristol Myers Squibb doles out $8M in new grants to improve health equity with cardiovascular, oncology focus (Fierce)
  • Congruence pulls in $50M series A to build a team of ‘drug hunters’ to go after rare disease targets (Fierce)
  • Bayer recruits oncology vet Christine Roth from GSK to lead oncology business unit (Endpoints)
  • Merck KGaA shuffles organization to boost its CDMO operation as a top exec retires (Endpoints)
  • Updated: Editas abruptly terminates CMO Lisa Michaels, revealing little in terse SEC filing (Endpoints)
  • Exclusive: ARCH-backed exercise-in-a-pill startup quietly laid off half its staff, ‘fully pivoted’ in October (Endpoints)
  • 'Very over sold': Biotech brags about PhII Alzheimer's data, but experts are underwhelmed (Endpoints)
  • A San Diego biotech’s massive valuation turned heads. Now, mass layoffs raise questions (STAT) (Endpoints)
  • Analysts question Karyopharm's PhIII endometrial cancer data as biotech will charge ahead to FDA (Endpoints)
  • New CRISPR tool maps out routes to better immune cell therapies for cancer, autoimmune diseases (Fierce)
  • Time To Address Root Causes Of IVDR Notified Body Capacity Shortfall, Commission Says (MedTech Insight)
  • MDUFA Negotiations Go Into Overdrive (MedTech Insight)
  • Illegally Imported COVID-19 Diagnostic Recalled In US (MedTech Insight)
  • Profit And Price Declaration Requirements Mar Otherwise Workable Vietnam Medtech Regulation (MedTech Insight)
  • Guardant Health targets colorectal cancer screening in 2022 (MedTech Dive)
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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