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