Recon: European Commission to propose MDR delay; FDA authorizes bivalent shots for children as young as 6 months

ReconRecon | 08 December 2022 |  By 

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

In Focus: US
  • U.S. FDA authorizes bivalent COVID shots for kids as young as 6 months old (Reuters) (STAT) (FDA)
  • GSK, Sanofi shares soar as Zantac litigation fears abate (Reuters)
  • U.S. FDA grants priority review to Pfizer's RSV vaccine (Reuters)
  • Sun Pharma gets FDA import warning for India plant, shares drop (Reuters)
  • Eli Lilly tightens access to diabetes drug, frustrating some people with obesity (STAT)
  • Jynneos mpox vaccine provided strong protection against infection, new CDC data show (STAT)
  • No. 2 Theranos Executive Is Sentenced to Nearly 13 Years for Fraud (NYTimes) (FDA)
In Focus: International
  • Exclusive: EU to propose delay to medical device law amid supply worries (Reuters) (Euractiv) (MedtechInsight)
  • Germany to allow Sinovac vaccine for Chinese citizens only – Spiegel (Reuters)
  • French health authority advises against use of Valneva's COVID-19 vaccine (Reuters)
  • Novavax to make COVID-19 vaccine shots in Canada (Reuters)
  • Japan's Takeda secures EU nod for its dengue vaccine (Reuters)
  • At start of WHO talks on pandemic pact, developing countries seek fairness (Reuters)
  • Uganda receives 1,200 doses of Ebola vaccine candidates for trials (Reuters)
  • Malaria deaths dip in 2021 after rising in first year of COVID, says WHO (Reuters)
  • European Commission lays groundwork to unwind Illumina's $7B+ Grail merger (Endpoints)
  • ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies (EMA)
Pharma & Biotech
  • The prices of 7 drugs were hiked without proof of new benefits, costing the U.S. $805 million in 2021 (STAT)
  • FDA halts imports of several Sun Pharma drugs made in India due to outstanding quality issues (Endpoints)
  • QC violations raised by FDA at another Aurobindo site (Endpoints)
  • Prometheus’ inflammatory bowel drug succeeds in two mid-stage trials (STAT)
  • Sensei and Instil Bio let go large chunks of workforces, shift pipelines (Endpoints)
  • Vor Biopharma says first patient given its gene editing therapy for leukemia is in remission (Boston Globe)
  • In ‘landmark’ study, cell therapy exceeds expectations in melanoma patients (STAT)
  • Mark Cuban teams with a business coalition in bid to lower drug costs for employers (STAT)
  • Avrobio touts early clinical data and plans new gene therapy trial in 2023 (Endpoints)
  • Novartis' iptacopan meets PhIII test in fight against rare blood disease (Endpoints)
  • FDA pulls Oncopeptides' Pepaxto indication, opening the door for dangling accelerated approval enforcement (Endpoints)
  • Sanofi walks away from $500M deal, leaving Revolution alone in pushing SHP2/KRAS combo (Endpoints)
  • Q&A with Gates leader: Women taking on more roles in pharma manufacturing, but still work to do (Endpoints)
  • Gilead terminates early-stage FLT3 trial in solid tumors (Endpoints)
  • Big Pharmas team up with local Singapore organizations to boost manufacturing (Endpoints)
  • Vertex just found the next big ‘transformative’ thing for the pipeline — at a biotech just down the street (Endpoints)
  • Congress has a chance to close the FDA’s Theranos loophole (STAT)
  • Roche nets FDA clearance for CSF-based Alzheimer’s diagnostic tests (Fierce)
  • FDA Updates Abiomed’s Heart Pump Labeling After Post-Approval Clinical Study (MedtechInsight)
  • Dexcom finally ties up long-awaited G7 diabetes sensor clearance after FDA resubmission (Fierce)
Government, Regulatory & Legal
  • Teva's UK Appeal Over Patent For MS Drug Gilenya Falls Flat (Law360)
  • Apple wins battle in patent war with AliveCor over portable ECG tech (Fierce)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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