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

• 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)

• 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)

• 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)

• 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)