Recon: FDA approves J&J and Legend’s CAR-T cancer therapy; Gilead lands CRL for HIV drug over glass vial concerns

• 'We are ready to go': FDA OKs J&J and Legend's BCMA CAR-T, setting stage for showdown with Bristol Myers (Endpoints) (Fierce) (STAT) (Reuters)
• Breakthrough gene-editing technology belongs to Harvard, MIT -U.S. tribunal (Reuters)
• U.S. FDA extends review period for expanded use of Abbvie's psoriasis drug (Reuters)
• FDA rejects Gilead’s next big HIV drug over glass vial issues (Endpoints) (Reuters)
• Pfizer Covid vaccine is less effective in kids 5 to 11, study finds (STAT) (Reuters) (NYT)
• FDA approves CTI BioPharma's bone marrow cancer drug (Reuters) (FDA)
• Novavax expects to apply for full approval of COVID vaccine in H2 (Reuters)
• FDA Warns Against Using Certain Celltrion Covid Tests (Bloomberg)
• BMS ‘Slow-Rolled’ Approval of Liso-Cel, Investors Claim, Citing Timeline Of Other CAR-T Therapies (The Pink Sheet)
• Pfizer fails phase 3 C. diff vaccine test but still spies possible path forward (Fierce)
• Biden’s State Of The Union Will Mention Drug Prices, But Not Outline Any New Plans (The Pink Sheet) (Inside Health Policy)
• Warren, 12 other U.S. lawmakers press drugs lobby group on price increases (Reuters)

• Sputnik: COVID-19 Vaccine Caught Up in Sanctions On Russia Over Ukraine Invasion (The Pink Sheet) (Bloomberg)
• AstraZeneca, Swiss firm Neurimmune ink $760 million deal for antibody drug (Reuters)
• DARWIN EU: The Go-To Place For Real World Data (The Pink Sheet)
• China Proposes Rolling Submissions For Innovative New Drugs (The Pink Sheet)
• Bayer CEO Outlines Action In Aftermath Of Ukraine Invasion (Scrip)
• Indonesia extends AstraZeneca vaccine shelf life as 6 mln doses near expiry (Reuters)

• AbbVie adds to its neuro pipeline with a $1B buyout deal, bolting on a new drug aimed at Alzheimer’s (Endpoints)
• 2021’s top clinical trial flops (Fierce)
• Ants, spiders, and mold: Why a big compounding pharmacy recently recalled all its products (STAT)
• In the wake of patient death, Sutro says its Chinese partner is rethinking their deal and withholding $40M (Endpoints)
• Sanofi, Regeneron build their case for yet another approval for immunology star Dupixent (Endpoints)
• As Eli Lilly steams ahead with a closely-watched BTK drug, its rivals at Merck are taking a $275M write-down on delay (Endpoints)
• Pfizer and Alvotech look to interchangeability to stand out in a crowded Humira biosimilar field (Endpoints)
• Emergent's troubled Baltimore site gets $100M upgrade (Endpoints)

• FDA's performance against MDUFA IV decision goal falls to new low (MedTech Dive)
• European Regulatory Roundup February 2022: Major Push Now On IVD Regulation Preparedness (MedTech Insight)
• Medtech, hospitals on alert for cyberattacks after Russia's invasion of Ukraine (MedTech Dive)
• FDA Stresses Need For Routine Monitoring Of Endovascular Aortic Repair Patients (MedTech Insight)
• Boston Scientific touts early results of real-world Watchman FLX study (MedTech Dive)

• Endo Held Liable in Opioid Case Via Default Judgment (Bloomberg)
• Diabetes Drugmakers Seek Judgment After Plaintiffs’ Expert Axed (Bloomberg)
• Eli Lilly Whistleblower Advances Medicaid Drug Suit Toward Trial (Bloomberg)
• Justices Probe Proof Burden in ‘Pill Mill’ Prosecutions (Bloomberg)
• HHS sets out plans to make medical device, diagnostics supply chains pandemic-proof (MedTech Dive)