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

ReconRecon
| 01 March 2022 | By Joanne S. Eglovitch 

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

In Focus: US
  • '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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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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