Recon: FDA adcomm rejects Y-mAbs brain cancer drug due to weak clinical trial data; EMA moves to restrict use of JAK inhibitors amidst safety concerns

ReconRecon | 31 October 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA Panel: All Thumbs Down for Antibody to Treat Metastatic Neuroblastoma (MedPage Today) (Fierce)
  • Common Kids’ Antibiotic Amoxicillin in Shortage, US FDA Says (Bloomberg)
  • FDA extends review of Amicus muscle disorder therapy for second time (Reuters) (Endpoints)
  • Genmab and Abbvie submits new cancer drug for FDA and EMA approval (Medwatch)
  • US FDA Needs ‘More Clout’ To Get Supply Chain Information, Califf Says (Pink Sheet)
  • FDA loosens marketing rules for authorized Covid drugs, but will it move the needle? (Endpoints)
  • NIH to study Pfizer's Paxlovid in long Covid as demand — and infections — continue to fall (Endpoints)
  • ‘Science is just rocketing forward’: A Q&A with former NIH director Francis Collins (STAT)
In Focus: International
  • EMA Recommends New Measures For JAK Inhibitors After Confirming Serious Risks (Pink Sheet) (Endpoints)
  • Data Packages, Inspections & Delayed Submissions: EMA Addresses Frequent Questions About Raw Data Pilot (Pink Sheet)
  • EU IHI's Research Projects To Include Patient-Generated Evidence, Minipig Drug Safety Studies (Pink Sheet)
  • EU politicians summon Pfizer CEO again after no-show (Medwatch)
  • ‘Let's Be Ambitious,’ EMA Official Says Of Tackling GDPR Issues In Clinical Trials (Pink Sheet)
  • EU regulator recommends adding heavy periods to side effects of mRNA COVID shots (Reuters)
  • Cholera Outbreaks Surge Worldwide as Vaccine Supply Drains (NYT)
  • Canada approves indication expansion for Novo Nordisk hemophilia drug (Medpage Today)
  • Indonesia revokes firms' fever syrup licenses amid inquiry into 150 deaths (Reuters)
  • China bars GSK from bulk-buy drug programme for 18 months (Reuters)
  • Ethiopia's Tigray runs out of medical supplies amid health crisis: WHO (Reuters)
  • Battling cholera, Lebanon gets first vaccines, and sharp words, from France (Reuters)
Pharma & Biotech
  • In wake of bempeg blowup, Sanofi rethinks $2.5B bet on IL-2 after midphase efficacy falls short (Fierce)
  • CytoDyn Yanks BLA Submission for Leronlimab in HIV, Blames CRO (Biospace) (Fierce)
  • Death of patient in closely watched Alzheimer’s trial raises concern about risk for some groups (STAT)
  • Janssen can’t conjure up enough patients for phase 1 prostate cancer study with ESSA (Fierce)
  • AbbVie preps for an onslaught of Humira biosimilars in 2023, with Skyrizi and Rinvoq to fill the gap for now (Endpoints)
  • Curia breaks ground on $100M expansion project in New Mexico (Endpoints)
  • In final pivot from cancer to rare disease, Agios offloads its share of Tibsovo royalties for $131M (Endpoints)
  • AbbVie drops midphase psoriasis prospect over preclinical toxicology data, sinking partner’s stock (Fierce) (Biospace)
  • Drug that acts on brain’s dorsal raphe nucleus could rapidly treat depression (Fierce)
  • FDA anticipates fewer novel medical device approvals in 2022 (Fierce) (MedTech Dive)
  • EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash (MedTech Insight)
  • How Lack Of Clarity In The EU Data Act Could Cause Confusion For Medtech (MedTech Insight)
  • FDA Updates 'Least Burdensome' Guidance To Match MDUFA V (MedTech Insight)
  • Thermo Fisher will buy The Binding Site for $2.6B to gain specialty diagnostics portfolio (MedTech Dive)
Government, Regulatory & Legal
  • Gilead finds 'critical holes' in the government's HIV patent case against it (Endpoints)
  • Lineage Cell Therapeutics, Asterias Investors Propose Settlement  (Bloomberg)
  • AbbVie Sues to Block Copies of Orilissa Endometriosis Drug (Bloomberg)
  • J&J Unit’s Laser Eye Surgery Patent Survives Alcon Challenge (Bloomberg)
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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