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

• 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)

• 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)

• 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)

• 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)