Recon: FDA expected to crack down on PI3K inhibitor approvals at adcomm; Another trio of Class I recalls ordered for Philips ventilators

• As safety signals mount, FDA aims to crack down on PK13K blood cancer nods (Fierce) (The Pink Sheet) (Endpoints)
• Gene Therapy Reviews Return To US FDA Advisory Committee Schedule (The Pink Sheet)
• Teva receives CRL for reformulated schizophrenia drug developed with French biotech (Endpoints) (Biospace)
• Struggles with FDA continue for Lupin as it is handed another Form 483 (Endpoints)
• US FDA Seeks Funding To Modernize Inspection-Related Technology Systems (The Pink Sheet)
• GSK Can Seize Chance In Anemia After Rivals Rejected But FDA Caution Will Remain (Scrip)
• CDC Advisors to Discuss Booster Plans at Wednesday Meeting (Bloomberg)
• FDA warns pediatric neurologist for failing to check eligibility of trial participants (Endpoints)
• FTC requires Hikma to let go of steroid drug as part of $375M acquisition of Custopharm (Endpoints)

• EU Aduhelm Filing: Biogen Faces Second High-Stakes Meeting At EMA (The Pink Sheet)
• EU Approval Decision Imminent For First CD20xCD3 Bispecific Antibody (The Pink Sheet)
• EU Regulator & HTA Bodies Prepare The Ground For New Collaborations (The Pink Sheet)
• Curious Case Of LHQW: Behind The TCM Central To China’s COVID Zero Policies (Scrip)
• Risk of medical gear shortage in Russia falls as West restores exports (Reuters)
• AbbVie takes next step in Ukraine, donating all Russia profits to relief (Endpoints)

• Moderna COVID-19 Vaccine Data Bring Multivalent Vs. Monovalent Debate Into Focus (Scrip)
• Arcturus COVID-19 Vaccine Hits Mark in Phase III Trial (Biospace)
• Tonix Pharmaceuticals Announces Results of Retrospective Observational Database Study In Over 50,000 Long COVID Patients (Biospace)
• Omicron BA.2 overall makes up more than 90% of COVID variants in U.S. – CDC (Reuters)
• COVID cases down in the Americas even as North America faces increase -PAHO (Reuters)

• J&J Continues Signaling Aggressive M&A Approach To Drive Growth (Scrip) (Endpoints)
• AbbVie Pulls Plus on Parkinson’s Partnership With BioArctic (Biospace)
• Blackstone Raises $1.6 Billion for Fund to Establish New Drugs (Bloomberg)
• Flagship-founded Tessera fuels up with $300M 'to go on a really big adventure' in gene editing (Endpoints)
• On heels of psych drug approval, BioXcel dives head first into oncology R&D with new cash infusion (Endpoints)
• Cancer drug hope raises Genmab’s spirits after legal defeat (Medwatch)
• Bavarian begins phase III trial of RSV vaccine in older adults (Medwatch)
• Too Crowded? ImmuneOncia Looks To Niches To Challenge PD-L1 Space (Scrip)

• Philips Probes Patient Death Link to Ventilator Shutdown (Bloomberg)
• Philips piles on another trio of Class I recalls for beleaguered ventilator portfolio (Fierce) (MedTech Dive)
• Abbott’s COVID test sales reach all-time high – and probably for the last time, the company says (Fierce)
• America's mask manufacturers take it on the chin (Reuters)
• Dentsply Sirona pulls CEO amid declining revenues, taps former Hillrom head to lead (Fierce)

• Supreme Court May Consider Ruling Invalidating Amgen’s Repatha Patents (The Pink Sheet)
• Covid-Linked Patient Scams Tally $292 Million in Fraud, DOJ Says (Bloomberg)
• Alabama settles for $276M with McKesson, J&J and Endo over opioid crisis (Endpoints)
• Gilead Secures Legal Victor in Battle Against HIV Drug Fraud (Biospace)
• Biotech fraud in ski town saga winds down as ex-president sentenced to 18 months in prison (Endpoints)