Recon: FDA places hold on Mersana’s ovarian cancer trials after deaths; Pfizer notifies FDA of pending penicillin shortage

• Another of Mersana’s ADCs slapped with FDA hold, this time over bleeding events that include 5 deaths (Fierce) (Biospace) (Reuters)
• Pfizer to run out of penicillin this year, and its supplies will be limited for much of 2024; letter (Fierce) (Endpoints) (FDAnews)
• FDA committee set to discuss strain selection for next round of COVID-19 boosters (Fierce) (Reuters)
• Cancer Drug Shortages Force Doctors to Ration Vital Therapies (Bloomberg)
• Are US FDA Advisory Committees Too Big? Lecanemab Shows Benefit Of Thinking Small (Pink Sheet)
• Viatris Asks FDA Not To Approve Neffy Until Sponsor Conducts More PK/PD Studies (Pink Sheet) (Endpoints)
• Awaiting FDA’s decision, Aldeyra’s dry eye disease drug scores phase 3 win for conjunctivitis (Fierce) (Reuters)
• Natural History Studies: Launch With Care And Consider Alternative Evidence For Drug Approval, FDA’s Marks Says (Pink Sheet)
• Mandy Cohen, seen as next CDC director, would bring political chops to an agency lacking them (STAT)
• Pricey Alzheimer’s Drug Coverage Hinges on FDA Decision (Bloomberg)
• Sanders wants NIH to adopt ‘reasonable pricing’ language for drugs that agency research helps develop (STAT) (Endpoints)
• House Appropriations OKs Bill Reversing FDA Abortion Pill Policy (Bloomberg)
• US drug overdose deaths top 109,000 in the past year (Reuters)

• Pharma Worried By EMA’s Stricter Approach To New Active Substance Claims For Biologics (Pink Sheet)
• EU Ministers Back Greater Role For Member States In Updating EMA Fees (Pink Sheet)
• International Group Explains How Best To Evaluate Benefit-Risk (Pink Sheet)
• Investment In Medicines Manufacturing Must Be UK Priority (Pink Sheet)
• UK MHRA Guidance: 150-day assessment for national applications for medicines (UK MHRA)
• Crovalimab Filed In Japan As More Phase III Results Released At EHA (Scrip)

• Verve Snags $60M in Lilly Support for Cardio Gene Editing (BioSpace) (Fierce)
• Astellas Bets Potential $1.9B on Cullgen’s Protein Degrader Tech (BioSpace)
• Patient death leads Seattle Children’s to pause study of 2seventy bio’s CAR-T cell therapy  (BioSpace)  (Endpoints)
• New AMA President Urges More Action on Substance Use Disorder, Mental Illness (MedPage Today)
• Pfizer refiles Seagen acquisition paperwork, deal still expected to close within the year (Endpoints)
• Syncona blames €80M drop in its biotech valuations on ‘challenging market’ (Fierce)
• 'Moderna will be a rare disease company,' CEO says, as mRNA company plots expansion in genetic diseases and eyes n-of-1 treatments (Endpoints)
• ProKidney drops $25.5M on North Carolina manufacturing site for cell therapy prospect (Fierce)
• Axsome reports delay to PhIII narcolepsy study, unveils peak sales estimates on its drugs (Endpoints)
• Merck’s efinopegdutide bests Ozempic in tease of phase 2 NASH data (Fierce)
• Biogen lines up potential deal for ALS drug, doubling down on neurofilament biomarker (Endpoints)
• Full circle for Paul Burton as Moderna exec returns to Amgen, this time for expanded CMO role (Fierce) (Endpoints)
• Biopharma Companies with the Biggest CEO-Employee Pay Gaps (BioSpace)
• Muzzled for years, vindicated MIT professor says fraud investigation into his lab did lasting damage (STAT)

• EU AI Act Proposal Adopted By Parliament In Landslide Plenary Vote (MedTech Insight)
• The importance of trust in AI as a medical device (MedTech Dive)
• Neuronetics gets FDA clearance for NeuroStar add-on in OCD (Fierce) (MedTech Insight)
• Small Change, Large Impact: The FDA’s Final Guidance On Premarket Submissions For SAMD/SIMD (MedTech Insight)
• FDA label update eases access to Inspire’s sleep apnea implant (Fierce)
• Federal advisory group rejects proposal to make medical device tracking easier (STAT)
• Covid Test Maker Once Crucial to US Response Slated to Liquidate (Bloomberg)

• Merck gets a patent win for muscle relaxant reversal drug (Endpoints)
• Trade Groups Appeal Dismissal Of Device ‘Right To Repair’ Case (MedTech Insight)
• Pfizer advertising communications to Meta subpoenaed by state of Texas as part of privacy lawsuit — report (Endpoints)
• AbbVie sues BeiGene over brand-new Imbruvica patent as blood cancer rivalry heats up (Fierce) (Bloomberg)