Recon: FDA approves Sage’s oral treatment for postpartum depression; WHO warns of Indian-made contaminated cough syrup in Iraq

• FDA Approves First Oral Treatment for Postpartum Depression (FDA) (STAT)
• Biogen, Sage face challenges as FDA rejects pill for clinical depression (Reuters) (Fierce Pharma)
• Major US health systems expect to offer Alzheimer's drug Leqembi in a few months (Reuters)
• After tornado, Pfizer puts Rocky Mount meds on emergency ordering list to thwart hospital shortages (Fierce Pharma)
• FDA approves second geographic atrophy drug but caps use period, as Astellas’ Iveric looks to spar with Apellis (Endpoints) (BioSpace)
• BARDA orders more smallpox and mpox vaccines from Bavarian Nordic (Endpoints)
• Born out of Omega push for pandemic treatments, Aerium Therapeutics enters long Covid R&D (Endpoints)
• Nektar says Eli Lilly miscalculated data in eczema trial before breaking off rezpeg partnership (Endpoints) (BioSpace)

• WHO flags contaminated India-made syrup in Iraq (Reuters)
• Galapagos scraps applications for Jyseleca in Europe and slashes sales projection (Fierce Pharma)
• Bavarian Nordic makes plans to submit chikungunya vaccine for approval after second positive PhIII trial readout (Endpoints)
• Biotech investment in UK ticks up in Q2 (Pharmaporum)
• EU Pulls Authorization of Novartis’ Sickle Cell Disease Drug (BioSpace)
• EU’s New Unitary Patent Proves Popular, Albeit With A High Opt-Out Rate (Pink Sheet)
• 20 years in, Singapore still searches for its biotech success story (Fierce)

• Gene therapy is in crisis. For nine hours, the field’s leading minds looked for a solution (STAT)
• BioNTech reduces drug development spend as COVID vaccine sales plunge (Reuters)
• AbbVie's Skyrizi stays king of the drug ad spenders as total spending plummets (Fierce Pharma)
• Gilead, building out its oncology group, expects $3B from Trodelvy, Tecartus and Yescarta this year (Fierce Pharma)
• FDA Grants Orphan Drug Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy (BioSpace)
• Lilly pressures Blueprint further with positive Retevmo trial in newly diagnosed lung cancer (Fierce Pharma)
• Ikena inks small cash grab in all-stock deal for Pionyr to take cancer drug on Hippo pathway (Endpoints)
• Aceragen to pull out of Nasdaq and liquidate assets, ending tumultuous journey for Idera Pharma (Endpoints)

• Kidney doctors push to protect patients by including dialysis machines in emergency stockpile (STAT)
• Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts (MedTech Dive)
• European Commission Extends Time IVD Companies Can Use Lead In PVC Sensors (MedTech Insight)
• Eudamed: New Dates, Constant Challenges But Light At The End Of The Tunnel (MedTech Insight)
• Viz.ai collects de novo clearance for BMS-backed software to spot hypertrophic cardiomyopathy (Fierce)
• Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery (MedTech Dive)
• Stryker raises earnings forecast as procedures return to pre-pandemic levels (MedTech Dive)
• Penumbra says stroke device delayed at least 12 months due to FDA request (MedTech Dive)
• Ceribell’s brain monitor lands FDA clearance, CMS coverage for detecting hidden seizures (Fierce)
• Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook (MedTech Dive)

• J&J’s Stelara settlement streak rolls on with Fresenius Kabi, Formycon deal (Fierce)
• Purdue asks Supreme Court not to block opioid settlement during US appeal (Reuters)
• House E&C chair racks up campaign contributions from more than 30 biopharma companies so far in 2023 (Endpoints)
• BARDA seeks Consortium Management Firm to establish new Biopharmaceutical Manufacturing Preparedness Consortium aimed at expanding domestic vaccine and drug manufacturing capability (HHS)
• Michigan AG Nessel wants to restart insulin pricing investigation (WLNS)
• New Public Citizen Health Lead To Keep Banging Drum On Stronger Benefit-Risk Ratios (MedTech Insight)