Recon: Merck pens $1.4B deal to acquire Imago to bolster bone marrow disease pipeline; Teva names former Sandoz head as next CEO

• Apellis’ closely watched eye drug gets new FDA goal date after changes to its filing scared investors (Fierce)
• FDA hits Iovance with one more delay for TIL therapy, extending BLA filing until 2023 (Endpoints)
• FDA Action Alert: Spectrum, ImmunoGen, Scynexis and Y-mAbs (Biospace)
• Vanda Objects To FDA’s ‘Highly Prejudicial’ Hearing Process And ‘Extra-Regulatory’ Requirements (Pink Sheet)
• Congress takes another look at reclassifying psilocybin and MDMA (Endpoints)
• Analysis: U.S. midterms dampen Big Pharma hopes for drug price policy change (Reuters)
• Pfizer and BioNTech roll out new data for their bivalent booster against newer Omicron variants (Endpoints) (Reuters)
• CDC survey reveals Covid-19 vaccination rates for children remain low (Endpoints)
• Visually impaired people less likely to access health care, CDC says (Washington Post)
• Amoxicillin Alternative in Short Supply, University of Utah Says (Bloomberg)
• Elizabeth Holmes sentenced to 11-plus years in prison for defrauding Theranos investors (Fierce) (Bloomberg)
• Medicare And Lecanemab: House Republicans Lack ‘Proactive’ Plan For Ensuring Coverage (Pink Sheet)
• Biden Lays Path to Cyber Regulations for Critical Infrastructure (Bloomberg)
• Patients’ Experiences With Long Covid Detailed in HHS Report (Bloomberg)

• EMA Tackles How To Substantiate New Active Substance Claims For Biologics & ATMPS (The Pink Sheet)
• Exkivity Wins HTA Thumbs Up In England For Rare & Aggressive NSCLC (Pink Sheet)
• Australia Moves Closer To Reducing HTA Discount Rate For First Time In Decades (Pink Sheet)
• First Draft Of WHO’s Pandemic Treaty: IP Waivers, Tech Transfer & Price Transparency (Pink Sheet)
• Nearly half of world population suffers from oral diseases – WHO (Reuters)
• Regulatory Reliance Key To Cancer Drug Access in Lower-Income Countries (Pink Sheet)

• Merck & Co. inks $1.4B blood cancer biotech buyout to muscle in on Bristol Myers, Novartis (Fierce) (STAT) (Bloomberg)
• Teva picks former Sandoz head as new CEO to replace Kåre Schultz (Endpoints) (Fierce)
• Humira Biosimilar Drumbeats: Biocon Claims Edge For Adalimumab In US (Scrip)
• APAC As A Clinical Trials Powerhouse (Scrip)
• Legend CEO spells out path to $5B in sales for multiple myeloma CAR-T therapy Carvykti (Endpoints)
• mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next? (STAT)
• mRNA drugs with a built-in ‘copy machine’ could lead to safer, more effective therapies (STAT)
• Factbox: Vaccines and drugs in the pipeline for RSV (Reuters)
• European protein software startup Cradle launches with backing from Lyft, Twist CEOs (Endpoints)

• Roche Wins FDA Authorization On High-Volume Monkeypox Test (MedTech Insight) (Fierce)
• FDA looks to bypass cancer drugs’ companion diagnostics with new pilot program: Pazdur (Fierce)
• Philips Admits New Issues In Reworked Ventilators (MedTech Insight) (Reuters)
• AdvaMed pushes Biden to use $52B chip program to support medtech supply chains (MedTech Dive)
• Sema4 lays off another 448 employees amid exit from reproductive health testing (Fierce)

• Lawsuit Filed Against FDA to Block Access to Abortion Pill (Bloomberg)
• Takeda Won’t Face Norwich Copies of Vyvanese ADHD Drug—This Year (Bloomberg)
• Jazz Pharma Must Delist Xyrem Patent in Win for Rival Avadel (Bloomberg)