Recon: Merck pens $1.4B deal to acquire Imago to bolster bone marrow disease pipeline; Teva names former Sandoz head as next CEO
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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