Recon: Novo reports heart benefit for weight-loss drug Wegovy; Emergent to lay off 400 staff

• Novo's Wegovy shows heart benefit alongside weight loss in trial (Reuters) (STAT)
• Eli Lilly raises forecasts as diabetes drug Mounjaro powers upbeat results (Reuters) (Endpoints)
• Emergent BioSolutions to lay off about 400 employees (Reuters) (STAT)
• Medtronic expected to prevail at FDA renal denervation vote despite data doubts: analysts (MedTech Dive)
• Bluebird touts Zynteglo, Skysona launch progress as FDA decision on sickle cell therapy nears (Fierce Pharma)
• Merck, Ginkgo Bioworks strike deal worth up to $490M to 'optimize' biologics manufacturing (Fierce Pharma)
• FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products (FDA)

• EMA Prepares To Re-Start ‘Updated’ Clinical Data Publication Policy (Pink Sheet)
• India Set To Open Door To Human Challenge Trials (Pink Sheet)
• China's CanSino in mRNA vaccine deal with AstraZeneca (Reuters)
• New UK Vaccine Research & Testing Center Targets Pandemic Pathogens (Pink Sheet)
• WHO Meeting Reveals Differences Over Sharing Of Genomic Data In Public Health Crises (Pink Sheet)
• Pressure mounts for Illumina to divest Grail amid record fine, executive changes (MedTech Dive)
• Two AstraZeneca therapies accepted in Scotland (PharmaTimes)
• Only 1 in 5 people with opioid use disorder received medication in 2021 (The Hill)

• Oculis eye drop secures another late-stage win, this time in post-cataract surgery inflammation and pain (Endpoints)
• Novavax to sell 7% stake to South Korea's SK Bioscience (Reuters)
• Elevidys’ Age-Restricted Indication Not Negotiable, CBER’s Peter Marks Told Sarepta (Pink Sheet)
• Organon results beat estimates on demand for women heath products, biosimilars (Reuters)
• Intra-Cellular reups winning ad as bipolar drug builds momentum (Fierce Pharma)
• With sales in free fall, Bayer's new CEO Anderson considers structural change (Fierce Pharma) (Reuters)
• Bayer pulls plug on respiratory drug PEG-ADM (Pharmaphorum)
• FibroGen Looks to Regroup After Rocky Q2 Results, Ongoing Challenges (BioSpace)

• 2024 Fall CDRH ELP Proposal Submission Period is Now Open Through September 5, 2023 (FDA Law Blog)
• Women over 70 risk breast cancer overdiagnosis with screening, US study finds (Reuters)
• Bristol Myers introduces real patients in digital and social Sotyktu psoriasis campaign (Endpoints)
• Beam takes its time to the clinic; Aspen gets clearance to test Parkinson's cell therapy in humans (Endpoints)
• Contaminated Gas Risk Leads To Worldwide Ventilator Recall (MedTech Insight)
• The Book Of GLP-1s: For Medtech, They Giveth, As Well As Taketh Away (MedTech Insight)
• Abbott lands FDA clearance of Alinity complete blood count system (MedTech Dive)
• J&J subsidiary gains approval for heart ablation devices to use without fluoroscopy (MedTech Dive)
• How green is your digital health technology? (Pharmaphorum)

• More regulation could be coming for drug ads (STAT)
• Appeals court overturns ruling in Axonics-Medtronic neurostim patent dispute (MedTech Dive)
• DOD taps Valisure to carry out drug quality reviews amid generic shortages, concerns (Endpoints)