// Biotech and Pharma Therapeutics
Viking says biopsy data confirm MASH drug’s benefit
June 4, 2024 / MASH / NASH / VK2809 trial / Liver Disease
Viking’s VK2809 drug for MASH shows significant benefits in resolving NASH without worsening fibrosis, with similar side effect rates to placebo, paving the way for potential Phase 3 trials.
HubSpot announces HIPAA-compliant tools in public beta
June 5, 2024 / HubSpot / HIPAA / Healthcare / Data Security
HubSpot now offers HIPAA-compliant tools in public beta, enabling healthcare companies to store sensitive data, automate workflows, and personalize campaigns, enhancing patient engagement and business growth globally.
How the Healthcare Industry Can Strengthen Security in the Wake of Change Healthcare Breach
June 5, 2024 / Healthcare / Breach / Cybersecurity / Patient Data Protection
Change Healthcare suffered cyber-attacks, prompting the healthcare industry to enhance cybersecurity measures to protect patient data and ensure operational continuity.
Stolen MediSecure data allegedly leaked on dark web and more briefs
May 31, 2024 / MediSecure / Data Breach / Data Leak
MediSecure hackers leaked e-prescription data on the dark web; Tasmania digitizes specialist referrals for Aboriginal healthcare using HealthLink SmartForms and Telstra Health’s Communicare.
Sanofi’s Sarclisa shows significant promise in treating myeloma
June 5, 2024 / Sarclisa Myeloma Treatment / Sanofi
Sanofi’s Sarclisa (isatuximab) significantly improved progression-free survival in transplant-ineligible multiple myeloma patients, reducing disease progression or death by 40% in the phase 3 IMROZ study.
// 4th Industrial Revolution
5 first steps toward do-it-yourself AI governance
June 4, 2024 / UC Davis / Healthcare / AI
UC-Davis Health and Manatt advise hospitals to develop AI governance models proactively to manage risks and optimize AI benefits, recommending steps like creating prioritization processes and forming interdisciplinary oversight committees.
Deep learning model personalizes adaptive therapy for prostate cancer
June 4, 2024 / Prostate Cancer Therapy / Deep Learning Framework / University of Oxford
Researchers from Moffitt Cancer Center and the University of Oxford developed a deep learning model to personalize adaptive therapy schedules for prostate cancer patients.
AI reveals association between body composition, lung cancer outcomes
June 3, 2024 / AI / Lung Cancer / Immunotherapy
Mass General Brigham researchers’ AI tool found that changes in muscle mass and fat quality during immunotherapy are linked to poorer outcomes in advanced non-small cell lung cancer patients.
Eko Health Raises $41M to Scale AI-driven Heart, Lung Detection
June 5, 2024 / Eko Health / AI Heart Disease Detechtion / Cardiovascular Diagnostics
Eko Health raised $41 million to scale its AI-driven platform for early heart and lung disease detection, enhancing global access to effective diagnostic tools.
How AI and Machine Learning Can Transform Pharmacy Benefits Management
June 4, 2024 / AI / Machine Learning / Healthcare
AI and machine learning can transform pharmacy benefits management by optimizing healthcare data use, reducing friction, and enhancing user experience, as discussed by Abarca experts.
// Business & Markets
Lilly details MASH data for tirzepatide; Cytokinetics comments on past sale talks
June 5, 2024 / Eli Lilly / MASH / Clinical Trial Data / Obesity / Liver Disease
Eli Lilly’s tirzepatide (Zepbound) shows promise in improving liver fibrosis in MASH patients, with over half of treated participants seeing improvement compared to 30% with placebo, as per recent clinical trial data.
Viking’s MASH drug scored where Madrigal’s didn’t, but shares fall on lack of direction
June 4, 2024 / Viking / Liver Fat / MASH / Metabolic Dysfunction Drug
Viking Therapeutics’ VK2809 shows promise in reducing liver fat in MASH patients, achieving significant results in a phase 2b study, but executives remain unclear on its future direction amid competition.
Bristol Myers puts more than 860 jobs on chopping block in NJ as $1.5B savings campaign rolls ahead
June 5, 2024 / Bristol Myers Squibb / Layoffs
Bristol Myers Squibb is laying off 863 employees in Lawrenceville, NJ, as part of a $1.5 billion cost-saving campaign, following earlier cuts and targeting a total of 2,200 job reductions in 2024.
MedTech health and data company AcuityMD scores $45M and more digital health fundings
June 5, 2024 / AcuityMD / Medical Device Tracking / Digital Health
AcuityMD secured $45 million in funding to expand its health data platform for MedTech manufacturers, enhancing product tracking from sales to patient outcomes and planning to launch new products and grow their team.
Telstra Health to fully own pharma tech provider Fred IT
May 30, 2024 / Telstra Health / Digtial Health
Telstra Health will fully acquire Fred IT Group, solidifying its position in digital health. Fred IT will continue its operations under the current CEO, focusing on national electronic prescription services.
// Legal & Regulatory
FDA panel votes against MDMA therapy for PTSD, citing muddy data and safety concerns
June 4, 2024 / MDMA / PTSD / FDA
An FDA panel voted against approving MDMA for PTSD treatment, citing concerns over trial conduct and safety, despite significant benefits shown in late-stage studies by Lykos Therapeutics.
FDA Adcomm Votes Against Lykos’ MDMA-Assisted PTSD Therapy
June 5, 2024 / MDMA -assisted PTSD Therapy / FDA / Lykos Therapeutivs
The FDA advisory committee voted against Lykos Therapeutics’ MDMA-assisted PTSD therapy, citing insufficient data and safety concerns from Phase III trials, with the FDA’s decision expected by August 11, 2024.
Lykos’ MDMA treatment rejected by FDA committee, despite being ‘75% of the way there’
June 5, 2024 / MDMA PTSD Treatment / FDA Rejection
The FDA advisory committee voted against recommending Lykos Therapeutics’ MDMA treatment for PTSD, citing insufficient effectiveness and unfavorable risk-benefit balance, despite it being “75% of the way there.”
Oregon jury says Johnson & Johnson must pay $260M in mesothelioma talc case
June 4, 2024 / Johnson & Johnson / Talc Lawsuit / Baby Powder
An Oregon jury awarded $260 million to a woman claiming Johnson’s Baby Powder caused her mesothelioma, highlighting ongoing talc-related lawsuits despite Johnson & Johnson’s efforts to resolve most cases.
SCAN Health Wins Lawsuit Against HHS Over Bonus Payments
June 4, 2024 / SCAN Health Lawsuit / HHS Bonus Payments / Medicare Advantage
SCAN Health Plan won a lawsuit against HHS, with the court ruling that CMS must recalculate SCAN’s 2024 star rating, potentially affecting $250 million in 2025 bonus payments.
// Research & Development
Gilead, Ipsen Tout Phase III Primary Biliary Cholangitis Data as PDUFA Dates Loom
June 5, 2024 / Gilead / Liver Disease
Gilead’s seladelpar and Ipsen’s elafibranor show promising Phase III results for treating primary biliary cholangitis (PBC), with significant improvements in liver biomarkers and pruritus. Ipsen’s PDUFA date is June 10, 2024, and Gilead’s is August 14, 2024.
Vir Seeks to Challenge Gilead With Phase II Hepatitis Delta Data
June 5, 2024 / Vir Biotechnology / HDV Treatment
Vir Biotechnology’s monoclonal antibody tobevibart shows promising Phase II results for clearing hepatitis delta virus (HDV), achieving significant viral reduction in combination therapy, with no serious adverse events. Further details will be presented at an upcoming liver congress.
Walgreens will conduct clinical trials for Boehringer Ingelheim’s new obesity drug
June 3, 2024 / Walgreens / Clinical Trials / Obesity
Walgreens will conduct Phase III clinical trials for Boehringer Ingelheim’s obesity drug survodutide, developed with Zealand Pharma, using community pharmacies. The trials will compare survodutide’s efficacy with existing GLP-1 treatments like Ozempic and Wegovy.
NHS platform announced to accelerate personalised cancer vaccine clinical trials
May 31, 2024 / NHS / Cancer / Vaccines / mRNA
The NHS launched the Cancer Vaccine Launch Pad (CVLP) to accelerate personalized cancer vaccine trials, starting with the first patient treated in England. Partnering with Genomics England, the initiative involves 30 hospitals and aims to fast-track thousands of patients into clinical trials.
Gilead, with approval in sight, shows $4.3B liver disease drug improves outcomes out to 2 years
June 5, 2024 Gilead / Liver Disease / Drug Efficacy / CymaBay Therapeutics / Acquisition
Gilead Sciences’ liver disease drug seladelpar, acquired for $4.3 billion, shows sustained improvement in primary biliary cholangitis (PBC) over two years, reinforcing its efficacy ahead of near-approval, with data presented at a liver congress.
// Politics
Lawmakers request intelligence briefing on CDMO GenScript, Legend Biotech’s ties to China
June 4, 2024 / GenScript / FBI / Lawmakers
U.S. lawmakers are requesting an intelligence briefing on CDMO GenScript and its segment Legend Biotech due to concerns about ties to the Chinese Communist Party (CCP), highlighting the need for vigilance in safeguarding U.S. biopharma competitiveness.
Lawmakers Seek To Revive a $10 Fee for Prescriptions That Was Dropped by DFS
May 30, 2024 / Pharmacy / Healthcare Costs / New York / Drug Pricing Bill
Lawmakers in Albany are reintroducing legislation for a $10.18 dispensing fee for prescriptions, targeting pharmacy benefit managers (PBMs) and potentially adding billions to healthcare costs, despite broad opposition from various stakeholders.
House China panel seeks intel briefing on biotech
May 31, 2024 / House Committee / China / Supply Chain
The House Select Committee on the CCP is requesting a briefing from the Biden administration on biotech company GenScript to assess its ties to the Chinese Communist Party (CCP) and potential risks to U.S. national security.
Bipartisan Efforts To Legislate Pharmaceutical Patent Reform Heat Up
June 3, 2024 / Patent Reform / Generic drug Competition / Prescription Drugs
Bipartisan efforts in Congress aim to reform pharmaceutical patent laws to prevent tactics that extend monopoly pricing and delay generics, addressing high drug prices and ensuring timely competition for affordable medications.
Lawmakers approve change on Medicaid reimbursement for continuous blood glucose monitors
June 1, 2024 / Arkansas / Diabetes / Blood Sugar Monitoring / Medicaid
Arkansas’ Legislative Council approved a new rule changing Medicaid reimbursement for continuous blood glucose monitors, impacting diabetic patients’ access to these devices.