// Biotech and Pharma Therapeutics
CDC looks to expand capacity to test for H5N1 bird flu in people
July 2, 2024 / H5N1 Bird Flu Testing / CDC
CDC plans to enhance testing for H5N1 bird flu in humans, as the outbreak in dairy cows persists, posing potential risks to dairy workers.
Could Amazon or Google Hold the Key to the Future of Public Health Diagnostics?
July 2, 2024 / MedTech / Sustainablity / Amazon / Google
Tech giants like Amazon and Google could revolutionize public health diagnostics by developing a universal reader for self-testing, balancing innovation and sustainability.
One Conversation Could Be All It Takes to Identify Chronic Kidney Disease
July 1, 2024 / Chronic Kidney Disease / Patient Health
Early conversations about kidney health can identify chronic kidney disease (CKD) risk, leading to timely interventions and preventing kidney failure.
J&J unwraps pivotal data on $6.5B autoimmune asset as it prepares to crash argenx and UCB’s party
July 1, 2024 / Johnson & Johnson / FDA Approval
J&J’s phase 3 trial of nipocalimab in generalized myasthenia gravis (gMG) showed significant symptom improvement, positioning it against rivals argenx and UCB for FDA approval.
Female cancer survivors at low risk of developing obstetric complications
July 2, 2024 / Cancer / Obstetric Complications Risk / Pregnancy / Women’s Health
Study shows most female cancer survivors are at low risk of obstetric complications, except those with leukemia, cervical, and breast cancers.
// 4th Industrial Revolution
Emory Healthcare scores with an ‘Uber app’ for at-home PT
June 26, 2024 / Emory Healthcare / Luna Physical Therapy Services / Patient Centered
Emory Healthcare partnered with Luna to offer at-home physical therapy via a user-friendly app, enhancing patient care and accessibility, especially for those unable to travel frequently.
6 priorities for a national healthcare AI strategy from our friends in the UK
June 29, 2024 / Healthcare AI Strategy / NHS / Healthcare Workforce
The Health Foundation outlines six priorities for a national healthcare AI strategy, focusing on public involvement, targeted development, robust data infrastructure, rigorous testing, clear regulations, and workforce skill enhancement.
AI is Not One-Size-Fits-All for Clinicians
June 28, 2024 / AI in Healthcare / Remote Patient Monitoring / Device-less Healthcare Solutions
Joshua Liu, CEO of SeamlessMD, emphasizes that AI isn’t universally suitable for all clinicians and advocates for device-less remote patient monitoring to increase accessibility and efficiency in healthcare.
AdvancedMD Summer Release Streamlines Revenue Cycle, Enhances EHR and Patient Engagement
July 2, 2024 / AdvancedMD 2024 / Patient Engagement / Revenue Cycle Management
AdvancedMD’s 2024 summer release enhances revenue cycle management, EHR, and patient engagement with over 30 new features, including seamless payment processing and advanced practice management tools.
Radionetics deal takes Lilly deeper into radiopharma
July 2, 2024 / Eli Lilly / Radiopharmaceutical / Radionetics / Partnership / Oncology / Acquisition
Eli Lilly has partnered with Radionetics Oncology to advance GPCR-targeting radiopharmaceuticals for treating solid tumors, following its acquisition of POINT Biopharma.
// Business & Markets
K Health’s Latest Funding Round Brings the Primary Care AI Startup to $380M Raised
July 1, 2024 / K Health / AI / Primary Care / Startup / Telehealth
K Health has raised $50 million, bringing its total to $380 million and valuation to $900 million, to enhance AI-driven primary care, providing 24/7 telehealth services and improving access to diagnosis and treatment.
Foodsmart secures more than $200M for telenutrition platform
June 28, 2024 / Foodsmart Funding / Telenutrition / Virtual Dietitian / Medicaid / Medicare
Foodsmart secured over $200 million from TPG’s The Rise Fund to expand its telenutrition platform, providing virtual access to registered dietitians and food benefits management for Medicaid, Medicare, employers, and health plans.
Moderna receives $176 million from BARDA for mRNA influenza vaccines
July 2, 2024 / Moderna / mRNA Vaccines / Pandemic
Moderna received $176 million from BARDA to expedite the development of mRNA-based influenza vaccines, enhancing pandemic preparedness and leveraging mRNA technology’s advantages in efficacy, development speed, and scalability.
Samsung Bio Nabs $1B Manufacturing Contract With Undisclosed US Pharma
July 2, 2024 / Samsung Biologics / Biomanufacturing Deal / Partnership / Biosecure Act
Samsung Biologics signed a $1.06 billion contract with an unnamed U.S. pharmaceutical company, marking its largest deal ever. This partnership aligns with efforts to diversify manufacturing amidst potential impacts from the BIOSECURE Act.
Bayer, Rad AI partner for AI radiology workflow offering
July 1, 2024 / Bayer / Rad AI / Partnership / AI Radiology / Calantic Digital Solution
Bayer and Rad AI are partnering to integrate Rad AI’s generative AI tools into Bayer’s Calantic Digital Solution, enhancing radiology workflows with AI-enabled dictation, report generation, and follow-up management.
// Legal & Regulatory
Game on: Lilly’s Alzheimer’s drug Kisunla, a challenger to Biogen and Eisai’s Leqembi, gains full FDA nod
July 2, 2024 / Eli Lilly / Donanemab / Lequmbi / Alzheimer’s Disease
The FDA granted full approval to Eli Lilly’s Alzheimer’s drug Kisunla, an anti-amyloid therapy, offering less frequent dosing and potential cost savings compared to Biogen and Eisai’s Leqembi.
Two Senior Cassava Employees Subjects in Federal Probes After Former Advisor Indicted for Fraud
July 2, 2024 / Cassava Sciences / Investigation / Alzheimer’s Drug
Two senior Cassava Sciences employees are under federal investigation for alleged scientific misconduct in Alzheimer’s studies, following the indictment of a former advisor for fraud related to simufilam research.
FTC Investigates Teva Over Refusal to Remove Improperly Listed Patents from Orange Book
July 2, 2024 / Teva Pharmaceuticals / Investigation / FTC / Drug Price Inflation
The FTC is investigating Teva Pharmaceuticals for allegedly refusing to remove improperly listed patents from the FDA’s Orange Book, part of the FTC’s broader effort to address inaccurate patent listings that inflate drug prices.
After Gilead and J&J lawsuits, distributor Safe Chain sees its owners charged in criminal indictment
July 1, 2024 / Gilead Sciences / Biktarvy / Johnson & Johnson / Counterfit Drugs
Safe Chain owners were indicted for distributing $90 million in counterfeit HIV drugs, allegedly involving fraud and mislabeling. Gilead and Johnson & Johnson had already filed civil lawsuits against Safe Chain for similar offenses.
GSK takes another Zantac personal injury case off its plate with settlement in Illinois
July 1, 2024 / GSK / Zantac / Settlement
GSK settled another Zantac lawsuit in Illinois, addressing claims that the heartburn medication caused prostate cancer. The company maintains there is no consistent evidence linking ranitidine to cancer and continues to defend against remaining claims.
// Research & Development
Boehringer Ingelheim and Gubra begin Phase I trial of drug candidate for obesity
July 2, 2024 / Boehringer Ingelheim / Obesity Trial / Clinical Trials
Boehringer Ingelheim and Gubra have started a Phase I trial for BI 3034701, a long-acting peptide for obesity treatment. This trial will assess the drug’s tolerability, safety, and pharmacokinetics in healthy and overweight or obese adults.
NeuroSense Demonstrates Statistically Significant Efficacy and Survival Benefits in People Living with ALS: The Promising Results from the 12-Month PARADIGM Study Highlight PrimeC’s Potential as a Disease Modifying Drug
July 1, 2024 / NeuroSense / ALS Treatment
NeuroSense Therapeutics’ Phase 2b PARADIGM study shows PrimeC significantly improves ALSFRS-R scores and survival rates in ALS patients, with a 36% improvement in functional decline and a 43% increase in survival at 12 months.
Microbiome composition varies based on sampling time, mouse study finds
July 1, 2024 / Gut Bacteria sampling / Microbiomes / Circadians / Nature Metabolism
A mouse study in Nature Metabolism reveals that microbiome composition varies with sampling time due to circadian rhythms, impacting research reproducibility. This finding emphasizes the need to consider time of sample collection in microbiome studies.
Gilead’s Trodelvy Stumbles in Late-Stage Trials But Remains Prized Cancer Asset
July 1, 2024 / Gilead Sciences / Trodelvy / ADC / Oncology / Drug Development
Gilead’s Trodelvy failed to meet the primary endpoint in a Phase III trial for metastatic urothelial cancer, raising safety concerns. Despite this, analysts remain optimistic about its potential in oncology, particularly in breast cancer treatment.
10 clinical trials to watch in the second half of 2024
July 1, 2024 / Clinical Trials / Amgen / Obesity
Amgen’s executives expressed confidence in their experimental obesity drug, projecting it to enter late-stage trials soon, significantly boosting the company’s market value by nearly $20 billion.
// Politics
3 Recent Supreme Court Decisions that Affect Healthcare
July 2, 2024 / Supreme Court / Healthcare Rulings / Chevron / FDA Regulation / Reglation Impacts
Three recent Supreme Court decisions impacting healthcare include overturning the Chevron deference, affecting agency regulations; and restricting access to mifepristone, challenging the FDA’s approval and regulation of the abortion pill.
China-made injectable PD-L1 drug flunks pivotal trial, forcing US partner to seek strategic options
July 2, 2024 / San Diego Biotech / Tracon Pharma / Alphamab
Tracon Pharmaceuticals halted the development of the China-approved injectable PD-L1 drug envafolimab after it failed a pivotal trial for undifferentiated pleomorphic sarcoma and myxofibrosarcoma, leading the company to seek strategic alternatives.
Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures
July 2, 2024 / Emergent BioSolutions / Anthrax Vaccine / Smallpox / HHS
Emergent BioSolutions received over $250 million in contract modifications from the U.S. government to enhance the supply of medical countermeasures, including vaccines for anthrax and smallpox, and treatments for smallpox vaccine complications and botulism.
Biden joins Sanders’ campaign targeting Novo Nordisk, Eli Lilly’s diabetes and obesity drug prices
July 2, 2024 / Joe Biden / Bernie Sanders / Drug Prices / Ozempic
President Biden and Senator Sanders criticized Novo Nordisk and Eli Lilly for high prices of diabetes and obesity drugs, advocating for expanded Medicare price negotiations and lower drug costs for all Americans.
Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority
July 1, 2024 / Chevron Doctrine / FDA Regulatory / Supreme Court
The Supreme Court’s overturning of the Chevron deference doctrine may limit the FDA’s regulatory authority, allowing more legal challenges to its drug approvals and jurisdictional decisions.