// Biotech and Pharma Therapeutics
BridgeBio sends rare disease drugs to new company
August 21, 2024 / BridgeBio / GondolaBio / Rare Disease Drugs / Life Sciences / Investing
BridgeBio Pharma has transferred several rare disease drug programs to GondolaBio, a new company with $300 million in investment from top life sciences investors, while retaining a 45% initial stake.
Dr Reddy’s, Aurigene and Kainomyx to co-develop anti-malarials
August 21, 2024 / Drug Development / Cytoskeletal Proteins / Malaria / Affordable Treatment
Dr Reddy’s, Aurigene, and Kainomyx have agreed to co-develop an innovative, affordable anti-malarial drug, focusing on a new mechanism targeting cytoskeletal proteins in parasites, with global access and market reach as key priorities.
GSK takes aim at less common lung cancer with novel ADC
August 20, 2024 / Breakthrough Therapy / Small-cell Lung Cancer / FDA / Clinical Results
GSK’s investigational ADC, GSK’227, received FDA Breakthrough Therapy designation for treating extensive-stage small-cell lung cancer (ES-SCLC) post-chemotherapy, based on promising early clinical results.
Eli Lilly Drug Reduces Risk of Diabetes Onset, Building Case for Broader Use of the Therapy
August 20, 2024 / Eli Lilly / Trizepatide / Type 2 Diabetes Risk Reduction / Obesity Treatment / Mounjaro / Weight Loss Trial
Eli Lilly’s tirzepatide significantly reduced the risk of progressing to type 2 diabetes by 94% in overweight or obese patients with prediabetes, demonstrating potential beyond weight loss in the longest clinical trial to date.
3 Health Systems Invest In Supply Chain Startup
August 21, 2024 / Supply Chain Management / AI / Health System Investments
Three health systems invested in Clarium, a startup enhancing hospital supply chain management through its AI-driven platform, Astra OS, which improves data visibility, standardization, and efficiency in inventory and preference card management.
// 4th Industrial Revolution
CancerIQ Raises Growth Capital for Personalized Cancer Detection
August 21, 2024 / CancerIQ / Precision Health / Genetic Testing / Cancer Risk Assessment / HER / Cancer Detection
CancerIQ secured growth funding to enhance its precision health platform, enabling healthcare providers to personalize cancer prevention and detection by integrating risk assessment and genetic testing into EHR workflows, improving patient outcomes and adherence to care plans.
BayCare to Deploy Cadence’s Remote Patient Monitoring for Chronic Disease Management
August 20, 2024 / Remote Patient Monitoring / Chronic Disease Management / BayCare / Partnership / Hypertension Care / Virtual Care
BayCare partners with Cadence to implement remote patient monitoring for seniors with chronic conditions like hypertension and type 2 diabetes. The program uses real-time data and continuous care to improve outcomes and prevent hospitalizations.
Ethical AI-based scribe tech helps WellPower slash documentation time
August 21, 2024 / Ethical AI Healthcare / Mental Health / WellPower Eleos / Clinical Workflow
WellPower’s ethical AI-based scribe technology, Eleos, has significantly reduced clinical documentation time by 60% in mental health therapy, enhancing patient care while ensuring privacy and reducing administrative burdens for therapists.
HITRUST unveils new tool for AI risk management
August 21, 2024 / AI Risk Management / HITRUST / Healthcare / AI Security Standards
HITRUST introduced an AI Risk Management Assessment tool to help healthcare and other organizations govern AI deployments, aligning with NIST and ISO/IEC standards to ensure comprehensive risk management and secure AI implementation.
PatientIQ Automates and Improves the Collection of Patient-Reported Outcome Measures
August 21, 2024 / PatientIQ / PROMs / Healthcare Data / Clinical Trial Efficiency / HER Integration
PatientIQ automates the collection and analysis of patient-reported outcome measures (PROMs), enhancing personalized care and research by integrating PROMs into EHR workflows, improving survey response rates, and supporting evidence-based clinical decisions.
// Business & Markets
In launching epinephrine nasal spray, ARS Pharma has a ‘blue sky opportunity,’ analyst says
August 21, 2024 / Neffy Nasal Spray / Needle-free Epinephrine / ARS Pharma
ARS Pharma’s newly FDA-approved needle-free epinephrine nasal spray, Neffy, targets a large, untapped market of patients and first responders, offering a convenient alternative to autoinjectors, with an expected U.S. launch in October and potential European expansion.
PreciseDx Raises $20.7M for AI-Powered Cancer Risk Assessments
August 21, 2024 / AI / Oncology Diagnostics / PreciseDx Funding / Cancer Risk
PreciseDx raised $20.7M in Series B funding to enhance its AI-powered oncology diagnostics platform, focusing on cancer risk assessment through morphology-driven analysis, aiming to expand operations, validate its PreciseBreast™ tool, and form strategic partnerships.
Business Group on Health: Healthcare Costs Expected to Surge at Highest Rate in 15 Years
August 21, 2024 / Healthcare Cost Increase / Employer Healthcare Spending / GLP-1 Impact / Chronic Disease Cost Management
Healthcare costs for employers are expected to surge nearly 8% by 2025, the highest in 15 years, driven by rising pharmacy costs, GLP-1 medications, and chronic conditions like cancer. Employers plan to absorb most costs and reevaluate vendor partnerships.
Hong Kong IPO takes TYK Medicines public with $74 million
August 21, 2024 / TYK Medicines IPO / Non-small-cell Lung Cancer / Hong Kong Biotech
TYK Medicines raised $74 million through a Hong Kong IPO to advance its lead drug, TY-9591, which targets non–small-cell lung cancer (NSCLC) with EGFR mutations, particularly focusing on brain metastases.
Ambrosia lands $16m to ‘improve on existing GLP-1 drugs’
August 21, 2024 / Ambrosia Biosciences / GLP-1 Drug Development / Obesity Treatment
Ambrosia Biosciences raised $16 million in Series A funding to develop novel, orally delivered small-molecule therapies targeting incretins and GPCRs for obesity and metabolic disorders, aiming to improve upon existing GLP-1 drugs like semaglutide.
// Legal & Regulatory
Japan’s Astellas says employee indicted by China’s prosecutors
August 21, 2024 / Astellas Pharma / Employee Indictment / China-Japan Relations
A Japanese employee of Astellas Pharma, detained in Beijing since March 2023 on espionage charges, has been formally indicted by Chinese authorities, according to the company and Japan’s Foreign Ministry.
FDA rejects Regeneron’s blood cancer bispecific, delaying would-be challenger to J&J and Pfizer
August 21, 2024 / Regeneron / FDA / Third-party Manufacturing Issues / Blood Cancer Market Competition
The FDA issued a complete response letter to Regeneron, delaying the approval of its bispecific antibody linvoseltamab for multiple myeloma due to manufacturing issues at a third-party facility, postponing its challenge to J&J and Pfizer in the blood cancer market.
Humana to pay $90 mln to settle claim that it overcharged Medicare for drugs
August 16, 2024 / Humana Medicare Settlement / Lawsuit / Whistleblower
Humana agreed to pay $90 million to settle a whistleblower lawsuit alleging it overcharged Medicare for prescription drugs by misrepresenting costs. The settlement marks the first of its kind related to Medicare’s prescription drug contracting process.
FDA grants tentative approval of Yutrepia
August 21, 2024 / FDA / PAH Treatment Approval / Hypertension
The FDA has granted tentative approval to Liquidia’s Yutrepia, an inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), pending final approval after a competitor’s exclusivity ends in May 2025.
Lawmakers’ letter to FDA targets trials at China’s military hospitals, studies in Xinjiang
August 20, 2024 / FDA / China Trials / Clinical Trials / Lawmakers
U.S. lawmakers have urged the FDA to tighten oversight of biopharma companies conducting clinical trials at Chinese military hospitals and in Xinjiang, highlighting concerns over collaborations with the People’s Liberation Army (PLA) and human rights issues.
// Research & Development
Merck Ebola vaccine Ervebo shown to offer substantial protection
August 21, 2024 / Merck Ebola / Vaccines / DRC Ebola Protection
Merck’s Ebola vaccine, Ervebo, demonstrated 84% effectiveness in protecting against Ebola during the 2018-2020 outbreak in the Democratic Republic of the Congo, according to a new study, offering significant protection in real-world conditions.
Aadi axes 80% of staff after registrational Phase II trial fails
August 21, 2024 / Aadi Biosciences / Layoffs / mTOR Inhibitor Trial
Aadi Biosciences halted its Phase II PRECISION1 trial for nab-sirolimus after an independent committee found it unlikely to meet efficacy for accelerated approval. The company is cutting 80% of its R&D staff and restructuring to extend cash reserves into 2026.
Exact Sciences kicks off multi-cancer detection study
August 21, 2024 / Exact Sciences MCED Study / multi-cancer Early detection / DNA
Exact Sciences has initiated the Falcon registry study, enrolling 25,000 participants aged 50-80 for multi-cancer early detection (MCED) testing over five years. The study will evaluate the clinical performance and psychological impact of MCED testing, following promising results from the ASCEND-2 study.
Data show diabetes delayed by tirzepatide treatment
August 21, 2024 / Trizepatide Diabetes Prevention / Eli Lilly / Type 2 Diabetes
Eli Lilly’s tirzepatide significantly delayed the onset of type 2 diabetes by 94% in pre-diabetic adults with obesity or overweight, according to positive results from the three-year SURMOUNT-1 Phase III trial.
New study suggesting suicidal ideation risk for Novo’s Ozempic adds to ongoing safety debate
August 20, 2024 / Semaglutide Suicidal Ideation / Ozempic / GLP-1 Drugs / Mental Health / Novo Nordisk
A new JAMA study suggests a potential link between Novo Nordisk’s semaglutide (Ozempic, Wegovy) and increased suicidal ideation, particularly in patients using antidepressants. However, experts caution that the study’s findings do not establish causality, and Novo continues to monitor the drug’s safety.
// Politics
Insurers confirm IRA will reduce patient treatment options
August 21, 2024 / Inflation Reduction Act / Insurer Coverage
A survey by Magnolia Market Access reveals that insurers plan to limit Medicare Part D coverage due to the Inflation Reduction Act, with 89% increasing utilization management tools and 83% excluding more medicines from formularies.
Pharma’s concerns pile up months after Supreme Court’s landmark Chevron decision
August 21, 2024 / US Supreme Court / Chevron Decision / FDA / Inflation Reduction Act / Drug Price Negotiations / Litigation Risks
The U.S. Supreme Court’s overturning of the Chevron deference could allow pharma companies to challenge FDA and CMS regulations, such as the Inflation Reduction Act, leading to greater uncertainty in drug development, pricing, and regulatory decisions.
US judge strikes down Biden administration ban on worker ‘noncompete’ agreements
August 21, 2024 / Biden Administration / FTC Ban / Noncompete Agreements Ban
A U.S. federal judge struck down the Biden administration’s FTC ban on noncompete agreements, ruling the agency lacks authority and did not justify the broad prohibition. The decision, seen as a win for businesses, may be appealed by the FTC.
Biden Administration Targets $6B Savings Through Medicare Drug Price Negotiations
August 15, 2024 / Medicare / Drug Price Negotiations / Biden Administration
The Biden administration’s Medicare drug price negotiations, part of the Inflation Reduction Act, are projected to save the U.S. government $6 billion in the first year starting in 2026, reducing out-of-pocket costs for Medicare recipients by $1.5 billion.
Big Pharma: The government revealed its list of negotiated drug prices. Here are the reactions.
August 15, 2024 / CMS / Drug Prices / Inflation Reduction Act / Medicare
The CMS released its first negotiated drug price list under the Inflation Reduction Act, effective in 2026. Pharma companies criticized the move as unconstitutional, warning of higher costs, restricted access, and fewer drug options for seniors.