// Biotech and Pharma Therapeutics
Weight-loss jab gets green light to be used to prevent heart attacks in UK
July 23, 2024 / Weight-loss / Semaglutide Heart Attack Prevention / Wegovy / Obesity / Drug Approval
The UK approved Semaglutide (Wegovy) for preventing heart attacks and strokes in overweight individuals with cardiovascular disease, marking its first use as a preventive treatment for heart-related conditions.
Bird flu puts BARDA back in the spotlight
July 23, 2024 / BARDA avian Flu / Vaccine / Public Health
Moderna received $176 million from BARDA to develop an mRNA-based avian flu vaccine, emphasizing BARDA’s role in public health preparedness and partnership with private companies for advanced medical countermeasures.
How Food Allergy Care Has Changed in the Last Decade
July 23, 2024 / FDA Approval / Clinical Trials / Oral Immunotherapy
Over the last decade, food allergy care has advanced significantly with oral immunotherapy and the FDA approval of Xolair for food allergies, offering new treatment options and improving the quality of life for many patients.
J&J vets burst into biotech with $165M Third Arc series A
July 23, 2024 /Johnson & Johnson / Autoimmune Treatment
Johnson & Johnson veterans launched Third Arc Bio with $165 million to develop multifunctional antibodies for solid tumors and autoimmune diseases, leveraging their expertise to drive innovative drug development.
HIV drug could be made for just $40 a year for every patient
July 23, 2024 / HIV Drug / Vaccines / Gilead
New research suggests Gilead’s HIV drug Lenacapavir, currently costing $42,250 annually, could be produced for just $40 per year per patient, making it significantly more affordable globally.
// 4th Industrial Revolution
Abridge partners with Epic, Mayo Clinic to create a genAI nurse workflow tool
July 23, 2024 / Abridge / AI / Mayo Clinic / Healthcare
Abridge, Epic, and Mayo Clinic are partnering to create a genAI documentation tool for nurses, integrating Abridge’s AI with Epic’s EHR to streamline Mayo Clinic’s inpatient workflows, targeting release by end of 2024.
AI-Powered Pathology: Proscia Unveils Multi-AI Workflows for Concentriq ® AP
July 23, 2024 / AI / Cancer / Precision Medicine / Digital Pathology
Proscia’s latest Concentriq® AP update introduces multi-AI workflows to enhance pathology by integrating multiple AI applications for comprehensive analysis, aiming to improve cancer diagnosis and precision medicine.
Providence developing AI tools designed to reduce clinician burnout
July 23, 2024 / AI / Clinical Burnout / MedPearl / Clinical Intelligence
Providence is developing AI tools like MedPearl to reduce clinician burnout by optimizing workflows and enhancing decision-making. These AI implementations aim to alleviate the workload and support clinical care without replacing human expertise.
New Flagship spinout designs drugs using generative AI, chemistry
July 23, 2024 / Flagship Pioneering / Startup / Generative AI
Flagship Pioneering’s new startup uses generative AI and high-throughput chemical synthesis to design innovative drugs called “Synteins,” advancing medicinal chemistry and drug development.
Microsoft, Mass General Brigham & UW Health to Advance GenAI in Medical Imaging
July 24, 2024 / Generative AI / Patnership / Microsoft
Microsoft, Mass General Brigham, and UW Health are collaborating to advance generative AI in medical imaging, aiming to improve radiology by reducing clinician workloads, enhancing report accuracy, and speeding up diagnoses, while prioritizing responsible AI development.
// Business & Markets
Dental AI Company Pearl Raises $58M to Expand FDA-Cleared Dental Solutions
July 24, 2024 / AI / Funding / FDA / Pearl Dental
Dental AI leader Pearl raised $58M in Series B funding to expand its FDA-cleared AI solutions for dental diagnostics, aiming to enhance accuracy, consistency, and patient care in over 120 countries with advanced AI capabilities.
Flagship Pioneering Launches Startup Abiologics to Advance New Class of Biologic Drugs
July 23, 2024 / Synthetic Proteins / Flagship Pioneering / Startup / AI / Drug Design
Flagship Pioneering’s startup, Abiologics, aims to improve biologic drugs by using non-standard amino acids to design synthetic proteins called Synteins, potentially offering better stability, reduced immune responses, and new treatment options for cancer and metabolic diseases.
Brenig Therapeutics Raises $65M in Series A Financing
July 23, 2024 / Brenig Therapeutics / Funding / Drug Discovery / AI
Brenig Therapeutics raised $65M in Series A funding to advance its AI/ML-discovered small molecule LRKK2 inhibitor, BT-267, through clinical studies for Parkinson’s disease, with funding led by NEA and participation from OrbiMed and others.
Agilent Pays $925M to Buy CDMO Biovectra to Boost Biologics, CRISPR Capabilities
July 23, 2024 / Agilent Biovectra / Acquisition / Gene Editing / CRISPR Technology
Agilent Technologies is acquiring CDMO Biovectra for $925 million to enhance its biologics and CRISPR capabilities, offering a comprehensive gene-editing service. The acquisition includes Biovectra’s advanced facilities and expertise in various therapeutic areas.
Headway scores $100M, more than doubling its valuation to $2.3B
July 23, 2024 / Mental Health / Medicare / Virtual Therapy
Mental health platform Headway raised $100 million in Series D funding, doubling its valuation to $2.3 billion. The funds will enhance product development, especially for Medicare and Medicaid services, and support its expansion plans.
// Legal & Regulatory
GSK Plots Blenrep’s Path Back to Market With EU Filing
July 22, 2024 / GSK / Blenrep / Treatment
GSK is seeking to relaunch Blenrep (belantamab mafodotin) in the EU for relapsed or refractory multiple myeloma as a combination therapy. Supported by Phase III DREAMM-7 and DREAMM-8 data, the EMA is reviewing its marketing authorization application.
MHRA approves GLP–1 receptor agonist Wegovy for new use
July 23, 2024 / MHRA Wegovy / Heart Risk Reduction / Novo Nordisk / Obesity
The UK MHRA has approved Novo Nordisk’s Wegovy (semaglutide) for a new use: reducing the risk of serious heart problems or strokes in overweight and obese adults. This GLP-1 receptor agonist was already approved for obesity treatment and weight management.
SEC Hits Allarity With Wells Notice, Flags Alleged Violations in FDA Meeting
July 23, 2024 / SEC / Allarity Therapeutics / FDA
The SEC issued a Wells Notice to Allarity Therapeutics for alleged federal securities law violations related to FDA meeting disclosures about its cancer drug dovitinib. Allarity plans to respond formally and is cooperating with the SEC.
Novo Nordisk’s Wegovy gets UK approval for use to lower heart risks
July 23, 2024 / Novo Nordisk / Weight-loss Drug / Cardiovascular Approval/ Obesity
Novo Nordisk’s weight-loss drug Wegovy received UK MHRA approval to reduce heart risks in overweight and obese adults, following similar US FDA approval. Wegovy, the first GLP-1 weight-loss drug for cardiovascular event prevention, showed a 20% risk reduction in trials.
Action by FDA ensures trial sponsors must consider diversity
July 23, 2024 / FDA / Clinical Trial / Clinical Research / Patient Trials
The FDA issued updated guidance requiring clinical trial sponsors to include diversity action plans, addressing long-standing diversity issues in trials. This ensures broader, more representative data collection and aims to improve the generalizability and ethics of clinical research.
// Research & Development
GSK’s Dovato Matches Efficacy of Gilead’s Biktarvy in Head-to-Head HIV Trial
July 23, 2024 / GSK Dovato Efficacy / HIV / Healthcare / Weight Gain
In a large Phase IV study, GSK’s two-drug HIV regimen Dovato matched the efficacy of Gilead’s three-drug regimen Biktarvy, with significantly less weight gain. Both maintained viral suppression, with Dovato showing non-inferior results to Biktarvy.
Merck claims late-stage study success for RSV antibody
July 23, 2024 / Merck RSV / Late-stage Study
Merck’s RSV antibody clesrovimab showed success in a late-stage study, aiming to compete in the lucrative RSV therapy market. The treatment could offer advantages over existing therapies like Beyfortus, with potential for high efficacy and simplified administration.
Merck Challenges AstraZeneca, Sanofi With Phase IIb/III Data for RSV Antibody
July 23, 2024 / Merck / RSV Study / Respiratory Infections
Merck’s Phase IIb/III study results show that clesrovimab significantly reduced the risk of medically attended lower respiratory infections in infants caused by RSV. Merck plans to present detailed data soon and file for regulatory approval globally.
Study reveals two proteins that may contribute to stroke recurrence or other MACEs
July 23, 2024 / Genetic Markers / Stroke Prevention
Researchers from BUSPH and the University of Bristol identified two proteins, CCL27 and TNFRSF14, that may contribute to stroke recurrence or major adverse cardiovascular events (MACEs), highlighting new potential drug targets to prevent stroke-related disabilities and mortality.
Robotic aid helped improve balance, gait in children with cerebral palsy
July 24, 2024 / Cerebral Palsy / Disability Therapy / Robotic Exoskeleton
A South Korean study published in JAMA Network Open found that robotic exoskeletons can improve gait, balance, and motor function in children with cerebral palsy, though the improvement was modest at 2.7%, highlighting the need for greater gains to replace conventional therapy.
// Politics
Healthcare leaders react to Biden withdrawing from 2024 presidential race
July 22, 2024 / Biden / Kamala Harris / Healthcare Price
Healthcare leaders responded to President Joe Biden’s decision to withdraw from the 2024 presidential race, emphasizing the need for healthcare price transparency and the importance of addressing healthcare system issues. Biden endorsed Vice President Kamala Harris as his successor.
President Biden touts drug pricing achievements as he steps down from re-election campaign
July 22, 2024 / Biden / Drug Pricing / Medicare / Price Negotiations / Inflation Reduction Act
President Joe Biden announced he is stepping down from the 2024 presidential race, highlighting his achievements in drug pricing reforms under the 2022 Inflation Reduction Act. These include Medicare price negotiations, insulin price caps, and out-of-pocket cost limits for Medicare beneficiaries.
Pharmacy benefit managers are often described as middlemen who drive up costs; but for employers, that’s not the case
July 19, 2024 / Pharmacy Benefit / Drug Prices / House Committee PBM Hearing / Drug Cost
The House Committee on Oversight and Accountability will evaluate pharmacy benefit managers (PBMs) amid claims they increase prescription drug costs and harm patient care. However, industry professionals argue that PBMs help employers reduce healthcare costs and improve medication access for employees.
Alabama employers sound alarm over scrutiny of prescription drug benefits ahead of U.S. House hearing
July 23, 2024 / Alabama / House Committee / PBM Hearing / Prescription Drug Cost Management / Healthcare Saving
Alabama employers are concerned about potential government interference in pharmacy benefit managers (PBMs) ahead of a U.S. House Committee on Oversight hearing. They argue that PBMs help manage and reduce prescription drug costs, and government mandates could increase costs for businesses and consumers.
House hearing keeps pressure on PBM practices while Congress considers reforms
July 23, 2024 / House Oversight / PBM Practices / Pharmacy Benefit
The House Oversight Committee continues to scrutinize PBM practices, revealing that PBMs steer patients to their own pharmacies and underpay competitors. The focus on PBM reforms may lead to legislative action during the upcoming lame duck period in Congress.