// Biotech and Pharma Therapeutics
GSK outpaces Pfizer in RSV vaccine market
November 1, 2023 / GSK / Pfizer / RSV / Vaccine
Though RSV is responsible for thousands of deaths and hospitalizations each year among young children and seniors, it’s defied scientists’ attempts to successfully develop a vaccine until now. The virus also isn’t nearly as well known as the flu or COVID-19.
New AstraZeneca, Cellectis Alliance Spans Up to 10 Cell & Gene Therapies
November 1, 2023 / AstraZeneca / Cell & Gene Therapies / Cellectis / Oncology / Immunology
According to deal terms announced Wednesday, AstraZeneca is kicking off the alliance with $105 million, which breaks down to $25 million in upfront cash and an $80 million equity investment in Cellectis. At the outset, AstraZeneca’s stake in its new partner will be about 22%, but that could soon grow.
Lilly’s obesity portfolio in ‘all-of-the-above mode’
November 2, 2023 / Eli Lilly / Tirzepatide / Mounjaro / Earnings
Eli Lilly is in “all-of-the-above mode” in obesity, with the research teams moving as fast as possible to advance an oral candidate and build a portfolio of complementary treatments.
Walmart Health Expands Affordable Access to Healthcare in Florida
November 1, 2023 / Walmart / Healthcare / Affordable Access / Orlando Health
Walmart Health and Orlando Health have agreed to more closely align on their approach to serving patients and managing patient outcomes in the Orlando community. Working together, they will streamline the patient experience through effective transitions of care and ensure robust communication between Walmart Health Center and Orlando Health providers.
Clario presents a three-part webinar series on oncology trial solutions
October 31, 2023 / Clario / Oncology / Healthcare / Clinical Trial
Clario, a healthcare research technology company that delivers the leading endpoint technology solutions for clinical trials, announces a three-part educational webinar series on oncology trial solutions. Drawing from over 50 years of clinical trial expertise, Clario’s webinars will focus on improving the assessment of efficacy, safety and quality of life within oncology clinical trial development programs.
// 4th Industrial Revolution
CISA, HHS and HSCC release healthcare cybersecurity toolkit
October 26, 2023 / CISA / HHA / HSCC / Healthcare / Cybersecurity
The Cybersecurity and Infrastructure Security Agency and the Department of Health and Human Services released the Cybersecurity Toolkit for Healthcare and Public Health after a discussion on cybersecurity challenges the U.S. healthcare and public health sector system faces and how government and industry can work together to close the gaps in resources and cyber capabilities.
Generative AI for Mental Wellness: Balancing the Potential, Cybersecurity, and Ethics
October 30, 2023 / AI / Cybersecurity / Ethics / Mental Health / Chatbots
Mental health is one of the major challenges in today’s digitally-driven world. GenAI-powered Chatbots can provide real-time tailored replies, and a calming virtual space to those who require assistance, thanks to advanced algorithms. While they can democratize the availability of psychological care, the accompanying ethical concerns and cybersecurity issues are key aspects of this ever-evolving setting. GenAI can narrow the disparity between the growing need for psychological help and the constraints of conventional infrastructures.
AI twice as accurate as a biopsy when grading severity of sarcomas
November 2, 2023 / AI / ICR / New Tech
New research from the Institute of Cancer Research (ICR) and The Royal Marsden NHS Foundation Trust has revealed that artificial intelligence (AI) could be twice as accurate at grading the aggressiveness of some sarcomas as a biopsy.
The obesity drug effect: What medical device executives are saying
November 2, 2023 / Obesity Drug / Medical Device / New Tech / GLP-1 / Obesity
Strong demand for GLP-1 drugs to treat obesity has forced medical device companies to take a hard look at the potential impact on procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
How an AI-powered clinical notes API could boost telehealth
November 1, 2023 / AI / API / Telehealth / Healthcare
Kwindla Hultman Kramer, cofounder and CEO at Daily, developer of WebRTC, an open-source tool for developers to work with video and audio, has worked with healthcare professionals and telehealth application engineers to develop a technological capability with the goal of reducing documentation time by 80% or more.
// Business & Markets
Egyptian health tech Almouneer raises $3.6M to scale its platform for treating diabetes and obesity
October 31, 2023 / Egyptian health tech / Obesity / Diabetes
Obesity and prediabetes are major health concerns in Africa and the Middle East, affecting more than 40% of the population. In Egypt, 20% of adults have diabetes; the figure in Saudi Arabia is 30%. In Nigeria, one in 17 adults has diabetes. The issue of prediabetes and obesity is even more widespread. Yet, it’s essential to recognize that these health challenges are largely preventable through lifestyle management and monitoring.
AstraZeneca takes 22% stake in Cellectis as part of collab for 10 cell and gene therapies
November 1, 2023 / AstraZeneca / Cellectis / Licensing Deals / Cell Therapy / Gene Therapy
Despite a rethink that saw Cellectis drop its multiple myeloma CAR-T only five months ago, AstraZeneca wants in. The Big Pharma is handing over more than $100 million in upfront cash and equity investment for a 10-candidate deal.
AstraZeneca Drops $245M on Cell and Gene Therapies in Deal with Cellectis
November 1, 2023 / AstraZeneca / Cellectis / Gene Therapy / Cell Therapy
A lucrative collaboration agreement with AstraZeneca sent Cellectis shares skyrocketing over 180% in premarket trading Wednesday. The pharma giant is investing $245 million in the French biotech, strengthening its commitment to developing cell and gene therapy products.
Novo, Lilly buoyed by fast-growing GLP-1 drug sales
November 2, 2023 / Novo / Eli Lilly / GLP-1 / Drug Sales
Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
Revvity Stock Tumbles 18% as Demand From Pharma and Biotech Customers Falls
October 30, 2023 / Revvity / Pharma / Biotech
Revvity stock was tumbling Monday after the health sciences company missed third-quarter earnings estimates and slashed its fiscal 2023 earnings outlook.
// Legal & Regulatory
FDA advisers see no roadblocks for gene-editing treatment for sickle cell disease
October 31, 2023 / FDA / Sickle Cell Disease / Gene-Editing
During the hearing, Vertex Pharmaceuticals of Boston, which developed the treatment with CRISPR Therapeutics also based in Boston, reported exa-cel appears to be safe and highly effective at preventing episodes of excruciating pain that plague sickle cell disease patients.
FDA Adcomm Sides with Vertex, CRISPR on Safety Testing for SCD Gene Therapy
November 1, 2023 / FDA / CRISPR / Vertex / Gene Therapy / SCD
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee on Tuesday agreed that Vertex Pharmaceuticals had sufficiently demonstrated the safety of its investigational sickle cell disease gene-edited therapy exagamglogene autotemcel (exa-cel).
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
November 1, 2023 / FDA / Patient Death / Mersana Therapeutics
The FDA has lifted its full clinical hold on Mersana Therapeutics’ Phase I study of XMT-2056, its investigational STING-directed antibody-drug conjugate, the company announced Tuesday.
FDA advisers wave through first CRISPR-based therapy, satisfied with off-target tests
November 1, 2023 / Vertex / CRISPR Therapeutics / CRISPR-Cas9 / Sickle Cell Disease
FDA advisers appear satisfied with CRISPR Therapeutics and Vertex Pharmaceuticals’ assessment of potential off-target effects from their CRISPR-based gene therapy exa-cel, quelling the top concern from the FDA as an approval deadline nears.
New drug gets FDA approval for the treatment of common genetic disease in young boys
October 31, 2023 / FDA / New Drug
A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.
// Research & Development
With first microbiome drug approved, Seres slims R&D efforts and workforce
November 2, 2023 / Seres Therapeutics / Microbiome / Restructuring / Nestle Health Science
After securing the first-ever approval for an oral microbiome therapy in April, Seres Therapeutics is facing some tough choices, resulting in a restructuring that will claim 41% of staff.
First Patient Enrolled in Phase III Clinical Trial of Boan Biotech’s Nivolumab Injection
October 30, 2023 / Clinical Trial / Boan Biotech / Phase III
Boan Biotech (6955.HK) announced today that the first patient in Phase III clinical trial of its Nivolumab Injection (BA1104) in China has been enrolled. BA1104 is the first biosimilar to Opdivo® to undergo a Phase III study in China.
Bristol Myers’ neuroscience research head explains the big pharma’s return to brain drugs
October 27, 2023 / Bristol Myers / Neuroscience / Alzheimer’s
As a field, neuroscience represents a major opportunity for drugmakers. Alzheimer’s disease affects millions of people in the U.S. alone, and puts an enormous strain on the healthcare system. Patients with ALS, Huntington’s and other disorders hallmarked by the breakdown or nerve cells are in desperate need of new treatments.
BioLabs Pegasus Park Cultivates Life Science Ecosystem
October 30, 2023 / BioLabs Pegasus Park / Texas / Life Science / Startup
Life science startups account for just 8% of global startups but are the second largest driver of investment capital, according to a 2022 report. Cell and gene therapies, machine learning technologies and other innovations have spurred the growth of life science companies. But the life science sector gained attention during the Covid-19 pandemic in a way that it hasn’t had for a long time. The pandemic highlighted the critical role the life science industry plays in creating diagnostics for viruses, disease, and precision medicine.
Citius Pharmaceuticals Announces Publication in Frontiers of Immunology of Positive Results from Solid Tumor Study of LYMPHIR™ in Combination with Checkpoint Inhibitor
October 31, 2023 / Citius Pharmaceuticals
The article reported positive results from a preclinical study that showed that denileukin diftitox in combination with an anti-PD-1 checkpoint inhibitor was more effective in the treatment of solid tumors (liver and colon) than either therapy alone. Data from this study contributed to the design and dosing regimen of two Phase 1 investigator-initiated studies currently underway at the University of Pittsburgh and the University of Minnesota.
// Politics
President Biden’s executive order on AI directs HHS to establish safety program
October 30, 2023 / Biden / Executive Order / AI / White House
The Biden Administration on Monday issued what it’s calling a “landmark” executive order designed to help channel the significant promise and manage the many risks of artificial intelligence and machine learning.
What they’re saying about the White House’s executive order on AI
November 1, 2023 / AI / White House
In the Biden administration’s latest push to encourage beneficial AI innovation while discouraging hazardous AI risk-taking, the president on Monday announced an executive order fleshing out that coupled call.
Congress must act to protect patients’ health care access
November 2, 2023 / Congress / Healthcare / Patients Access
The Centers for Medicare & Medicaid Services (CMS) finalized cuts to the physician fee schedule for 2024, which will impact the ability of medical practices to cover expenses like equipment, rent, and nursing and office staff salaries. Put plainly, our ability to care for our patients is threatened, putting patients at risk of more hospitalizations for untreated illnesses and chronic conditions.
What healthcare reform means to the ASC CEO running for Congress
November 1, 2023 / Healthcare / CEO / Congress
Healthcare reform is key to the platform of Austin Cheng, CEO of New York City-based Gramercy Surgery Center and candidate to represent New York’s 3rd Congressional District.
New recommendations outline how Congress could lower ground ambulance costs
November 2, 2023 / Ambulance Costs / Congress
To lower costs and improve billing for patients who need ground ambulance services, federal lawmakers should ban surprise bills, limit patient cost-sharing and make bills easier to understand, according to a committee formed by Congress to explore how to tackle these issues.