// Biotech and Pharma Therapeutics
Viking stays in obesity drug race with early data for weight loss pill
March 26, 2024 / Viking Therapeutics / Obesity Pill / Weight Loss
Viking Therapeutics’ early trial data for its dual-acting obesity pill, VK2735, showed a 5% weight loss in four weeks with high tolerability, positioning it as a strong contender in the obesity drug market.
Thermo Fisher, Bayer partner to develop companion diagnostics
March 21, 2024 / San Diego / Thermo Fisher / Bayer / Cancer Therapies
Thermo Fisher and Bayer have partnered to develop next-generation sequencing-based companion diagnostics for precision cancer therapies, aiming to enhance therapy access through rapid, decentralized genomic testing.
Avenzo Closes $150M Oversubscribed Series A-1 to Advance Cancer Therapies
March 27, 2024 / Avenzo Therapeutics / Oncology / Cancer Treatment
Avenzo Therapeutics secures $150M in Series A-1 funding to advance oncology therapeutics, including its lead program AVZ-021, a CDK2 selective inhibitor aimed at overcoming resistance in cancer treatments.
Unable to find a partner for stem cell therapy, Gamida accepts sale to investment firm to survive
March 27, 2024 / Stem Cell Therapy / FDA Approval / Highbridge Capital
Facing financial difficulties, Gamida Cell transitions to private ownership under Highbridge Capital Management to secure funding for the commercialization of its FDA-approved stem cell therapy, Omisirge, aimed at reducing infection risk in blood cancer patients.
What Are the Challenges Facing the Pharmacy Industry Right Now?
March 20, 2024 / Covid-19 / Vaccines / Regulatory / Indusrty Challenges
The pharmacy industry faces challenges such as a highly regulated environment, workforce shortages, and increasing responsibilities post-Covid-19. Efforts to automate and leverage technicians are underway, amid discussions on forming a national pharmacy union for better working conditions.
// 4th Industrial Revolution
Large language AI put to the test for potential adopters in primary care
March 26, 2024 / AI / Chat GPT / New Study / Healthcare
Large language AI like ChatGPT shows promise in summarizing medical study abstracts efficiently and with minimal bias, although it struggles to identify relevant studies for specific patient populations, as revealed by University of Kansas researchers.
AI alone won’t save lives or improve health: Kaiser Permanente AI exec
March 22, 2024 / AI / Kaiser Permanente / Healthcare Regulation
Kaiser Permanente’s VP of AI highlights the challenges and necessities in AI adoption, emphasizing the need for alignment with healthcare goals, regulatory oversight, and the establishment of standards to ensure AI enhances quality, equitable care.
Healthy datasets are the cornerstone of effective AI initiatives
March 26, 2024 / AI / Healthcare / Data Transparency
Machine learning models can precisely predict the risk of major adverse limb events or death within one year after endovascular treatment for peripheral artery disease.
UC Irvine is making big strides with nursing-focused AI models
March 21, 2024 / UC Irvine / AI / Patient Health / Healthcare
UC Irvine’s nursing faculty is pioneering AI-driven models to predict patient outcomes, focusing on leveraging large datasets and machine learning. Their work includes using national cancer registries and wearable sensor data for predictions, and developing race-specific models to improve care for minority populations.
Novosound locks down patent for wearable ultrasound imaging platform
March 26, 2024 / Novo Nordisk / Wearable Device / Heart Failure
Novosound received a patent for its Slanj digital platform, introducing a gel-free, WiFi-enabled wearable ultrasound device aimed at revolutionizing the medical and wearable-device market by enabling continuous blood pressure monitoring and more.
// Business & Markets
Novo Nordisk inks $1B Cardior buyout to pump up heart failure plans
March 25, 2024 / Novo Nordisk / Heart Failure
Novo Nordisk acquires Cardior Pharmaceuticals for over $1 billion, aiming to enhance its heart failure treatment portfolio with CDR132L, an innovative antisense oligonucleotide targeting miR-132, implicated in heart failure progression.
PocketHealth secures $33M for patient-facing medical records platform
March 21, 2024 / Pocket Health / AI / Healthcare / Patient Imaging Access
PocketHealth raises $33 million in Series B funding to expand its AI-enabled platform that allows patients to access and share their medical imaging and records, enhancing patient care and data accessibility.
AbbVie to buy immune drug developer Landos
March 25, 2024 / AbbVie / Inflammatory Disease Drugs / Mergers / Crohn’s Disase Treatent
AbbVie acquires Landos Biopharma for approximately $138 million, gaining an innovative inflammatory bowel disease drug, NX-13, currently in mid-stage trials for ulcerative colitis, with potential in Crohn’s disease.
Stoke’s Early-Stage Data for Genetic Epilepsy Drug Sends Stock Skyrocketing
March 26, 2024 / Stroke Therapeutics / Epilepsy Drug
Stoke Therapeutics’ early data on its Dravet syndrome drug, STK-001, showed significant seizure reduction, sending its stock soaring. The FDA approved escalated dosing, positioning STK-001 as a potential first disease-modifying therapy for this genetic epilepsy.
Amgen, facing potential Enbrel price cap in Colorado, takes state’s new drug affordability board to court
March 26, 2024 / Amgen / Lawsuit / Drug Pricing / Colorado / Patent
Amgen sues Colorado over a proposed price cap on its arthritis drug Enbrel, challenging the state’s Prescription Drug Affordability Board’s decision as unconstitutional and a violation of federal law, amidst concerns of undermining patent protections.
// Legal & Regulatory
FDA clears first-of-its-kind Duchenne drug for broad use
March 22, 2024 / FDA Approval / Duchenne Muscular Dystrophy
The FDA approves Italfarmaco’s Duvyzat, the first non-steroidal pill for Duchenne muscular dystrophy applicable to all patients aged six and above, showing significant motor function improvements.
FDA rejects Regeneron lymphoma drug, setting back company’s oncology push
March 25, 2024 / FDA Rejection / Oncology Trials
The FDA has deferred approval of Regeneron’s lymphoma drug, odronextamab, pending further trial progress, marking a delay in the company’s entry into the competitive oncology market.
FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma
March 27, 2024 / Blackstone Life Sciences / Investment / Moderna / Vaccines / mRNA Technology
Blackstone Life Sciences invests $750 million in Moderna’s flu vaccine program, aiming to bolster mRNA technology development. The funds will reduce R&D expenses, with Moderna maintaining full control over the program.
Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair
March 26, 2024 / Merck / FDA Approval / Pulmonary Arterial Hypertension / Hypertension / Acquision
Merck receives FDA approval for Winrevair, the first disease-modifying treatment for pulmonary arterial hypertension, marking a significant advancement in PAH therapy with a potential to improve survival rates.
AstraZeneca’s Ultomiris Wins FDA Approval for Rare Autoimmune Disease
March 26, 2024 / FDA Approval / AstraZeneca / NMOSD
AstraZeneca’s Ultomiris receives FDA approval for treating neuromyelitis optica spectrum disorder (NMOSD) in adults with anti-AQP4 antibodies, offering a long-acting treatment option that significantly reduces relapse risk.
// Research & Development
Pfizer Terminates Phase III Sickle Cell Study Due to Slow Patient Recruitment
March 27, 2024 / Pfizer / Sickle Cell Disease / Phase III
Pfizer discontinues a Phase III study on the sickle cell disease treatment inclacumab due to slow patient recruitment, despite the drug’s potential and FDA designations, emphasizing ongoing efforts for approval by 2026.
Nanoscope eyes market after gene therapy restores vision for patients with retinal disease
March 26, 2024 / Nanoscope Therapy / Gene Therapy
Nanoscope Therapeutics plans to seek FDA approval for its retinal disease gene therapy, MCO-010, after a phase 2b study shows significant vision improvement in patients with advanced retinitis pigmentosa.
Altimmune bails on hepatitis B after phase 2 data disappoint, quashing partnering plans
March 27, 2024 / Weight loss / Metabolic Dysfunction
Altimmune discontinues its hepatitis B vaccine candidate, HepTcell, after insufficient phase 2 results, refocusing on its promising GLP-1/glucagon receptor agonist, pemvidutide, for weight loss and metabolic dysfunction.
Menopause Brain Fog or Dementia? Midi Health, Neurotrack Team Up To Offer Screening
March 25, 2024 / Menopause / Women’s Health / Brain Fog / Midi Health / Digital Health
Midi Health partners with Neurotrack to offer cognitive screenings for women experiencing menopause-related brain fog, distinguishing it from more serious conditions like dementia, utilizing a simple, quick, and accurate online test.
European study finds popular ALS drug ineffective
March 27, 2024 / ALS Drug Trial / Clinical Trials / Patient Care
A European clinical trial concludes that a widely used ALS drug, TUDCA, fails to slow disease progression, showing no significant benefits over a placebo, challenging current treatment approaches for ALS patients.
// Politics
U.S.-China Decoupling Poses Supply-Chain Risks for Drug Companies
March 23, 2024 / China / Supply-chain / Biosecure Act
U.S. efforts to decouple from China raise supply-chain concerns for drug companies, with potential blacklisting of Chinese biotech firms threatening cost-effective drug development partnerships and government contract eligibility.
States step in to hasten provider recovery in wake of Change Healthcare cyberattack
March 27, 2024 / Healthcare / Cyberattck
States are stepping in to support healthcare providers affected by the Change Healthcare cyberattack by offering advanced payment relief and easing claims processing, complementing CMS’s efforts to mitigate financial disruptions.
Senate probe examines high-risk biotech research
March 21, 2024 / Senate / Biotech / Covid
The Senate is investigating national security risks from high-risk biological research, focusing on U.S.-China biotech competition and COVID-19 origins, with potential implications for Chinese contract research organizations and U.S. research funding.
Anti-China bills portend massive blow to biotech: BioCentury survey
March 21, 2024 / Biotech / China / Drug Development
Legislation targeting Chinese CDMOs could significantly disrupt biotech, with a BioCentury survey revealing industry concerns over replacing manufacturing capacity and potential delays in drug development.
Supreme Court mifepristone arguments focus on physicians’ right to sue, not FDA judgment
March 26, 2024 / Supreme Court / FDA
Supreme Court justices appeared skeptical of the claim that physicians have standing to challenge the FDA’s relaxed prescribing rules for the abortion pill mifepristone, focusing more on the legal right to sue than on the FDA’s judgment.