// Biotech and Pharma Therapeutics
Public-private collaboration aims to take ALS therapies beyond ‘a shot in the dark’
May 29, 2024 / ALS Treatment / Partnership
Public-private partnership AMP ALS aims to revolutionize ALS diagnostics and treatments, leveraging collaborative expertise to advance therapies and improve patient outcomes.
Bristol Myers Squibb checks ‘yes’ on another Prothena neurodegenerative therapy
May 29, 2024 / Bristol Myers Squibb / Neurodegenerative Therapy / Disease Treatment
Bristol Myers Squibb acquires exclusive global rights to Prothena’s neurodegenerative therapy PRX019, set to begin human trials, for $80 million, continuing their collaborative efforts in addressing neurodegenerative diseases.
Biotech Sector Working to Combat Rising Cases of Colorectal Cancer in Young Adults
May 28, 2024 / Colorectal Cancer / Immunotherapies / HIV / Innovation
Biotech companies are developing advanced immunotherapies and innovative treatments to combat rising colorectal and anal cancer rates in young adults, addressing the challenges posed by concurrent HIV diagnoses.
UK MRC and AstraZeneca partner for translational clinical research
May 23, 2024 /AstraZeneca / Partnership / Clinical Research / Clinical Trials
The UK MRC and AstraZeneca partnership offers industry placements for six MRC clinical fellows, aiming to enhance their regulatory and clinical trial expertise, supporting future translational clinical research in the UK.
After 5-year quest to streamline cell and gene therapy production, Ori Biotech reveals automated platform
May 29, 2024 / Ori Biotech / Cell Therapy / Gene Therapy / Automation / Therapy Manufacturing
Ori Biotech’s new IRO platform automates and standardizes cell and gene therapy manufacturing, reducing labor, costs, and processing times, addressing major production barriers and improving patient access.
// 4th Industrial Revolution
The only thing to fear from AI in healthcare is fear of AI in healthcare itself
May 29, 2024 / AI / Healthcare / AI Medical Systems / AI Risks
AI in healthcare will neither perform miracles nor cause catastrophes, balancing its immense data-processing capabilities with its inability to replicate human empathy. Understanding and managing AI’s risks and benefits are crucial for its successful integration.
How AI can boost cancer, depression and perioperative care
May 29, 2024 / AI / Cancer Care / Mental Health / Depression
AI is revolutionizing cancer, depression, and perioperative care by enhancing early detection, predicting complications, and improving treatment efficiency, despite implementation challenges in healthcare systems.
AI tool predicts autoimmune disease risk using genomic data
May 29, 2024 / AI / Autoimmune Disease / Disease Prediction
Penn State researchers developed the AI-driven EXPRESSO model, which uses genomic and epigenetic data to predict autoimmune disease risk by identifying risk genes, as detailed in a recent Nature Communications study.
Medable Partners with Masimo to Bring Wearable Devices to Clinical Research, Capturing Better Data
May 29, 2024 / Medable Masimo / Partnership / Wearable Devices / Clinical Trials
Medable partners with Masimo to integrate wearable devices like the MightySat® Rx pulse oximeter into clinical research, enhancing data collection and patient participation, thereby improving trial efficiency and outcomes.
This French start-up wants to use AI to develop new medicines more quickly
May 24, 2024 / Startup / Generative AI / Drug Development / Clinical Trial Data / Partnership
French start-up Yseop partners with AWS to leverage generative AI, aiming to accelerate drug development by streamlining clinical trial data processing and report generation.
// Business & Markets
Merck to pay up to $3B for ophthalmology-focused biotech EyeBio
May 29, 2024 / Merck / Merck EyeBio / Acquision / Ophthalmology / Disease Treatments / Retinal Therapy
Merck acquires ophthalmology-focused EyeBio for up to $3 billion, aiming to enhance its pipeline with EyeBio’s retinal disease treatments, including the lead candidate, Restoret.
Atropos Health lands $33M to scale AI-powered real-world evidence, build out pharma partnerships
May 23, 2024 / AI / Atropos Health / Healthcare / Clinical Decision AI Support
Atropos Health secures $33M to enhance its AI-driven real-world evidence platform, Geneva OS, and expand pharma partnerships, enabling rapid, high-quality observational studies and improving clinical decision-making and patient outcomes.
Health And Biotech Startups Now Get The Majority Of US Series A Funding
May 24, 2024 / Startup / Investment / Healthcare
In 2024, biotech and healthcare startups received 53% of U.S. Series A funding, totaling $5.6 billion. This sector’s dominance is driven by large financing rounds, highlighting the industry’s growing investment appeal.
Radar Therapeutics Raises $13 Million to Design Therapies Using RNA Sensors
May 23, 2024 / RNA Sensor Therapies / Radar Therapeutics / Genetic Treatment / Innovation / mRNA
Radar Therapeutics raised $13.4M to advance RNA sensor-based genetic therapies, aiming for scalable in vivo treatments targeting specific cellular RNA signatures, enhancing accessibility and safety for complex diseases.
Fortress Biotech Insiders Placed Bullish Bets Worth US$3.08m
May 29, 2024 / Fortress Biotech / Insider Buying / FBIO Stock
Insiders at Fortress Biotech, including Executive Chairman Lindsay Rosenwald, have significantly increased their holdings, purchasing $3.1M in shares over the past year, indicating strong confidence in the company’s prospects.
// Legal & Regulatory
Amgen Wins FDA Approval for First Biosimilar to AstraZeneca’s Soliris
May 29, 2024 / Amgen / Bkemv Amgen Approval / FDA / Atypical hemolytic uremic syndrome therapy
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) for treating PNH and aHUS, with a boxed warning for serious meningococcal infections and availability through a restricted program.
With ruling, Pfizer can escape some claims in legal battle over Chantix carcinogen allegations
May 29, 2024 / Pfizer / Pfizer Chantix Lawsuit / Drug Recall / Class Action ruling
A New York judge narrowed the legal claims against Pfizer in a class action lawsuit over carcinogen allegations in its smoking cessation drug Chantix, dismissing several claims but allowing others to proceed.
Landmark Ruling as Ghanaian Court Dismisses Suit Challenging GM Products
May 29, 2024 / Ghana GM Products Ruling / Lawsuit
Ghana’s Human Rights Court dismissed a lawsuit challenging GM products, allowing the National Biosafety Authority to introduce PBR Bt cowpea to farmers, with directives for public sensitization and GM product labeling.
Paragard IUD Lawsuits Settlement Amounts
May 24, 2024 / Paragard IUD / Lawsuit / Settlement
Over a thousand women filed lawsuits claiming Paragard IUDs fractured during removal due to design defects. Consolidated in Georgia’s federal court, the first trial is set for early 2025, with hopes for a global settlement beforehand.
Fifth Circuit Remands Drugmaker Defense in Failure-to-Warn Case
May 28, 2024 / Fifth Circuit remands case / Failure-to-warn lawsuit / Chemotherapy Drug Litigation
The Fifth Circuit vacated and remanded a ruling, allowing drugmakers another chance to argue that they lacked new information to warn about chemotherapy-induced alopecia from docetaxel, in a failure-to-warn case involving Hospira and Accord Healthcare.
// Research & Development
J&J antidepressant eases symptoms, improves sleep in key trial
May 29, 2024 / Johnson & Johnson / Antidepressant Sleep Improvement / Mental Health / Depression and Insomnia Treatment
Johnson & Johnson’s antidepressant seltorexant, designed as an adjunctive therapy for major depressive disorder and insomnia, significantly eased symptoms and improved sleep in a Phase 3 trial, meeting all primary and secondary goals.
AstraZeneca Touts Early-Stage Results for Oral PCSK9 Inhibitor
May 29, 2024 / AstraZeneca / PCSK9 Inhibitor Results / Cardiovascular Disease Therapy
AstraZeneca’s Phase I trial of AZD0780, an oral PCSK9 inhibitor, showed a significant reduction in LDL cholesterol by 52% in statin users and 78% in treatment-naïve patients. The drug was well-tolerated with no serious adverse events reported.
Cystic fibrosis: global clinical trials landscape and treatments
May 24, 2024 / Cystic Fibrosis / Clinical Trials / CFTR Modulators Treatment
Cystic fibrosis (CF), a genetic disorder affecting chloride and bicarbonate transport, impacts 162,400 globally. Recent advances have increased life expectancy. Over 450 CF clinical trials since 2018 focus on treatments like CFTR modulators to improve patient outcomes.
Terran Biosciences prepares for trials of schizophrenia drug
May 24, 2024 / Terran Biosciences / TerXT Trials / Schizophrenia Drug Development / Clinical Trials
Terran Biosciences plans to start two Phase I trials for TerXT, a long-acting pro-drug of KarXT, aimed at treating schizophrenia. These trials will evaluate safety and pharmacokinetics, with a focus on rapid 505(b)(2) approval post-BMS exclusivity.
Medable partners with Masimo to use its pulse oximeter in clinical trials
May 29, 2024 /Medable Masimo / Partnership / Clnical Trials / Oncology Clinical Research
Medable partners with Masimo to integrate the MightySat Rx pulse oximeter into its digital clinical trial platform, enhancing data collection for decentralized trials in oncology. This collaboration supports over 3,000 patients across 25 countries.
// Politics
‘First federal CIO’ gives 3 reality checks on governmental AI
May 23, 2024 / AI / White House
Mark Forman critiques the White House’s AI guidance for executive-branch agencies, emphasizing the need for AI projects to address strategic needs, adopt customer-centric approaches, and focus beyond compliance to achieve meaningful government performance gains.
Novo attempts to parry Sanders’ GLP-1 pricing complaints by calling out pharma middlemen
May 29, 2024 / Novo Nordisk / Drug Pricing / Ozempic / Wegoovy / Middlemen Impact
Novo Nordisk responded to Sen. Bernie Sanders’ inquiry into high U.S. prices for its GLP-1 drugs, Wegovy and Ozempic, by highlighting differences in global healthcare systems and the role of pharmaceutical middlemen in pricing.
Dark money group runs ads on China biotech bill
May 28, 2024 / Lawsuit / Biden / American Healthcare Association
The American Health Care Association and others are suing to block the Biden administration’s new nursing home staffing rule, seeking a favorable ruling in Texas following a similar but unsuccessful attempt by PhRMA.
Biden Administration Urges Supreme Court Review in Terrorism Funding Lawsuit Against Pharma Companies
May 23, 2024 / Biden Administration / Supreme court / Anti-Terrorism Act
The Biden administration urges the U.S. Supreme Court to review a ruling involving 21 pharma and medical equipment companies accused of funding terrorism in Iraq, citing a precedent that may undermine the plaintiffs’ claims under the Anti-Terrorism Act.
Insulin Cap Supporters Say Schumer Could Bridge Senate Divides
May 21, 2024 / Insulin / Cost Cap Legislation / Medicare / Bipartisan Insulin Cost Bill
Senate Majority Leader Chuck Schumer is urged to advance legislation extending Medicare’s $35 per-month insulin cap to private insurance. Despite bipartisan support, differing policy approaches have stalled progress.