// Biotech and Pharma Therapeutics
Astellas Gene Therapies to turn out the lights at South San Francisco production plant
September 4, 2024 / Astellas / Gene Therapy / San Francisco / Layoffs
Astellas Gene Therapies is closing its South San Francisco biomanufacturing plant, affecting around 100 employees, and consolidating operations at its North Carolina facility. Research activities on the West Coast will continue at their newly opened innovation center.
Eli Lilly bets $1B in biobucks on Haya to scour dark genome for obesity targets
September 4, 2024 / Eli Lilly / Obesity / Dark Genome / RNA-based Obesity Research
Eli Lilly has partnered with Haya Therapeutics, investing up to $1 billion to explore long noncoding RNA (lncRNA) targets in the “”dark genome”” for obesity treatment, aiming to develop novel genetic therapies addressing obesity and metabolic conditions.
Pharma’s ‘it’ therapy — a new drug class gaining steam
September 4 27, 2024 / Cancer Therapy / Pfizer Collaboration / Neurological Disease Therapies
Protein degraders, a promising drug class, target disease-causing proteins for elimination via the cell’s natural disposal system. Arvinas Therapeutics’ vepdegestrant, in phase 3 trials for metastatic breast cancer, may pioneer FDA approval by 2025, advancing cancer and neurological treatments.
Novartis builds out radiopharma production with expansion, new factory
September 4, 2024 / San Diego Biotech / Carlsbad Radiopharma Facility / Cancer therapy
Novartis is expanding radiopharmaceutical production with a new facility in California and an expansion in Indianapolis to meet rising demand for cancer treatments like Pluvicto and Lutathera. The new sites aim to enhance manufacturing resiliency and delivery efficiency.
Acepodia partners with Pfizer to advance cell therapies
September 4, 2024 / Pfizer / Ignite / Partnership / Autoimmune Diseases
Acepodia has partnered with Pfizer Ignite to advance its Antibody-Cell Conjugation (ACC) platform for autoimmune diseases, leveraging Pfizer’s resources and expertise to expand beyond oncology.
// 4th Industrial Revolution
The AI Act: help or hindrance to the pharma industry?
September 4, 2024 / EU AI Act Pharma Impact / Drug Discovery / Clinical Trials
The EU AI Act, effective August 1, imposes strict standards on AI systems, potentially complicating pharmaceutical adoption of AI for drug discovery and clinical trials. Ambiguities in its definition of AI create challenges for compliance in the highly regulated pharma industry.
The AI Act: help or hindrance to the pharma industry?
September 4, 2024 / Telehealth / Virtual Behavioral Health Services / Telehealth
Dr. Kate Sowerwine of Recuro Health highlights telehealth’s role in reducing healthcare disparities, advancing advocacy, boosting behavioral health, and enhancing at-home lab services. Telemedicine improves access to equitable, continuous care, particularly for chronic conditions and mental health.
Signia Launches Advanced Prescription-Grade Earbuds
September 4, 2024 / Signia Active Pro / Hearing Aids / Bluetooth-enabled Hearing Aids
Signia has launched the Active Pro IX, earbuds that double as prescription-grade hearing aids using its Integrated Xperience platform. These earbuds enhance real-time conversations, reduce background noise, and offer Bluetooth connectivity, making advanced hearing technology more accessible.
Recognizing and Mitigating Cybersecurity Risks: Strategies for Healthcare Organizations
September 4, 2024 / Cybersecurity Risks / AI / Healthcare / Data Bdreach Prevention
Healthcare organizations face growing cybersecurity risks, including ransomware, AI-driven threats, and data breaches, which can lead to sanctions, financial loss, and reputational harm. Proactive risk assessments, collaboration with experts, and robust cyber protections are key mitigation strategies.
Samsung Galaxy Watch Receives Validation From University of Michigan for Accurate Fitness Tracking
September 3, 2024 / Samsung Galaxy Watch / University of Michigan / Heart Rate Monitoring
The University of Michigan validated the Samsung Galaxy Watch for accurate fitness tracking, showing strong correlations with clinical-grade devices for heart rate, sweat loss, VO2 max, and body fat percentage, confirming its reliability for health and fitness monitoring.
// Business & Markets
BioAge files for IPO, plans pair of midstage obesity trials
September 4, 2024 / BioAge Labs IPO / Obesity Trials / Weight Loss
BioAge Labs, focused on metabolic diseases, has filed for an IPO and plans mid-stage obesity trials for azelaprag, a small molecule combined with semaglutide and tirzepatide. These trials aim to enhance weight loss while preserving muscle mass and insulin sensitivity.
Avenzo and Gilead partner for breast cancer combination regimen trial
September 4, 2024 / Avenzo Gilead Breast Cancer Trial / Breast Cancer Therapy
Avenzo Therapeutics and Gilead Sciences are partnering to test a breast cancer combination therapy using Avenzo’s CDK2 inhibitor, AVZO-021, with Gilead’s antibody-drug conjugate, Trodelvy. The trial will target HR+/HER2- breast cancer patients.
$325 million added to ArsenalBio’s cell therapy arsenal
September 4, 2024 / Asrsenal Biosciences / CAR T-cell Therapy / Solid Tumors
Arsenal Biosciences secured $325 million in Series C funding to advance its CAR T-cell therapies for solid tumors. The funds will support pipeline development, innovative T cell engineering technology, and the creation of new therapeutic candidates.
Semnur Pharma and Denali Capital sign merger agreement
September 4, 2024 / Semnur Pharma / Merger
Semnur Pharmaceuticals and Denali Capital Acquisition have signed a merger agreement valuing Semnur at $2.5 billion. Post-merger, the combined company will be listed on Nasdaq as “”Semnur Pharmaceuticals”” under the ticker symbols SMNR and SMNRW.
Rite Aid Picks Insider CEO As Company Emerges From Bankruptcy
September 3, 2024 / Rite Aid / bankruptcy / Retail pharmacy Debt Reduction
Rite Aid has emerged from bankruptcy, eliminating $2 billion in debt and appointing Matt Schroeder as CEO. The company now operates 1,700 pharmacies across 16 states, following store closures during its restructuring.
// Legal & Regulatory
Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia Gravis
August 29, 2024 / FDA Approval / Johnson & Johnson
Johnson & Johnson has submitted a Biologics License Application (BLA) for nipocalimab to the FDA, aiming to treat generalized myasthenia gravis (gMG). The Phase 3 Vivacity-MG3 study showed significant improvement in antibody-positive patients using nipocalimab combined with standard care.
FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN
August 28, 2024 / FDA / Neurofibromatosis type 1 therapy / SpringWorks therapeutics
The FDA has granted Priority Review to SpringWorks Therapeutics’ New Drug Application for mirdametinib, a MEK inhibitor for treating NF1-associated plexiform neurofibromas in adults and children. Mirdametinib may become the first approved therapy for NF1-PN.
FDA advisory panels in the spotlight, as reform talks heat up
September 3, 2024 / FDA Advisory Panel / Aduhelm drug approval controversy
The FDA is considering reforms to its advisory panel process, including changes to voting and conflict of interest rules. These discussions follow contentious drug approval decisions, highlighting the need for transparency and expert involvement in the review process.
Illumina avoids fine for Grail purchase in European court victory
September 3, 2024 / Illumina Grail Acquisition / European Court Ruling / dGrail Cancer test
Illumina won a European court ruling voiding a €432 million fine imposed by the European Commission over its $8 billion Grail acquisition. The court ruled that the Commission exceeded its jurisdiction, and the fine is no longer payable.
ProKidney halts one CKD cell therapy phase 3 trial considered surplus to FDA approval
September 3, 2024 / ProKidney Phase 3 Trial / FDA Approval / CKD Cell Therapy
ProKidney halted its international phase 3 trial for rilparencel, an autologous cell therapy for chronic kidney disease, to focus on the U.S.-based trial. This strategic move prioritizes FDA approval through an expedited pathway, freeing up significant financial resources.
// Research & Development
3 execs resign as Dyne posts mixed data for DMD candidate
September 3, 2024 / Dyne therapedutics / DMD Trial
Dyne Therapeutics reported mixed phase 1/2 data for its Duchenne muscular dystrophy (DMD) therapy, DYNE-251, including functional improvements but also serious adverse events like acute kidney injury. Concurrently, three executives resigned, unsettling investors.d
Moderna’s mpox vaccine prevents severe symptoms in monkeys compared to Bavarian Nordic’s Jynneos
September 4, 2024 / Moderna / mRNA Vaccine / Clinical Trials / mpox
Moderna’s mRNA-based mpox vaccine, mRNA-1769, outperformed Jynneos in preventing severe symptoms and reducing viral load in monkeys. This promising candidate is currently in phase 1/2 trials, aiming to improve protection against the rapidly spreading mpox virus.
US allows increased production of Takeda’s ADHD drug to address shortage
September 4, 2024 / ADHA Drug Shortage / Takeda Pharma
The U.S. DEA increased Takeda’s production limit for Vyvanse, an ADHD drug, by 24% to address ongoing shortages in the U.S. and globally. This follows the FDA’s request due to heightened demand and previous shortages of ADHD medications like Adderall.
Roche trumpets new fenebrutinib data in relapsing MS
September 4, 2024 / Fenebrutinib relapsing MS trial / Roche / Congress
Roche’s BTK inhibitor, fenebrutinib, demonstrated near-complete suppression of disease activity in relapsing multiple sclerosis (MS) in a phase 2 trial, with 99% of patients showing no active inflammation at 48 weeks. Full results will be presented at ECTRIMS.
RegenxBio touts positive data for rare disease drug RGX-121
September 3, 2024 / Hunter Syndrome Therapy / Gene Therapy
RegenxBio’s gene therapy RGX-121 for treating Hunter syndrome (MPS II) showed an 85% reduction in cerebrospinal fluid heparan sulfate levels, sustained for up to two years. RegenxBio plans a rolling biologics license application submission in Q3 2024.
// Politics
Should Government Play a Bigger Role in Healthcare Cybersecurity?
September 4, 2024 / Cybersecurity / Healthcare Funding / Partnerships
With rising cyberattacks on healthcare, experts argue the U.S. government should enhance its role in healthcare cybersecurity by offering guidance, resources, and regulatory support, such as through HIPAA and recent HHS funding, to protect vital healthcare infrastructure from digital threats.
US will still pay at least twice as much after negotiating drug prices
September 3, 2024 / Medicare / Drug Price Negotiation / Inflation Reduction Act
Despite the U.S. government negotiating drug prices under the Inflation Reduction Act, Medicare will still pay at least twice as much as other high-income countries. The new prices, starting in 2026, will save $6 billion but remain significantly higher than international prices.
How US politics could shape the future of biopharma
August 29, 2024 / Inflation Reduction Act / US Drug Development Legislation / Mergers + Acquisitions
A Demy-Colton webinar explored how U.S. political outcomes could influence biopharma, discussing potential changes to the Inflation Reduction Act, new laws, and Federal Trade Commission (FTC) regulation of mergers and acquisitions (M&As) impacting drug development.
How can biotechnology be harnessed for economic development?
September 4, 2024 / BioE3 Policy / Sustainability
The BioE3 policy aims to transform industries by using biotechnology to develop sustainable, eco-friendly manufacturing processes. Biotechnology’s potential spans fields like synthetic biology, gene editing, and precision fermentation, offering environmental and economic benefits through more efficient production methods.
Despite Medicare Negotiations, Americans May Still Have To Pay More For Prescription Drugs
September 3, 2024 / Medicare / Drug Price Negotiations
Despite Medicare’s negotiated drug prices set for 2026, U.S. patients will still pay significantly more than in other countries, with prices sometimes double or more. Factors include lack of generic competition and the U.S.’s acceptance of higher costs for early access.