// Biotech and Pharma Therapeutics
3 Ways Healthcare Active Archive Benefits Hospitals and Health Systems
January 2, 2025 / Healthcare Active Archives / Legacy Data Management / Cybersecurity / AI
Healthcare active archives modernize legacy data management, enhancing cybersecurity, regulatory compliance, and actionable insights. They facilitate secure, accessible storage while unlocking innovation and efficiency through AI and advanced analytics for improved decision-making and collaboration.
New $2,000 out-of-pocket Rx drug cap takes effect in USA
January 2, 2025 / Medicare Part D Prescription Cap / Out-of-pocket Drug Cost / Inflation Reduction Act / Drug Affordability
The new $2,000 annual cap on out-of-pocket costs for Medicare Part D prescription drugs, effective January 1, 2025, aims to provide significant savings for seniors, enhancing affordability and access under the Inflation Reduction Act.
Teva looks to peel back the onion on CNS, mental health conditions as it works on long-acting schizophrenia candidate
December 31, 2024 / Long-acting Schizophrenia Treatment / Olanzapine Injection / CNS Innovation / Mental Health
Teva’s long-acting schizophrenia treatment, TEV’749, leverages SteadyTeq technology to enhance adherence and reduce relapse risk. It reflects Teva’s broader CNS innovation strategy, addressing stigma, misdiagnosis, and unmet needs in mental health and neurological conditions.
Brain Cipher begins to leak stolen Rhode Island data
December 31, 2024 / Rhode Island Data Breach / Cybersecurity Attck / Stolen Health
Rhode Island’s RIBridges system suffered a cyberattack, compromising 650,000 individuals’ personal data, including health and social benefits information. Hackers leaked some data online, prompting extended enrollment periods, manual processing, and free credit monitoring for affected individuals.
How can CDMOs drive ADC success from lab to launch?
December 30, 2024 / ADCs / Targeted Cancer Therapy / ADC Development Process
Antibody-drug conjugates (ADCs) combine monoclonal antibodies with cytotoxic drugs for targeted cancer therapy. CDMOs play a pivotal role in ADC success, ensuring seamless development, scalable production, and quality control from lab to clinical launch.
// 4th Industrial Revolution
AI Developers Need Real-World Data — and Atropos Health Is Stepping Up to Help
January 2, 2025 / Healthcare Data / AI / Clinical Trial Simulation / Atropos Health Evidence Network / AI Models
Atropos Health’s real-world evidence network supports AI development in healthcare by providing access to over 300 million patient records for model training and validation, enhancing predictive accuracy, clinical trial simulation, and improving patient care outcomes.
QALO unveils new silicon smart ring
January 2, 2025 / QRNT Smart Ring / Health Tracking / Wearable Tech / Stress and Sleep Tracking Devices
QALO’s new QRNT silicone smart ring tracks heart rate, oxygen saturation, sleep stages, and stress levels via a free app. It combines accessible health monitoring with customizable style, advancing the growing smart-ring market in personalized wellness.
Empowering the Aging Population with Tech-Driven Care in 2025
January 2, 2025 / Tech-enabled Senior Care / Aging / Remote Vitals Monitoring / Independent Living Healthcare Solutions
Tech-enabled care, including monitoring devices, virtual management, and emergency response systems, empowers seniors to age at home. These solutions improve health outcomes, support preventative care, enhance independence, and reduce strain on the healthcare system.
4 Tech-Enabled Strategies to Improve Patient Medication Adherence in 2025
January 2, 2025 / Medication Adherence Technology / AI in Patient Engagement / Smart Medication / Digital Health
Tech-enabled strategies, including AI, smart products, apps, and omnichannel communications, improve medication adherence by addressing barriers, personalizing outreach, and leveraging data analytics, reducing non-adherence costs and enhancing patient outcomes in healthcare.
Boston Children’s brings engineering precision to pediatric heart surgery
January 2, 2025 / Computational Fluid Dynamics in Surgery / Pediatric Heart Surgery Innovation / Congenital Heart Defects
Boston Children’s Hospital uses computational fluid dynamics (CFD) to model pediatric heart surgeries, improving outcomes and reducing variability. CFD enhances preoperative planning, engages families with 3D simulations, and accelerates workflows for precise, patient-specific interventions.
// Business & Markets
Roche Kicks Off 2025 Committing a Potential $1B for Another ADC From China
January 2, 2025 / Roche / ADC Partnership / Small Cell Lung Cancer Treatment / Oncology
Roche has partnered with Innovent for $1 billion to develop IBI3009, a DLL3-targeted antibody-drug conjugate (ADC) for small cell lung cancer. The deal strengthens Roche’s ADC pipeline, focusing on innovative therapies addressing efficacy and toxicity challenges.
With $608M divestment, Hutchmed continues to focus on ADC development
January 2, 2025 / Hutchmed ADC Pipeline Development / Oncology Advancements / Lung Cancer Therapy
Hutchmed is divesting its 45% stake in SHPL for $608M to focus on advancing its antibody-drug conjugate (ADC) pipeline and innovative cancer therapies, including a combination treatment for EGFR-mutant non-small cell lung cancer.
IDEAYA Biosciences in-licenses Hengrui’s SHR-4849
January 2, 2025 / IDEAYA SHR-4849 Licensing / ADC Development / Hengrui and IDEAYA Partnership / Cancer Therapy Pipeline Expansion
IDEAYA Biosciences licensed SHR-4849, a DLL3-targeting antibody-drug conjugate from Hengrui, for $1.045 billion. This expands IDEAYA’s ADC portfolio, including IDE034, as it advances innovative cancer therapies toward clinical trials by 2025.
Type 1 diabetes market to reach $9.9 billion in 7MM by 2033
January 2, 2025 / Type 1 Diabetes / Market Growth / T1D Immunomodulatory Therapies / Drug Pipeline / Market Expansion
The type 1 diabetes market in seven major markets (7MM) is projected to grow from $2.2 billion in 2023 to $9.9 billion by 2033, driven by immunomodulatory therapies and strong growth in the U.S. market share.
HOOKIPA Pharma in early talks to acquire Poolbeg
January 2, 2025 / Hookipa Poolbeg Acquisition / Cancer Immunotherapies / Arenaviral Immunotherapy Development
HOOKIPA Pharma and Poolbeg Pharma are in early talks for an all-share acquisition to form a Nasdaq-listed biopharma company focused on next-generation immunotherapies for cancer and other serious diseases, addressing critical unmet medical needs.
// Legal & Regulatory
Regulatory tracker: Merck’s blockbuster hopeful Winrevair snags PAH approval in UK
January 2, 2025 / Merck Winrevair PAH Approval / Sotatercept pulmonary hypertension drug / FDA
Merck’s Winrevair (sotatercept) received U.K. approval for pulmonary arterial hypertension (PAH), following FDA and EU approvals. The therapy, enhancing exercise capacity in PAH patients, could achieve peak sales of $3-4 billion globally.
Bristol Myers celebrates 10 years of Opdivo with FDA approval for subcutaneous version
January 2, 2025 / Opdivo Qvantig Subcutaneous Approval / Cancer / FDA Approval / Cancer Immunotherapy / Bristol Myers Opdivo Innovations
The FDA approved Bristol Myers’ Opdivo Qvantig, a subcutaneous version of the PD-1 inhibitor nivolumab, for solid tumors. This new formulation shortens administration time, eases care delivery, and enhances accessibility in monotherapy and oral drug combination settings.
Verastem soars on FDA priority review for avutometinib
January 2, 2025 / FDA Priority Review / Cancer Therapy / Ovarian Cancer
The FDA granted Priority Review for Verastem’s avutometinib, a RAF/MEK clamp, with defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer. The NDA, under the accelerated approval pathway, has a PDUFA date of June 30, 2025.
Tarlatamab greenlighted by MHRA for small cell lung cancer
December 31, 2024 / Tarlatamab Small Cell Lung Cancer / MHRA Approval / Amgen / Orbis Cancer Drug Approval
The MHRA approved Amgen’s tarlatamab (Imdyllytra) for metastatic small cell lung cancer (SCLC) under Project Orbis, expediting access to this innovative treatment for one of the most aggressive lung cancer types.
Securities Fraud Class Action Lawsuit Filed Against Applied Therapeutics, Inc.
December 28, 2024 / Applied Therapeutics Lawsuit / Clinical Trial Transparency Issues
Applied Therapeutics faces a securities fraud lawsuit alleging false statements and trial misconduct for its drug govorestat, potentially jeopardizing FDA approval. The case underscores the importance of clinical trial transparency and adherence to regulatory standards.
// Research & Development
10 clinical trials to watch in the first half of 2025
January 2, 2025 / 2025 Clinical Trials to Watch / Incretin Diabetes Heart Studies / CRISPR / Gene Editing / RNA-based Cystic Fibrosis Therapy
Key clinical trials in 2025 include studies on incretin therapies, protein degradation, autoimmune diseases, RNA-based treatments, and CRISPR gene editing, targeting conditions like diabetes, cancer, Alzheimer’s, cystic fibrosis, and cardiovascular diseases, shaping biotech innovation and patient care.
Novartis’ Phase III spinal muscular atrophy therapy trial meets primary endpoint
December 31, 2024 / Novartis STEER Trial Results / Gene Therapy / Spinal Muscular Atrophy Treatment / Type 2 Motor Function Improvement
Novartis’ Phase III STEER trial of intrathecal gene therapy OAV101 IT for spinal muscular atrophy (SMA) Type 2 showed improved motor function and a favorable safety profile, supporting potential regulatory approval in 2025.
Neumora laid low by depression trial failure
January 2, 2025 / Neumora navacaprant trial failure / Opioid Receptor / Depression Treatment
Neumora’s Phase III trial for navacaprant in major depressive disorder (MDD) failed to meet primary and secondary endpoints. However, promising efficacy signals in female patients warrant further analysis, with additional trials and other indications still ongoing.
After delay with FDA, Novartis touts pivotal trial win for intrathecal Zolgensma in older SMA patients
January 2, 2025 / Novartis / Cell & Gene Therapy / Clinical Data / FDA
Novartis’ Phase III Steer trial showed intrathecal Zolgensma (OAV-101 IT) significantly improved motor function in older Type 2 SMA patients. This gene therapy expansion could address unmet needs, with FDA submission planned for early 2025.
After phase 3 setbacks, troubled Marinus inks $151M sale to Immedica Pharma
January 2, 2025 / Marinus Pharma / Ztalmy / M&A / Rare Disease Drug Portfolio
Marinus Pharmaceuticals sold to Immedica Pharma for $151M amid Phase III setbacks and financial challenges. Immedica acquires seizure drug Ztalmy (ganaxolone), expanding its rare disease portfolio and U.S. presence with a revenue-generating asset.
// Politics
Trump tariffs and drug prices: 3 notes
December 31, 2024 / Trump / Tariffs / Drug Pricing / Generice Drug Supply Chain Risks / Medical Device Manufacturing
Proposed Trump tariffs on imports from Mexico, Canada, and China could increase drug costs, disrupt generic drug and medical device supplies, and strain the U.S. healthcare system, despite aims to boost domestic manufacturing and economic growth.
Massachusetts House, Senate find last-minute common ground to rein in pharmaceutical drug costs. Will it be enough before the legislative session expires?
December 28, 2024 / Massachusetts / Prescription Drug Reform / Healthcare Oversight / Legislative Healthcare Cost Reduction
Massachusetts lawmakers reached an agreement on bills to reduce prescription drug costs, regulate pharmacy benefit managers, and improve healthcare market transparency. These reforms aim to lower out-of-pocket expenses and address private equity’s impact on healthcare providers.
Can a State Destroy Trade Secrets Through Regulation? The Ninth Circuit Will Soon Address That Question
December 27, 2024 / PhRMA Trade Secret Case / Drug Pricing Disclosure Law / Ninth Circuit Drug Pricing Ruling
PhRMA challenges Oregon’s law requiring disclosure of drug pricing factors, arguing it unconstitutionally destroys trade secrets under the Fifth Amendment. The Ninth Circuit will soon decide if such regulations violate protections against regulatory takings.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2, 2025 / Skinny Labeling Legislation / Biosimilar Market Expansion / Generic Drug Patent Protection / Big Savings Act
The bipartisan Skinny Labels, Big Savings Act (S 5573) aims to protect “”skinny labeling”” for generic and biosimilar drugs, accelerating market entry, lowering drug costs, and shielding manufacturers from excessive patent litigation, thereby improving patient access to affordable medications.