// Biotech and Pharma Therapeutics
Why Traditional Healthcare Institutions Should Act More Like Startups
September 24, 2024 / Healthcare Innovation / Startup / Innovation
Traditional healthcare systems can enhance innovation by adopting startup-like agility, focusing on consumer-centric design, fostering internal innovation labs, and supporting provider well-being. These strategies enable them to leverage existing strengths while improving patient experiences.
Italian biotech Aptadir hopes new class of RNA inhibitors can reverse tricky cancers
September 24, 2024 / Emerging Biopharma / Oncology / Cell & Gene Therapy / Venture Capital / Biotech
Italian biotech Aptadir is developing RNA inhibitors (DiRs) aimed at reversing cancers and genetic disorders by reactivating hypermethylated genes. Their lead candidate, targeting myelodysplastic syndrome, is expected to enter clinical trials by 2025.
Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy
September 24, 2024 / Vertex Pharma / Partnership / CRISPR Therapy / Sickle Cell Disease / Gene Therapy
Vertex Pharmaceuticals has partnered with Lonza to produce Casgevy, the first CRISPR-based therapy approved for sickle cell disease and beta thalassemia. Global production will begin in the Netherlands, expanding to the U.S. in 2024.
Cancer Grand Challenges launches global initiative to take on toughest problems
September 24, 2024 / Cancer Grand Challenges Initiative / Global Cancer Research Funding / UK Collaborations
Cancer Grand Challenges, co-founded by Cancer Research UK and the NCI, has launched global think tanks to identify major cancer research obstacles. Insights will guide future multi-million-pound funding, fostering interdisciplinary, global collaboration for breakthrough treatments.
Novo says Ozempic to be eligible for US price negotiations in less than a year
September 23, 2024 / Ozempic / Price Neogtiations / Medicare Drug Price Negotiations / Wegovy / Inflation Reduction Act
Novo Nordisk’s diabetes drug Ozempic will be eligible for U.S. price negotiations within a year, as confirmed by CEO Lars Jorgensen. Set for potential inclusion on the 2027 Medicare price negotiation list, Ozempic and Wegovy have faced criticism over high U.S. prices.
// 4th Industrial Revolution
How AI Humanizes Mental Healthcare
September 24, 2024 / AI / Mental Health / Clinical Burnout
AI enhances mental healthcare by improving accessibility, automating assessments, supporting patients between sessions, and alleviating clinician burnout. By handling administrative tasks, AI allows providers to focus on personalized, human-centered care.
Can AI reduce health care fraud, AI firm in Texas AG’s crosshairs, and more
September 24, 2024 / AI / Healthcare Fraud Detection / Texas AG AI Settlement / Medical Claim Screening AI
AI can help reduce healthcare fraud by screening claims, as shown in a study identifying $12 million in inappropriate charges. Meanwhile, the Texas AG settled with Pieces, a health AI firm, over inaccurate claims about its product’s accuracy.
The future of interoperability: shaped by patient experience priorities and the needs of AI
September 24, 2024 / Patient Data Exchange / Zen Health IT / TEFCA Healthcare Data
Interoperability, driven by platforms like Zen Healthcare IT, improves patient experiences and outcomes by enabling seamless health data exchange. AI’s effectiveness in healthcare also relies on better interoperability to enhance care and support personalized treatment.
AI Medical Scribe for Veterinarians Scribenote Secures $8.2M
September 24, 2024 / Scribenote / Medical Records Automation
Scribenote, an AI medical scribe for veterinarians, raised $8.2M to automate documentation, reducing burnout and improving work-life balance. Its AI captures appointment conversations, generating medical records, allowing vets to focus on patient care.
South Korea to digitise medical image exchange system
September 24, 2024 / South Korea / Digital Health Record System / Patient Data Exchange
South Korea is piloting a digital system to improve medical image exchange, allowing patients to share records electronically between hospitals. This aims to enhance patient convenience, reduce duplicate testing, and ensure continuity of care.
// Business & Markets
Regeneron’s stock drops as it loses bid to block Amgen’s Eylea biosimilar
September 24, 2024 / Regeneron Amgen Eylea Biosimilar / Eylea Patent Dispute / Market Entry / Eye Disease Drug / Patent Litigation
Regeneron’s attempt to block Amgen’s Eylea biosimilar, Pavblu, was denied, allowing its potential market entry. Regeneron has appealed the ruling, while Eylea, a key drug for eye diseases, remains crucial to its revenue.
Bluebird bio lays off 25% of workforce as gene therapy pioneer struggles to stay afloat
September 24, 2024 / Bluebird Bio / Gene Therapy / Sickle Cell Gene Therapy
Bluebird bio is cutting 25% of its workforce to reduce expenses and focus on commercial gene therapies. Facing financial challenges, the company aims for cash-flow break-even by 2025, while continuing to raise funds and expand patient treatments.
BioAtla out-licenses T cell therapy in $134 million deal
September 24, 2024 / BioAtla T Cell Therapy / Context Therapeutics Partnership / Active Biologics
BioAtla licensed its T cell therapy, BA3362, to Context Therapeutics in a $134 million deal. BA3362 targets Nectin-4 in solid tumors, leveraging BioAtla’s Conditionally Active Biologic platform. BioAtla will receive $15 million upfront and milestone payments.
Legend Biotech inks deal for ‘priority access’ to Multiply Labs’ robotic cell therapy production tech
September 24, 2024 / Legend Biotech / Cell Therapy / Robotic Cell Therapy Production / CAR-T Therapy Manufacturing
Legend Biotech has partnered with Multiply Labs for priority access to its robotic cell therapy production technology. The collaboration aims to automate the cell therapy process, potentially reducing costs and addressing labor shortages in the field.
Novartis inks $1B-plus biobucks deal with Flagship’s Generate
September 24, 2024 / Novartis / Generate / Partnership / Protien Therapeutics Development / AI / Novartis / Drug Discovery
Novartis signed a $1 billion+ deal with Generate to develop protein therapeutics using AI-driven biology. Novartis will pay $65 million upfront, with potential milestone and royalty payments, targeting multiple disease areas through a multi-target collaboration.
// Legal & Regulatory
Exclusive: Two lawmakers try to preserve telehealth addiction treatment
September 24, 2024 / Telehealth Addiction Treatment / Controlled Substances
Two U.S. lawmakers are drafting a bill to maintain telehealth access for prescribing controlled substances like buprenorphine. This legislation seeks to ensure continued care for addiction treatment patients as pandemic-related DEA waivers near expiration.
Veltassa approved in Japan for hyperkalemia
September 24, 2024 / Veeltassa Hyperkalemia Treatment / Patiromer Japan Approval / Zeria Partnership / Hyperkalemia Therapy / Chronic Kidney Disease
Veltassa (patiromer) has been approved in Japan for treating hyperkalemia, a condition with high blood potassium levels. This approval, granted to CSL Vifor’s partner Zeria Pharmaceutical, aims to help over 300,000 affected patients, particularly those with chronic kidney disease or heart failure.
Otsuka’s Lupkynis approved in Japan
September 24, 2024 / Lupkynis Lupus Nephritis Treatment / Japan Approval
Japan’s Ministry of Health approved Otsuka’s Lupkynis (voclosporin) for treating lupus nephritis, a serious kidney inflammation caused by systemic lupus erythematosus (SLE). Lupkynis is an oral immunosuppressant that targets calcineurin to reduce T-cell activation.
Ahead of adcomm, FDA challenges broad use of PD-1 drugs in stomach cancer patients
September 24, 2024 / FDA / Stomach Cancer / Gastric Cancer Treatment
The FDA is reconsidering the broad use of PD-1 inhibitors, like Opdivo and Keytruda, in HER2-negative stomach cancer patients with low PD-L1 expression, citing unclear benefits. The advisory committee will assess restricting these treatments based on PD-L1 levels.
US FDA approves IntraBio’s drug for rare genetic disease
September 24, 2024 / Aqndeursa Niemann-Pick Treatment / FDA / Rare Disease Drug / Type C Therapy
The FDA approved IntraBio’s drug Aqneursa (IB1001) for Niemann-Pick disease type C, a rare genetic disorder affecting the nervous system. Aqneursa, taken orally, reduces symptoms but may cause embryo-fetal harm. IntraBio raised $40M to support its launch.
// Research & Development
Two regulatory approvals for Astellas
September 24, 2024 / Astellas Pharma / Keytruda urothelial carcinoma therapy / Cancer First-line Treatment
Astellas Pharma received Japanese approval for Padcev (enfortumab vedotin) combined with Merck’s Keytruda (pembrolizumab) as a first-line treatment for unresectable urothelial carcinoma, providing an alternative to platinum-based chemotherapy. Approval was based on positive Phase III EV-302 trial results.
UCB and Biogen are advancing dapirolizumab pegol
September 24, 2024 / UCB Biogen lupus drug / Clinical Trials / Lupus Therapy
UCB and Biogen’s dapirolizumab pegol, an anti-CD40L drug, showed positive Phase III results in treating moderate-to-severe systemic lupus erythematosus (SLE). It improved disease activity versus placebo, with a safety profile consistent with previous studies.
IDEAYA’s rare cancer drug shows promise as company lays out Phase III plans
September 24, 2024 / Clinical Trials / Cancer Treatment / Eye preservation therapy / Darovasertib uveal melanoma
IDEAYA Biosciences’ darovasertib, a PKC inhibitor, showed 30% tumor shrinkage and a 61% eye preservation rate in a Phase II trial for uveal melanoma. A 400-patient Phase III trial is planned, focusing on eye preservation and time to vision loss.
StudyTeam for Sites Reaches 10,000 Global Research Sites, Streamlining Clinical Trials
September 24, 2024 / StudyTeam / Clinical Trial Management / Global Research
OneStudyTeam’s StudyTeam platform, used by over 10,000 global research sites, streamlines clinical trial management by enhancing patient recruitment, data capture, and financial workflows. This cloud-based solution improves trial efficiency, reducing site burden and accelerating therapy development.
Can MRIs ensure prostate cancer screening does more good than harm?
September 25, 2024 / MRI Prostate Cancer Screening / dPSA Testing Harms
A study published in the New England Journal of Medicine shows that using MRI scans in prostate cancer screening reduces unnecessary diagnoses and treatments by over 50%. This finding could lead to updated screening guidelines, improving the benefit-harm balance.
// Politics
Novo Nordisk CEO prepares to defend Ozempic, Wegovy US pricing at Senate hearing
September 24, 2024 / Novo Nordisk / Senate Hearing / Pricing Debate / GLP-1
Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, will testify before the U.S. Senate on the high pricing of Ozempic and Wegovy. The hearing follows scrutiny of Novo’s pricing practices, with Jørgensen defending R&D costs and emphasizing insurance coverage issues.
US Senator Sanders says middlemen won’t punish Novo if it cuts weight-loss drug prices
September 24, 2024 / US Senate / Bernie Sanders / Novo Nordisk / Drug Coverage
U.S. Senator Bernie Sanders announced that major pharmacy benefit managers (PBMs) committed to expanding coverage for Novo Nordisk’s Ozempic and Wegovy if the company lowers list prices. Despite this, Novo’s CEO did not commit to reducing prices during the Senate hearing.
Bavarian Nordic Secures $63 Million U.S. Government Contract for Vaccine Production
September 24, 2024 / Bavarian Nordic Jynneos Vaccine / Vaccine Production Deal
Bavarian Nordic secured a $63 million U.S. government contract to produce 1 million freeze-dried doses of its Jynneos vaccine for mpox and smallpox by 2026. This deal replenishes stock depleted during the 2022 mpox outbreak, now a global public health emergency.
THE CONTRERAS REPORT: Governor Newsom, veto Big Pharma’s grab for more profits
September 24, 2024 / Big Pharma Drug Pricing / California / Governor Newsom / Drug Legislation
The article urges Governor Newsom to veto legislation favoring Big Pharma’s profit margins. Highlighting the high cost of prescription drugs in California, it contrasts local prices with cheaper alternatives in nearby Mexico, emphasizing affordability issues for patients.
Temporary Injunctive Relief for Nondebtors in Bankruptcy Court Post-Purdue Pharma
September 23, 2024 / Purdue Pharma / Bankruptcy Ruling
Recent rulings confirm that the Supreme Court’s Purdue Pharma decision does not prevent bankruptcy courts from issuing temporary injunctive relief to protect nondebtors. Courts in Delaware, Illinois, and Louisiana upheld temporary stays, distinguishing them from permanent nonconsensual releases addressed in Purdue Pharma.