// Biotech and Pharma Therapeutics
Why CVS Pharmacy Technicians Have Been On The Picket Lines
October 23, 2024 / CVS Pharmacy Strike / Pharmacy Technician Wages / Unfair Labor Practices / Healthcare
CVS pharmacy technicians in Southern California are striking for fair wages, safer staffing, and better working conditions. They report unsafe environments, retaliatory practices, and insufficient pay despite performing critical healthcare roles, like administering vaccinations and managing prescriptions.
Roche culls cough candidate, pivots KRAS program after revaluing entire pipeline
October 23, 2024 / Roche / Drug Failure / Chronic Cough Phase 2 Trial / Roche Pipeline
Roche terminated its chronic cough drug candidate after a phase 2 trial showed no significant efficacy. The company also dropped multiple other programs, including a KRAS inhibitor trial, while pivoting focus to more promising NSCLC treatments.
Otsuka to take advantage of newly charted accelerated pathway for IgA nephropathy
October 22, 2024 / Otsuka Sibeprenlimab / proteinuria surrogate endpoint / IgA nephropathy treatment
Otsuka’s sibeprenlimab met the primary endpoint of reducing proteinuria in IgA nephropathy, potentially enabling accelerated approval based on this surrogate marker. Detailed data from the interim analysis remains undisclosed.
Editas Medicine Seeks Partner for Ex Vivo Gene-Editing Program as Focus Turns to In Vivo R&D
October 22, 2024 /Gene Therapy / Editas Medicine / CRISPR Sickle Cell Treatment
Editas Medicine plans to out-license its ex vivo CRISPR therapy for sickle cell disease and beta thalassemia to focus on in vivo gene-editing therapies, supported by promising preclinical data. The company aims to streamline costs and resources.
New gene therapy could provide two-eye option for wet AMD
October 22, 2024 / Gene Therapy / Injection Reduction
Regenxbio and AbbVie’s gene therapy, ABBV-RGX-314, showed a 97% reduction in anti-VEGF injections for wet AMD patients in a Phase II trial. 78% of patients remained injection-free, offering a promising treatment option for both eyes.
// 4th Industrial Revolution
The Rise of AI in Telemedicine: Enhancing Efficiency and Accessibility
October 23, 2024 / AI / Telemedicine Innovation / Medical Scribe / Remote Patient Monitoring / Telehealth Efficidency
AI is revolutionizing telemedicine by enhancing diagnostic accuracy, reducing healthcare costs, and improving remote patient monitoring. Technologies like AI-driven medical scribes and diagnostics enable more efficient, accessible care, particularly for conditions requiring ongoing management and proactive interventions.
Nexalin trials Halo neurostimulation device in traumatic brain injury
October 23, 2024 / Nexalin Technology / UC San Diego / Neurostimulation Traumatic Brain Injury / Post-Consussion
Nexalin Technology and UC San Diego are trialing the Gen-3 Halo neurostimulation device as an at-home treatment for mild traumatic brain injury. The study aims to assess brain activity changes and symptom relief in veterans with post-concussion symptoms.
Winning cybersecurity warfare is the ultimate millstone for CISOs
October 23, 2024 / Healthcare Cybersecurity / CISO Role / Ransomware / Healthcare Attacks / AI
Healthcare CISOs face escalating cyberattacks, particularly ransomware, requiring robust cybersecurity measures to protect patient care. Adopting strategies like breach assumption and leveraging AI for defense are critical for improving system resilience and minimizing operational disruptions.
It’s Time to Combat Medicare Advantage “Instafraud”
October 23, 2024 / Medicare Advantage Fraud / AI / Instafraud Healthcare / Medical Auditing
Medicare Advantage “Instafraud” involves AI-driven upcoding of medical diagnoses, costing billions in fraudulent claims. Combating this requires real-time auditing, AI standardization, and human oversight to ensure accuracy and prioritize patient care over profit.
How A Human-AI Partnership Can Boost Clinical Trial Recruitment
October 23, 2024 / AI / Clinical Trial Recruitment / AI Partnership
AI enhances clinical trial recruitment by efficiently identifying potential participants, but human interaction is crucial for retention and thorough screening. This human-AI partnership can increase trial participation rates and improve patient experiences.
// Business & Markets
Merck sets sights on brain cancer with $30M Modifi acquisition
October 23, 2024 / Merck Modifi Acquisition / Cancer Therapy / GBM Brain Cancer / DNA Repair
Merck acquired Modifi Biosciences for $30 million, targeting glioblastoma (GBM) with its preclinical asset, MOD-246. This innovative small molecule aims to treat GBM by blocking DNA replication in cancer cells resistant to current therapies like temozolomide.
Roche CEO says Novo’s Catalent buyout ‘could be a problem’ for smaller drugmakers
October 23, 2024 / Roche / Novo Holdings / Catalent Buyout / CMOs
Roche CEO Thomas Schinecker criticized Novo Holdings’ $16.5 billion Catalent acquisition, warning it could limit manufacturing capacity for smaller biopharma companies. While Roche is unaffected, Schinecker argues the deal might reduce competition in contract manufacturing.
Ipsen posts strong third quarter results, raises outlook
October 23, 2024 / Ipsen Q3 2024 Results / Oncology Sales Growth / Neuroscience Segment / Rare Disease Revenue
Ipsen reported strong third-quarter 2024 results, with €837 million in sales, an 8.6% year-on-year increase. Growth was driven by oncology (€604M, +5.6%) and neuroscience (€182M, +10%) segments, boosting the company’s financial outlook.
Can Herbal Alternatives Ease the Economic Burden of Weight Loss Drugs?
October 23, 2024 / Terns Pharmaceuticals / Oral GLP 1 / Obesity Drug Alternative / Weight Loss Remedies / Weight Management
Terns Pharmaceuticals’ new oral GLP-1 drug offers a lower-cost alternative to injectable weight-loss drugs like Ozempic. Herbal remedies, including adaptogens and berberine, are also gaining attention as affordable, holistic options for weight management.
Roche’s strong sales growth continues
October 23, 2024 / Roche / Sales Growth / Immunodiagnostic / Product Sales
Roche’s sales rose 6% at constant exchange rates, reaching CHF 45 billion ($52 billion) in the first nine months of 2024. Growth was driven by strong demand for novel medicines and diagnostics, despite declining COVID-19 sales and biosimilar erosion.
// Legal & Regulatory
Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package
October 22, 2024 / Sangamo Therapeutics / FDA Approval / Gene Therapy / Fabry Disease
Sangamo Therapeutics secured FDA alignment on an accelerated approval pathway for its Fabry disease gene therapy, ST-920, potentially cutting three years off time to market. The ongoing Phase 1/2 trial will serve as the basis for approval, targeting a 2025 submission.
FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage
October 21, 2024 / FDA GLP-1 / Compounded Tirzepatide Drugs / Eli Lilly Mounjaro Shortage / Lawsuit / Weight Loss
The FDA is re-evaluating whether compounded GLP-1 drugs can remain on the shortage list, following legal action. This decision affects compounding pharmacies producing cheaper alternatives to Eli Lilly’s tirzepatide drugs. The final outcome may limit compounding pharmacies’ operations.
Red light, green light: England’s NICE not sold on Lilly’s Kisunla despite UK approval
October 23, 2024 / NICE Kisunla Rejection / Eli Lilly / Alzheimer’s Drug / Alzheimer’s Treatment
Despite U.K. regulatory approval, NICE declined coverage for Eli Lilly’s Alzheimer’s drug Kisunla, citing insufficient cost-effectiveness relative to its limited cognitive benefits. NICE’s decision mirrors previous refusals for similar drugs, pending further review.
Amgen pledges to launch Eylea biosim after legal win—but Regeneron stresses the fight’s not over yet
October 23, 2024 / Amgen / Eylea Biosimilar / Regeneraon Patent Lawsuit / Pavblu FDA Approval
Amgen is set to launch its Eylea biosimilar, Pavblu, after winning a legal battle against Regeneron. While Regeneron plans to continue appealing, Amgen will move forward with its rollout, potentially disrupting the market for Eylea’s blockbuster sales.
New FDA approval for Pfizer’s RSV vaccine Abrysvo
October 23, 2024 / Pfizer / Abrysvo / RSV Vaccine / Pregnant Women / Women’s Health / Lower Respiratory Tract Disease Prevention
The FDA approved Pfizer’s RSV vaccine Abrysvo for preventing lower respiratory tract disease (LRTD) caused by RSV in at-risk adults aged 18-59. It remains the only RSV vaccine approved for pregnant individuals to protect newborns up to six months.
// Research & Development
Alto Neuroscience’s Depression Trial Failure Sends Shares Into Downward Spiral
October 23, 2024 / Alto Neuroscience / Depression Drug Phase 2b Trial / Depression Treatment / Brain Biomarkers / Mental Health
Alto Neuroscience’s ALTO-100 failed in a Phase 2b depression trial, raising doubts about its precision medicine approach. The stock dropped 64.5%, though Alto remains optimistic, with other trials ongoing for ALTO-300 and additional in-licensed assets.
Calluna Pharma completes successful phase 1 trial of new fibrotic disease drug
October 23, 2024 / Calluna Pharma / Fibrotic Disease Treatment
Calluna Pharma successfully completed Phase 1 trials for CAL101, a monoclonal antibody targeting fibrotic diseases like idiopathic pulmonary fibrosis. The study demonstrated favorable safety, pharmacokinetics, and target engagement, allowing progression to Phase 2 trials in 2025.
World-first clinical trial for treating spinal cord injury using olfactory cell nerve bridges
October 21, 2024 / Cell Therapy / Spinal Cord Injury Treatment / Nerve Bridge Transplantation
A groundbreaking Phase 1 clinical trial is testing olfactory cell nerve bridges for treating chronic spinal cord injuries. The trial involves transplanting patients’ own olfactory cells into the spinal cord, followed by intensive rehabilitation, offering new hope for spinal cord injury repair.
IDWeek 2024: Moderna’s norovirus vaccine mRNA-1403 shows potential in Phase I/II trial
October 21, 2024 / Moderna / mRNA / Norovirus Vaccine Development / Norovirus Immunization Strategy
Moderna’s mRNA-1403 vaccine showed promising safety and immune response results in a Phase I/II trial for norovirus. The trivalent mRNA-based vaccine targets prevalent norovirus strains and may offer protection, especially for high-risk groups like older adults.
Oral version of Novo diabetes drug protects heart health in large study
October 21, 2024 / Cardiovascular Benefits / Novo Nordisk / Diabetes Heart Health Medication / FDA Approval / Oral Semaglutide Heart Protection
Novo Nordisk’s oral diabetes drug, Rybelsus, reduced heart attack, stroke, and cardiovascular death risk by 14% in a large Phase 3 trial for patients with diabetes and heart or kidney disease. Novo plans to seek FDA approval by late 2024.
// Politics
More state Medicaid programs consider covering GLP-1 drugs
October 23, 2024 / Medicaid GLP-1 Coverage / GLP-1 Drugs / Obesity
While all state Medicaid programs cover GLP-1 drugs for type 2 diabetes, only 13 cover them for obesity. However, many states are considering expanding coverage for obesity treatments despite high costs, per a recent KFF report.
Biotech veteran Tony Coles on partisan politics and fulfilling a promise to his co-founder
October 17, 2024 / Drug Pricing Debate Biotech / Tony Coles
Biotech veteran Tony Coles emphasized corporate responsibility and diversity at the STAT Summit, urging industry leaders to engage in drug pricing and legislation debates. Coles continues advocating for diversity and patient-focused responsibilities within the pharmaceutical industry.
What’s on the docket for Congress post-election: Chinese biotech, Medicare payments, ACA subsidies
October 23, 2024 / Medicare Payment Legislation / China Biotech Regulation / Congress
Congress will address health care issues after the Nov. 12 elections, including Chinese biotech, Medicare payments, and ACA subsidies. The lame-duck session could be an ideal time for passing healthcare legislation before major policies expire next year.
Biden highlights drug price reductions with New Hampshire visit
October 22, 2024 / Drug Price Negotiation / Inflation Reduction Act / Medicare
President Biden, during a New Hampshire visit, highlighted drug price reductions achieved through the Inflation Reduction Act, which capped out-of-pocket Medicare drug costs. He emphasized ongoing efforts to lower medication prices, while acknowledging the need for further progress.
BARR: Are Mark Cuban, Big Pharma And VP Harris Plotting To Raise Drug Prices?
October 17, 2024 / Kamala Harris / Drug Pricing / Mark Cuban / Cost Plus Drugs
Mark Cuban and Vice President Kamala Harris are criticized for aligning with Big Pharma to regulate pharmacy benefit managers (PBMs), which help lower drug costs. This move is seen as benefiting Cuban’s business, Cost Plus Drugs, and Big Pharma’s pricing strategies.