// Biotech and Pharma Therapeutics
Astellas doesn’t see eye to eye with Europe on geographic atrophy drug Izervay
October 28, 2024 / Astellas Izervay Europe Approval / Apellis Syfovre Challenges
Astellas has withdrawn its European application for Izervay in geographic atrophy (GA) after CHMP’s rejection of Apellis’ Syfovre, citing insufficient clinical benefits. Despite setbacks, Astellas continues advocating Izervay’s global GA availability.
Green shoots of recovery bring biopharma hope
October 29, 2024 / Biopharma Market Recovery / Q3 / Federal Reserve Rate Cuts
Biopharma saw a 2% market cap increase in Q3 2024, with renewed investor optimism driven by U.S. Federal Reserve interest rate cuts, boosting industry recovery potential.
How FirstHealth is improving outcomes with observation at home
October 28, 2024 / Telehealth Hospital Capacity Solutions / FirstHealth / Remote Patient Monitoring
FirstHealth’s “Observation at Home” program boosts hospital capacity by enabling stable patients to receive paramedic-supported, telehealth-supervised care at home. Results include higher patient satisfaction and reduced readmission rates, particularly for heart failure.
Oracle Health to Apply for TEFCA QHIN Status
October 28, 2024 / Oracle Health / Data Exchange / Oracle Cloud Healthcare Data / Secure AI-driven Healthcare
Oracle Health is applying for QHIN status under TEFCA, aiming to enhance secure, standardized data sharing across healthcare networks. This move enables broader, interoperable access to diverse health data, supporting efficient care and advanced AI applications.
Ottimo Pharma launches under former Seagen chief exec
October 28, 2024 / Ottimo Pharma Launch / David Epstein / Industry Leaders / Pfizer Acquisition
Ottimo Pharma, led by former Seagen CEO David Epstein, has launched with a prominent executive team, including Mehdi Shahidi and James Sabry, aiming to drive innovative biotech advancements following Epstein’s successful Seagen-Pfizer acquisition.
// 4th Industrial Revolution
‘You Almost Have to Be Doing It’: Why Scott Gottlieb Thinks All Doctors Will Use LLMs Soon
October 29, 2024 / Scott Gottlieb / LLMs Clinical Decision Support / AI in Medical Diagnosis / HIPPA-compliant
Scott Gottlieb advocates for LLMs in clinical workflows, citing their high accuracy on medical exams and clinical cases. He envisions LLMs becoming essential diagnostic tools, though HIPAA-compliant access in healthcare settings remains a hurdle.
A Plethora of Announcements Focused on AI at eClinicalWorks Annual Conference
October 28, 2024 / eClinicalWorks / AI in EHR solutions
At the eClinicalWorks Annual Conference, CEO Girish Navani introduced multiple AI-driven EHR advancements to enthusiastic attendees, highlighting the company’s dynamic culture and commitment to innovation in healthcare technology.
ChatGPT’s language bias poses risk in public health response: study
October 29, 2024 / ChatGPT Language Bia / Public Health LLM Challenges / AI / Digital Divide
A study highlights ChatGPT’s language bias, which risks public health outcomes by producing inaccurate responses in low-resource languages like Vietnamese. Researchers urge improvements in LLM language inclusivity to prevent misinformation.
Considerations and Safeguards Addressing Potential Vulnerabilities in Connected Medical Devices and the Internet of Things (IoT)
October 29, 2024 / Healthcare loT Security / Medical Device Vulnerabilities / Cybersecurity / Patient Data
Healthcare’s digital transformation heightens the need for strong cybersecurity in connected medical devices and IoT. Experts recommend safeguards like network segmentation, strong encryption, access control, and regular monitoring to mitigate risks and protect patient data.
Data Storage: The Foundation to an AI-Driven Health System
October 29, 2024 / Healthcare Data Storage AI / AI-driven Patient Care / Healthcare Solutions
Effective data storage is essential for healthcare AI, enabling reliable, accurate outputs that support clinical and administrative advancements. Health systems benefit from a flexible, secure platform for data storage to streamline innovation and enhance patient care.
// Business & Markets
HOPO Therapeutics gets $226 million award from BARDA
October 29, 2024 / HOPO Therapeutics BARDA Contract / FDA / New Drug Application
HOPO Therapeutics secured a BARDA contract worth up to $226 million to develop HOPO-101 as a countermeasure for radiological threats, with plans for FDA submission following early toxicology, pharmacology, and manufacturing studies.
Aignostics Secures $34M to Advance AI-Powered Pathology and Precision Medicine
October 29, 2024 / Aignostics AI Pathology Funding / Mayo Clinic / Drug Discovery / AI
Aignostics secured $34M in Series B funding to expand AI-driven pathology solutions and precision medicine efforts, including U.S. growth and partnership with Mayo Clinic to enhance drug discovery, diagnostics, and translational research.
Philips Secures $25M DoD Contract to Advance AI Predictive Health Monitoring
October 29, 2024 / Philips Rate AI Algorithm / Predictive Health Monitoring / Military Infaction Early Detection
Philips received a $25M DoD contract to advance its RATE AI algorithm, which detects pre-symptomatic infections in military personnel. This predictive health monitoring aims to enhance readiness by enabling early intervention and disease containment.
Vara Raises $8.9M to Expand AI-Powered Breast Cancer Screening Globally
October 29, 2024 / Vara AI Breast Cancer Screening / Early Cancer Detection
Vara raised $8.9M to expand its AI-driven breast cancer screening platform, which improves detection rates and reduces false positives, globally. The technology, already part of Germany’s screening program, aims to expand access in emerging markets.
AbbVie punts $1.4 billion to buy early-stage Alzheimer’s drug developer Aliada
October 29, 2024 / AbbVie / Aliada Therapeutics / Acquisition / Alzheimer’s Drug Development
AbbVie acquired Aliada Therapeutics for $1.4 billion, aiming to leverage Aliada’s BBB-crossing technology and lead Alzheimer’s candidate, ALIA-1758, to advance central nervous system therapies after discontinuing its own anti-amyloid program.
// Legal & Regulatory
Publicis Media dismisses dozens of US employees for ‘egregious’ RTO policy violations
October 29, 2024 / Publicis Media Layoffs / Layoffs / Remote
Publicis Media dismissed fewer than 1% of its U.S. employees for repeatedly violating its three-day-per-week office return policy, which mandates in-office presence on Mondays, with flexibility for medical and pre-existing remote contracts.
ACE Market-bound OB Holdings in legal dispute over alleged breach of contract, IP infringement
October 25, 2024 / OB Holdings IPO / Orient Biotech
Ahead of its IPO, OB Holdings’ subsidiary Orient Biotech faces a contract and IP dispute with Nature One Dairy, which claims product similarities. Orient denies the allegations and aims for an amicable resolution, stating minimal financial impact.
Avyakta Law Advises Micro Labs On Strategic Acquisition Of Swiss Pharma Nigeria
October 30, 2024 / Micro Labs Swiss Pharam Nigeria Acquisition / Pharma Market / Africa Expansion
Avyakta Law advised India-based Micro Labs on acquiring Swiss Pharma Nigeria, expanding its presence in the African market. The acquisition strengthens Micro Labs’ reach in specialized therapeutics, supporting affordable, high-quality medicine across Nigeria and Africa.
Novartis eyes year-end filing in US for Fabhalta in C3G
October 28, 2024 / Novartis / FDA Filing / Complement Inhibitor Kidney Disease / Oral Therapy C3G Approval
Novartis plans to file Fabhalta for FDA approval in C3 glomerulopathy (C3G) by year-end. Recent trial data shows Fabhalta significantly reduces kidney damage biomarkers in this rare, progressive disease, offering the first oral treatment option.
Novartis, Apellis drop dueling datasets as they race for approval in rare form of kidney disease
October 28, 2024 / Novartis / Apellis Pharma / Sobi / Empaveli / Syfovre
Novartis and Apellis revealed positive data on Fabhalta and pegcetacoplan, respectively, for treating rare kidney diseases C3G and IC-MPGN. Both drugs showed significant proteinuria reduction, with Apellis demonstrating earlier proteinuria impact and stabilization of kidney function.
// Research & Development
After prior trial flop, EyePoint’s Duravyu bounces back with promising data in DME
October 28, 2024 / EyePoint Pharma / Ophthalmology / Eye Diseases / Diabetic Macular Edema
EyePoint’s Duravyu shows promising interim results in diabetic macular edema (DME), with improved visual acuity and retinal thickness over aflibercept in the VERONA trial, suggesting strong potential for DME and other retinal diseases after previous trial challenges.
Bavarian eyes mpox vaccine label expansion to include toddlers, kickstarts Phase II trial
October 29, 2024 / Bavarian Nordic mpox vaccine / Vaccines / Smallpox Vaccine
Bavarian Nordic initiates a Phase II trial to expand its MVA-BN mpox/smallpox vaccine label to children aged 2-11, assessing safety and immunogenicity in comparison to adults, with recruitment in African countries affected by mpox outbreaks.
Biogen shows its IgAN hand with felzartamab data
October 28, 2024 / Biogen / IgAN Trial / Kidney Disease / Felzartamab Results
Biogen’s anti-CD38 antibody, felzartamab, showed promising Phase 2 results in IgA nephropathy, achieving significant proteinuria reduction and stable kidney function. Biogen plans to advance the treatment to Phase 3 trials, aiming to address unmet IgAN needs.
Corxel and LENZ share positive results from Phase III China trial
October 29, 2024 / LNZ100 presbyopia treatment / FDA Approval / Vision Loss Eye Drops
Corxel Pharmaceuticals and LENZ Therapeutics report positive Phase III results in China for LNZ100, an aceclidine-based eye drop to treat presbyopia, affecting 400 million people in China. LENZ also seeks U.S. FDA approval for the product.
Immune cell discovery offers new potential for cancer immunotherapy
October 28, 2024 / Novel Immune Cells Immunotherapy / Anti-tumor Immunity Activation / Cancer Immunotherapy
Researchers at Emory’s Winship Cancer Institute discovered stem-like CD4 T cells that enhance anti-tumor immunity when activated, offering potential for improving immunotherapy in resistant cancers by reprogramming these cells from a suppressive to an active state.
// Politics
CVS workers in California reach tentative labor deal
October 25, 2024 / CVS California Labor Deal / Healthcare and Wages / California
Over 7,000 CVS workers in Southern California reached a tentative labor agreement after striking for better wages, healthcare, and staffing. The deal awaits a member vote following accusations of unfair labor practices by CVS.
6 races to watch that could shape health care policy
October 19, 2024 / Healthcare Policy Key Races / 2024 Election / Congress
Key races, including those involving Sens. Baldwin and Tester, Gov. Hogan, and Rep. Schweikert, could reshape health care policy, influencing Congress’s direction on affordability and access as new members enter and the political landscape shifts.
D.C. Diagnosis: Could RFK Jr. go ‘wild’ on health and medicine?
October 29, 2024 / Trump / RFK Jr. / Health Policy / Vaccine Health
In recent public appearances, former President Trump discussed health priorities, including RFK Jr.’s potential influence on vaccines and health agencies, hinting at possible shifts in health policy direction.
How a Mumbai Drugmaker Is Helping Putin Get Nvidia AI Chips
October 27, 2024 / Shreya Life Sciences Nvidia / Russia AI / India
Mumbai-based Shreya Life Sciences aids Russia’s access to Nvidia AI chips despite Western export restrictions, spotlighting India’s evolving role as a technology intermediary amid heightened U.S. and EU concerns.
Mark Cuban on prescription drug costs and PBM reform
October 29, 2024 / Mark Cuban PBM Reform / Drug Cost Transparency / Prescription Pricing Reform / Kamala Harris / Cost Plus Drug Company
Mark Cuban emphasizes the need for transparency and PBM reform to reduce drug costs, supporting VP Kamala Harris’s commitment to tackling PBM practices that obscure true drug pricing and increase patient expenses.