// Biotech and Pharma Therapeutics
Regeneron faces new biosimilar threats; an AI biotech lays off staff
May 22, 2024 / Regeneron Biosimilars / Boehringer Ingelheim / OSE Deal / GSK
Regeneron faces new competition from FDA-approved biosimilars for Eylea. Boehringer Ingelheim expands a deal with OSE Immunotherapeutics. GSK’s asthma drug succeeds in Phase 3 trials. Bristol Myers Squibb anticipates early FDA decision for Opdivo. Exscientia announces workforce reductions.
J&J Positions Tremfya as Stelara Successor with Strong Head-to-Head Data
May 22, 2024 / Johnson & Johnson / Crohn’s Disease / Tremfya vs Stelara
Johnson & Johnson’s Tremfya shows superior endoscopic outcomes compared to Stelara in Crohn’s disease Phase II/III trials, positioning it as a potential successor amid rising biosimilar competition.
AstraZeneca to harness China’s explosion of innovation to boost cell therapy R&D
May 21, 2024 / AstraZeneca / China / Cell Therapy / Pascal Soriot / Investors
AstraZeneca leverages China’s innovation to advance cell therapy R&D, aiming to nearly double revenues to $80 billion by 2030, driven by existing blockbusters and 20 new drug launches.
Bristol Myers lines up Opdivo treatment in Pakistan, Rwanda and beyond as part of 10-year access campaign
May 22, 2024 / Bristol myers Squibb / Cancer Treatment
Bristol Myers Squibb launches a 10-year campaign to expand cancer drug Opdivo’s access in low- and middle-income countries, targeting over 200,000 patients by 2033 through strategic collaborations and distribution pathways.
Concert Health, WellSpan Health partner to support PCPs in Pennsylvania
May 22, 2024 / Concert Health / Digital Health / WellSpan Health / Mental Health
Concert Health partners with WellSpan Health to offer same-day behavioral health services for primary care patients in Pennsylvania and Maryland via a collaborative care model using digital health technology.
// 4th Industrial Revolution
9 notable quotes from 1 big day at an epicenter of AI in healthcare
May 21, 2024 / Pheon Therapeutics / Cancer Treatment / Clinical-Stage Biotech / Therapy Development
Pheon Therapeutics raises $120M in Series B funding to advance its novel antibody-drug conjugates (ADCs) for hard-to-treat cancers, planning to enter clinical trials in 2024 and expand in-house ADC technologies.
AI-based risk scoring is driving surgical efficiency in Emirates Health Services
May 20, 2024 / Emirates Health Services AI / SurgiSense / AI / Surgeon Performance / Innovation
Emirates Health Services (EHS) uses AI in the SurgiSense project to evaluate surgeon performance via 14 indicators, enhancing surgical efficiency and professional development. The initiative is part of broader AI-driven efforts to improve healthcare operations and outcomes.
Uber Health Announces Solution for Caregivers
May 17, 2024 / Uber Health / Caregiver Support / Healthcare
Uber Health introduces Uber Caregiver, enabling caregivers to manage rides, grocery deliveries, and prescriptions for care-receivers, along with real-time updates and communication features, starting this summer.
Is Korea turning to AI to resolve ER crisis?
May 21, 2024 / South Korea / ER / AI / Investments
South Korea’s Ministry of Health and Welfare is investing $16.7 million in AI to develop a clinical decision support system for emergency departments, aiming to improve ER efficiency and predict critical conditions amid ongoing doctors’ strikes.
WearLinq Acquires AMI Cardiac Monitoring, Raises $6.7M for FDA-Cleared 6-Lead ECG Device
May 21, 2024 / WearLinq AMI Acquisition / Wearables / Cardiac Monitoring / FDA
WearLinq acquires AMI Cardiac Monitoring and raises $6.7M to expand its FDA-cleared eWave 6-lead ECG device, enhancing AFib detection and cardiac care nationwide with advanced, comfortable long-term monitoring technology.
// Business & Markets
Biogen, looking to diversify, acquires immune drugmaker HI-Bio for $1.15B
May 22, 2024 / Biogen / Kidney Trials / Biogen Pipeline / Drug Acquisition
Biogen acquires HI-Bio for $1.15 billion to diversify its pipeline beyond neurology, focusing on the immune drug felzartamab, which has completed Phase 2 trials for kidney conditions. The acquisition aligns with CEO Chris Viehbacher’s strategy to expand into immunology.
Virtual speech therapy platform Expressable secures $26M
May 22, 2024 / Series B Funding / Virtual Speech Therapy / Telehealth
Expressable, a virtual speech therapy platform, raises $26 million in Series B funding to expand its therapist network, enhance the platform, and grow provider and health plan partnerships, catering to various speech and language disorders.
Boehringer pays OSE $42M to expand collab into cardio disease, grab new asset
May 22, 2024 / Boehringer Ingelheim / Cardio-renal-metabolic Diseases / Drug Development / Clinical Trials
Boehringer Ingelheim pays OSE Immunotherapeutics $42 million to expand their collaboration, adding cardio-renal-metabolic disease research and acquiring a new preclinical anti-PD1/cytokine drug, while continuing to develop existing oncology assets.
Epic’s EHR market share gains continue, KLAS report shows
May 20, 2024 / Epic Systems / Market Share / Meditech
Epic Systems leads the U.S. acute care EHR market, gaining 153 new clients and covering over half of inpatient multispecialty beds, while Oracle Health and Meditech face client attrition, according to the KLAS 2024 report.
Click Therapeutics Acquires Better Therapeutics, Expands into Obesity and Cardiometabolic Disease
May 22, 2024 / Click Therapeutics / Acquisition / Digital Therapeutics / Obesity
Click Therapeutics acquires Better Therapeutics’ assets, expanding its digital therapeutics (DTx) portfolio into obesity and cardiometabolic diseases, including type 2 diabetes, hypertension, hyperlipidemia, and MASH, enhancing its personalized, AI-powered treatment solutions.
// Legal & Regulatory
Sanofi, Bristol Myers on the hook for $916M in do-over of Plavix marketing case in Hawaii
May 22, 2024 / Sanofi / Bristol Myers / Lawsuit / Blood Thinner
A Hawaii judge orders Sanofi and Bristol Myers Squibb to pay $916 million for failing to warn about Plavix’s reduced effectiveness in some nonwhite patients, following a second trial in a decade-long legal battle.
FTC orders Blackbaud to report on data practices
May 22, 2024 / FTC / Settlement / Ransomware Attack / Data Security
The FTC orders Blackbaud to improve its data security practices and notify customers promptly after a 2020 ransomware attack, settling allegations of inadequate security and delayed breach notification. The company must also implement a comprehensive information security program.
Henrietta Lacks family can proceed with lawsuit over use of HeLa cells after ‘milestone’ ruling
May 21, 2024 / Henrietta Lacks / Lawsuit / HeLa Cells Compensation / Medical Research Ethics
A federal judge allows Henrietta Lacks’ family to sue Ultragenyx Pharmaceutical for using HeLa cells taken without consent in 1951. The cells are crucial in medical research. This ruling marks a significant step toward accountability and compensation.
Tracking the opioid lawsuit settlements amidst calls for oversight
May 16, 2024 / Purdue Pharma / Bankruptcy / Opioid Epidemic / Addiction Treatment
Purdue Pharma’s 2019 bankruptcy, amid extensive litigation over the opioid epidemic, led to a $6 billion settlement. This settlement addresses lawsuits and funds addiction treatment and prevention programs, highlighting Big Pharma’s accountability in the opioid crisis.
Lab at center of Zantac saga claims GSK hid drug’s risks for decades
May 21, 2024 / Valisure / Whistleblower / Lawsuit / GSK / FDA
Valisure’s whistleblower lawsuit against GSK alleges the company concealed Zantac’s carcinogenic risks for decades. The lab claims GSK knowingly provided false data to secure FDA approval, leading to widespread litigation over the heartburn drug’s safety.
// Research & Development
AltruBio lands up to $225M after shift to immune drug research
May 21, 2024 / AltruBio / Drug Research / Inflammatory Disease / Drug Development
AltruBio secures up to $225 million in Series B funding after shifting from cancer to immune drug research in 2020. The funds will support mid-stage trials for their ulcerative colitis drug, ALTB-268, amid rising interest in immune disease therapies.
Otsuka Drops Alzheimer’s Agitation Drug Following Phase III Failure
May 22, 2024 / Otsuka / Alzheimer’s Treatment / Agitation Drug
Otsuka Pharmaceuticals terminates development of its Alzheimer’s-related agitation drug, AVP-786, following a failed Phase III trial. Despite this setback, Otsuka continues to market Rexulti for AD agitation, with competition intensifying in the field.
Rezolute’s oral Eylea rival hits phase 2 goal, sending stock up and sparking partnership talk
May 22, 2024 / Oral Eye Disease / Drug Development
Rezolute’s oral eye disease drug, RZ402, achieved significant reduction in macular edema in a Phase 2 trial, boosting stock prices and sparking potential partnership discussions. The drug may rival injectable Eylea for diabetic macular edema treatment.
Otsuka pulls plug on Alzheimer’s agitation drug after 2nd failed trial
May 22, 2024 / Otsuka / Alzheimer’s Treatment / Clinical Trials
Otsuka Pharmaceutical halts development of AVP-786 for Alzheimer’s-related agitation after failing to meet the primary endpoint in a second Phase 3 trial. This follows a history of mixed results and previous trial failures for the drug.
UK lung cancer study demonstrates further evidence on importance of CT screening
May 22, 2024 / UK / Cancer Screening / Lung Cancer
A UK study highlights the benefits of low-dose CT lung cancer screening across socioeconomic groups, showing improved survival rates for lower-income individuals. Screening also reduces mortality from other smoking-related diseases like COPD and emphysema.
// Politics
About that bipartisan $32B ‘roadmap’ for AI policy: What’s in it for healthcare?
May 16, 2024 / Bipartisan / AI policy / Healthcare Legislation / Healthcare Innovation
A bipartisan Senate group proposes a $32 billion AI policy roadmap for 2026, emphasizing healthcare improvements. Key points include supporting AI deployment with safety measures, enhancing NIH AI research, equipping HHS for AI regulation, ensuring transparency, and promoting AI innovations in healthcare.
Pharma Facing Growing Risks From Geopolitics, Industry Leaders Warn
May 16, 2024 / US-China Pharmaceutical Risks / Biosecure Act / Supply Chain Disruption
Industry leaders at the Financial Times Pharma and Biotech Summit warn that strained US-China relations pose significant risks for the pharmaceutical industry, potentially leading to supply chain disruptions and increased regulatory pressures amid the BIOSECURE Act’s impending legislation.
Pharma industry fears Bulgarian political crisis could hurt negotiations
May 21, 2024 / Bulgarian / EU Legislation
The Bulgarian pharmaceutical industry fears the ongoing political crisis will hinder the country’s ability to effectively negotiate new European pharmaceutical legislation, potentially affecting access to innovative therapies and data protection mechanisms.
New Emails Show First Lady Provided a Pharmaceutical Company High-Level Access to Key State Official
May 16, 2024 / Behavioral Health Officals / Oregon / Janssen Pharmaceutical
Oregon’s first lady, Aimee Kotek Wilson, facilitated meetings between Janssen Pharmaceuticals and state behavioral health officials regarding long-acting schizophrenia injectables, raising concerns about pharmaceutical influence. Janssen made significant campaign contributions following these interactions.
In pharma tax probe, Wyden puts Pfizer in hot seat with CEO letter
May 21, 2024 / Senate Finance Committee / Pfizer / Big Pharma Tax Strategies
Senate Finance Committee Chair Ron Wyden has questioned Pfizer’s tax strategies, highlighting its low tax rates despite high sales. Wyden’s letter to Pfizer’s CEO seeks detailed tax and earnings information, part of a broader investigation into Big Pharma’s tax practices.