// Biotech and Pharma Therapeutics
CDC will offer seasonal flu shots to farmworkers to lower bird flu risk
July 30, 2024 / CDC / Vaccine / Bird Flu
The CDC is funding a $5 million program to vaccinate livestock workers against seasonal flu to lower the risk of H5N1 bird flu evolving into a pandemic strain.
Eisai, Biogen show Leqembi provides added benefits over time as Alzheimer’s showdown with Lilly heats up
July 31, 2024 / Alzheimer / Eli Lilly / Biogen
Eisai and Biogen’s Leqembi shows continued cognitive benefits over 36 months for Alzheimer’s patients, enhancing its appeal against Eli Lilly’s Kisunla, despite EMA’s marketing rejection due to safety concerns.
India’s cost-effective pharma model attracts global giants amid start-up surge
July 31, 2024 / Partnerships / India / Start-ups
Global pharmaceutical giants are partnering with Indian firms for cost-effective manufacturing and innovation, driven by government initiatives boosting pharma start-ups from 283 in 2021 to 1,397.
Merck shares slide as Gardasil sales drop in China
July 31, 2024 / Merck / Vaccine / HPV Vaccine / Zhifei / Partnership
Merck’s shares dropped nearly 10% due to reduced Gardasil shipments in China, a critical market for the HPV vaccine. Factors include an anti-bribery drive and decreased promotional efforts by partner Zhifei.
WebMD Ignite Helps Healthcare Providers Control Patient Leakage
July 31, 2024 / WebMD / Healthcare / Data Analysis
WebMD Ignite introduces new analytics and targeting solutions to help healthcare providers control patient leakage and enhance referral growth through robust data analysis and omnichannel targeting.
// 4th Industrial Revolution
Axena Health, UpScriptHealth partner on telehealth service for women
July 30, 2024 / FDA / Axena Health / Partnership / Leva Pelvic Health / Women’s Health
Axena Health partners with UpScriptHealth to offer telehealth consultations and treatments for women’s urinary incontinence using the FDA-cleared Leva Pelvic Health System, enhancing access to pelvic floor muscle training.
How Are Health Systems and Health Tech Addressing Cybersecurity? A Timely Panel Discussion at INVEST Digital Health
July 31, 2024 / Cybersecurity / Healthcare / Digital Health / Electronic Health
At the INVEST Digital Health conference, health system and tech leaders will discuss strategies to bolster cybersecurity against ransomware attacks, highlighting collaboration efforts and challenges, including setbacks like the recent Crowdstrike software outage.
Ochsner Health to Deploy DeepScribe’s Ambient AI to 4700 Clinicians
July 31, 2024 / Ochsner Health / AI / DeepScribe / Healthcare / Patient Care
Ochsner Health will implement DeepScribe’s ambient AI technology for clinical documentation across 46 hospitals and 370 care centers, aiming to enhance clinician efficiency and patient outcomes by automating transcription and providing real-time insights.
The Perfectly Valid Reason Why Some Physicians are Hesitant About Ambient Clinical Voice
July 31, 2024 / Healthcare / AI / Clinical Voice
Physicians are cautious about ambient clinical voice solutions due to concerns over AI biases, privacy risks, and past disappointments with EHR implementations, despite the potential benefits highlighted by proponents like Dr. Michael Blackman.
TytoCare Awarded FDA Clearance for AI Lung Sound Analysis
July 31, 2024 / FDA / AI / TytoCare / Lung Analysis
TytoCare received FDA clearance for its AI-powered Tyto Insights for Crackle Detection, enhancing its Home Smart Clinic’s ability to identify lung abnormalities during remote exams, improving clinician efficiency and patient care.
// Business & Markets
Biotech Startup AIRNA Adds $60M to Advance RNA-Editing Therapy for Rare Protein Deficiency
July 31, 2024 / RNA-Editing / AIRNA Biotech Funding / Liver Damage / Lung Damage
AIRNA secures $60M to advance its RNA-editing therapy for alpha-1 antitrypsin deficiency (AATD), aiming to provide a disease-modifying treatment for this protein deficiency that causes liver and lung damage.
FibroGen lays off 75% of US staff as cancer drug flunks 2 more trials
July 31, 2024 / FibroGen / Cancer Drug / Cancer Trials / Drug Development
FibroGen is laying off 75% of its U.S. staff and halting investment in its lead cancer drug, pamrevlumab, following the failure of two late-phase pancreatic cancer trials.
LTZ Therapeutics raises over $20 million
July 31, 2024 / LTZ Therapeutics / Cancer Treatment / Autoimmune Disease
LTZ Therapeutics raised over $20 million in Series A funding to advance its Myeloid Engager pipeline for treating cancer and autoimmune diseases, led by Lapam Capital and supported by GL Ventures, K2 Venture Partners, and Shunwei Capital.
Pfizer, Merck Beat Wall Street Expectations Amid Strong Biopharma Q2 Earnings Season
July 30, 2024 / Pfizer / Merck / Wall Street / Earnings
Pfizer and Merck surpassed Wall Street expectations in Q2 earnings, driven by strong sales of their key drugs. Pfizer’s revenue reached $13.2 billion, led by Vyndaqel’s growth, while Merck’s Keytruda achieved $7.2 billion in sales.
Zing Health, Story Health Partner To Bring Cardiology Support to At-Risk Members
July 31, 2024 / Zing Health / Partnership / Cardiology / Virtual Healthcare
Zing Health partners with Story Health to provide cardiology support for at-risk members, offering in-home, virtual, and asynchronous care to improve health outcomes and reduce hospital admissions for those with cardiovascular conditions.
// Legal & Regulatory
FDA accepts Vertex’ suzetrigine NDA for priority review
July 31, 2024 / Vertex Pharma / FDA / Acute Pain Treatment / NDA
The FDA accepted Vertex Pharmaceuticals’ New Drug Application for suzetrigine, an oral NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pain, granting it priority review with a target action date of January 30, 2025.
FDA drug application costs set to rise to $4.3m from October
July 31, 2024 / FDA / Drug Application Costs / Market Costs
The FDA announced that filing a drug application with clinical data will cost $4.3 million in 2025, up by $300,000 from 2024. Applications without clinical data will cost $2.2 million, while prescription drug program fees have slightly decreased.
J&J touts new ‘foundational’ frontline multiple myeloma treatment as Darzalex Faspro nabs quadruplet FDA nod
July 31, 2024 / Johnson & Johnson / Perseus Trial Results / Darzalex Faspro Approval
The FDA approved J&J’s quadruplet therapy Darzalex Faspro with VRd for newly diagnosed multiple myeloma patients eligible for stem cell transplants, based on phase 3 PERSEUS trial results showing a 60% reduced risk of disease progression or death.
Sanofi sues Sarepta, claiming Duchenne gene therapy Elevidys infringes 2 manufacturing patents
July 30, 2024 / Sarepta / Genzyme / Elevidys / Sanofi
Sanofi’s Genzyme sued Sarepta, alleging its Duchenne muscular dystrophy gene therapy, Elevidys, infringes on two manufacturing patents related to viral vector formulations. Genzyme seeks a jury trial and damages, with the patents expiring in June 2025.
With FDA Nod for Colorectal Cancer Screening, How Much Market Share Can Guardant’s Blood Test Get?
July 30, 2024 / FDA Approval / Guardant Health Shield / Liquid Biopsy / Non-invasive Cancer Test
FDA approved Guardant Health’s Shield, the first liquid biopsy for colorectal cancer screening. Shield, targeting unscreened populations, faces commercialization challenges due to established options like colonoscopy and Cologuard, and competition from other liquid biopsies.
// Research & Development
AAIC data hint at possible use for GLP-1s in Alzheimer’s
July 31, 2024 / GLP-1 / Novo Nordisk / Alzheimer’s
New Phase IIb trial data presented at the AAIC suggests Novo Nordisk’s older GLP-1 agonist, liraglutide, may reduce brain shrinkage in areas related to memory and decision-making, indicating potential benefits for Alzheimer’s disease.
AC Immune claims new class of Alzheimer’s-focused ADC has ‘landmark’ CNS potential
July 31, 2024 / EMA / Alzheimer’s / Clinical Trial / ARIA
The European Medicines Agency (EMA) rejected the marketing authorization for Eisai and Biogen’s Alzheimer’s drug, Leqembi, citing a small clinical benefit and significant risks of serious adverse events like amyloid-related imaging abnormalities.
Apollo and Oxford University enter drug discovery and development collaboration
July 31, 2024 / Apollo Therapeutics / Drug Discovery / Oxford University / Oncology / Drug Development
Apollo Therapeutics and the University of Oxford have partnered to translate Oxford’s biomedical research into new medicines, focusing on oncology, immunological, and inflammatory disorders, with Apollo providing expertise and funding to accelerate drug development and clinical trial access.
Despite Late-Stage Hemophilia Win, Sangamo Remains in Do-or-Die Situation
July 31, 2024 / Gene Therapy / Pfizer / Sangamo Hemophilia / Partnership
Sangamo’s hemophilia A gene therapy, developed with Pfizer, showed positive Phase III results. Despite this, Sangamo faces severe financial challenges with limited cash, risking potential bankruptcy unless new deals or funding are secured.
EPSRC launches two new hubs to transform early disease diagnosis in the UK
July 31, 2024 / EPSRC / Quantum Imaging
The EPSRC has launched two quantum technology hubs, Q-BIOMED and QuSIT, with £38.3 million funding to transform early disease diagnosis in the UK, focusing on infectious diseases, cancer, and dementia.
// Politics
3 Big Pharma cancer drugs facing inflation penalties
July 31, 2024 / Bristol Myers Squibb / Pfizer / Medicare / Inflation Reduction Act
Big Pharma must pay Medicare inflation penalties for drugs whose prices have risen faster than inflation, including Pfizer’s Adcetris and Padcev, and Bristol Myers Squibb’s Abecma and Breyanzi. These penalties are part of the Inflation Reduction Act.
Biden administration should push for addiction medication in recovery houses, groups say
July 31, 2024 / Healthcare / Methadone / Biden / Addiction Policy
A coalition of healthcare and recovery groups urges the Biden administration to ensure recovery houses provide access to addiction medications like methadone and buprenorphine, highlighting ongoing discrimination and non-compliance with federal guidelines and the Americans with Disabilities Act.
BIOSECURE Act Could Signal a Seismic Shift for Biopharma in US and China
July 31, 2024 / Biosecure Act / China / Biopharma Relations / Supply Chain / Gene Therapy
The BIOSECURE Act, aimed at reducing U.S. dependency on Chinese biopharma services, could significantly impact the industry by imposing penalties and restrictions. This may lead to increased domestic investment and diversification but could disrupt global collaboration and innovation.
Bipartisan effort tries to tackle crisis facing local pharmacies in Pennsylvania
July 26, 2024 / Transparency Act / Pharmacy Audit Integrity Act / Pharmacy Law
The bipartisan Pharmacy Audit Integrity and Transparency Act, signed into law in Pennsylvania, aims to protect local pharmacies from predatory practices by Pharmacy Benefit Managers (PBMs), ensuring fairer reimbursement and reducing the steering of patients to larger chains.
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025
July 31, 2024 / FDA / VQIP / Modernization Act
The FDA announced the fiscal year 2025 fee for the Voluntary Qualified Importer Program (VQIP), set at $9,999, effective August 1, 2024. This fee supports expedited review and importation processes for food importers, ensuring compliance with the Food Safety Modernization Act.