// Biotech and Pharma Therapeutics
AstraZeneca withdraws COVID-19 vaccine, citing declining demand
May 14, 2024 / AbbVie / Drug Development / Neuroplasticity / Psychedelic Medicine / Mental Health
AbbVie partners with Gilgamesh Pharmaceuticals to expand its psychiatric drug pipeline, focusing on developing safer alternatives to psychedelic medicines for disorders like depression.
Unlike Regeneron, Bayer doesn’t feel as much of a pinch from Roche’s Vabysmo
May 14, 2024 / Bayer / Sales Performance / Roche / Market Impact
Despite market pressures from Roche’s Vabysmo, Bayer’s Eylea sales remain strong, showing resilience outside the U.S., aided by strategic launches and competitive pricing strategies.
Oncolytics Biotech approved to expand pancreatic cancer program
May 9, 2024 / Pancreatic Cancer / Oncolutics Biotech / Immunotherapy
Oncolytics Biotech is expanding its pancreatic cancer program with a new GOBLET study cohort in Germany, testing pelareorep in combination with Folfirinox and potentially atezolizumab for better treatment outcomes.
East Bay biotech raises $105 million, aims to enter clinical trials with eczema drug
May 10, 2024 / Clinical Trials / Skin Disease / Drug Development
East Bay biotech Attovia raised $105 million to fund clinical trials for its inaugural drug aimed at treating atopic dermatitis, commonly known as eczema.
Eisai sets new revenue target for Alzheimer’s drug Leqembi
May 15, 2024 / Eisai / Alzheimer’s / Sales Growth / FDA Approval
Eisai sets a realistic revenue target of approximately $361 million for its Alzheimer’s drug Leqembi in FY 2024, reflecting confidence in the drug’s market uptake and ongoing sales growth.
// 4th Industrial Revolution
The Era of AI – A Renaissance or Revolution for Healthcare?
May 15, 2024 / AI / Healthcare / Medical Devices
AI’s integration into healthcare presents a pivotal moment: Will it be a renaissance enhancing human creativity or a revolution reshaping medical practices? Advances in generative AI could profoundly affect diagnosis, treatment personalization, and policy frameworks.
The Many Ways Biopharma Can Use Artificial Intelligence, Including Generative AI
May 15, 2024 / AI / Drug Development / Pharmacovigilance
The biopharma industry is harnessing generative AI for diverse applications, including optimizing R&D processes, drug repurposing, patient matching, and enhancing pharmacovigilance, promising significant advancements despite prevailing skepticism.
Fortis Healthcare gets AI boost for mental health vertical
May 14, 2024 / Fortis Healthcare / Mental Health / AI / Telehealth
Fortis Healthcare has launched Adayu Mindfulness in collaboration with United We Care, integrating AI to enhance mental health services in India, offering virtual and in-person care options to address the prevalent stigma around mental health.
Vendor Notebook: AI tackles patient deterioration, obesity and stroke
May 14, 2024 / AI / Stroke Care / Machine Learning
New AI tools from RapidAI, Clew Medical, and Dandelion are enhancing healthcare by improving acute stroke care, predicting patient deterioration, and advancing obesity treatment insights through comprehensive data analysis.
AI enhances computational performance of artificial pancreas system
May 14, 2024 / AI / Pancreas / Type 1 Diabetes / New Tech
UVA researchers have improved an artificial pancreas system by integrating AI, enhancing its efficiency in managing type 1 diabetes without compromising performance.
// Business & Markets
SmarterDx Rakes In $50M For Its AI That Helps Hospitals Capture More Revenue
May 14, 2024 / SmarterDx / AI / Healthcare
SmarterDx, a healthcare AI startup, secured $50 million in Series B funding to enhance hospital revenue capture by automating clinical reviews and quality audits of medical claims with AI.
Samsung Medison buying French ultrasound AI startup for $92M
May 14, 2024 / Samsung / AI New Tech / Startup / FDA
Samsung Medison acquires Sonio, a French AI ultrasound startup for $92M, enhancing prenatal diagnostic technology and expanding its AI capabilities in the ultrasound market.
Novo Holdings buys stake in life sciences tools company; BioMarin lays off 170
May 15, 2024 / Novo Nordisk / BioMarin / Pipeline Review / Life Sciences
Novo Holdings acquires a major stake in Single Use Solutions, BioMarin announces layoffs following a pipeline review, and Novo Nordisk reports a successful trial for a hemophilia A treatment.
LG launches Primefocus Health for providers to deliver home healthcare
May 15, 2024 / LG Electronics / Primefocus Health / Remote Patent Monitoring / Healthcare / New Tech
LG Electronics launches Primefocus Health, a new venture offering a healthcare delivery platform that enables remote patient monitoring and integrates with EHR systems using AI and machine learning to enhance home healthcare.
Ballad Health and Sevaro Health Partner To Optimize Stroke Care
May 15, 2024 / Ballad Health / Stroke Care / Innovation / Healthcare
Ballad Health partners with Sevaro Health to integrate advanced teleneurology services into its emergency departments, aiming to provide the fastest stroke response times in the U.S. and improve neurological care in rural areas.
// Legal & Regulatory
Right-to-Repair Laws Could Threaten Healthcare Safety
May 14, 2024 / Right-to-repair / Medical Devices / FDA / Regulation / Cybersecurity
The expansion of right-to-repair laws may jeopardize patient safety by allowing unqualified repairs on critical medical devices, potentially leading to catastrophic failures and cybersecurity risks.
The FDA approves Apple Watch’s heart monitoring tool for use in clinical trials
May 14, 2024 / FDA / Clinical Trials / Hepatitis B / Vaccine
The FDA denied Dynavax’s request to expand its hepatitis B vaccine for adults on hemodialysis, citing insufficient data on effectiveness and safety from its HBV-24 study.
Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval
May 9, 2024 / Jazz Pharmaceutical / FDA / Lawsuit / Orphan Drug Act
Jazz Pharmaceuticals is challenging the FDA in court over its approval of a rival narcolepsy drug, Lumryz, claiming the agency wrongly interpreted “clinical superiority” to bypass exclusivity rights granted under the Orphan Drug Act.
US FDA extends review of Ascendis Pharma’s hormone disorder therapy
May 14, 2024 / FDA / Ascendis Pharma / TransCon / Market Approval
The FDA has extended its review of Ascendis Pharma’s TransCon PTH, a therapy for adult hypoparathyroidism, by three months due to a major amendment in the application, with a new decision expected by August 14.
Another delay for Ascendis’ hormone therapy as FDA extends review by 3 months
May 14, 2024 / FDA / FDA Approval / Ascendis Pharma
The FDA has delayed its decision on Ascendis Pharma’s TransCon PTH for hypoparathyroidism by three months due to a major amendment in its application, extending the review deadline to August 14, 2024.
// Research & Development
Novo Nordisk’s Hemlibra rival hits goals in phase 3, teeing up blockbuster showdown with Roche
May 14, 2024 / Novo Nordisk / Hemophilia Drug
Novo Nordisk’s Mim8 successfully met primary endpoints in a phase 3 trial, challenging Roche’s Hemlibra with potential monthly dosing options for hemophilia A, teeing up a major market competition.
Study reveals heart failure device could monitor patients and prevent hospitalisation
May 14, 2024 / Heart Failutre / New Tech / CPM System / Heart Monitoring
Researchers at the University of Glasgow have shown that Analog Devices Inc’s Sensinel CPM System can effectively monitor heart failure patients, potentially reducing hospital admissions by detecting fluid overload.
After traumatic brain injury, life support decisions can use more time
May 14, 2024 / Brain Injury / Clinical Resource / Patient Recovery
A study suggests extending the decision-making period for withdrawing life support in severe traumatic brain injury cases, advocating for more data collection to better predict recovery outcomes.
US study reveals interferon combinations cause lupus symptoms and affect treatment
May 15, 2024 / Autoimmune Disease / Lupus Symptom Management
Johns Hopkins Medicine researchers have discovered that specific combinations of interferons contribute to symptom severity and treatment responses in lupus, potentially guiding new approaches to managing the autoimmune disease.
Eisai, Biogen Launch Rolling BLA for Subcutaneous Alzheimer’s Therapy Leqembi
May 15, 2024 / Alzheimer’s / FDA Approval / Partnership
Eisai and Biogen have initiated a rolling BLA for a subcutaneous formulation of Leqembi, their Alzheimer’s therapy, aimed at providing patients with a more convenient weekly maintenance dose after an initial biweekly phase.
// Politics
HHS suspends federal funding for EcoHealth Alliance
May 15, 2024 / EcoHealth / Infectious Disease
The U.S. Department of Health and Human Services has suspended and plans to terminate future federal funding to EcoHealth Alliance due to concerns over its research and reporting practices, particularly its association with the Wuhan Institute of Virology.
Shocking: Covid Vaccine injury claims ignored by government, Big Pharma shielded
May 14, 2024 / Biosecure Act / US Drug Supply / China
The BIOSECURE Act, targeting Chinese biopharma ties, could disrupt the U.S. drug supply by barring federal contracts with companies that work with designated Chinese firms, potentially affecting millions.
Bernie Sanders urges Danish pharma giant Novo Nordisk to lower its drug prices: ‘Help the American people’
May 13, 2024 / Bernie Sanders / Novo Nordisk / Drug Pricing
U.S. Senator Bernie Sanders has called on Denmark to pressure Novo Nordisk, the country’s largest company, to reduce its drug prices to aid American consumers.
Rising Cancer Rates Drive Biotech Advancements Despite Political Hurdles
May 9, 2024 / Cancer / Oncology / Clinical Trials
Amid political challenges, rising global cancer rates are driving biotech advancements. Despite funding issues for the U.S. Cancer Moonshot initiative, biotech companies are progressing with new cancer treatments, evidenced by recent significant clinical developments.
US House panel voices support for legislation restricting business with Chinese biotech firms
May 15, 2024 / China / Legislation / National Security
A U.S. House committee has endorsed legislation to restrict business interactions with Chinese biotech firms like BGI and WuXi AppTec, citing national security concerns, with a formal vote pending.