// Biotech and Pharma Therapeutics
Following Boehringer’s lead, AstraZeneca caps monthly out-of-pocket inhaler costs at $35 in the US
March 18, 2024 / AstraZeneca / Symbicort / Inhaled Medicines / Asthma
AstraZeneca on Monday revealed it’s expanding a savings program across its entire U.S. respiratory portfolio. The plan is to cap monthly out-of-pocket inhaler costs for eligible patients at $35.
GSK Builds Case for Broader Jemperli Label in Endometrial Cancer with Phase III Data
March 18, 2024 / GSK / Endometrial Cancer / Patient Health
GSK on Saturday unveiled new data from its Phase III RUBY program demonstrating better survival outcomes in a wide range of endometrial cancer patients treated with Jemperli (dostarlimab), potentially setting the PD-1 blocker up for a label expansion.
Novo is building a really big computer
March 20, 2024 / Novo Nordisk / Clasp Therapeutics / Acelyrin
Specifically, it’s putting up about $90 million to construct Gefion, a Danish supercomputer running on hardware and software from the trillion-dollar tech firm Nvidia. The idea is to put “extreme AI computing power” to tasks including “drug discovery, disease diagnosis, and treatment,” Novo Nordisk Foundation CEO Mads Krogsgaard Thomsen said in a statement. The work will also include “green transition” and other of “the world’s biggest problems,” according to the foundation.
Orchard sets out to sell world’s priciest gene therapy
March 20, 2024 / Orchard / Gene Therapy / Drug Price
Gene therapy makers like Orchard are counting on insurers to recognize the value proposition of their products. Unlike traditional pharmaceuticals that might be taken regularly for the rest of a person’s life, gene therapies carry the promise of a long-lasting treatment that can alter the course of a disease and offer significant savings for the care needed to treat patients.
Takeda Reaps Rewards of $5.2B Ariad Bet as FDA Expands Iclusig’s Label
March 20, 2024 / Takeda / FDA / Lymphoblastic Leukemia
The FDA on Tuesday expanded the label of Takeda’s Iclusig (ponatinib). The kinase inhibitor can now be used with chemotherapy to treat adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia in the first-line setting.
// 4th Industrial Revolution
AI-based system reduces claims denials for Community Medical Centers of Fresno
March 18, 2024 / AI / Fresno / Medical Centers
In roughly the last 10 years, payers have increased their delay tactics – one method has been to do that with denials, said Eric Eckhart, director of patient financial services at Community Medical Centers of Fresno.
New diabetes app emphasises foot care, foot ulcer awareness
March 19, 2024 / Diabetes / MedTech / Chatbot Assistant
Developed in consultation with clinicians from Tan Tock Seng Hospital (TTSH) and National Healthcare Group, the app called WellFeet delivers comprehensive patient education through animations in multiple languages, including English, Mandarin, Malay and Tamil.
Predictive tool use has little effect on knee surgery decision-making
March 14, 2024 / Knee Arthroplasty / Patient Recovery
Researchers demonstrated that the use of a tool to predict total knee arthroplasty (TKA) in patients with knee osteoarthritis had little impact on patient-reported willingness to undergo the procedure, according to a study published recently in JAMA Network Open.
S’porean startup behind wearable system for stroke rehab gets $5M Series A funding
March 19, 2024 / Startup / Wearable Device / Stroke / MedTech / Neurodevelopmental Disorders
SynPhNe (Synergistic Physio-Neuro Platform) claims to be the world’s first connected wearable solution that trains both brain and muscle simultaneously in one system, supporting the rehabilitation of stroke patients and individuals dealing with neurodevelopmental and neurodegenerative disorders.
CTS Europe: The roadmap for generative AI in the pharma industry
March 7, 2024 / Generative AI / Pharma Industry / CTS Europe
It’s going to take more than tech-first approaches to achieve the quadruple aim, and despite intense focus on how to leverage and safeguard artificial intelligence to enhance care delivery – the topic du jour – AI is only one element of the digital health universe.
// Business & Markets
San Diego’s latest biotech, Contineum Therapeutics, files to go public
March 18, 2024 / San Diego / Contineum Therapeutics / IPO
The company submitted its paperwork Friday with the Securities and Exchange Commission a little over a week after Boundless Bio filed San Diego’s first initial public offering of 2024.
Pfizer set to collect roughly $2.6B in sell-off of Haleon shares, reducing stake from 32% to 24%
March 18, 2024 / Haleon / Pfizer / Public Offerings
Pfizer is set to reduce its stake in Haleon from 32% to 24% by selling 630 million shares in a public offering, Haleon said. The value of the shares is roughly 2 billion pounds ($2.6 billion), according to Reuters.
With MS & Fibrosis Trials Planned, J&J-Partnered Contineum Now Preps for IPO
March 18, 2024 / Johnson & Johnson / IPO / Contineum Therapeutics / Partners
Johnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO.
Clasp Emerges with $150M Series A Financing to Advance T Cell Engagers
March 20, 2024 / Immunotherapies / Startup / Clasp Therapeutics
Clasp Therapeutics launched Wednesday with $150 million in Series A financing to develop a portfolio of next-generation immunotherapies that are both personalized and off-the-shelf to target hard-to-treat tumors.
German biotech Tubulis rides wave of ADC interest to $138M financing round
March 14, 2024 / Tubulis / Series B / Antibody Drug Conjugates / Solid Tumor
TUB-040 focuses on the tumor-antigen Napi2b, a well-known area of interest for ovarian and lung cancer that is also the target of Mersana and GSK’s ADC UpRi. UpRi was released in November 2023 from a clinical hold implemented by the FDA related to a patient death.
// Legal & Regulatory
EPA bans asbestos, a deadly carcinogen still in use decades after partial ban
March 18, 2024 / EPA / Asbestos Ban
The Environmental Protection Agency on Monday announced a comprehensive ban on asbestos, a carcinogen that is still used in some chlorine bleach, brake pads and other products and that kills tens of thousands of Americans every year.
FDA approves first MASH drug: Madrigal’s Rezdiffra breaks ground in notorious biopharma graveyard
March 14, 2024 / FDA Approval / Launches / Marketing / Fatty Liver Disease
The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease.
FDA panel backs broader use of J&J, Bristol Myers cell therapies for myeloma
March 15, 2024 / FDA / Bristol Myers / Cell Therapies / Johnson & Johnson
Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in a patient’s disease, overlooking safety concerns raised by agency reviewers earlier this week.
OCR launches HIPAA investigation into Change Healthcare breach
March 14, 2024 / OCR / HIPAA Investigation / Congress / Health Systems
The Office for Civil Rights in the U.S. Department of Health and Human Services announced that it is opening an investigation into the cyberattack that targeted UnitedHealthcare Group’s Change Healthcare subsidiary and has sent ripples of disruption across the healthcare ecosystem for the past month.
Takeda’s Iclusig wins first-line FDA nod to treat rare Philadelphia chromosome-positive ALL
March 19, 2024 / Takeda / Iclusig / Ariad / Acute Lymphoblastic Leukemia
Twelve years after Takeda’s Iclusig (ponatinib) earned a restricted FDA approval to treat certain patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use.
// Research & Development
Clinical diabetes drug trials in Hawaii could help better develop medicine for residents
March 13, 2024 / Diabetes / Drug Trials / Hawaii / Patient Health
A local physician is a leader in diabetes research helping to develop diabetes drugs for Islanders. The clinical trials being conducted on the local population can help physicians and researchers to better find medicines suited for those living in the Islands.
Roche partners with Cardiff researchers to uncover new research into dementia
March 14, 2024 / Roche / Partners / Cardiff University / Machine Learning
Using cutting-edge imaging and machine learning (ML), researchers will analyse the brains of patients living with Parkinson’s disease (PD) and Alzheimer’s disease (AD).
Fetal tissue research gains in importance as roadblocks multiply
March 20, 2024 / Fetal Tissue / Down Syndrome / Genetic Disorders
Scientists at the University of Wisconsin-Madison have spent years trying to unravel the details of Down syndrome: What happens inside the womb, how the genetic disorder alters the formation of neurons, and what specific processes affect brain development. The work can’t proceed without studying fetal tissue.
Crinetics pads case for oral hormone disorder drug, showing regulation of key biomarker in phase 3
March 19, 2024 / Crinetics / Human Growth Hormone / Acromegaly / Rare Diseases
Crinetics Pharmaceuticals’ oral med paltusotine regulated levels of a hormone associated with the pituitary gland disorder acromegaly in a phase 3 test, setting up a regulatory submission for the second half.
Acelyrin eye drug heads to late-stage testing after trial win
March 20, 2024 / Acelyrin / Eye Drug / Late-Stage Testing / Amgen
A young biotechnology company plans to move an experimental medicine for a rare eye disease into late-stage testing after results from a small study signaled that it is generally safe and works as intended.
// Politics
Advocacy group activates Lung Force to push Congress for cash
March 19, 2024 / American Lung Association / Congress / NIH / CDC
The American Lung Association is sending “LUNG FORCE Heroes” to Washington, D.C. to ask Congress to loosen the purse strings and give federal agencies money that could lead to improved cancer outcomes.
Bill to help health workers with burnout moves ahead in Congress
March 20, 2024 / Congress / Healthcare Workers / Mental Health
A bill designed to help counter depression, burnout and suicide amoung healthcare providers cleared a key hurdle Wednesday, passign unanimously out of the House Energy and Commerce Committee
Congress edges toward action amid Change Healthcare outage
March 15, 2024 / Congress / Healthcare / Cyberattack
More than three weeks since a cyberattack that continues to disrupt U.S. healthcare operations, Congress is still groping for a response. But paths forward have begun to emerge as awareness of the damage slowly spreads on Capitol Hill.
Congress Sets Its Sights on Limiting Access to Chinese Biotech Companies
March 19, 2024 / Congress / China / Biosecure Act
The BIOSECURE Act would prohibit federal agencies from contracting with, extending loans to, or awarding grants to, any company with existing or pending agreements with identified biotechnology companies. This limits funding to both the procurement of biotechnology companies and funding flowing to any entity using these technologies.
After calling on Congress to fund women’s health, Biden directs agencies to boost R&D
March 18, 2024 / Joe Biden / NIH / FDA / Women’s Health
Ten days after asking Congress to fund women’s health research with $12 billion, President Joe Biden is doing what he can to boost investment via an executive order to expand and improve research on women’s health.