// Biotech and Pharma Therapeutics
Why the evolution of patient advocacy organizations means better data for your rare disease trial
October 23, 2023 / Drug Development / Patients / Clinical Trials
As a Therapeutic Strategy Lead for Rare Disease at Worldwide Clinical Trials, Juliane Mills is invested in seeing patient communities continue to evolve as influential players in rare disease research. Their transformation from advocacy organizations to research organizations holds great promise, empowering all stakeholders in rare disease research to find better treatments and cures.
Roche Pays $7.1B to Roivant for Rights to Telavant’s IBD Candidate
October 23, 2023 / Roche / Roivant / Drugmakers
Under the agreement, Roche is making an upfront payment of $7.1 billion and providing a near-term milestone of $150 million. The companies expect to close the deal in the fourth quarter of this year or the first quarter of 2024.
Exo Is On a Mission to Put an Ultrasound Machine In Every Care Provider’s Pocket
October 19, 2023 / Exo / New Tech / Medical Devices / Ultrasound Device
With Iris, Exo is seeking to take point-of-care ultrasound beyond just the emergency medicine field — into areas like urgent care, primary care and the home. The grander vision is that the device will one day be in the pockets of every care provider, said Kurt Hammond, the company’s chief commercial officer.
UM-led consortium receives grant to support biotechnology innovation
October 23, 2023 / University of Mississippi / The Tech Hubs Program
This federal investment will support strategy development to grow the region’s biomanufacturing capabilities over the next 5-10 years. The funding will enable the SEBC to conduct several strategy activities, including developing comprehensive plans to recruit biomanufacturing companies to the region, improve access to capital, augment workforce development capabilities and build commercialization mechanisms.
Excision gives first look at gene editing therapy for HIV
October 25, 2023 / HIV / Gene Editing Therapy / CRISPR-based treatment / Cell Therapy
Excision’s results are early, from only a few treated individuals and don’t show whether EBT-101 actually might be effective as a treatment for HIV.
// 4th Industrial Revolution
Why this AI solution provider emphasises on-prem hosting amid growing cloud adoption
October 11, 2023 / AI / Healthcare / Digitalise / New Tech
While many organisations are on the lookout for cloud-based computing services to facilitate their digital transformation, Augnito came out with on-premises hosting as part of its service offerings.
How Healthcare Communication Platforms Can Harness Generative AI in a HIPAA-Compliant Way
October 20, 2023 / Healthcare / HIPAA / AI
When the sector is set to face shortages of between 37,800 and 124,000 physicians by 2034, generative AI could alleviate administrative work, such as summarizing patient calls and managing electronic health records (EHRs), to allow medical staff to focus on improving patient care. Yet, privacy laws and a fragmented market have kept the healthcare industry from reaping generative AI’s full potential — until now.
Patient outcomes point to efficacy of telehealth and virtual care
October 24, 2023 / Telehealth / Virtual Care / Patients / Telemedicine
The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
Focus on Accessibility to Improve the Patient Experience
October 24, 2023 / Patients / Digital Care / Healthcare / Accessibility / CDC
One in four American adults has some type of disability, according to the Centers for Disease Control and Prevention (CDC). Yet, less than five percent of the top hospitals are compliant with the latest WCAG (Web Content Accessibility Guidelines), the baseline for private and public sector organizations to provide digitally accessible solutions to consumers and, in the case of healthcare, patients with disabilities.
AstraZeneca granted licence for Nanoform’s AI technology
October 23, 2023 / AstraZeneca / AI / Nanoform / Licence / STARMAP
Nanoform’s STARMAP is a digital AI version of its Controlled Expansion of Supercritical Solutions (CESS) technology, a technology that enables the creation of API nanoparticles directly from solution, which allows in-silico experiments to decide which molecules should be nanoformed.
// Business & Markets
Weight Loss Startup Calibrate Is Changing Hands
October 23, 2023 / Weight Loss / Startup / Drug Shortages / Calibrate / GLP-1 Drugs
Insider first reported the news after two of the startup’s employees told the publication that the plan had been announced via Slack message on Friday. A spokesperson for Calibrate confirmed the restructuring via email on Monday.
It’s Hard to Be a Biotech Bull in This Market, but This Stock Is a Buy
October 24, 2023 / Stock / Biotech
Biotech stocks are in the midst of a multi-year bear market. Speaking to this point, the SPDR S&P Biotech ETF is presently down by over 60% from its 5-year high. This extreme bearishness stems from a variety of factors, but the most oft-cited cause is the sharp rise in borrowing costs over the past two years.
Cargo Therapeutics prepares IPO to carry CAR-T through phase 2 trials
October 23, 2023 / Cargo Therapeutics / Biotech IPO / Initial Public Offering / CAR-T
Despite launching in 2021, the San Mateo, California-based biotech only came into view this past March, with a $200 million series A round co-led by Third Rock Ventures. Cargo has used the money to push its autologous CD22 CAR-T therapy into a phase 2 large B-cell lymphoma trial in August.
Quince Therapeutics Completes Acquisition of EryDel S.p.A.
October 23, 2023 / Quince Therapeutics / Acquisition / EryDex / Patients
Quince’s newly acquired Phase 3 lead asset, EryDex, targets a rare neurodegenerative disease, Ataxia-Telangiectasia (A-T). Currently, there are no approved treatments for A-T and the market represents a $1+ billion estimated peak sales opportunity globally. EryDex utilizes a highly differentiated and proprietary technology platform for autologous intracellular drug encapsulation (AIDE), which is designed to optimize the biodistribution of dexamethasone sodium phosphate (DSP; a pro-drug) by using an A-T patient’s own red blood cells to deliver the sustained therapeutic over a once monthly treatment period.
NCQA Wins $18M CMS Office of Minority Health Contract
October 23, 2023 / NCQA / Minority Health
// Legal & Regulatory
Pfizer wins FDA approval of new meningococcal vaccine
October 23, 2023 / Pfizer / FDA / Vaccine / Meningococcal
The Centers for Disease Control and Prevention recommends children aged 11 or 12 receive a MenACWY conjugate vaccine, followed by a booster at age 16. People 10 years or older who are at higher risk of meningococcal disease should receive a vaccine against serogroup B, according to the CDC.
Visgenx Announces Issuance of a U.S. Patent Claiming Compositions of Candidate ELOVL2 Gene Therapy
October 25, 2023 / Visgenx / Gene Therapy / San Diego Biotech
Visgenx, Inc., a biotechnology company focused on developing gene therapies for degenerative retinal diseases, today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 11,793,890, entitled “ELOVL2 Constructs for Human Gene Therapy”. The patent, which is exclusively owned by Visgenx, has an expiration date of October 19, 2041.
After FDA found misconduct at trial site, BioXcel touts result from 3rd-party audit and eyes filing
October 25, 2023 / BioXcel Therapeutics / Alzheimer’s Disease / Precedex / Fierce Pharma
After misconduct at a key trial site raised questions of data integrity earlier this year, BioXcel Therapeutics’ Alzheimer’s agitation prospect faced a grim outlook. Now, with a third-party audit in hand, the company believes things are looking up.
FDA Meeting Feedback Puts Turn Biotechnologies on Track to be First Longevity Company Taking Cell Rejuvenation Therapy to Clinic
October 25, 2023 / FDA / Cell Rejuvenation / mRNA / Turn Biotechnologies
Turn Biotechnologies, a cell rejuvenation company developing novel mRNA medicines for untreatable, age-related conditions, received positive feedback during an FDA Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting to review progress and plans for its therapeutic treatment to rejuvenate skin cells.
With $385M settlement, Indivior closes out long-running Suboxone antitrust case
October 23, 2023 / Indivior / Suboxone / Antitrust
With a $385 million settlement, Suboxone maker Indivior is moving to wrap up years of antitrust litigation tied to its opioid addiction treatment.
// Research & Development
Araclon vaccine appears to slow Alzheimer’s in exploratory phase 2 analysis, spurring review of next steps
October 25, 2023 / Grifols / Alzheimer’s Disease / Clinical Trial Data / Clinical Data
Araclon Biotech has provided early evidence that its Alzheimer’s disease vaccine is effective, linking the candidate to a 38% slowdown in disease progression compared to placebo in an exploratory analysis of phase 2 data.
J&J’s Robotic Bronchoscopy System Could Help Physicians Detect Cancer Sooner, Research Finds
October 25, 2023 / Johnson & Johnson / Cancer / Monarch Platform
Johnson & Johnson released new studies this month examining the efficacy of robotic-assisted bronchoscopy (RAB) delivered through its Monarch platform. The research, presented at the American College of Chest Physicians’ annual conference, found that RAB reaches smaller and harder to reach pulmonary nodules, boosts diagnostic yield and increases biopsy success.
On heels of FDA approval, trial results set up GSK’s RSV vaccine for label expansion
October 25, 2023 / GSK / RSV / Arexvy / Pfizer
Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy.
Johns Hopkins study shows potential for chemical vaccine against malaria
October 24, 2023 / John Hopkins / Malaria / Vaccine
A study from the Johns Hopkins Bloomberg School of Public Health has provided evidence supporting the potential of an injectable chemical vaccine for malaria.
Second person to receive pig heart transplant recovering well
October 23, 2023 / Pig Heart Transplant / Heart Transplant
In 2022, David Bennett, a 57-year-old man from the US, became the first human to receive a genetically modified pig’s heart. Unfortunately, he passed away two months after the surgery, not because of his body rejecting the foreign organ but because the donor’s heart was already infected by a virus.
// Politics
New healthcare coalition to push Congress for workforce, immigration solutions
October 23, 2023 / American Healthcare Association / Congress
Biden Asks Congress to Fund ACP Low-Income Broadband Through 2024
October 25, 2023 / Biden / Congress / ACP
President Biden asked Congress to fund a variety of initiatives today, including the Affordable Connectivity Program (ACP), which pays up to $30 a month toward the cost of broadband for low-income households, but which is expected to run out of funding next year.
Biden aims to boost investment in clean energy, biotech, semiconductors with tech hubs
October 23, 2023 / Biden / Biotech / Science Act / CHIPS
2.3M People Would Gain Coverage If Remaining 10 States Expanded Medicaid
October 23, 2023 / Medicaid / Insurance
The Urban Institute report, published Monday, was supported by the Robert Wood Johnson Foundation. The estimates detailed in the report were based on a microsimulation model of the healthcare system that is “designed to estimate the cost and coverage effects of proposed healthcare policy options.”
Senate committee advances Biden’s NIH nominee Monica Bertagnolli
October 25, 2023 / Senate / NIH Nominee / Biden
A Senate health panel on Wednesday voted to send President Biden’s nominee to lead the National Institutes of Health to the chamber’s floor, moving Monica Bertagnolli one step closer to taking the longtime vacant role of permanent director.