Healthcare Industry News Weekly Wrap-Up: January 19, 2024

// Biotech and Pharma Therapeutics

Kyverna sets plans for IPO in test of biotech enthusiasm

January 17, 2024 / Kyverna / IPO / Startup

More than two years after the bottom fell out for biotech stocks, the market for IPOs is showing early signs of life, though investors are generally looking for more well-established companies than in the past. Four of the five companies who have filed for IPOs in January – including Kyverna – have drugs in Phase 2 testing or later.

YouTube Health makes first aid and emergency care videos more accessible

January 12, 2024 / YouTube Health / Google / Healthcare

Google’s video platform YouTube Health announced today it is making step-by-step videos pertaining to first aid and emergency care by reliable healthcare organizations the top search results when users are seeking first aid-related information.

Backed by billionaires, a new biomedical institute tests an unorthodox approach

January 12, 2024 / Harvard / Drug Research

A group of high-profile scientists and billionaire financiers are building a new biomedical research institute that they claim will offer a new model for studying disease biology and developing new drugs.

More patients are getting their meds online. Big Pharma wants in on the action

January 17, 2024 / Telehealth / Obesity / Diabetes

Since the pandemic, patients have become increasingly comfortable with getting their medications online. Direct-to-consumer telehealth has made it easy to schedule a virtual visit and get a script, sometimes within minutes, with prescriptions shipped to your doorstep.

Allakos to lay off half of staff, scrap drug after study setback

January 16, 2024 / Allakos / Immune Diseases

Allakos plans to lay off about half of its workforce and halt development of its most advanced drug prospect after the therapy failed a pair of key trials, the company announced Tuesday.

// 4th Industrial Revolution

Menopause Startup Launches AI-Powered Hot Flash Care Product

January 11, 2024 / Menopause / Startup / AI / Women’s Health

Loewen Cavill, co-founder and CEO of Amira, never expected to work in the menopause space. But then her aunt was unexpectedly hospitalized due to severe menopause symptoms.

Deep Learning Tool May Help Detect Pediatric Rheumatic Heart Disease

January 17, 2024 / Heart Disease / Deep Learning / American Heart Association

Researchers from Children’s National Hospital have developed a deep learning (DL) to detect latent rheumatic heart disease (RHD) in children, which may improve case identification and treatment in low-resource areas, according to a study published this week in the Journal of the American Heart Association.

AI-Driven Eye Exams May Increase Screening Rates Among Diabetic Youth

January 18, 2024 / AI / Diabetic Eye Exam

A research team from Johns Hopkins Children’s Center has found that an autonomous artificial intelligence (AI) tool to screen youth populations for diabetic eye disease (DED) can also increase the likelihood of screening completion, according to a recent study published in Nature Communications.

Fitbit, Quest partner to study metabolic health using wearable data

Jaunary 17, 2024 / Fitbit / Metabolic Health / Wearables

The pilot study, dubbed Wearables for Metabolic Health (WEAR-ME), will combine Fitbit’s behavioral and biometric data with health information from Quest Diagnostics’ lab tests to garner insights on assessing metabolic health and possibly preventing disease.

Growing AI adoption for fall prediction in Singapore and other AI integrations across APAC

January 13, 2024 / AI / R&D / Alzheimers

Co-developed with medical technology company Longway AI Technologies, the AI system was trained via a 3D convolutional neural network, a deep learning model that teaches a computer to process data the way the human brain and nervous system do. Over 200 hours of videos of human activities involving gait were fed on and trained with the system so it could detect signs of unsteady gait and then alert relevant care teams.

// Business & Markets

Cell Therapy Startup With Stanford Roots Unveils $75M to Seek Inflammation Cures

January 17, 2024 / Cell Therapy / Startup / Immune System

When immune cells go awry and spark inflammation, a different type of immune cell stands ready to counteract that effect and return the immune system to a state of balance. Therapies based on such cells are part of an emerging area of research for the treatment of a wide range of autoimmune diseases. The work of Tr1X focuses on a particular type of these cells and the startup has emerged from stealth with $75 million and a lead program on track for the clinic later this year.

After 17-year courtship, Sun and Taro finally agree on $348M buyout

January 18, 2024 / Sun Pharmaceutical / Taro Pharmaceuticals / Buyouts / M & A

On Thursday, the companies revealed their long-awaited merger, with Sun of Mumbai, India, agreeing to purchase outstanding shares in the Israeli drugmaker for $43 each. The deal nets out to $348 million for a 48% premium on Taro’s share price of $29

BridgeBio strikes drug royalty deal for cash infusion

January 18, 2024 / BridgeBio / FDA Approval

BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if the medicine, called acoramidis, receives Food and Drug Administration approval.

General Catalyst’s HATCo plans to purchase Ohio healthcare system Summa Health

January 17, 2024 / HATCo / Summa Health

Venture capital firm General Catalyst announced its recently formed business venture Health Assurance Transformation Corporation (HATCo) intends to purchase Ohio-based Summa Health, a nonprofit healthcare system with over 30 locations throughout the Akron and Canton areas.

A South Korean investment firm starts first US biotech fund

January 18, 2024 / Drugmakers / Cancer / Neuroscience / Metabolic Disease / Investment

Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK.

// Legal & Regulatory

FDA says no ‘clear relationship’ between GLP-1 drugs and suicide risk

January 12, 2024 / FDA / Ozempic / GLP-1 / Diabetes / Obesity

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and the other was taking Ozempic, Novo’s weekly diabetes shot that is often used off-label for obesity. Icelandic authorities also reported one case of self-harm in a person taking Saxenda.

US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

January 17, 2024 / Seagen / Daiichi Sankyo / Enhertu

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark Office (U.S. PTO) has handed Daiichi the latest win in the saga.

USPTO Rules Against Seagen in ADC Patent Battle with Daiichi Sankyo

January 17, 2024 / USPTO / Daiichi Sankyo

The U.S. Patent and Trademark Office has ruled in favor of Daiichi Sankyo in its years-long patent war with Seagen over key linker technology used in its blockbuster Enhertu (fam-trastuzumab deruxtecan-nxki) antibody-drug conjugate for cancer, the Japanese company announced on Wednesday.

Takeda Gets FDA Label Expansion for HyQvia in Rare Autoimmune Disorder

January 17, 2024 / Takeda / FDA / Autoimmune Disorder

The FDA on Tuesday approved the use of Takeda’s HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase) as a treatment for chronic inflammatory demyelinating polyneuropathy.

FDA widens approval of Vertex’s CRISPR medicine to treat beta thalassemia

January 16, 2024 / FDA / Vertex / CRISPR / Casgevy

The Food and Drug Administration on Tuesday approved Vertex Pharmaceuticals’ CRISPR-based medicine Casgevy for the inherited blood condition beta thalassemia, expanding its use six weeks after issuing a landmark clearance in sickle cell disease.

// Research & Development

New data reveals out-of-hospital cardiac survival results remain low in England

January 11, 2024 / England / Cardioac Risk / Clinical Trials

New data published by the Out-of-Hospital Cardiac Arrest Outcomes (OHCAO) Registry, based at the University of Warwick Clinical Trials Unit, has revealed that out-of-hospital cardiac arrest survival rates remain low in England.

Study reveals antibiotic use is not the only driver of antibiotic resistance

January 12, 2024 / Antibiotics / New Study

Results showed that the increase in treatment-resistant bacteria varied depending on the type of broad-spectrum antibiotic used. Specifically, the rate of resistance to a commonly used antibiotic to treat urinary tract infections caused by E. coli ranged from 8.4% to 92.9%, depending on the country.

Novartis Ends Phase III Peanut Allergy Trial in Another Flop for Potential Xolair Successor

January 18, 2024 / Novartis / Clinical Trials

The clinical trials listing does not indicate the reason behind the peanut allergy study termination and the company has yet to make a statement as of this writing. Novartis’ pipeline still lists the asset for food allergy, marked as a lead indication. The pharma had previously projected a market size of greater than $1 billion for its food allergy antibody, according to Endpoints News.

Poolbeg’s cytokine release syndrome drug shows potential

January 17, 2024 / Poolbeg / New Drug

Poolbeg – a company focused on innovative medicines – has announced promising in vivo results for POLB 001 in treating cancer immunotherapy-induced cytokine release syndrome (CRS).

Synendos receives EMA nod for brain therapy

January 18, 2024 / EMA / Brain Therapy / Synendos Therapeutics

Synendos Therapeutics – a company focused on innovative endocannabinoid system (ECS) treatments – has announced that it has received approval from the European Medicines Agency (EMA) to begin a phase 1 study of its SYT-510 asset.

// Politics

Will Congress get any health policy done this year?

January 18, 2024 / Congress / Healthcare

Republicans and Democrats swapped offers on policies, including a monthslong renewal of pandemic-era bumps to doctors’ Medicare payments, a couple behavioral health programs, and increasing funding for community health centers, but the talks ultimately broke down late last week.

Despite lawsuits, NJ drugmakers take part in Medicare negotiations

January 15, 2024 / Lawsuit / Drugmakers / Medicare / Biden

Despite suing the Biden administration over a controversial new government program aimed at reducing the cost of prescription drugs for older Americans, New Jersey’s biggest pharmaceutical companies are taking part in price-setting negotiations.

Federal watchdog to probe FDA’s handling of major device recalls, including Philips’

January 17, 2024 / FDA / GAO / Philips / Recall

Following a series of reports on the FDA’s alleged history of mishandling medical device recalls, which in turn sparked a request for a government probe of the regulator, the U.S. Government Accountability Office has agreed to take on the job.

CMS finalizes rule setting prior authorization deadlines for payers

January 17, 2024 / Prior Authorization / Medicare Advantage

To combat growing criticism of prior authorization delays by payers, Centers for Medicare & Medicaid Services finalized a rule Wednesday that requires health plans to send prior authorization decisions within three days for urgent requests and seven days for standard requests starting in 2026.

Welch introduces bill to streamline drug patent litigation, lower drug costs

January 16, 2024 / Welch / New Bill / Congress / Lower Drug Costs

Vermont Business Magazine Senator Peter Welch (D-Vt.), Senator Mike Braun (R-Ind.), and Senator Amy Klobuchar (D-Minn.) last week introduced bipartisan, bicameral legislation to streamline drug patent litigation, encourage fair market competition, and lower prescription drug prices by making it easier for generic and biosimilar companies to enter the market. Rep. Jodey Arrington (TX-19) introduced companion legislation in the House.