Healthcare Industry News Weekly Wrap-Up: November 17, 2023

// Biotech and Pharma Therapeutics

Mural Oncology wants to paint a new picture in IL-2 after Alkermes spinout

November 15, 2023 / Alkermes / Spinoff / Interleukin-2 / Solid Tumor

Mural Oncology, Alkermes’ cancer spinoff, has officially landed with $275 million in funding and a mission to develop an interleukin-2 (IL-2) candidate for solid tumors. Alkermes announced the plan to separate into two a year ago, with a spinout taking on the oncology work and the legacy company continuing in neuroscience.

Overheard in Africa: AI may be just what the doctor ordered for better healthcare, stronger society

November 15, 2023 / AI / Healthcare / Africa

According to the online Nigerian newspaper the Premium Times, a consensus emerged on that topic: “AI could be what Africa needs to build a resilient, society-wide primary healthcare system and ensure adequate and quality health services for all.”

Blue Shield of California, Mahmee Expand Maternal Health Partnership

November 10, 2023 / Blue Shield of California / Mahmee / Healthcare

Los Angeles-based Mahmee offers support during pregnancy, birth and postpartum, and focuses on marginalized communities. Each patient has a team of nurses, lactation consultants, doulas, mental health coaches, nutritionists and care coordinators. Patients can communicate with their care team through messages, group sessions and one-on-one appointments. They can also attend support groups and classes. The services are available virtually and in person at one of Mahmee’s clinics in California.

How to Leverage the Patient Journey for Market Strategy Development

November 15, 2023 / Healthcare / Patient Journey

GLP-1s are making headlines and are in high demand for their ability to help people lose weight, with five million prescriptions written in 2022. For many people who’ve struggled with obesity, they represent a transformational clinical advance. But what happens if the meds are no longer taken, whether due to high cost or side effects? The weight often comes back, sometimes with a vengeance.

Vertex, CRISPR gain ‘historic’ nod in UK for exa-cel. But will cost watchdogs embrace the gene-editing therapy?

November 16, 2023 / Vertex Pharmaceuticals / CRISPR / Sickle Cell Disease / Beta Thalassemia

Vertex and CRISPR Therapeutics have scored authorization in the U.K. for their exa-cel gene therapy to treat patients with severe forms of sickle cell and transfusion-dependent beta thalassemia, two genetic disorders of the blood.

// 4th Industrial Revolution

Inito, a startup that helps women quickly track fertility hormones at home, raises $6M

November 15, 2023 / Startup / Women’s Health / Fertility

Inito, a YC alum that helps women track fertility hormones quickly at home, has raised $6 million in Series A funding led by Fireside Ventures. The startup’s fertility monitor and kit is designed to give users easy-to-read fertility diagnostic results directly on their phone in just 10 minutes.

Medtech’s iPhone Moment: Pioneering Patient Experience-Focused Design in Medical Devices

November 15, 2023 / Medtech / Medical Devices / Apple

It’s been over 15 years, but the advent of Apple’s iPhone still represents one of the biggest paradigm shifts in the world of consumer technology. It fused style with substance; form with functionality. A sleek device simply and seamlessly integrated into our lives, transforming our day-to-day experiences—as well as how we interacted with its clunkier traditional counterpart, the personal computer.

Edge Computing’s Role in Shaping the Future of Wearable Healthcare

November 15, 2023 / Healthcare / Wearable Devices / Remote Patient Monitoring

Remote patient monitoring (RPM) has become an integral part of modern healthcare, utilizing wearable devices to track patients’ conditions outside the clinic or hospital setting. Devices like these collect critical information from patients, such as their heart rate, activity levels, and temperature, which providers can use for real-time insights to guide treatment and identify conditions proactively.

‘Medical-grade’ AI is poised to help health systems manage their data

November 15, 2023 / AI / ChatGPT / genAI

There’s been a lot of hype around generative artificial intelligence tools such as ChatGPT over the past year or so. But for all the emerging healthcare use cases involving large language models, it’s worth remembering that one major value of LLMs is their ability to improve natural language processing capabilities that have been around for decades.

Mercy’s AI-Powered Texting Platform Intercepts Chemo-Related Hospital Admissions

November 15, 2023 / AI / Chemo-Related / Chemotherapy / Patient

Mercy has developed a new AI-driven texting platform called The Chen Chemotherapy Model, which is helping to keep chemotherapy patients out of the hospital by raising red flags before symptoms become severe. The model was created by Jiajing Chen, a data scientist who passed away from cancer earlier this year.

// Business & Markets

Gilead hands Arcellx $285M to expand BCMA cell therapy deal, sparking fresh push for congested market

November 15, 2023 / Gilead Sciences / Kite Pharma / Arcellx / Immuno-oncology

Gilead Sciences’ Kite Pharma is paying Arcellx $285 million to inject a SparX into its pursuit of BCMA. In return for the outlay, $200 million of which is being invested in Arcellx, Kite has secured rights to an early-phase BCMA CAR-T candidate and expanded its existing midphase cell therapy collaboration to cover lymphomas.

A gene editing biotech’s struggles end with reverse merger

November 15, 2023 / Gene Editing / Biotech / Merger / Lenz Therapeutics

Graphite went public in June 2021, raising $238 million on the promise of genetic therapies for conditions including sickle cell disease. The company’s shares, which traded at a bit above $2 early Wednesday, soared above $28 in July 2021.

Elucid scores $80M for AI imaging analysis software and more digital health fundings

November 10, 2023 / AI / Digital Health / Eleos Health / Elucid / Cardiovascular Disease

Boston-based medical technology company Elucid, which offers AI-enabled imaging analysis software for cardiovascular disease, announced that it has scored $80 million in Series C funding, bringing its total raise to $121 million.

West Coast investor Red Tree on its San Diego expansion and staying bullish in biotech

November 16, 2023 / San Diego Biotech / Biotech / Cargo Therapeutics / Red Tree Venture Capital

Based in the San Francisco Bay Area, the fledgling firm pitched itself as a West Coast answer to deep-seeded biotechnology investment funds in Boston. Instead of drawing top-tier talent from Harvard and the Massachusetts Institute of Technology, it aimed to pull from institutions like Stanford and the University of California, Berkeley.

Pfizer’s cost-cutting campaign hits Sandwich site in UK, where 500 workers will lose jobs

November 14, 2023 / Pfizer / Layoffs / Job Cuts / United Kingdom

Pfizer plans to cut approximately 500 roles and ax its Pharmaceutical Sciences Small Molecule (PSSM) capabilities at its site in Sandwich in Kent in the U.K., a company spokesperson confirmed over email. The spokesperson described the layoffs as a “one of the consequences” of Pfizer’s enterprisewide cost realignment program, which the drugmaker unveiled in mid-October.

// Legal & Regulatory

FDA’s oncology office uses advisory committee to spotlight timely accelerated approval confirmation

November 15, 2023 / U.S. FDA / Accelerated Approval / FDA Advisory Commitee / Non-Hodgkin Lymphoma

External experts invited by the FDA will discuss during a meeting Thursday two accelerated approvals by Acrotech Biopharma. The two nods are for Folotyn and Beleodaq in relapsed or refractory peripheral T-cell lymphoma (PTCL), granted in 2009 and 2014, respectively.

FDA grants approval for first time to a home test for chlamydia and gonorrhea

November 15, 2023 / FDA / Drug Approval / Home Test

The Food and Drug Administration granted marketing approval to a home test for chlamydia and gonorrhea on Wednesday, the first such authorization of a home test to detect the two most common sexually transmitted infections in this country.

FDA skeptical of Merck’s gefapixant, even after cough recount

November 16, 2023 / Merck & Co / FDA Advisory Committee / FDA / GSK

Ahead of an advisory committee panel to be held tomorrow, the FDA has raised questions about Merck’s gefapixant—a P2X3 receptor antagonist medicine—after the agency’s own analysis found little difference between treatment groups. The scrutiny was published in FDA briefing documents yesterday.

Bristol Myers’ $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

November 16, 2023 / Bristol Myers Squibb / U.S FDA / FDA Approvals / Non-small Cell Lung Cancer

The FDA has cleared Bristol Myers’ repotrectinib, to be branded as Augtyro, to treat non-small cell lung cancer (NSCLC) patients whose tumors have ROS1 oncogenic fusions. The New Jersey pharma company said it plans to make the drug available starting in mid-December.

Navigating the Challenges of HIPAA Compliance in the Digital Age

November 16, 2023 / HIPAA / Digital Age / HIPAA

HIPAA compliance is a topic that weighs heavily on the healthcare industry and for a good reason. The issue is far more nuanced than it appears. Among these, the right of access provision — part of the HIPAA regulations — is one that often goes overlooked. It’s not just the major breaches that make the headlines; numerous breaches go unreported simply because patients are either unaware of their rights or unwilling to come forward.

// Research & Development

Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

November 15, 2023 / Novo Nordisk / Eli Lilly / Wegovy / Zepbound

Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry.

Real-world evidence in pharmaceutical drug development – faster, safer and more relevant?

November 13, 2023 / Drug Development / New Drugs / Pre-Clinical Trials

The cost of innovation is high. Pharmaceutical drug development requires significant upfront investment and long-lead development programs. And yet, only a small fraction of these programs succeed in the form of new drug approvals.

Study shows how congenital heart disease affects blood supply before birth

November 15, 2023 / Heart Disease / Birth Defect / CHD

Researchers from the School of Biomedical Engineering and Imaging Sciences and clinicians at Evelina London Children’s Hospital, as part of Guy’s and St Thomas’s NHS Foundation Trust, have shown how congenital heart disease (CHD) can affect early brain development in children.

New womb cancer test could prevent need for invasive diagnostic procedures

November 9, 2023 / Womb Cancer / Healthcare

Published in The Lancet Oncology and funded by the Eve Appeal, the European Research Council and Land Tirol, the WID-qEC test took samples from 400 peri- and post-menopausal women being investigated at the UCL hospital gynaecological rapid access clinic with abnormal vaginal bleeding, which identified 12 women with womb cancer.

Type 2 diabetes prevention programs can work at large scale, study finds

November 15, 2023 / Type 2 Diabetes / Clinical Trials

Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world.

// Politics

CancerX Startup Accelerator launched with White House support

November 14, 2023 / White House / CancerX / Startup

CancerX is a public-private partnership announced by The White House as a national accelerator to boost innovation in the fight against cancer as part of the reignited Cancer Moonshot.

Co-hosted by Moffitt Cancer Center and Digital Medicine Society (DiMe), it cites its purpose as bringing together a number of stakeholders to ‘unlesh the power of innovation to fight cancer’.

House moves to limit so-called gain-of-function research

November 15, 2023 / House / New Bills / National Institutes of Health

House lawmakers late Tuesday voted to attach a U.S. ban on controversial infectious disease research to legislation that could ultimately fund federal health agencies like the National Institutes of Health The bill would bar any federal agencies from funding so-called gain-of-function research, which involves altering a pathogen to study its spread, potentially making it more transmissible or severe in the process.

3 things to know about the prescription drug bill the Mass. Senate could vote on this week

November 13, 2023 / Massachusetts Senate / Prescriptions / Drug Cost

The Massachusetts Senate is expected to vote on a bill Wednesday that would lower drug costs in the state while holding pharmaceutical companies accountable for price hikes.

Michigan bill that would pare back pharma liability shield law moves closer to enactment

November 13, 2023 / Michigan Bill / New Bill / Legislation

A bill designed to allow product liability lawsuits to be filed against drug companies passed the Michigan Senate last month and then passed the House last week. The legislation, which won overwhelming majorities in both chambers but was opposed by the Michigan Chamber of Commerce and a pharmaceutical industry trade group, now goes to Gov. Gretchen Whitmer.

What health policies could hitch a ride on a spending bill?

November 14, 2023 / Spending Bill / Healthcare

The major health committees have cleared health care policies they’re hoping can hitch a ride on a government funding bill — and measures that save money are always more likely to pass. Thus, I give you: The Unofficial STAT Offset Menu, courtesy of the Congressional Budget Office (can you tell I’ve been catching up on The Bear?). All savings are over a decade, and are mostly based on estimates from the Energy & Commerce and Finance Committees. Further options could come, as Senate HELP and House Ways & Means have scores in limbo, and E&C has a subcommittee markup this week that could eventually lead to new bills in the mix.