Healthcare Industry News Weekly Wrap-Up: November 24, 2023

// Biotech and Pharma Therapeutics

To address shortage, Novo Nordisk will cut production of Victoza to boost supply of Ozempic

November 22, 2023 / Novo Nordisk / Ozempic / Victoza / Wegovy

Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic.

Mayo Clinic, Ayble Health Team Up Make GI Care Less Complicated

November 22, 2023 / Mayo Clinic / Ayble Health Team / Digital Health / Health Systems

Boston-based digital health platform Ayble Health is partnering with Mayo Clinic to offer patients a hybrid care model for digestive health that matches them with the appropriate virtual and in-person services based on the acuity of their symptoms and needs. The hybrid care model is available for large employers and health plans.

Evelo’s voyage ends as Flagship-founded biotech finds dissolution is only viable option

November 22, 2023 / Evelo Biosciences / Flagship Pioneering / Biotech Graveyard / Microbiome

Evelo Biosciences is dissolving. One month after starting a search for strategic alternatives, the Flagship Ventures-backed microbiome biotech has found its only option is to close its doors and hand any cash to creditors.

Summer Health Expands to Primary Care for Parents

November 22, 2023 / Summer Health / Primary Care

Summer Health, established in July 2022, aimed to revolutionize healthcare communication by leveraging SMS. With over 22 million millennial parents in the U.S. alone, the company recognized the preference for text communication over phone calls among this demographic. Moreover, physicians have found that high-quality images or videos from smartphones enable remote diagnosis of various conditions.

Pharma is racing to oncology’s first line, causing a rethink of early-stage disease treatment

November 17, 2023 / MD Anderson Cancer Center / Regeneron Pharma / Novartis / ESMO 2023

Timothy Yap, Ph.D., used to see patients nearing the end of their cancer journey in his phase 1 department at the University of Texas’ MD Anderson Cancer Center. Either they fit into a phase 1 trial, or they were off to hospice for end-of-life care.

// 4th Industrial Revolution

Health tech startups warn that overregulating AI could hamper innovation

November 22, 2023 / White House / Startups / Health Tech / Innovation / AI

Entrepreneurs across the country desperate to bring the power of AI into health care are urging Washington to consider the risk of blocking innovation, bringing into focus a chasm between the startup world’s race toward deployment and regulators’ attempts to protect patients from harmful, biased algorithms.

AstraZeneca launches Evinova to bring AI to clinical trials

November 22, 2023 / AstraZeneca / AI / Clinical Trials

Pharmaceutical giant AstraZeneca announced the launch of Evinova, a health technology business focused on bringing digital health solutions already in use globally by the pharma company to clinical research organizations (CROs), trial sponsors and care teams, and patients.

Implementing AI? Heathcare organizations ‘must have a specific measurable goal’

November 20, 2023 / AI / Healthcare / Health Systems

Most hospitals and health systems still are evaluating whether artificial intelligence is right for their organization. Many, though, are seeking to expand existing AI and machine learning implementations.

Prisma Health saves $4M, and counting, with patient engagement tech

November 21, 2023 / Prisma Health / Health System

Prisma Health, the largest nonprofit healthcare provider in South Carolina, says that by integrating digital patient communications, it’s decreased no-shows to the tune of $4 million in savings within the first two years.

Toward a Wider Adoption of Digital Insurance Cards

November 22, 2023 / Digital Insurance Cards / OnyxOS / Healthcare / SMART Health

The insurance card in my wallet—where I always keep it in case of emergency—is getting pretty dog-eared and frayed. So I was intrigued when Mark Scrimshire, chief interoperability officer of OnyxOS, introduced me to developments over the past few years that will make digital insurance cards feasible. This article looks at what it will take to let us all check in to our doctor’s office as easily as we wave our cell phone before a scanner in a retail store.

// Business & Markets

Roche’s Genentech partners with Nvidia in AI drug deal

November 21, 2023 / Roche / AI / Nvidia / Machine Learning

Roche’s Genentech unit is partnering with computing giant Nvidia in a multiyear deal that highlights the pharmaceutical industry’s growing hopes of using artificial intelligence to speed up the process of designing and developing new drugs.

Investment firm Syncona throws lifeline to Freeline by buying out struggling biotech

November 22, 2023 / Freeline Therapeutics / Syncona / Mergers & Acquisitions / Deals

London-based investment firm Syncona will pay $6.50 for each remaining American depositary share of the British biotech that it doesn’t already own—equivalent to a 51% premium on the company’s share price before it first extended the offer.

Flagship-backed microbiome biotech Evelo to shut down

November 22, 2023 / Evelo / Microbiome / Regulatory Filing

The move follows setbacks for the company, which was testing its lead drug candidate for inflammatory skin conditions. That drug failed the main goal of a Phase 2 trial, data announced Feb. 1 showed. As a result, Evelo laid off 48 people in January, and let go of another unspecified number of employees in the second quarter.

Viatris-partnered ulcerative colitis drug fails interim phase 3 review, sending InDex’s stock down 60%

November 22, 2023 / InDex Pharma / Ulcerative Colitis / Topical Drug Delivery / Failed Trials

InDex Pharmaceuticals may be struggling to think of reasons to be thankful. The Swedish biotech has rocked investors with news it is stopping a phase 3 ulcerative colitis trial early in response to lackluster efficacy, sending its share price down 60%.

Boehringer builds out cancer capabilities with $500M deal for bacteria-focused Swiss biotech

November 22, 2023 / Boehringer Ingelheim / T3 Pharma / M&A / Acquisition

The addition of Allschwil, Switzerland-based T3 will “significantly expand” the German drugmaker’s immuno-oncology pipeline and aligns with some of the company’s existing R&D programs, Michel Pairet, a member of the board of managing directors at Boehringer Ingelheim, said in a Nov. 22 release.

// Legal & Regulatory

AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

November 17, 2023 / AstraZeneca / Cancer / FDA / AKT Genetic Alterations

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy.

FDA rebuffs Entrada’s attempt to get yearlong hold on DMD drug lifted

November 22, 2023 / Entrada Therapeutics / Duchenna Muscular Dystrophy / Clinical Hold / FDA

Despite Entrada Therapeutics’ efforts to persuade the FDA with additional information, the regulatory agency has rejected the company’s attempts to lift the nearly yearlong clinical hold on its leading Duchenne muscular dystrophy (DMD) candidate.

Mixed study results for MorphoSys blood-cancer drug raise questions about approval

November 21, 2023 / Blood-Cancer / Drug Approval / Drug Trial / MorphoSys

An experimental blood cancer drug from MorphoSys hit its primary target in a pivotal trial, the company announced late Monday, but the drug faltered in addressing patient symptoms, causing the company’s stock to fall in early Tuesday trading.

AbbVie flexes litigation muscle with Rinvoq patent lawsuit against Sandoz, other generic players

November 22, 2023 / AbbVie / Rinvoq / Humira / Sandoz

In a lawsuit filed in Delaware federal court Monday, AbbVie accused Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals and Sun Pharmaceutical of trying to sidestep dozens of patents protecting Rinvoq through the next decade.

AstraZeneca’s first-in-class FDA approval for Truqap marred by surprise restriction

November 17, 2023 / AstraZeneca / FDA Approvals / Breast Cancer / FDA

The FDA has approved AstraZeneca’s Truqap, or capivasertib, in combination with the company’s Faslodex to treat certain patients with HR-positive, HER2-negative advanced breast cancer, AZ said Friday.

// Research & Development

InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

November 22, 2023 / InDex Pharmaceuticals / Late-Stage Study

InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis.

Lab-grown blood vessels could potentially treat strokes and vascular dementia

November 21, 2023 / Blood Vessels / Lab-Grown / Dementia / Strokes

Scientists from the University of Cambridge’s Victor Phillip Dahdaleh Heart and Lung Research Institute have grown small blood vessel models in labs to potentially treat major causes of stroke and vascular dementia.

Overdose deaths during pregnancy spiked over the past few years, study says

November 22, 2023 / Overdose / Pregnancy / Postpartum

The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.

Bioforum Expands Clinical Trial Technology and Services with Acquisition of Validify

November 20, 2023 / Clinical Trial / Acquisition / Bioforum

Validify provides a proven, agile, cloud-based platform that is fully configurable and rapidly deployable, enabling clinical trial sponsors to digitize their validation process, implement a risk-based computer software assurance (CSA) approach, and eliminate the burdens of the traditional CSV process with a comprehensive automation solution. Pharmaceutical, biotech, medical device, and other life sciences organizations leverage Validify to reduce validation risks and improve regulatory compliance, accelerate project timelines, enhance traceability and audit readiness, avoid over-testing and shorten cycle times, and enable collaboration.

PREDICTOM trial backed by €21m for early Alzheimer’s detection

November 22, 2023 / Alzheimer’s / AI / Dementia / Healthcare

Currently, more than seven million people in the EU are living with dementia, which is set to double by 2050. Worldwide, around 55 million people are believed to be living with AD, a progressive neurodegenerative disease that slowly destroys memory and thinking skills.

// Politics

White House and Congress Propose AI Legislation as FDA Continues to Act as AI Regulatory Gatekeeper

November 22, 2023 / White House / Congress / AI / FDA / AI / Executive Order

As artificial intelligence (AI) continues to be adopted by the pharmaceutical industry, regulatory bodies in the United States and other countries are evolving to tackle challenges within the industry. These include data privacy, bias, accuracy and access, as well as appropriate uses of AI and incorporating checks and balances into its usage. On October 30, the White House’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (EO) instructed agencies to design plans for the appropriate and responsible use of AI across industries, including charging HHS with developing a safety program. Congress responded within weeks with an in-depth AI proposal while the FDA has steadily been working to address AI.

Congress concludes illegal California biolab had Chinese connections, slams CDC

November 19, 2023 / Congress / California / CDC

Congressional investigators allege that the man who set up the laboratory had significant connections to the Chinese Communist Party apparatus and he ran an illegal laboratory that housed approximately 20 types of infectious disease samples and sold COVID-19 tests without a proper permit.

Health legislative train might have left the station

November 21, 2023 / Legislation / Congress / Healthcare

Congress’ recent agreement to temporarily fund the government has Washington emptying out for Thanksgiving and lobbyists, congressional staffers and at least one key lawmaker confronting the reality that there could be no more legislative vehicles for health policy priorities this year.

New pharma laws face balancing act

November 21, 2023 / New Pharma / European Commission

Participants from the European Parliament, European Commission, and the Spanish health authority emphasised their ambition to be more flexible in the new EU Pharmaceutical Regulation and Pharmaceutical Directive currently making their way through the European Parliament and Council of the European Union. They stressed the importance of such an approach given that the two new sets of laws are so long and complicated that they most likely will not be reviewed again for another 20 years.

UK Announces New Five-Year Voluntary Drug Pricing Deal

November 20, 2023 / Drug Pricing / UK

The VPAG includes a gradual rise in allowable branded medicine sales to the NHS and differentiated payment mechanisms for older and newer products. Industry will also commit to invest £400m in “pioneering” clinical trials, innovative manufacturing, and novel approaches to health technology assessments.