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Business Meeting


October 2023 - December 2023

FDA to form advisory committee for digital health and AI

The FDA plans to establish a new advisory committee in 2024 focused on digital health, covering areas such as artificial intelligence, therapeutic apps, wearable devices, remote patient monitoring, and virtual and augmented reality tools. The committee will provide counsel on cross-cutting technical and scientific issues, as well as potential interactions with agency policies and regulatory proposals. Troy Tazbaz, director of the FDA's Digital Health Center of Excellence, emphasized the need for ongoing dialogue with the industry to address significant health needs. The committee, with nine core members and temporary specialists, will operate independently of the FDA's device-focused center and aims to hold its first meeting in 2024.

Rite Aid files for bankruptcy

Rite Aid filed for Chapter 11 bankruptcy protection due to a challenging environment for drug stores, intensified by legal battles over alleged unlawful opioid prescriptions. While CVS and Walgreens face similar issues, Rite Aid, in worse financial shape, couldn't withstand industry challenges. The company expected significant losses in the past quarter, having accumulated nearly $3 billion in losses over six years. Rite Aid, with $135.5 million in cash and $3.3 billion in debt, filed for bankruptcy after being unable to submit its latest financial report. The company secured $3.5 billion in financing to navigate bankruptcy, accelerate store closures, and address legal disputes.

Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule

Novartis has entered a technology export contract with Korean biotech firm Chong Kun Dang Pharmaceutical for the early-stage HDAC6 inhibitor CKD-510. Novartis will pay an upfront fee of $80 million, with potential additional payments reaching nearly $1.23 billion in development and regulatory milestones. CKD-510, currently positioned for potential use in Charcot-Marie-Tooth disease, cleared a Phase I study in 2021. While indications are not specified, preclinical studies also suggest its potential against atrial fibrillation. Novartis has been streamlining its business, shedding assets and franchises, and this deal follows a series of partnerships and discontinuations in its development pipeline. 

Council On Supply Chain Resilience Tasked With Strengthening Domestic Supply Chains And Limiting Reliance On Foreign Medical Supplies

On November 27, 2023, the White House Council on Supply Chain Resilience held its inaugural meeting, marking the beginning of the Biden-Harris Administration's initiative to enhance domestic access to critical medicines and vaccines. The focus is on strengthening national supply chains, boosting economic and national security, and reducing reliance on foreign suppliers. The President plans to issue a Presidential Determination broadening the Department of Health and Human Services' authority under the Defense Production Act, enabling increased investment in essential medicine and countermeasure manufacturing. This move aims to ensure the U.S. has the resources to meet domestic needs and respond to public health emergencies, with a quadrennial supply chain review expected by December 31, 2024.

Why Recent Regulatory Changes Require a Deeper Focus on Health Equity

Eli Lilly's newly approved obesity treatment, Zepbound, is now available in U.S. pharmacies at a potential monthly cost of $550 for uninsured customers, half its list price. Zepbound enters the growing weight-loss drug market projected to reach $100 billion by the decade's end. Analysts anticipate Zepbound's 2024 sales at $2 billion, competing with Novo Nordisk's Wegovy, expected to reach $7.5 billion in sales. Both drugs, GLP-1 agonists originally for diabetes, reduce cravings and slow stomach emptying. Pfizer abandoned its oral obesity drug, while Zepbound, added to Express Scripts' preferred medicines list, may cost as little as $25 for insured patients.

AI Could Fuel Biden’s Cancer Moonshot

The White House is incorporating artificial intelligence (AI) into its Cancer Moonshot initiative, aiming to reduce the cancer death rate by half over 25 years and enhance the lives of patients and caregivers. Catherine Young, Assistant Director for Cancer Moonshot Engagement and Policy, emphasized the ambitious yet achievable goals and highlighted the role of AI in advancing the initiative. Key areas for AI implementation include aiding radiologists in faster cancer diagnosis, processing large data quantities, streamlining drug discovery and testing, and evaluating new drugs' effectiveness. Young stressed the need for proper controls to avoid exacerbating healthcare inequalities and biases in AI applications.

AbbVie to buy Cerevel Therapeutics in $8.7 billion all-cash deal

AbbVie Inc. is set to acquire Cerevel Therapeutics Holdings Inc. for $8.7 billion, emphasizing Cerevel's robust neuroscience pipeline for psychiatric and neurological illnesses. The deal values Cerevel at $45.00 per share in cash. Cerevel's stock rose 14%, with AbbVie's dropping 1.3%. The acquisition includes Cerevel's clinical and preclinical-stage medications targeting diseases like schizophrenia, Parkinson's, and mood disorders. AbbVie anticipates the deal, subject to shareholder approval, to close in mid-2024. The collaboration, including late-stage trials for medications like emraclidine, is seen as a growth opportunity for both companies and is expected to contribute to AbbVie's adjusted earnings by 2030.

F.D.A. Approves Sickle Cell Treatments, Including One That Uses CRISPR

The FDA has approved the first gene editing therapy, Casgevy, for sickle cell disease, offering hope to the 100,000 Americans, mainly Black individuals, afflicted by this debilitating blood disorder. Another approved treatment, Lyfgenia, uses conventional gene therapy. However, widespread adoption faces challenges, including limited authorized medical centers, individualized gene editing requirements, onerous procedures, and high costs (Casgevy: $2.2 million, Lyfgenia: $3.1 million). The intricate process involves bone marrow stem cell collection, CRISPR editing, and reintroduction, with few centers possessing the capability. Insurance hurdles and uncertainties about long-term effects further impede accessibility, limiting the initial beneficiaries to a small fraction of eligible patients.

Self-service CarePods touted as ‘first AI doctor’s office’ for $99/month

Forward, a company, plans to introduce "the world’s first AI doctor’s office" called CarePod, revolutionizing healthcare. Set to launch in major U.S. cities in 2024, CarePod is a self-service cube located in malls, gyms, and offices. Patients undergo screenings for diabetes, hypertension, and mental health issues, with diagnostic results integrated into Forward's Health Apps program. Memberships cost $99 monthly. CarePods also facilitate real-time heart health monitoring and blood drawing, claiming a painless process using a vacuum chamber. Forward envisions expanding to screen for advanced cancers, prenatal care, and polygenic analysis. The first CarePods will be in Sacramento, Chandler, and Chicago. 

AdvaMed confirms GE HealthCare CEO Arduini as chair, launches imaging lobbying division

Peter Arduini, President and CEO of GE HealthCare, has been chosen as the new chair of the board of directors for AdvaMed, the medical device trade association. Arduini will serve a two-year term, effective immediately. AdvaMed announced that it will become the "new home" for federal- and state-level advocacy duties, previously handled by the Medical Imaging & Technology Alliance (MITA). Patrick Hope, former executive director of MITA, will now be the executive director of AdvaMed's imaging division. AdvaMed recently expanded into imaging technology and established a digital health division, both led by mini-boards of directors composed of industry executives.

FDA Delays Implementation of MoCRA

The implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has been postponed for six months, moving the compliance date from December 29, 2023, to July 1, 2024. MoCRA is considered the most significant expansion of the FDA's authority to regulate cosmetics since 1938. It grants the FDA access to certain records related to cosmetic products, the authority to order mandatory recalls, and establishes new requirements for the industry, including adverse event reporting, facility registration, product listing, and safety substantiation. The postponement allows for smoother implementation, including the launch of Cosmetic Direct, the FDA's electronic submission portal.

Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Pfizer has completed its $43 billion acquisition of Seagen, marking the biopharma industry's largest M&A deal since AbbVie's 2019 acquisition of Allergan. The purchase of Seagen, an antibody-drug conjugate (ADC) specialist, has doubled Pfizer's pipeline to 60 programs and added four FDA-approved cancer drugs. With nine oncology medications in its portfolio, Pfizer anticipates $3.1 billion in Seagen-related revenue by 2024, growing to $10 billion by 2030. The deal faced scrutiny from the Federal Trade Commission, and to secure approval, Pfizer agreed to donate royalties on Bavencio sales to the American Association for Cancer Research. The acquisition positions Pfizer as a leader in ADC therapies, a trend followed by other major pharmaceutical companies. Pfizer's move comes after the success of its COVID-19 products in 2021-22, though its share price has since dropped by nearly 49%.


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