Vertex’s Exa-cel to Biogen and Sage’s Zurzuvae: Notable Product Approvals of 2023

01/03/24 • 25 min

As we move into 2024, Back Bay’s strategic advisors summarize key product approvals from three classes and indications over this past year, including the December CRISPR and Vertex approval of Exa-cel, Biogen and Sage’s August approval of an oral treatment for women with postpartum depression and Genmab and Roche’s May approval in oncology.

In this episode:

CRISPR and Vertex’s approval of Exa-cel, the first CRISPR-based genetic medicine approved by the FDA in the US
The major depressive disorder vs. postpartum depression for Biogen/Sage
GenMab and Roche approvals
AbbVie acquisition of Cerevel Therapeutics strengthen neuroscience pipeline

In 2023, on The Life Science Report, Back Bay covered a wide range of topics featuring stories from the frontline of healthcare development to the rising trends in cardiology to the transactional landscape of antibody drug conjugates. We always welcome listener questions or topics you’d like to learn more about. You can listen to previous episodes or submit your inquiries here.

Back Bay provides a snapshot of the healthcare markets every Monday. For IPO, Follow-On and M&A updates, subscribe to our healthcare updates.

In this episode:

CRISPR and Vertex’s approval of Exa-cel, the first CRISPR-based genetic medicine approved by the FDA in the US
The major depressive disorder vs. postpartum depression for Biogen/Sage
GenMab and Roche approvals
AbbVie acquisition of Cerevel Therapeutics strengthen neuroscience pipeline

Back Bay provides a snapshot of the healthcare markets every Monday. For IPO, Follow-On and M&A updates, subscribe to our healthcare updates.

Previous Episode

Monthly Roundup of News from Healthcare Development

In our latest podcast, Back Bay Life Science Advisors focused on the chronic and rare disease development of kidney disease. Recently, there have been some changes in treatment, some recent commercial launches and certainly some interest from pharma consolidators, as M&A activity picks up in this area.

In this next installment of The Life Science Report, Dr. Pete Bak and Christian Thienel of Back Bay Life Science Advisors talk about kidney disease and the various aspects of the renal disease landscape.

Topics in this podcast include:

The links between cardio and metabolic diseases and the therapeutic approaches and label expansions taking place in the renal disease landscape
Historic evolutions beyond Chronic Kidney Disease (CKD), from rare diseases to all types of indications of CKD
Understanding potential treatment priorities when some therapies have benefits in multiple indications
Recent deals, including Novartis’ acquisition of Chinook Therapeutics and Novo Nordisk’s acquisition of KBP Biosciences’ ocedurenone, etc.
The impact of Sodium-glucose cotransporter-2s (SGLT2s) in kidney disease over the last ~5 years, and how that has precipitated broader interest in renal indications across the industry

Next Episode

Trends and Investment Activity in Radiopharmaceuticals and Psychedelics

A Podcast Discussion on the Trends and Investment Activity in Radiopharmaceuticals and Psychedelics

Guests: Pete Bak and Christian Thienel
Length: 25 minutes

Here at Back Bay we’ve seen a number of notable trends in the radiopharmaceutical and psychedelic spaces playing out over the past couple of years. Increasingly, investors have been asking our opinions and perspectives on these topics.

Our team has written these whitepapers to address industry interest:

The Radiopharmaceutical Renaissance: Radiating Hope in Medicine
Vision of Commercial Success: Investment and Partnering Landscape for Psychedelics

In this episode, Dr. Pete Bak and Christian Thienel talk through the uptick of activity in these focus areas and discuss where the future of radiopharmaceuticals and psychedelics might be heading.

Topics in this podcast include:

A brief introduction into the history of radiation and radiopharma
Why the early promise of first-generation radiopharmaceuticals like Zevalin and Bexxar didn’t turn out to be as commercially successful
Key advancements in manufacturing and production for second-generation products like Xofigo, Lutathera and Pluvicto
The “theranostic” (therapeutic and diagnostic) potential of radiopharmaceuticals
The growing investment and R&D support for psychedelics from private companies and academics, especially with the Otsuka and Mindset acquisition for $80M in 2023
Realities within the new paradigm of novel treatments and patient/provider protocols adhering to the FDA’s Risk Evaluation and Mitigation Strategy
The evolving nature of the antibacterial space and some notable financing deals, three within two months (Antabio, Clarimedix and Revagenix)

Listen to the full episode here.