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The potential impacts on clinical trial outcomes warrant a discussion surrounding the current definition of women’s health.

In the second episode on our series on women's health, we discuss what may happen to future generations if women, the custodians of generational health, are not comfortable sharing complete medical histories. Additionally, we discuss how broadening the definition will open funding to address women’s health.



Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠BioSpace⁠  



Guests

⁠Sans Thakur⁠, Founder and Chairwoman of ⁠Tower Capital⁠

⁠Chia Chia Sun⁠, Chief Commercial Officer at ⁠Fab Biopharma⁠

⁠Elisa Cascade⁠, Chief Product Officer of at ⁠Advarra⁠

Shawana Moore, Medical Advisor on the ⁠Advisory Council for Healthy Women⁠

⁠Katie Schubert⁠,  President and Chief Executive Officer of the ⁠Society for Women’s Health

Sanofi will cut an undisclosed number of jobs as it revamps its U.S. vaccines commercial operations, as well as 99 employees from its Belgian sites—moves that are part of a full pipeline reprioritization. Meanwhile, the company got a win this week, with its investigational BTK inhibitor rilzabrutinib generating positive results in a Phase III study for adult patients with persistent or chronic immune thrombocytopenia. Sanofi will present its Q1 earnings tomorrow.

Meanwhile, the FDA announced an update to the boxed warnings it now requires for CAR T cell therapies regarding the heightened risk of secondary T cell malignancies. Additional requirements involve various aspects of the label, including the warnings and precautions, post-marketing experience, patient counseling information and medication guide sections.

And finally, GLP-1s are once again making headlines, as Eli Lilly’s Zepbound produced positive Phase III results that could earn the weight-loss drug a label expansion into sleep apnea and a new company, New York–based Metsera emerged from stealth with $290 million in financing. The startup’s pipeline includes multiple GLP-1 agonists in early-stage development.

The past two weeks have seen Amylyx lose its only marketed product but receive numerous accolades for its decision to voluntarily withdraw Relyvrio after a failed Phase III trial in amyotrophic lateral sclerosis. Analysts and insiders spoke with BioSpace this week about the company's future and a possible regulatory precedent for other drugs approved based on a single trial.

Elsewhere, antibody-drug conjugates continue to steal the show in oncology. At the American Association for Cancer Research’s annual meeting, Merck and Kelun Biotech presented Phase I/II data showing that their TROP2-directed ADC elicited promising disease control and a potential survival benefit in gastric cancer patients, and Bristol Myers Squibb–backed TORL netted $158 million in an oversubscribed Series B to advance its pipeline of novel ADC candidates.

Finally, drug shortages in the U.S. have reached an all-time high, according to the latest data from the American Society of Health-System Pharmacists, with both basic and life-saving products on the list.

Last month, President Biden signed an Executive Order on Advancing Women’s Health Research and Innovation, signalling the significance of women's health to the government and consequently investors.

While women’s clinical trial participation has increased, clinical trials still largely are not designed for women. In this episode, our guests discuss the many areas where trials can be improved, such as human and historical diagnosis and screening biases, accessibility, data capturing, and more. They further discuss the importance of women’s health for the future.



Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace  



Guests

Sans Thakur, Founder and Chairwoman of Tower Capital

Chia Chia Sun, Chief Commercial Officer at Fab Biopharma

Elisa Cascade, Chief Product Officer of at Advarra

Shawana Moore, Medical Advisor on the Advisory Council for Healthy Women

Katie Schubert,  President and Chief Executive Officer of the Society for Women’s Health

Conference season is in full swing, with the American Association for Cancer Research and American College of Cardiology concurrently holding their annual meetings in San Diego and Atlanta, respectively. From opposite coasts, biopharma companies are presenting their latest data in the cancer and cardiology spaces, both hits and misses alike.

Oncology continues to be a hot area for investment, with several highly anticipated readouts coming down the pike. In addition to all the data coming out of AACR, conference organizers this year put together the meeting’s first-ever industry event, bringing together investigators, investors and Big Pharma.

Over at ACC, one exciting race to watch will be between Ionis and Arrowhead, both of whom presented positive data on their ApoC3-targeting drugs for diseases associated with elevated triglyceride levels.

Meanwhile, as the BIOSECURE Act sits before Congress, biopharma companies detail the potential fallout to the growing geopolitical tensions between the U.S. and China.

WuXi AppTec was once again in the news this week, with speculation that the China-based biotech allegedly handed a U.S. client’s intellectual property over to the Chinese government without consent.

Meanwhile, Lonza’s $1.2 billion buy of a Roche biologics plant in California—one of the world’s largest biologics manufacturing facilities by volume—bodes well for the CDMO market, and BMS pulls ahead of Amgen in the race to bring a fully approved KRAS inhibitor to market for patients with certain types of non-small cell lung cancer, acing a confirmatory Phase III trial for Krazati.