BioSpace

The weight loss market is the gift that keeps on giving—at least for Novo Nordisk—as Wegovy continues to demonstrate its prowess with label expansion. Also discussed: biosimilar approvals for Fresenius Kabi, and Sandoz. More news at the forefront of Alzheimer's treatment: Eli Lilly's donanemab decision date got pushed and now the FDA wants to discuss the drug’s safety and efficacy at an upcoming adcomm. And finally, politics: President Biden's State of the Union address ruffles feathers as he strikes out at Big Pharma and drug prices, and how the industry is reacting to the election.

These days you can hardly move without figuratively bumping into antibody-drug conjugates (ADCs). This week we discuss Pfizer's strategic priorities for oncology - focused on ADCs and less on small molecules - and how the market is being influenced by the IRA.

When it comes to drug pricing, there have been (and are) bad actors in the industry, but the conversation usually ends there. Five KOLs from different parts of the industry come together to discuss the complexities surrounding drug spend and pricing, innovation, funding, and the overall healthcare system. This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series. Host ⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests Ali Pashazadeh, CEO,Treehill Partners Dan Smithey, President, CEO and Co-founder, Serán BioScience Matthew Price, COO and Co-founder, Promontory Therapeutics Peter Rubin, Executive Director, No Patient Left Behind Rob Williamson, President and COO, Triumvira Immunologics

This week Lori, Greg and Tyler discuss AbbVie: how longtime CEO Richard Gonzalez navigated Humira's LOE, his victorious retirement announcement, and the future of biosimilars. Also discussed: Earlybird Health's $186m VC fund; and definitely not the IRA.

This week Lori, Greg and Tyler discuss the Accelerated Approval of Amtagvi, the first one-time cell therapy for solid tumors and the first TIL therapy; the FTC and HHS probe into generic drug shortages and some recent ADC-focused raises from ProfoundBio and Firefly Bio.

This week, Greg, Heather and Tyler discuss reaction to Novo Nordisk's purchase of Catalent and speculate on what that means for existing manufacturing contracts, customers and consequences with regulators; as well as discussion around the ongoing issues with drug shortages and manufacturing challenges and whether it the move will help accelerate manufacturing for Wegovy and Ozempic. Plus, what's next for Alzheimer's treatment following Biogen's withdrawal of Aduhelm? As mentioned in this episode: you can subscribe to ClinicaSpace for our latest special edition on Leqembi.

This week Lori, Greg and Tyler discuss drug pricing reforms. CMS sent offers to manufacturers of the 10 drugs that have been selected for Medicare price negotiations. What's the best way forward that benefits patients while still supporting the innovation that makes these drugs possible? How will the election impact negotiations? Also discussed earnings including Novo Nordisk, who beat analyst expectations largely due to sales of Ozempic and Wegovy, AbbVie, Merck, and GSK.

Almost 30,000 patients have now been treated with CAR-T cell therapies since it was the first approval in 2017. In November 2023, the FDA launched a probe into malignancies caused by CAR T therapies, and just last week the agency called for a class-wide box warning on all commercial CAR-T therapies with ongoing investigations into cases of secondary malignancies. How do we approach this balancing act of treatment and side effects? Also this week: IPOs march on with ArriVent, CG Oncology, Alto Neuroscience, Fractyl Health; and what's happening re: Congressional Budget Office, Centers for Medicare & Medicaid Services and drug pricing. Join BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen as they discuss.

Following a challenging year of layoffs and limited funding, Chantal Dresner, VP of Marketing at BioSpace, discusses the findings of our most recent Employment Outlook Report including unemployment, anticipated job search activity, hiring trends and current workforce sentiment.

The first surge of IPO activity this year sees Alto Neuroscience, ArriVent Biopharma, CG Oncology, Kyverna Therapeutics and Metagenomi making announcements. Lori, Greg and Tyler also discuss gene therapy pricing including Vertex/CRISPR's Casgevy.

The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco. There was an air of hope and optimism concerning biopharma funding - but will it last? Lori Ellis, Greg Slabodkin and Tyler Patchen discuss.

We're still in San Francisco covering the JP Morgan Healthcare Conference and Biotech Showcase, bringing you key themes from day three: disruptive AI ⁠is still a hot topic including generative AI; M&A and VC funding; and general whiffs of cautious optimism. Join Lori, Greg and Tyler as they discuss what's been top of mind today. You can ⁠⁠⁠follow our coverage⁠⁠⁠ as our team adds updates throughout the day.

Once again we're recording from San Francisco covering the JP Morgan Healthcare Conference and Biotech Showcase, bringing you key themes from day two: AI, cell and gene therapy innovation and pricing, and the risks of CAR T cell therapy. Join Lori, Greg and Tyler as they discuss what's been top of mind. You can ⁠⁠follow our coverage⁠⁠ as our team adds updates throughout the day. Join us tomorrow for Day 3 highlights!

Hello from San Francisco! BioSpace is reporting from #JPM2024 bringing you key takeaways and highlights from day one. Join Lori, Greg and Tyler as they discuss what's moving and shaking. You can ⁠follow our coverage⁠ as our team adds updates throughout the day. Get Greg's take on ⁠what this year might hold⁠ in store and how the Biden administration's policies may ⁠play a role in discussions⁠. Join us tomorrow for Day 2 highlights!

The last year has demonstrated that a sound financing strategy and compelling company narrative are essential to securing funding – it’s become more important than ever that investors are excited before taking the plunge. Given the current economic environment that is causing challenges in biopharma, how should companies be approaching funding in 2024? Listen to this discussion on different kinds of funding options available, how companies can optimize their chances to secure funding and how they should be assessing VCs in addition to alternative partners – particularly if your company will be seeking funding at JPM next week. Our host and guests also discuss current challenges, how to weather adversity, and what investment trends are anticipated for next year. You can also watch the roundtable on BioSpace. Host ⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests Jeff Burton, CFO, Halia Therapeutics Karen Harris, CFO and Head of Mission-Related Investing, The Alzheimer's Drug Foundation Rob Williamson, President and COO, Triumvira Immunologics

Welcome to 2024! This week we're discussing BioSpace's tenth annual list of the hottest new life sciences companies in the U.S. NextGen Class of 2024⁠ includes organizations that launched between September 2022 and September 2023 with a Series A funding. BioSpace's Greg Slabodkin, Heather McKenzie and Tyler Patchen discuss.

How can startup leaders support long-term sustainable growth and investment? BioSpace’s Lori Ellis speaks with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen for their advice and recommendations on how biopharma startups should approach funding. Host ⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠Ansbert Gadicke⁠, Managing Director, MPM Capital ⁠Martin Gershon⁠, Managing Partner & CIO, Endeavor Venture Fund ⁠Mike Goguen⁠, Founder and Managing Partner, Two Bear Capital

Biden administration flexes regulatory muscles, putting pressure on the biopharma industry over ‘price gouging’ and invoking march-in rights; meanwhile Sanofi throws in towel over threat of injunction Renewed interest in psychedelics after MindMed’s Phase IIb trial of its LSD-based candidate meets primary endpoint in patients with generalized anxiety disorder. Bluebird bio changes its tune, signing an ‘outcomes- based’ agreement with commercial payer, and Pfizer struggles continue. BioSpace's Lori Ellis, Greg Slabdodkin and Tyler Patchen discuss. And that's a wrap on 2023! We'll see you in the New Year.

What needs to happen for funding in biopharma to bounce back? BioSpace’s Lori Ellis discusses the macroeconomic environment and biopharma funding outlook with venture capital guests Ansbert Gadicke, Martin Gershon and Mike Goguen. Host ⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠, Head of Insights, BioSpace Host ⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Ansbert Gadicke⁠⁠, Managing Director, MPM Capital ⁠⁠Martin Gershon⁠⁠, Managing Partner & CIO, Endeavor Venture Fund ⁠⁠Mike Goguen⁠⁠, Founder and Managing Partner, Two Bear Capital

That was Week with a capital W. Two major FDA approvals for sickle cell came through on Friday - Casgevy, the first-ever CRISPR-based gene editing therapy from Vertex and CRISPR Therapeutics, and bluebird bio’s Lyfgenia, which comes with a hefty price tag and a black box warning. Axcella announced its closure; what does the future of long-covid treatments look like, especially as attention shifts to different markets like ADCs and neurological treatments? Also discussed - Vanda drops $100m on rights to MS drug Ponvory, AI regulatory developments in Europe. BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen discuss.

This is the second part of our discussion on the evolution of artificial intelligence and its impact on life sciences with guests from Microsoft and IQVIA. We dive into regulation, real-time management, and AI's various applications and how it can streamline different processes. We also discuss the cost and affordability of AI; the tremendous investment required and when holding off on new tech is valuable. Hear how AI is highlighting society's flaws and may become the catalyst for societal change. Host ⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠Matt O’Donnell⁠, Industry Executive Health & Life Sciences, Microsoft ⁠⁠⁠Mike King⁠⁠⁠⁠, Senior Director of Product and Strategy, IQVIA

Over the last year, the reaction to generative AI has changed - and so have behaviors. People are integrating AI to become more productive and it is happening now in healthcare and life sciences. Hear from senior leaders at Microsoft and IQVIA to get their take on how generative AI is impacting productivity, employee engagement and how to mitigate risks. Host ⁠⁠⁠Lori Ellis⁠⁠⁠, Head of Insights, BioSpace Guests Matt O’Donnell, Industry Executive Health & Life Sciences, Microsoft ⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA

The weight loss market sees more ups and downs - Altimmune joins the fray and sees a stock jump while Pfizer experiences setbacks; and European Medicines Agency seeks additional information as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class. Meanwhile, AbbVie buys ImmunoGen for a cool $10B and scores a win with Teliso-V as ADC momentum continues to build. Plus, the FDA investigates malignacies linked to CAR-T. BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen discuss.

Patient behavior has always had an influence on clinical trials - so how do we contend with missing and/or irregular data now that it is feeding AI models? And how do providers continue to work with patients to optimize and grow data pools? This is the third and final part of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Host ⁠⁠Lori Ellis⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Paul Agapow⁠⁠, Director of Innovation, Data Science and Strategy, GlaxoSmithKline⁠⁠⁠ ⁠Mike King⁠⁠, Senior Director of Product and Strategy, IQVIA ⁠⁠Nindhana Paranthaman⁠⁠, Executive Medical Director, Exelixis ⁠⁠Moritz von Stosch⁠⁠, Chief Information Officer, DataHow

The breadth of AI in healthcare applications is broad. How much human oversight is necessary or preferred when leveraging AI in the interest of patient safety? Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction. This is part two of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Host ⁠Lori Ellis⁠, Head of Insights, BioSpace Guests ⁠Paul Agapow⁠, Director of Innovation, Data Science and Strategy, GlaxoSmithKline⁠ Mike King⁠, Senior Director of Product and Strategy, IQVIA ⁠Nindhana Paranthaman⁠, Executive Medical Director, Exelixis ⁠Moritz von Stosch⁠, Chief Information Officer, DataHow

This week we talk struggles with GLP-1 drug shortages and what that might mean for Novo/Lilly competitors; Regeneron and Sanofi positive results for ⁠⁠Dupixent⁠⁠ in COPD. Plus, Merck buys Caraway, Beigene's deal with Ensem, ups and downs for Flagship. Join BioSpace's Lori Ellis, Greg Slabodkin and Tyler Patchen as they discuss the most important biopharma news this week.

Last Thursday, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved CRISPR/Cas9 gene-edited therapy exagamglogene autotemcel (exa-cel). Will the FDA follow suit? What can patients expect the price tag to be? Plus, a good handful of approvals for AstraZeneca, Pfizer and Astellas' Xtandi, and Keytruda. Join BioSpace's Lori Ellis, Greg Slabodkin and Heather McKenzie as they discuss the news this week.

This is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise. Host Lori Ellis, Head of Insights, BioSpace Guests Paul Agapow, Director of Innovation, Data Science and Strategy, GlaxoSmithKlineMike King, Senior Director of Product and Strategy, IQVIA Nindhana Paranthaman, Executive Medical Director, Exelixis Moritz von Stosch, Chief Information Officer, DataHow

Last week, the FDA approved Eli Lilly's obesity drug Zepbound, creating an anticipated intense competition between it and Novo Nordisk's Wegovy. BioSpace's Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the weight loss race and the future of this drug class. Plus, a quick recap on Valneva, the FDA's first Chikungunya vaccine approval.

This week (our inaugural episode!) BioSpace's Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma's reported Q3 earnings. They also tackle what's going on at Pfizer, ADCs, deals and more. Want to dive deeper on BioSpace? Read more on Pfizer's recent cuts⁠ as part of their cost-savings program and more insight on Q3 earnings for Gilead, ⁠⁠Novo Nordisk,⁠⁠ ⁠⁠Moderna⁠⁠, ⁠⁠Vertex⁠⁠, ⁠⁠BMS⁠⁠, ⁠⁠Lilly,⁠⁠ ⁠⁠GSK⁠⁠. Meanwhile, industry-wide ⁠layoffs⁠ march on and in case you missed it - bankruptcies reached a record high.