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J&J and BMS’ challenges to Medicare drug price negotiations shut down in federal court less than a week after BMS announced it was laying off more than 2,000 employees. Earlier this week, a federal judge in New Jersey added fuel to the ongoing legal battle between Big Pharma and the government over the Inflation Reduction Act. The judge on Monday dismissed claims from Johnson & Johnson and Bristol Myers Squibb that Medicare’s drug price negotiations program is unconstitutional. The big news last week also involved BMS, which announced it will let go 2,200 people by the end of 2024 in what the company is calling a “strategic productivity initiative.” Layoffs are already underway in New Jersey, California and elsewhere, and may be related to the pharma giant’s recent M&A spending spree. Elsewhere around the industry, Q1 earnings season rolls on, with Sanofi and AstraZeneca also announcing cuts to their pipeline, while Gilead, Merck, and Lilly all touted numbers that exceeded expectations. Finally, on the regulatory front, X4 Pharmaceuticals got a win this week with the approval of its first commercial drug—and the first therapy for an ultra-rare disease called WHIM.

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.

The pharmaceutical industry is facing critical attention, particularly around drug pricing and development costs. Drug development cost is about 10% of the total healthcare spend in the United State. Broader issues such as local monopolies, utilization, unit, and costs and local monopolies, politics and a fragmented payer system contribute to the increasingly high costs to patient. Challenging as these issues are, they must be addressed to lower patient costs. In this episode, our guests discuss more efficient drug development practices but also some of the broader issues within the United States healthcare system and the IRA’s impacts on not only US patients but the world. 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

It was another busy week! Bayer reduced its executive suite from 14 to 8 as part of a major restructuring. Meanwhile, the government announced it will pay for Wegovy for patients with heart disease after the Novo Nordisk therapy was approved earlier this month for the cardiovascular indication. Plus, Mirador’s emergence from stealth and the FDA’s approval of the third therapy for Duchenne muscular dystrophy in less than a year.

This week, we're talking money! Following the release of BioSpace's 2024 Salary Report, we discuss salary trends and how they are impacting the biopharma workforce. Considering growth rates, we also discuss asking for raises vs looking for a new job and what salary trends may spell out for the rest of the year. Guest Chantal Dresner, VP of Marketing, BioSpace Angela Gabriel, Content Manager - Careers, BioSpace Host ⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Phew, what a week! One of the most anticipated FDA decisions of the year dropped last week when the regulator approved Madrigal’s Rezdiffra as the first therapy for MASH (formerly known as NASH). Then on Friday, BioSpace kept a close eye on an advisory committee discussing J&J’s Carvykti and BMS’s Abecma, two CAR-T therapies seeking label expansions as earlier lines of treatment in multiple myeloma despite the risk of early death. Also discussed: BIO’s decision from last week to cut ties with the China-based biotech WuXi AppTec.

Continuing on from our previous episode "The gap is where the pain is", this episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients. Topics explored in this discussion are potential reasons behind the small molecule negotiation timeline decision, the antibody drug conjugates (ADC) boom, the investment environment, and positive steps the government is making through legislation to equalize the negotiation timeline. 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

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.