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PODCAST

BioSpace

Unravel the business of science with BioSpace. We dive into biopharma"s top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

science life sciences

All Episodes

00:18:12

Lilly’s I&I Play, ADC Investment and GLP-1 Momentum...

BioSpace ·

2024/07/10

After securing approval last week for Alzheimer’s drug Kisunla, Eli Lilly was back in the news Monday with the $3.2 billion acquisition of immunology biotech Morphic Holding. This represents another deal in the lucrative immunology and inflammation (I&I) space, which saw $12.3 billion in M&A activity last year, with analysts predicting this momentum would carry over into 2024. Investment continues to pour into another hot therapeutic space: antibody-drug conjugates (ADCs). British biopharma

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00:15:08

FDA Approves Lilly’s Donanemab While Rejections...

BioSpace ·

2024/07/03

The biggest news of the week was the FDA approval of Eli Lilly’s Kisunla (donanemab) on Tuesday. While not unexpected, it was one of the year’s most highly anticipated decisions. And last week saw another big approval from the FDA—that of Verona’s novel COPD drug.But the regulator has also dropped three Complete Response Letters on drugmakers in the last seven days. Two of these were directly related to issues with third-party manufacturers. Though it’s unclear if those contract development and

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00:23:18

DE&I: Understanding That We Don’t Understand at...

BioSpace ·

2024/07/02

Data is the essential piece for both science and technology. The lack of DE&I data is becoming even more imperative as we move towards personalized medicines. Without understanding why there are differences in outcomes, the industry will continue to see worsening outcomes. However, DE&I is still not at the forefront of the mind during clinical trial designs, which influences not only the training but the application of AI models. Additionally, what this means not only for life sciences but

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00:12:34

Sarepta’s Big DMD Approval, Alnylam’s Clinical Win...

BioSpace ·

2024/06/26

The biggest news of the last week was easily the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy, Elevidys. CBER Director Peter Marks again overruled FDA staff members and review teams to grant the therapy full approval and a broad label expansion despite its missing the primary endpoint in a Phase III confirmatory study. This approval has us thinking about other big FDA decisions to watch this year, first and foremost, Eli Lilly’s anti-amyloid antibody donanemab. If given

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00:09:34

BioSpace at #DIA2024: Workforce Trends, Trial Design,...

BioSpace ·

2024/06/20

BioSpace's ⁠Lori Ellis⁠ and ⁠Chantal Dresner⁠ are bringing live updates from ⁠#DIA2024⁠ in San Diego this week where we've been attending sessions on trial design, digital twins, cell and gene therapy regulation, clinical research workforce trends, professional development and many more. We discuss some of our key takeaways and event highlights, including Lori's exclusive interview with CBER director Dr. Peter Marks.Hosts ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of

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00:23:16

Challenging Research Models to Improve Health Equity

BioSpace ·

2024/06/20

Diversity, equity and inclusion (DEI) continues to be a challenge for drug and medical device developers. While there has been some improvement in clinical trials, our guests note that unless there is a commercial or regulatory need, DEI is still an afterthought for many developers when designing clinical trials. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guests ⁠⁠Ali Pashazadeh⁠⁠, CEO,Treehill Partners Charlotte Jones-Burton, Board Member, bluebird bio; Founder & President,

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00:14:41

BIOSECURE’s Surprise Absence, the $100+ Billion...

BioSpace ·

2024/06/19

We’re off to a rocky start this week on the clinical side, with some safety issues. BioNTech and MediLink’s ADC was placed on partial hold after multiple patient deaths, and some safety concerns were also revealed for Gilead’s blood cancer therapy magrolimab. But on a more upbeat note, DIA in San Diego is filled with hope of collaboration and a focus on the patient experience. Head of Insights Lori Ellis joins BioSpace’s editorial team to discuss what’s she’s observed so far at the meeting and what

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00:05:28

BioSpace at #DIA2024: Convergence and Collaboration

BioSpace ·

2024/06/17

BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions. The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder,

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00:16:24

Donanemab’s Promise, BIO Wrap and Mass Layoffs

BioSpace ·

2024/06/12

The big news of this week so far was Monday’s FDA advisory committee for Eli Lilly’s Alzheimer’s drug donanemab, where the vote was unanimous in support of the anti-amyloid antibody. If approved, donanemab would be a direct competitor of Biogen and Eisai’s Leqembi, but analysts believe there’s plenty of room in the market forboth, and even predict that donanemab’s potential approval could be beneficial for Leqembi in the long run by increasing investments in advocacy and infrastructure. The mood

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00:21:33

BioSpace x DIA: Robust Integrated Regulatory Strategies

BioSpace ·

2024/06/06

How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology?Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement. Additionally, we are joined by Tamei Elliott of DIA who shares insights on key discussions and themes of the upcoming meeting in San Diego. This is the third and final episode in our preparation for the roundtable discussion: ⁠⁠Pioneering New

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00:12:34

The ABCs of Biopharma This Week: ASCO, BIO and Cancer

BioSpace ·

2024/06/05

Conference season kicked into high gear this week with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and the BIO International Convention in San Diego. Check out BioSpace’s ASCO24 Tracker with all the biggest data and other news from the cancer meeting, which wrapped up on Tuesday.Among the trial results highlighted at ASCO24 were BMS’ Phase III study results in liver cancer. There was also a lot of news on non-small cell lung cancer (NSCLC): Pfizer presented results

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00:18:51

BioSpace x DIA: Advanced Therapy Product Regulatory...

BioSpace ·

2024/05/30

Regulators suggest developers engage in discussions early, however those conversations cannot take place unless developers are sure of the asset's category.Existing confusion surrounding advanced therapy products may become more challenging as both science and technology evolve. With both developers and regulators, two risk adverse entities, addressing this evolution and continually updated regulations, advanced therapy product development continues to be a collaborative process. This is the

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00:13:44

AstraZeneca’s Ambitious Target, Pharma Layoffs...

BioSpace ·

2024/05/28

At its Investor Day 2024 event last week, AstraZeneca announced plans to reach $80 billion in total revenue by 2030—up from $45.8 billion in 2023—and to launch 20 new medicines by the end of the decade. Does AstraZeneca have the assets and developmental pipeline to hit this lofty target? Meanwhile, Bayer, BMS and Pfizer are looking to conserve cash through cost-savings plans that include layoffs. It’s a trend we’ll be keeping a close eye on as companies face potential implications from upcoming

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00:20:20

BioSpace x DIA: Navigating the Emergence of CGT...

BioSpace ·

2024/05/23

With every new advancement in either science or technology there is increased excitement as we see the potential. Cell and gene therapies (CGT) as combination products are emerging as the stage in the evolution of technology and science merging together. While the potential benefits for patients are great, there are risks and challenges that must be carefully considered.This discussion is part of one of a precursor of the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery

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00:13:31

Bayer’s New Strategy, Novo Vs. Lilly and Psychedelics

BioSpace ·

2024/05/22

Bayer’s recent layoffs of 1,500 mark a step toward CEO Bill Anderson’s stated goal of removing managerial layers at the company—“fewer bosses, fewer rules,” he told The Wall Street Journal. The move follows BMS’ announcement that it will let go more than 2,000 people. In other news, J&J expanded its dermatology portfolio, paying $850 million in cash plus potential milestone payments for California-based Proteologix and its Phase I–ready atopic dermatitis candidate. J&J is competing with

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00:14:45

Bayer Layoffs, a Big Alzheimer’s Deal and ASGCT Wrap

BioSpace ·

2024/05/15

Bayer made news this week announcing 1,500 layoffs as part of an effort to save €500 million ($540 million) in 2024 and €2 billion ($2.16 billion) in 2026, reminiscent of BMS’ announcement of a major restructuring that will involve 2,200 layoffs and aims to save $1.5 billion by the end of 2025. Bayer’s news just about rounds out the Q1 2024 earnings season highlighted by strong sales of GLP-1 weight loss drugs. However, it was Amgen that emerged as a big winner, with revenue increasing over 22% from

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00:21:53

Women's Health: Where Politics and Science Meet

BioSpace ·

2024/05/09

12 billion dollars: one of the boldest women’s health research moves an administration has made for women’s health research. On a global scale, this has caused countries and sovereign states to start investing in women’s health. But in the United States, the funding is not guaranteed. It depends on congressional approval, which is complicated during an election year. As the United States continues to grapple with politics and science meeting, the global healthcare sector is already beginning to

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00:11:54

ASGCT, Adcomm for Lilly’s Donanemab, Vertex Vs. Bluebird

BioSpace ·

2024/05/08

In this edition of The Weekly, Managing Editor Jef Akst and News Editor Greg Slabodkin share their insights from the American Society of Gene & Cell Therapy’s 27th annual conference, including advances around adeno-associated viruses and the ongoing discussion about the FDA’s accelerated approval program and how it relates to rare diseases. Also, on Tuesday, Eli Lilly announced that an advisory committee meeting will be held for its Alzheimer’s drug donanemab on June 10. Lilly is aiming for

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00:12:20

BioSpace Heads to #ASGCT, Along with Thousands in...

BioSpace ·

2024/05/03

In this special edition of The Weekly, we discuss the much-anticipated annual meeting of the American Society of Gene & Cell Therapy in Baltimore. It starts Tuesday and will hit on wide-ranging issues facing the cell and gene therapy (CGT) space, from new therapeutic advances to safety concerns and regulatory considerations to manufacturing and commercialization.Big hitters in the CGT space will be there. Sarepta, whose gene therapy for Duchenne muscular dystrophy Elevidys received accelerated

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00:15:48

The IRA, BMS’ Big Cuts, First WHIM Approval

BioSpace ·

2024/05/01

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

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221 results

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