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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

00:23:16

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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00:22:24

Where Do We Go From Here? The Future of Women's Health

BioSpace ·

2024/04/25

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

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00:17:55

Sanofi Layoffs, CAR-T Warnings and a New GLP-1 Player

BioSpace ·

2024/04/24

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

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00:20:06

Amylyx and ALS, Continued ADC Excitement, Dire Drug...

BioSpace ·

2024/04/17

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

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00:19:30

It's a Design Problem: Women and Clinical Trials

BioSpace ·

2024/04/11

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

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00:16:44

Alphabet Soup: AACR and ACC Dominate Headlines This Week

BioSpace ·

2024/04/10

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

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176 results

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