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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

00:12:50

Lilly’s DTC Obesity Push, Layoffs, and an Eye on...

BioSpace ·

2024/09/04

Eli Lilly shook up the weight loss market again last week,announcing plans to sell single-dose vials of its blockbuster GLP-1 drug Zepbound directly to consumers. Meanwhile, Novo Nordisk said Monday that it expects the shortage for the lower doses of its own GLP-1 therapy Ozempic to persist into the fourth quarter of 2024. This week, we take a closer look at eyes, where gene therapy is breaking through against wet AMD, a common cause of blindness—potentially significantly minimizing the number of

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00:25:15

Future-Proofing: Inclusive and Protective Patient...

BioSpace ·

2024/08/29

As the legal landscape continues to evolve, the uncertainty surrounding diversity, equity and inclusion (DEI) initiatives increases though the life sciences industry continues to move forward with DEI initiatives to include all patients in clinical trials. In this episode, our guests discuss framing strategies designed to protect DEI initiatives from legal challenges. Additionally, the guests acknowledge the importance of clinical trial sites in gaining patient trust. We also address the increased

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00:15:21

A Tough Ending, New Beginnings and China-U.S....

BioSpace ·

2024/08/28

Gene editing startup Tome Biosciences is laying off nearly its entire workforce, as biopharma companies continue to face challenges in the current market. Meanwhile, Bayer, which cut 1,500 jobs in May, is parting with another 150 in Basel, Switzerland. On the other side of the spectrum, two new companies debuted last week. Novartis and Versant Ventures launched Borealis Biosciences to develop RNA medicines for kidney diseases, and BridgeBio spawned GondolaBio to focus on therapies for genetic and

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00:16:24

New IRA Drug Prices, Lots of Layoffs, Moderna’s...

BioSpace ·

2024/08/21

With the Democratic National Convention underway, the Biden Administration’s announcing the first 10 drug pricesnegotiated under the under the Inflation Reduction Act seems likely to be a political move. But it’s still unclear how much the government is really saving—and what sorts of discounts patients will see. Separately, the biopharma industry saw a flood of layoffs. Lykos Therapeutics slashed around 75% of its staff following the FDA’s rejection of its MDMA-assisted therapy for PTSD

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00:23:27

Eyes Wide Open: Gaining Patient Trust in the Face of...

BioSpace ·

2024/08/15

In the second part of the discussion, our guests address clinical trial design which if done without careful consideration of the patient population can exclude patients from clinical trials instead of being inclusive. Using specific examples, our guests highlight the progress the industry has made to design inclusive clinical trials but stress the continuing need for improvement. In parallel, our guests discuss the continual judicial actives at the federal and state level surrounding women's

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00:21:10

Lykos Rejection, Pfizer’s RSV Win, Lilly Vs. Novo and...

BioSpace ·

2024/08/14

In one of the year’s most highly anticipated decisions, the FDA rejected Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder (PTSD). Reaction from Lykos was swift, with the company stating its intention to “ask for reconsideration of the decision.” Meanwhile, against the backdrop of the CDC’s recent RSV guidelines, Pfizer scored a big Phase III win for its shot in immunocompromised adults. Separately, Merck halted a Phase III trial of its Keytruda, anti-TIGIT, chemo combo

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00:18:39

Pharma Campaign Contributions, Vaccine Hiccups and...

BioSpace ·

2024/08/07

This week, Kamala Harris selected Minnesota Governor Tim Walz as her running mate. In July, Harris’ campaign netted a whopping $310 million—so where do pharmaceutical-connected contributions stand? Meanwhile, Q2 earnings continue to roll in, and the picture isn’t looking so bright for some companies particularly vaccine makers like BioNTech, Moderna and Pfizer, who have been hit hard by the COVID-19 cliff and new CDC guidelines around RSV vaccines. The FDA has also been busy of late, approving

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00:22:47

The Political Shape of the Future Clinical Trial Space

BioSpace ·

2024/08/01

The 2023 New Benchmarks on Demographic Disparities in Pivotal Trials study indicates that as Black representation increases, clinical trial enrollment time decreases.This is contradictory to what has been reported in the past. However, the highest disparity in clinical trial enrollment remains to be Black or African descent patients, with only a third being enrolled in clinical trials. Understanding not just the benefits on patient lives, but also the cost-effectiveness of adequate representation,

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00:18:08

2 Earnings Bonanza, M&A Accelerates and Alzheimer’s Data

BioSpace ·

2024/07/31

Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing. As July comes to a close, biopharma second-quarter earnings continue to roll in with Pfizer, Merck, AbbVie, AstraZeneca and many more reporting. So far, everything is coming up roses with most major companies beating Wall Street

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00:15:36

Layoffs Persist, GLP-1s Launch for Weight Loss in China

BioSpace ·

2024/07/24

While the biopharma industry has seen glimmers of economic optimism, there were still more than 14,000 employees laid off in the first half of 2024. And BioSpace’s readers are among them. In this week’s Job Market Trends, H2 Update, 43% of respondents indicated they are currently unemployed, the highest-ever rate since BioSpace started conducting surveys. One large company that intends to eliminate around 680 jobs in its project development sector over the next few years is Novartis. Despite this,

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00:19:28

Who Is Driving The Bus - Drug Developers & Healthcare...

BioSpace ·

2024/07/18

This is the third episode of Denatured's discussion on diversity, equity and inclusion (DE&I).AI represents unlimited opportunities to increase efficiency, but as our guests note, it can also do incredible harm to patients and society. It largely comes down to training of the professionals using AI, as well as understanding how the AI model was grounded or trained. The data quality must be accurate and clean, but as they noted, DE&I is an issue the industry has been struggling with for

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00:13:55

Pfizer’s Oral GLP-1 Push, Lilly Vs. Novo and PBMs...

BioSpace ·

2024/07/17

Pfizer stole the show late last week with the announcement that it will move forward with its oral GLP-1 analog danuglipron. While Pfizer may hope to advance in the already crowded race to bring an oral GLP-1 to market, some analysts reacted to the news with caution, mainly due to lack of data. Meanwhile, in the injectable GLP-1 space, it’s primarily a two-horse race between Novo and Lilly. While Novo had a two-year head start, Lilly has been picking up ground since the November 2023 approval of

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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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