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BioSpace
BioSpace
188 episodes
3 days ago
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.
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Life Sciences
Science
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All content for BioSpace is the property of BioSpace and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Life Sciences
Science
Episodes (20/188)
BioSpace
Inside the 2026 Biotech Landscape: Innovation, Investment and Global Momentum

In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO at Zymeworks and Josh Smiley, president and COO at Zai Lab, about how renewed confidence is driving biotech entering 2026.

As we look towards conversations that will shape this year's J.P. Morgan Healthcare Conference, the biotech industry is fueled by improving market sentiments, visible at recent meetings like Jeffries in London, and reinforced by a wave of partnerships, strategic acquisitions and Chinese collaboration that is recalibrating investor expectations.


Host

Jennifer Smith-Parker, Director of Insights, BioSpace


Guests

Kenneth Galbraith, CEO, Zymeworks

Josh Smiley, President and Chief Operating Officer, Zai Lab


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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2 weeks ago
28 minutes 37 seconds

BioSpace
Lilly’s Triple Triumph, Prasad’s COVID Error, J&J’s Surprise Voucher, M&A Targets

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China’s OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.  

 

Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.  

 

Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration’s sentiment on vaccines, Bourla prominsed Pfizer’s continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus. 

 

The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency’s new Commissioner’s National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.  

 

In ClinicaSpace this week, we highlighted 5 of 2025’s Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner’s circle, Immunome’s desmoid tumor drug and and Kyverna’s CAR T for stiff person syndrome both aced pivotal trials, while Sanofi’s MS drug tolebrutinib and Gilead and Arcus’ TIGIT therapy domvanalimab each failed Phase III tests.  

 

And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma’s Next M&A Target, and more M&A predictions for 2026.  

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2 weeks ago
20 minutes 4 seconds

BioSpace
Beyond the Gluten-Free Diet: A New Era in Celiac Disease Treatment

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology, The Mayo Clinic; Marilyn Gellar, CEO, The Celiac Disease Foundation; and Dr. Paul Lizzul, chief medical officer, AnaptysBio, about the unmet need for effective treatments for celiac disease, the limitations of the gluten-free diet and the development of ANB033, a first-in-class CD122 antagonist designed to modulate IL-2/IL-15 signaling.


Host

Jennifer Smith-Parker, Director of Insights, BioSpace


Guests

Dr. Joe Murray, Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine and Department of Immunology, The Mayo Clinic

Marilyn Geller, CEO, Celiac Disease Foundation

Dr. Paul Lizzul, Chief Medical Officer, AnaptysBio

 

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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3 weeks ago
40 minutes 21 seconds

BioSpace
Weight Loss Waves, Pazdur’s Exit and FDA Instability, New Neuro Breakthroughs

Pfizer followed up its winning $10 billion bid forobesity startup Metsera by adding another molecule to its obesity cabinet, thisone from Chinese firm YaoPharma in a deal worth up to $1.9 billion licensing deal announced Tuesday. Meanwhile, Wave Life Sciences and Structure Therapeutics may have changed the weight loss landscape with early and mid-stagedata from their candidates that analysts called “very disruptive” and “highlycompetitive,” respectively.

 

At the FDA, the confusion and instability continuewith the retirement of agency veteran Richard Pazdur just three weeks into hisrole as CDER director. Pazdur’s exit leaves the FDA with just three veteran leaders from one year ago. The CDC similarly made headlines last week as therevamped vaccines advisory committee voted to recommend postponing the hepatitis B vaccination from birth to two months of age for some infants.

 

Meanwhile, the Clinical Trials on Alzheimer’s Disease (CTAD)conference generated excitement in the space as Roche, Eisai and others presentednew data from their respective candidates. The star of the show was Roche’snext-gen antibody trontinemab, which lowered amyloid levels below the threshold of positivity in 92%of treated patients in a mid-stage study. Meanwhile, Eisai isdetermined to buck the losing the trend in the anti-tau space. The company’s etalanetugreduced all measurable forms of MTBR-tau243—a specific biomarker of tau tanglepathology in Alzheimer’s—in a Phase Ib/II trial, according to an oralpresentation at CTAD.

 

Finally, check outthis week’s deep dives in BioPharm Executive on what pharmas are learning fromthe Chinese biotech sector and how Japan’s pharma industry is setting itssights on the global market.

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3 weeks ago
21 minutes 30 seconds

BioSpace
New Approach Methodologies: Redefining Animal Testing Alternatives

Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced.  The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing.


In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development.


Host

Jennifer Smith-Parker, Director of Insights, BioSpace


Guests

Patrick Smith, Senior Vice President, Translational Science, Certara

Stacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of Health


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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1 month ago
25 minutes 1 second

BioSpace
Prasad’s Leaked FDA Memo, Alzheimer’s Ups and Downs, Next-Gen Obesity Drugs

Vinay Prasad’s memo, leaked over the weekend, has sent vaccine makers’ stocks slipping and experts clamoring for more evidence to support the CBER director’s claim that COVID vaccines have led to the deaths of at least 10 children. It’s the latest insult to the vaccine sector from the healthcare administration this year, with other challenges coming on the CDC side, where the recently revamped advisory committee is heading into its next meeting with a brand new chair. 

 

Elsewhere at the FDA, newly promoted Center for Drug Evaluation and Research Director Richard Pazdur has filed the paperwork to retire from the agency just weeks after reportedly reluctantly accepting the position.  

 

Meanwhile, the Alzheimer’s space is buzzing as the 2025 Clinical Trials on Alzheimer’s Disease (CTAD) conference continues in San Diego. Last week saw a mid-stage flop for Johnson & Johnson’s anti-tau candidate and the “definitive” failure of Novo’s GLP-1 semaglutide—which analysts say may actually help uptake of anti-amyloid therapies from Biogen and Eli Lilly. Meanwhile, Roche announced positive results for its latest antibody, putting the pharma back in the game it had once stepped back from in the tumultuous days of Aduhelm.  

 

In the weight loss space, Novo Nordisk revealed ‘competitive’ mid-stage data for its next-gen amycretin, which showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes. Meanwhile, the pricing war for approved and future GLP-1s from Novo and obesity rival Eli Lilly rages on, with Lilly this week announcing another price drop for Zepbound through its LillyDirect self-pay platform. 

 

In BioPharm Executive this week, we review the top venture capital rounds for female-founded biotechs and examine the 2026 biotech market outlook. 

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1 month ago
22 minutes 39 seconds

BioSpace
Billions More in M&A, Another Bidding War and More FDA Drama

Acquisitions have ticked up this month as all eyes were on Pfizer and Novo’s fight over Metsera. The past week saw that deal finalized with Pfizer as the winner plus a handful of other M&A stories, including Merck’s $9.2 billion buyout of Cidara Therapeutics and Johnson & Johnson’s $3 billion bet on Halda Therapeutics. Additionally, a separate bidding war has broken out between Lundbeck and Alkermes for sleep biotech Avadel Pharmaceuticals. 

Outside of M&A, the FDA dominated headlines again this week. The agency effectively closed the loop on one of the messiest stories of the year—Sarepta’s gene therapy Elevidys—when it formally added a black box warning for serious liver toxicities and risk of death and removed the nonambulatory indication from the label. The agency will also require that the company complete a postmarketing observational study of around 200 patients. 

This happened just as Richard Pazdur accepted the role of director of the Center for Drug Evaluation and Research (CDER) that was recently vacated by George Tidmarsh amidst conflict with Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad. By all accounts, Pazdur, a 26-year FDA veteran, is a highly respected and thoughtful regulator, and sources told BioSpace that if Prasad tries to supersede Pazdur’s authority, “there will be hell to pay and resignations to be handed in.” 

In other FDA drama, FDA Commissioner Marty Makary is apparently butting heads with Health Secretary Robert F. Kennedy Jr. Meanwhile, the agency revealed details of its plausible mechanisms pathway teased by Makary earlier in his tenure. 

Finally, in Biopharm Executive this week, check out our deep dives into GLP-1 pricing. Coming off Trump’s deal with both Eli Lilly and Novo Nordisk to offer their GLP-1s at a lower cost through the president’s new direct-to-consumer platform, Novo CEO Maziar Mike Doustdar announced a sale on its company’s products. Bargain bin pricing like this so early in a drug’s market life is unprecedented. It’s changing the investment calculations for the next-generation of obesity treatments. 

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1 month ago
21 minutes 19 seconds

BioSpace
How Biotech Funding is Changing Executive Search and Hiring Processes

A lean funding environment has changed how biotechs approach workforce organization and executive hiring. Searches are becoming more targeted and intentional, and accountability–both for employers and candidates–is high. In this episode of Denatured, Leslie Loveless of Slone Partners describes how biotechs should approach building their executive teams, working with boards and investors to make decisions that will enable growth. She also discusses how the search and hiring processes has changed for both employers and candidates.

This episode is presented in partnership with Slone Partners.


Host

Chantal Dresner, Vice President of Marketing, BioSpace

Guest

Leslie Loveless, Co-CEO and Managing Partner, Slone Partners


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.


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1 month ago
21 minutes 13 seconds

BioSpace
Pfizer Wins Metsera, Trump Strikes GLP-1 Pricing Deal, FDA Awards More Priority Vouchers

One of biopharma’s most memorable bidding wars finally came to an end on Friday—with Metsera right back in the arms of its original suitor, but with Pfizer paying around $10 billion for the rights to the obesity biotech, a nearly $3 billion increase over its original bid. But while Novo Nordisk may have bowed out of that race, the company still made headlines this past week, with CEO Maziar Mike Doustdar joining Eli Lilly head David Ricks at the White House on Thursday to announce a deal that will see their GLP-1 drugs offered at about $350 per month.  

 

This marks a significant discount to the current list prices of $1086 and $1350 for Lilly’s obesity drug Zepbound and Novo’s comparator Wegovy, respectively. No matter how low they go, however, the GLP-1 leaders can still be undercut by compounders, Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, told BioSpace this week.  

 

Speaking of Lilly, the Indianapolis-based pharma had a busy week, reporting 20% weight loss in a mid-stage study of its amylin agonist eloralintide that William Blair analysts said “validates [the] amylin agonist class.” Lilly also netted two new partners, inking a $1.2 billion RNAi pact with SangeneBio to target metabolic diseases and licensing a genetic eye disease therapy from MeiraGTx Holdings for up to $475 million.  

 

On the regulatory front, the FDA awarded the second round of priority review vouchers under its new Commissioner’s National Priority Vouchers program. Unlike the first cohort of vouchers, which was announced in October, this group mostly consisted of products already on the market—with the exception of Lilly’s orforglipron.  

 

Finally, BioSpace dives into one the hottest trends in the immunology and inflammation (I&I) space—pipeline-in-a-product. Possibly motivated by blockbuster drugs like AbbVie’s Skyrizi and Rinvoq and Regeneron and Sanofi’s Dupixent, companies are optimizing shots on multiple goals in this lucrative space.  

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1 month ago
27 minutes 51 seconds

BioSpace
Thoughtful Tech: How Removing Technological Burdens Can Improve Clinical Trial Compliance and Patient Experience

This conversation features insights from Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII. Our guests continue their discussion on how autoinjectors and smart technologies can be integrated into clinical trials in a way that isn’t problematic or burdensome for patients, particularly for patients that may not be tech savvy.

They discuss that by focusing on patient experience, clinical trials can increase engagement and compliance.

This episode is presented in partnership with ⁠PII⁠.


Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace


Guests

Oliver Eden, Senior Business Unit Director, Jabil

Travis Webb, Chief Scientific Officer, PII


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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1 month ago
10 minutes 43 seconds

BioSpace
Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

Many of the top stories of 2025 are currently being written. We’re on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion.  

Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision.  

Speaking of the FDA, the regulator appears to have done its own 180—on uniQure’s investigational gene therapy for Huntington’s disease, three-year data from which sent the biotech’s stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question.  

Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator’s thinking and a new approach to gene editing approvals.  

On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results.  

One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer’s partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics. 

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1 month ago
26 minutes 26 seconds

BioSpace
Innovation, Resilience, and the Future of Global Manufacturing

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how China, historically focused on manufacturing, is increasingly becoming an innovation leader, particularly in pharmaceuticals. Ultimately, balanced strategies involve domestic capacity investments coupled with global collaboration.

This episode is presented in partnership with Element Materials Technology.

Hosts
Jennifer Smith-Parker, Director of Insights, BioSpace
Lori Ellis, Head of Insights, BioSpace

Guests

Dr. Jihye Jang-Lee, Director of Technical Services, Element Materials Technology

Dr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials Technology


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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2 months ago
14 minutes 15 seconds

BioSpace
Novartis’ Big Buy, Q3 Earnings, Regeneron’s Dropped Cell Therapy, More

Novartis started the week early with a Sunday afternoon announcement of the acquisition of neuromuscular drug developer Avidity Biosciences for $12B. That’s the second biggest buy of the year after Johnson & Johnson’s January acquisition of Intra-Cellular. The Avidity buy could read through positively to Dyne Therapeutics, as both are aiming to treat neuromuscular ailments with RNA-targeting therapies. Dyne shares have nearly doubled over the past month, jumping approximately 40% after Novartis’ news dropped. 

 

The Avidity deal is the latest in an uptick on the pharma M&A front. Also this week, Eli Lilly doubled down on gene therapy with a pick up of Adverum Biotechnologies and its lead program for wet age-related macular degeneration. And Roche, which last month acquired 89bio in a $3.5 billion deal centered on a MASH candidate, said in its third-quarter earnings call on Thursday that more deals could be in the future. Finally, beyond the big guys, Leerink Partners predicts which small- to mid-cap firms might also be on the hunt for new pipeline goodies. 

 

Following the dealmaking news, Novartis held its earning call on Tuesday. CEO Vas Narasimhan downplayed the deals Pfizer, AstraZeneca and Amgen have made with the White House, saying they don’t address the root of the drug pricing problem President Donald Trump hopes to solve.  

 

On other earnings calls, BioMarin announced plans to divest the hemophilia gene therapy Roctavian. Regeneron faced further questions about Eylea and issues with the Catalent plant that’s been tripping up its regulatory applications. But the company didn’t address last week’s news that it was dropping a CAR T asset picked up from 2seventy bio. These are but two of the latest examples of underperforming assets in the cell and gene therapy space. 

 

BridgeBio had positive news for patients with limb-girdle muscular dystrophy this week after acing a Phase III trial for an investigational substrate supplementation therapy. Analysts predict the asset could be before the FDA later this year or early next.  

 

Finally, with the U.S. government shutdown going on a month, BioSpace takes a look at how the FDA is operating. 

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2 months ago
26 minutes 36 seconds

BioSpace
How Supply Chain Turbulence is Reshaping Biotech Strategy

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney how in light of economic uncertainty, small biotechs can turn to international harmonization standards as a stable template. U.S. tariffs are redefining competitiveness in manufacturing nations like India, China, and other parts of Asia, with China emerging as a global innovator.

This episode is presented in partnership with Element Materials Technology.

Hosts
Jennifer Smith-Parker, Director of Insights, BioSpace
Lori Ellis, Head of Insights, BioSpace

Guests

Dr. Jihye Jang-Lee, Director of Technical Services, Element Materials Technology

Dr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials Technology

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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2 months ago
8 minutes 59 seconds

BioSpace
Novo Board Upended, ESMO Excitement, FDA Awards, Replimune’s U-Turn

Novo Nordisk dominated the news cycle this week, with more leadership changes as the Novo Foundation replaced the company’s board, which will now be headed by former CEO Lars Rebien Sørensen. Meanwhile, President Donald Trump promised last week that Novo’s Ozempic will cost about $150 when he and Centers for Medicare & Medicaid Services Administrator Mehmet Oz are done negotiating, though Oz clarified that said negotiations have not yet begun.

Over in Berlin, the 2025 European Society for Medical Oncology featured presentations from Akeso and Summit Therapeutics on PD-1/VEGF inhibitor ivonescimab in first linenon-small cell lung cancer (NSCLC) and Exelixis’ oralkinase inhibitor zanzalintini in colorectal cancer. In addition to reporting that ivonescimab “significantly improved” progression-free survival in first-line NSCLC, Summit said on a Q3 call Monday that it would submit a regulatory application with the FDA for the drug in second-line EGFR-mutatedNSCLC. In other cancer news, shares of Replimune soared after the FDA accepted its resubmitted biologics license applicationfor RP1 in advanced melanoma, nearly three months after its July rejection.

Also on the regulatory front, the FDA named the first nine recipients of its Commissioner’s National Priority Voucherprogram. Winners of the expedited review vouchers include Regeneron, Disc Medicine and Sanofi. The FDA agency also awarded its second-ever platform designation to Krystal Biotech—after granting the first such designation to Sarepta Therapeutics earlier this year for its AAV vector andthen rescinding it after the platform was linked to multiple deaths. Finally, Sandra Retzky, formerly director of the FDA’s Office of Orphan Products Development, joins the lengthy leadership exodus at the agency this year.

In BioPharm Executive, BioSpace look at how Johnson & Johnson weathered the erosion of its cornerstone drug Stelara. And is hair loss the new weight loss? Two biopharma companies—Veradermics and Pelage Pharmaceuticals—reeled in large financing rounds for their respective hair loss/regrowth programs. They’re part of an uptick in mega rounds of late, butexperts say it’s not a full biotech comeback just yet.

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2 months ago
31 minutes 24 seconds

BioSpace
Cost Control to Capability Building: Rethinking Supply and Strategy in Pharma

In this episode of Denatured, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney will explore how healthcare and pharmaceutical players — from hospitals and universities to manufacturers and investors — are rethinking their strategies amid global supply chain disruption.

The conversation highlights both immediate operational responses and long-term structural shifts shaping a more resilient, agile, and locally grounded ecosystem, especially in light of U.S. tariffs.

This episode is presented in partnership with Element Materials Technology.


Host

Jennifer Smith-Parker, Director of Insights, BioSpace

Lori Ellis, Head of Insights, BioSpace


Guests

Dr. Jihye Jang-Lee, Director of Technical Services, Element Materials Technology

Dr. Khanh Courtney, Biologics Technical Strategy Manager, Element Materials Technology


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Show more...
2 months ago
13 minutes 35 seconds

BioSpace
Work Smart, Build Trust: Connecting Technology, Patient Compliance and Data Processing

This episode continues the discussion with Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII, as they dive into the nuance, challenges and opportunities of autoinjectors and combination drug delivery systems.

In this conversation they focus on supporting decentralized clinical studies and how connected technology can improve patient compliance, trust and cleaner data processing.

This episode is presented in partnership with ⁠PII⁠.


Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace


Guests

Oliver Eden, Senior Business Unit Director, Jabil

Travis Webb, Chief Scientific Officer, PII


Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Show more...
2 months ago
14 minutes 5 seconds

BioSpace
Q3 Earnings Are Here, Novo Ditches Cell Therapy but Buys Akero, Gov’t Shutdown Hits CDC

Johnson & Johnson kicked off Q3 earnings season on Tuesday with the announcement that it is splitting its orthopedics and medtech operations and that it has yet to reach a drug pricing deal with the White House, though CEO Joaquin Duato did say those discussions are ongoing.  

In advance of its Nov. 5 earnings call, Novo Nordisk, under the direction of new CEO Maziar Mike Doustdar, has been busy making moves, doubling down on MASH last week with its $5.2 billion buy of Akero. Then this week, Novo became the latest company to cut cell therapy, following Takeda’s recent exit from the space. 

Meanwhile, as the government shutdown continues, so too does the chaos at the CDC, where more than 1,000 employees received termination notices last Friday—only for hundreds to be told never mind. At the FDA, however, there is some consistency despite the overhaul, with the agency on track for an average number of approvals this year. And a recent report on breakthrough designations shows that the regulatory award often leads to an FDA greenlight. 

On the legislative front, the BIOSECURE Act is back, as a slimmed down version passed the Senate last week as part of the defense spending bill. The latest version of BIOSECURE, which is meant to distance American biopharma from Chinese collaborators, doesn’t name specific companies as previous iterations did and must still gain the Senate’s support. 

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2 months ago
27 minutes 45 seconds

BioSpace
Bonus: Q3 2025 Job Market Update

In this discussion, BioSpace’s vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look at job market performance in the second quarter of 2025.


They discuss biotech and pharma job posting trends, wider U.S. employment data, the new $100,000 H-1B visa fees and more.


Want to receive our latest quarterly job market reports as soon as they’re published? ⁠⁠Subscribe⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

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2 months ago
11 minutes 10 seconds

BioSpace
Shutdown Pauses New Drug Reviews, CDC Issues New COVID Guidance, CGT Meets on Mesa

The U.S. government is now in its second week of a shutdown—with the FDA having paused acceptance of all new drug applications for the duration. But it was business as usual at the CDC, which adopted the recent recommendations of its newly revamped advisory committee on chickenpox and COVID-19 vaccines. And another senior leader, National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, was fired last week, after filing a whistleblower report.  

Across the country, cell and gene therapy leaders arrived in Phoenix for the annual Meeting on the Mesa, as the space remains in a state of flux—with regulatory and M&A momentum being stalled by commercial and market challenges. Takeda, for one, is looking to offload its cell therapy platform after years of hefty investment.  

President Donald Trump’s long-awaited tariffs did not hit on Oct. 1 as promised. But in the face of the looming levies, Pfizer signed a drug pricing deal with the White House that provides a three-year exemption. Amgen appears to be climbing onboard as well, announcing that its lipid-lowering drug Repatha will be available at a steep discount. These moves are all well and good for Big Pharma players, but a recent report from CRB reveals most smaller biopharma companies are not planning any investments to offset tariffs.  

In our weekly weight loss segment, Skye Bioscience’s cannabinoid receptor 1-targeting candidate nimacimab failed to outpace placebo in reducing body weight but elicited “intriguing synergy” in combination with Novo Nordisk’s Wegovy, according to William Blair analysts. And regulatory documents shed further light on Pfizer’s $4.9 billion takeover of Metsera, in which the New York pharma beat out two higher bidders for the promising obesity startup.  

Finally, make sure to check out The 5 Most Powerful Women in Biopharma and BioSpace’s inaugural 40 Under 40, highlighting 40 young leaders who have made an impact on the biopharma industry.  

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2 months ago
29 minutes 25 seconds

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.