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.
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.
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.
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.
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.
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.
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.
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.
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.
Clinical trials can present many challenges for patients–particularly injections.
Oliver Eden, senior business unit director at Jabil, and Travis Webb, chief scientific officer at PII, discuss nuance, challenges and opportunities of autoinjectors and combination drug delivery systems.
Additionally, they advocate that drug delivery systems enter the conversation earlier in clinical development stages given interdependencies.
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.
Genmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year’s fifth largest—came just a week after Pfizer acquired rising obesity star Metsera for $4.9 billion. Just seven days later, Metsera made the New York–based pharma look like a genius with mid-stage data for one of the deal’s centerpiece therapies, MET-097i, showing 14% placebo-adjusted weight loss over 28 weeks.
After months of tarrying and threats, President Donald Trump announced last week that 100% tariffs would take effect Oct. 1—with broad exceptions for companies that have taken steps to build out their domestic manufacturing footprints. One company that has answered that call—as well as a letter sent by the president to 17 of the largest pharma companies requesting action on his most-favored-nation drug pricing policy—is Pfizer. In a joint oval office announcement with Pfizer CEO Albert Bourla and HHS officials, Trump said Pfizer would offer all new medicines at MFN prices.
Meanwhile, over at the FDA, CDER Director George Tidmarsh, who has flown relatively under the radar since taking the post in July, took to LinkedIn to address the subject of relying on surrogate endpoints in drug approvals. In a since deleted post, Tidmarsh called out Aurinia Pharmaceuticals’ lupus drug as an “egregious” example of this phenomenon. CDER’s sister agency, CBER, also made a splash last week, publishing three draft recommendations intended to accelerate the development of cell and gene therapies.
Speaking of CGT, maybe the biggest clinical development news of the year emerged from this space last week when uniQure announced that its gene therapy for Huntington’s disease, AMT-130, slowed disease progression by 75% after three years. With these data in hand, uniQure plans to file for FDA approval of the treatment in the first quarter of 2026. If successful, AMT-130 would be the first genetic therapy for the intractable neurodegenerative disease.
Finally, biopharma’s glass ceiling just got a little more tightly sealed. Emma Walmsley, the industry’s first female CEO, is stepping down after nine years at GSK, handing the reins to current chief commercial officer, Luke Miels. When Walmsley officially departs on Dec. 31, she will leave Vertex CEO Reshma Kewalramani and incoming Takeda CEO Julie Kim to represent the sisterhood at the highest ranks of the biopharma industry.
The FDA is working to reapprove GSK’s long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “developmental delays with autistic features.” This immediately followed a much-anticipated press conference in which President Donald Trump, flanked by Health Secretary Robert F. Kennedy Jr and other healthcare administrators, linked the use of Tylenol during pregnancy to rising rates of autism.
Meanwhile, Pfizer woke us all up Monday with the news that it had acquired breakout obesity rockstar Metsera for $4.9B. The deal should pump new life into Pfizer’s portfolio, which over the last two years has suffered three discontinued assets. Bite-sized deals—or those at or below the $5 billion mark—have defined biopharma recently, with Roche picking up metabolic dysfunction-associated steatohepatitis biotech 89bio for a potential $3.5 billion last week and Novartis putting another $5.7 billion on the line with partner Monte Rosa Therapeutics in a second molecular glue agreement.
Another therapeutic space primed for M&A action is psychedelics. After AbbVie bought Gilgamesh Pharmaceuticals’ lead depression asset for $1.2B last month, BioSpace spoke sought opinions from experts on who might be next to take the plunge. A few potential names included Eli Lilly, Bristol Myers Squibb and Merck.
On the policy front, the CDC’s revamped vaccine advisory committee convened for their first meeting to discuss COVID-19, MMRV and hepatitis B vaccine schedules. Industry watchers who spoke to BioSpace commented on the “lack of knowledge” and dearth of previous experience on the committee. And while the advisors ultimately voted to change the schedule for the MMRV vaccine, it appears unlikely to significantly affect manufacturers’ bottom lines.
Finally, in rare disease, Stealth BioTherapeutics secured its long-sought approval for elamipretide—now Forzinity—in Barth syndrome—a disorder that would fall under the purview of the FDA’s new Rare Disease Evidence Principles framework for ultra rare diseases affecting less than 1,000 people in the U.S. And we said “Bye Bye Bluebird,” as the famed gene therapy biotech—which was recently bought out by two private equity firms—returned to its original moniker, Genetix Biotherapeutics.
Lastly, make sure to sign up for Biopharm Executive here for access to a special deep dive into China biopharma.
In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month. AI is a tool, a powerful one but a tool. Understanding this, they explore the connections between hammers, AI, The Planet of the Apes and monoliths.
In the end, it is all about compliance.
Host
Lori Ellis, Head of Insights, BioSpace
Guest
Colin Zick, Partner, Foley Hoag LLP
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more have canceled or suspended investments in the U.K. following a sizeable increase in a mandatory levy in the region.
In other business news, Novo Nordisk’s newly appointed CEO Maziar Mike Doustdar hit the ground running, cutting around 9,000 employees and informing those who remained that they would need to return to the office. Novo’s headcount had climbed 81% in five years as its revenue soared—and then fell. The obesity juggernaut has been a key presence at the European Association for the Study of Diabetes’ annual meeting this week, announcing that it would seek FDA approval for a high-dose formulation of Wegovy, and presenting new data for long-acting amylin analog cagrilintide. Meanwhile, Reuters reported that Eli Lilly’s orforglipron could potentially qualify for the FDA’s recently launched Commissioner’s Priority Voucher, which could see the oral obesity candidate approved this year.
The gene therapy space was hit with more bad news as Capsida Biotherapeutics reported the death of a patient being treated with its investigational gene therapy for epileptic disorders. This follows an unfortunate trend in 2025 that has also seen deaths attributed to Sarepta’s approved Duchenne muscular dystrophy gene therapy Elevidys and a monoclonal antibody used for lymphodepletion in a study of Allogene’s CAR T cell therapy cema-cell. According to a new analyst survey, however, doctors are still prescribing Elevidys to ambulatory patients.
Meanwhile, on the regulatory front, FDA Center for Drug Evaluation and Research Director George Tidmarsh reportedly told two separate groups last week that he “would like to get away” from advisory committee meetings, but quickly appeared to walk the comments back in a statement to Endpoints News.
Finally, in BioPharm Executive, BioSpace takes a deep dive into the FDA’s new crackdown on pharmaceutical drug ads, and spotlights Akeso CEO Michelle Xia who built the biotech from a $3 million angel fundraising round to its current $15 billion valuation.
The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country’s health, saying the U.S. now has “the highest chronic disease burden of any country in the world.”
Looking back to last week, all eyes were on HealthSecretary Robert F. Kennedy Jr.’s appearance before the Senate Finance Committee. The combative showdown amounted to little more than political theater, according to industry watchers, with Kennedy accusing former CDC Director Susan Monarez of lying in an op-ed published in the Wall Street Journal about his alleged request that she approve vaccine advisors’ recommendations in advance of their meeting later this month.
Over at the FDA, BioSpace combed through the latest cache of publicized complete response letters (CRLs), including one for Lykos’ MDMA-based therapeutic for post-traumatic stress disorder. Going forward, the agency has promised to release CRLs in real time. The greater transparency could help companies spinning on a carousel of confusion caused by all the recent regulatory change. In other FDA news, we take a deep dive into new expert panels, which some commentators view as one-sided, and into the new rare disease approval framework, which one critic called “all wrapper and no gift.” And in the weight loss space, the FDA debuted a consumer “green list” for GLP-1 ingredients.
Meanwhile, at the World Conference on Lung Cancer inBarcelona, several data readouts caught our attention. In particular, Summit Therapeutics released disappointing data for its PD-L1/VEGFa bispecific antibody ivonescimab in Western populations—a finding some analysts said could have readthroughs to Bristol Myers Squibb/BioNTech’s first ever global data readout for its L1/VEGFa bispecific.
Finally, in Biopharm Executive this week, check out features on contingent value rights, which have been getting tacked on to biopharma deals more and more, Amgen’s pipeline beyond the obesity drug MariTide and Novartis’ recent deal spree, which included the $1.4B acquisition of Tourmaline on Tuesday.
In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment. He explains that investors now demand more robust translational data showing real potential to impact human health, rather than just basic in vitro results, forcing researchers to generate better evidence packages earlier in development.
This episode is presented in partnership with Taconic Biosciences.
Host
Lori Ellis, Head of Insights, BioSpace
Guest
Mike Garret, CEO, Taconic Biosciences
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis’ agreement with Arrowhead for neurodegenerative diseases such as Parkinson’s.
But as we look ahead, Thursday’s Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F. Kennedy Jr. will answer questions after the ousting of CDC Director Susan Monarez. Her departure is reportedly linked to changes to the regulation of COVID-19 vaccines, for which the FDA last week issued restricted approvals to Moderna, Pfizer/BioNTech and Novavax and rescinded the emergency use authorizations. The next ACIP meeting—where COVID-19 vaccines will be on the agenda—is set for Sept. 18 and 19.
In the weight loss arena, Novo Nordisk presented results from a real-world study this weekend at the European Society of Cardiology Congress in Madrid showing that Wegovy cut the risk of heart attack, stroke or death by 57% compared to Eli Lilly’s tirzepatide in people with obesity and cardiovascular disease. The company also continues to throw money into the space, last week inking a $550 million deal with Replicate for RNA-based treatments for obesity and diabetes. Meanwhile, Lilly is dropping studies of one oral obesity candidate as another nears a regulatory filing. Finally, the FDA greenlit the first GLP-1 generic for obesity.
We also discuss reactions to the FDA’s new guidance on radiopharma drug development, four recent approvals for rare diseases, and everything you ever wanted to know about SPACs.
Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.
On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals’ lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs.
Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency’s COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily.
HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta.
Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.
Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.
While the 9.1% placebo-adjusted weight loss generated by Lilly’s orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735’s otherwise best-case efficacy scenario—10.9% weight loss after just 13 weeks. These murky results have left observers wondering, just how game-changing these pills will be and which ones will be most effective?
In such a hot space, Lilly’s and Viking’s results—which follow Novo Nordisk’s new drug application for an oral form of Wegovy in May—are only the tip of the iceberg. Stay tuned to BioSpace for further in-depth coverage of the space as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.
While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial failure rate. Most failures stem from fundamental gaps in biological understanding rather then the processes where AI is able to have the most impact.
The discussion highlights AI's strengths and ability to reduce preclinical costs. However, they caution that AI faces significant limitations in predicting complex biological properties like toxicity due to insufficient data, and regulatory acceptance of AI-only safety assessments remains unlikely, meaning traditional clinical trials will continue to be necessary.
This episode is presented in partnership with Cresset.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Mutlu Dogruel, VP of AI, Cresset
Mark Mackey, CSO, Cresset
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
