BioSpace

In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsLance Alstodt, Chairman & CEO, BioRestorative TherapiesPaul Mieyal, Chief Business Officer, South Rampart PharmaDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Biogen’s new data, presented at the Alzheimer's Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.

In this bonus episode, BioSpace Managing Editor Jef Akst and Angela Gabriel, content manager, life sciences careers, look at the Q2 job market and discuss encouraging signs for job seekers.

In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJack Crawford, CEO, DemeetraMagnus Gustafsson, Chief Commercial Officer, NorthX BiologicsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.

The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you’ll hear from Hakan Goker, managing director at M Ventures and Maina Bhaman, partner at Sofinnova Partners. We explore the UK biotech ecosystem : from the Golden Triangle’s evolving role to the challenges of scaling companies, unlocking pension capital and staying globally competitive. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hakan Goker, Managing Director, M VenturesMaina Bhaman, Partner, Sofinnova Partners Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

This year has been partly defined by a return to M&A. In the first quarter of 2026, biopharma spent nearly $47 billion in acquisitions across 19 deals, and this week, AbbVie notched another one for the second quarter, scooping up Apogee Therapeutics and its IL-23 blocker for atopic dermatitis for around $10.9 billion. The deal follows GSK’s $10.6 billion Nuvalent Bio acquisition earlier this month. These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi’s pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits.  Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington’s disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient. Also at the FDA, a policy memo on the agency’s consideration of Sanofi’s Commissioner’s Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months. For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026. And finally, on the Eli Lilly front, a new report from Evaluate projects that the company’s weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn’t resting on this envisioned success: the juggernaut is one of two companies circling Sangamo’s assets as the biotech files for bankruptcy.

In this episode of Denatured, you'll hear from Mark Lowdell, CSO & co-founder at INmuneBio Inc. and Vishwas Seshadri, CEO & director at Abeona Therapeutics. We examine how recessive dystrophic epidermolysis bullosa serves as a model for cell and gene therapy, and what this ultra-rare disease teaches us about scaling advanced treatments for the future. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Mark Lowdell, CSO & Co-Founder, INmuneBio Inc Vishwas Seshadri, CEO & Director, Abeona Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Moderna’s mRNA-based flu vaccine made headlines in February when the FDA declined to even review the application. Days later, the agency reversed course, setting a decision date for August and later scheduling an advisory committee meeting for June 18. In documents released ahead of that meeting, the FDA and Moderna seem to have reached alignment, though the agency did flag certain data gaps for advisors to review.Biotech IPOs are off the charts—literally. This past month has seen not one but two record-setting public debuts. First there was Kailera Therapeutics, which hit the market with $625 million in April, outpacing Moderna’s 2018 IPO of $600 million. And now we have Parabilis Medicines, which last week dethroned Kailera as the largest biotech IPO of all time, with $670 million.Meanwhile, the number of employees laid off spiked by almost 50% year-over-year in May, though that jump is mostly due to significant cuts at Takeda and BioNTech.Genentech also made a big change last week.Eli Lilly continued its dealmaking spree with AlzeCure, striking a licensing agreement worth up to $1 billion centering on a small-molecule asset for Alzheimer’s disease. But the bigger Lilly news in the past week was clinical results that show promise for the pharma’s $2.3 billion acquisition of Ajax Therapeutics in April.Earlier this month, the FDA held a public session to glean feedback regarding the Commissioner’s National Priority Voucher program, in which several groups called for a temporary pause to the pilot, citing concerns about transparency and political involvement. While the future of that program hangs in the balance, two voucher holders got updates this week. First, Sanofi’s diabetes drug Tzield was greenlit for older kids and teenagers, though it’s unclear whether a voucher was associated with the approval. Meanwhile, Disc Medicine’s rejected rare disease drug bitopertin appears to be back on track, with the biotech announcing last week that the FDA will allow its current Phase 3 trial to support another regulatory filing.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll hear from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc. We examine the rise of Southern Europe’s biotech ecosystem—from Portugal’s efforts to turn strong science into startups to Spain’s growing depth of capital and talent—and what it will take for the region to compete globally.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsHannah Franklin, Associate, Biovance CapitalPablo Gabriel Cironi Lopez, Director, Life Science Investment, Caixa Capital RiscDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Everything came up roses for Eli Lilly at the American Diabetes Association, as the pharma boasted positive results for its new pill Foundayo and next-gen asset retatrutide—not just for weight loss but also for other indications.Obesity rival Novo Nordisk, meanwhile, held a dinner, during which executives may have convinced analysts that the company is turning a corner after a rough couple of years.Also check out ADA updates from Roche and partner Zealand Pharma, Boehringer Ingleheim, Pfizer (touting results from its Metsera buy), AstraZeneca, Kailera Therapeutics and more.Outside of ADA, the biggest news of the past week came on Tuesday with GSK striking the biggest traditional pharma/biotech M&A of the year so far with its $10.6 billion acquisition of oncology focused Nuvalent Bio. And on Monday, J&J notched a smaller deal, buying out Firefly Bio for $1B. These deals add to continued uptick in M&A seen in biopharma this year, with much of that momentum being driven by Eli Lilly and its GLP-1 cash.At an FDA listening meeting last week on the Commissioner’s National Priority Voucher program, the agency heard multiple calls to pause it. Confusion also still persists around all of the new rare disease pathways, including the new plausible mechanism framework.

In this episode of Denatured, you'll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsDaniel Gil, CEO, Pelage PharmaceuticalsFrancisco Ramírez-Valle, Senior Vice President, Immunology Discovery, Eli LillyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

At the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this past weekend, packed plenary sessions from Revolution Medicines and Summit Therapeutics’ Chinese partner Akeso stole the show. For RevMed, analysts anticipate a potential approval in pancreatic cancer as early as this year, while Summit still has a tough road ahead showing that the survival benefit seen in Akeso’s clinical trial in China will hold up in a global population.Immuneering, BMS/BioNTech, Merck, Pfizer and many more also scored oncology wins at the annual meeting, as did Moderna, with “encouraging” 5-year survival for its mRNA-based personalized melanoma vaccine. Outside of ASCO, the past week saw Pfizer strike an unusual pact with China’s Innovent Biologics as it seeks to bolster its oncology pipeline. Reminiscent of another recent deal from BMS and Hengrui Pharma, it could signal a more collaborative approach to working with Chinese companies. We’ll also cover the latest deals from Eli Lilly, which continues to rack up partners with its GLP-1 windfall. Finally, learn about how BrainStorm is planning another FDA bid for its experimental ALS therapy NurOwn with former regulator Peter Pitts now on the board, and check out a preview of the 2026 American Diabetes Association, or ADA, which kicks off this weekend in New Orleans.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll be hearing from Ksenija Pavletic, partner and chief commercial officer at Jeito Capital and Thierry Laugel, managing partner at Kurma Partners. We dive into France’s biotech ecosystem and what still needs to happen for more early innovation to translate into investable, scalable biotech.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsKsenija Pavletic, Partner and Chief Commercial Officer, Jeito CapitalThierry Laugel, Managing Partner, Kurma PartnersDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly has been as acquisitive as ever, striking five new deals in the past week alone. On Tuesday, the company dove into the deep end of vaccine development with three separate buys in the space. Outside of vaccines, Lilly scooped up preclinical biotech Engage Bio for $202 million and teamed up with AI company Collaborative Drug Discovery for its life sciences data management solutions.These deals and Lilly’s skyrocketing revenue pushed the Indianapolis-based company to the top of IDEA Pharma’s list of best inventors and innovators.Lilly also continues to make headlines for its impressive data readouts, especially in the weight-loss space that it now reigns supreme. Last week, Lilly announced that next-gen asset retatrutide led to weight loss of 70 pounds, or 28.3% at 80 weeks, setting a new benchmark for the space.Moderna also made news this week with a surprising uptick in its share price that analysts are attributing to the so-called “fear trade” that is rising amid reports of a cluster of cases of hantavirus. Moderna also announced that its mRNA flu shot—initially turned away from the FDA but later accepted for review—will be discussed at an advisory committee on June 18.The annual conference of the American Society of Clinical Oncology starts on Friday in Chicago, where all eyes will be on Revolution Medicines’ investigational pancreatic cancer pill and Akeso’s Phase 3 trial HARMONi-6 for its Summit Therapeutics-partnered PD-1/VEGF bispecific ivonescimab.Finally, sign up for BioPharma Executive to receive this week’s special edition breaking down executive compensation packages across the biggest pharmas.

In this episode of Denatured, as part of our series of the European life science investment ecosystem, you'll be hearing from Regina Hodits, managing director at Angelini Ventures and Sofia Ioannidou, VC partner at Andera Life Sciences. They examine Germany’s biotech and life sciences landscape, focusing on the scientific, infrastructure and policy shifts required to enable European companies to scale globally while remaining anchored in Europe.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsRegina Hodits, Managing Director, Angelini VenturesSofia Ioannidou, VC Partner, Andera Life SciencesDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

FDA Commissioner Marty Makary officially resigned last week following reports of his ouster. Then, the acting directors for the agency’s two main review units also left their posts, as did the FDA chief of staff and chief AI officer. Domino effect aside, the reaction from the industry has been mostly positive, given Makary’s tumultuous reign. But he might be hard to replace. If it were up to the biotech industry, former longtime oncology regulator and short-lived CDER director Richard Pazdur would take the role. For now, FDA Deputy Commissioner for Food Kyle Diamantas is in charge.Eli Lilly’s David Ricks was the highest paid pharma CEO last year, but J&J’s Joaquín Duato made the most relative to rank-and-file employees, with a median pay ratio of 358 to one. He was on the top of BioSpace’s list last year, too, with a ratio of 293 to 1. Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. This week, Truist Securities went so far as to nominate RevMed as “the next oncology titan,” a title currently held by Merck and its blockbuster cancer drug Keytruda. Safety continues to challenge the gene therapy space, especially in Duchenne muscular dystrophy. Late last week, REGENXBIO announced mixed results from a Phase 3 program—the gene therapy did lead to functional improvements, but two serious adverse events caused the stock to drop 37%.Finally, Amgen’s rare disease drug Tavneos continues to face scrutiny. Last month, the FDA alleged that doctored data were filed to support Tavneos’ initial approval. Now, it’s been linked to 20 deaths in Japan.

In this episode of Denatured, you'll be hearing from Miguel Forte, president of the International Society for Cell and Gene Therapy (ISCT), and John Ellis, co-founder & CEO of Trenchant Bios, speaking live from the ISCT annual meeting. We dive into mesenchymal stem cells and induced pluripotent stem cells, exploring the science behind them, the manufacturing challenges, and the potential for scalable, engineered next-generation therapies.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJon Ellis, Co-founder & CEO, Trenchant BioMiguel Forte, President, International Society for Cell & Gene TherapyDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Moments after recording this episode of The Weekly, FDA Commissioner Marty Makary announced his resignation. Reports first circulated last Friday that President Donald Trump had signed off on his ouster. The president initially denied this account, originally from The Wall Street Journal, on Saturday morning, but appears to have now confirmed the plan. This confusion underscores a key theme in Robert F. Kennedy Jr.’s health department: lack of transparency and clear communication. Makary’s exit also highlights the high level of senior leadership turnover across the Department of Health and Human Services. With Makary is on his way out, the FDA will reportedly be helmed by an acting commissioner, Kyle Diamantas. This would also be fitting for an agency whose two key review divisions—the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER)—are currently led by temporary directors. Meanwhile, one of Makary’s key initiatives, the Commissioner’s National Priority Review (CNPV) program, hit a snag last week as Sanofi has reportedly requested that the FDA remove its diabetes prevention drug Tzield from the scheme. This comes after acting CDER director Tracy Beth Høeg apparently intervened in the drug’s review. And in the business realm, BioSpace kicks off our annual compensation report. Who made the most money in 2025? Was it Eli Lilly’s David Ricks or Johnson & Johnson’s Joaquin Duato? Read BioPharm Executive to find out. Not subscribed? Sign up here for all of BioSpace’s insightful newsletters.

In this episode of Denatured, you'll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder & Chief Medical Officer of Calluna Pharma. We dive into IPF and fibrosis challenges, unpacking treatment hurdles, emerging targets, unmet needs and expansion paths beyond the lung.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsGeorg Vo Beiske, CEO, Tribune TherapeuticsJonas Hallén, Co-Founder & CMO, Calluna PharmaDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

First quarter earnings continue to roll in, with Pfizer, Eli Lilly, Amgen and more reporting in the past week. While Pfizer beat consensus estimates, it wasn’t enough for analysts, who had greater expectations for the New York pharma. Analysts were more than satisfied with Lilly’s 56% revenue increase, though the company itself appeared to want more—a feat executives believe it could have achieved had it not lowered prices on many of its medicines. Meanwhile, a host of small– to-medium biotechs are beginning to report, with analysts focused squarely on key near-term catalysts. On the regulatory beat, the FDA tapped Katherine Szarama as a temporary replacement for outgoing Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, whose controversial reign over the biologics division ended April 30. And the FDA held its first advisory committee meeting in nine months, for two AstraZeneca cancer drug applications, which former regulator Harpreet Singh said was missing the “Pazdur moment,” after stalwart oncology leader Richard Pazdur left the agency last November.Over in R&D, an optimistic story is unfolding in a treatment space that has endured much heartache over the past few years: ALS. In the past week, QurAlis and Corcept Therapeutics both reported positive mid-stage data for their respective candidates, with QurAlis’ QRL-201 eliciting an up to 50% in decrease progression, and Corcept reporting a two-year survival advantage for patients talking its dazucorilant.Finally, in BioPharm Executive this week, senior BioSpace editor Annalee Armstrong sits down with biotech founders to discuss the challenges of being a founder today.

In this episode of Denatured, you'll be hearing from Yaniv Sneor, founder of the Mid Atlantic Bio Angels and Alex Pederson, an investor at Mid Atlantic Bio Angels and partner at Alloy Bio Consulting. We discuss why a life sciences-only angel group matters, how they evaluate opportunities, and the importance of strong teams, capital efficiency and a realistic path to exit.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsYaniv Sneor, Founder, Mid Atlantic Bio AngelsAlex Pederson, Investor, Mid Atlantic Bio Angels & Partner, Alloy Bio ConsultingDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House.Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner’s National Priority Vouchers to unnamed psychedelic drug developers. Finally, who will replace Vinay Prasad, the head of the agency’s Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?

In this episode of Denatured, you'll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.

After entering the CAR T arena in February, Eli Lilly jumped onto the in vivo bandwagon, penning a deal worth up to $7 billion for Kelonia Therapeutics and its gene therapy delivery tech iGPS. Meanwhile, Belgium-based UCB scooped up Neurona Therapeutics for $650 million upfront and up to $500 million in milestone payments.On the policy front, President Donald Trump signed a new executive order that analysts believe could help psychedelic therapies become the “key next wave” of mental health therapies. The EO instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that have secured breakthrough designation, a move that could cut review timelines from 10-12 months to 1-2 months for these therapies.Elsewhere, the FDA’s rebuff of Replimune’s advanced melanoma drug RP1 continues to make waves, with CEO Sushil Patel slamming the agency for failing to exercise flexibility, while experts have lamented the regulator’s inconsistency.On the business side, Kailera managed to break biopharma’s all-time IPO record, raising $625 million last week. The new all-time high prompted BioSpace to take a look back at other historic IPOs in the industry, with mRNA heavyweight Moderna’s 2018 debut falling into second place.BioSpace also spoke with Denali Therapeutics CEO Ryan Watts about the company’s long-awaited FDA approval for Hunter syndrome drug Avlayah. “It was the greatest professional moment of my life,” Watts said during an event put on by Utah’s biotech community hub, BioHive.

In this episode of Denatured, you'll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsEdoardo Negroni, Co-Founder & Managing Partner, AurorA-TTNaveed Siddiqi, Senior Partner, Venture Investments, Novo HoldingsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Johnson & Johnson kicked off Q1 earnings season with a “modest” beat, raking in $24.1 billion in sales as it targets $100 billion in revenue in 2026. J&J, as always, is the first to report results from a first quarter that has seen a wave of deals across biopharma; this M&A rush is expected to headline investor calls as more companies, including Novo Nordisk and Eli Lilly, report their Q1 results in the coming days. Meanwhile, IPOs are also on an upswing, with Kailera Therapeutics eyeing a raise that could reach as high as $533 million. On the regulatory front, Replimune failed for a second time to secure approval for its advanced melanoma therapy RP1, as the FDA held its ground, requesting a Phase 3 trial that CEO Sushil Patel indicated in a statement last week “will not be viable.” This comes as analysts say the FDA’s new policy of making complete response letters public is increasing accountability. Along with transparency, another key theme for the FDA this year has been its promise to be flexible, particularly when it comes to therapies for rare diseases. While BioSpace has closely covered the myriad cases where the agency has appeared to reverse its guidance to sponsors, two companies—Rezolute & CERo Therapeutics—lauded recent interactions with the FDA, calling reviewers “collaborative” and “curious.” Finally, heading into the American Association for Cancer Research’s annual meeting this weekend, several companies—including Revolution Medicines, Allogene and IDEAYA Biosciences and Servier—got a jump start, reporting positive data in a number of indications. Revolution’s report was especially seminal. The company’s therapy, daraxonrasib, doubled survival in pancreatic cancer—a disease that has just a 13% survival rate five years after diagnosis.

Listen to BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss 2026 job market performance so far, sharing the latest BioSpace data.They touch on positive signs they saw between January and March, including a reduced number of layoffs, and what this year might have in store for those seeking employment in 2026. 

In this episode of Denatured, you'll listen to Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of  Autolomous. They discuss how cell and gene therapy manufacturing is facing growing pressure to scale more quickly and efficiently, driving developers and manufacturers toward automation, digitization, robotics and broader collaboration across the ecosystem.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJason Jones, Head of Global Business Development, Cellular OriginsAlexander Seyf, Founder & CEO, AutolomousDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly won FDA approval last week for orforglipron—now Foundayo— officially launching what promises to be a heated battle between Lilly and chief rival Novo Nordisk.  Elsewhere, the M&A space keeps chugging along, with Gilead Sciences gobbling up partner Tubulis for up to $5 billion and Neurocrine Biosciences nabbing Soleno Therapeutics for $2.9 billion. The industry will be on high alert for more deals, as analysts say Amgen, AbbVie and Bristol Myers Squibb all have more money to spend. At the White House, President Donald Trump levied his long-promised tariffs on the pharma industry, but myriad carveouts mean many companies will be safe from the 100% tax, at least for now. And Trump’s Most Favored National pricing scheme is endangering access to new drugs in Europe as companies forgo launches  in countries that could pull down U.S. prices. Meanwhile, the Trump administration came out with its proposed 2027 budget on Friday, with several requests for the FDA and Department of Health and Human Services overall. In line with the administration’s efforts to accelerate development of therapies for rare diseases, the FDA proposes is seeking to permanently authorize the rare pediatric disease priority review voucher program. Other proposals include a new clinical trial notification pathway and expanded authority to regulate post approval manufacturing changes. These requests come during a time when the agency is, as always, walking the precarious tightrope of rigor vs. unmet need—with rare disease leaders calling for clarity around topics like externally controlled trials.

In this episode of Denatured, you'll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech's next big frontier.Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Marc Hedrick, President & CEO, Plus Therapeutics Philip Kantoff, Co-founder & CEO, Convergent TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations. 

Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—representing three of this year’s four biggest takeovers. First, Merck picked up Terns Pharmaceuticals and its mid-stage leukemia drug for $6.7 billion. Then, on Tuesday, Lilly and Biogen struck, acquiring Centessa Pharmaceuticals and Apellis Pharmaceuticals respectively.Those big-ticket deals aren’t the only recent transactions, however. Others include Novartis’ up to $2 billion pick up of Excellergy and Gilead’s $2.1 billion purchase of Ouro Medicines. Meanwhile, Kevin Tang—the newly minted CEO of Aurinia Pharmaceuticals—again has his sights set on Kezar Life Sciences, which he previously targeted in 2024. This time, biopharma’s “clean-up” man is offering $50 million for the chronic disease–focused biotech.Last week also saw nods for Denali Therapeutics’ Avlayah, the first treatment for Hunter syndrome to target the disease’s neurological complications, and Rocket Pharmaceuticals’ Kresladi for leukocyte adhesion deficiency-I. And it’s been a big week for Biogen, which besides moving on Apellis, won approval of a high-dose formulation of spinal muscular atrophy drug Spinraza and scored a Phase 2 win for lupus candidate litifilimab in cutaneous lupus erythematosus.On the weight loss front, Wave Life Sciences’ stock was cut in half after its obesity candidate WVE-007 failed to impress investors in a Phase 1 trial.

In this episode, you'll be listening to Sergey Jakimov, managing partner at LongeVC and Artem Trotsyuk, operating partner, US, LongeVC. We discuss how developers in the longevity space should stop chasing aging as an abstract target and concentrate on specific mechanisms that can clearly tackle age-related conditions. HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsSergey Jakimov, Managing Partner, LongeVCArtem Trotsyuk, Operating Partner-US, LongeVC 

Immunology & inflammation stole the show this week, as Gilead dropped up to $2.1 billion for Ouro Medicines and its T cell engager OM336—an investment it hopes to split with longtime partner Galapagos. Meanwhile, Sanofi also added a T cell engager in a licensing deal with Kali Therapeutics worth $180 million upfront.One I&I partnership that bore fruit last week was that of Johnson & Johnson and Protagonist Therapeutics which got their IL-23 receptor blocker Icotyde across the FDA finish line for plaque psoriasis. Icotyde is the first commercial product for Protagonist.Even the drama this week came from the I&I space, as Kevin Tang took the reins as CEO of Aurinia Pharmaceuticals, which you may remember was the company at the heart of former Center for Drug Evaluation and Research Director George Tidmarsh’s exit from the FDA.Outside of I&I, the CDC’s Advisory Committee on Immunization Practices made headlines once again as Vice Chair Robert Malone posted to social media that the group was being disbanded. The Department of Health and Human Services quickly corrected the record, but Malone posted a few hours later that “dissolving and reforming remains one of options being considered.”In FDA policy news, BioSpace recaps the now nine-month-old Commissioner’s National Priority Voucher pilot program and unpacks new draft guidance on animal testing alternatives. Plus, check out an opinion article on the need for precision ALS drugs and features on gene therapy for hearing loss and Big Pharma’s overall R&D spending in 2025.

In this episode, you'll be listening to  Akshay Rai, principal, Healthcare & Biotech Investments at Premji Invest and Viswa Colluru, CEO and founder, Enveda. They discuss how AI platforms must now prove themselves through data, focused pipelines and clinical readouts and that promises of faster, cheaper drug discovery are not enough to entice strong investor engagement.  HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsViswa Colluru, CEO & Founder, EnvedaAkshay Rai, Principal, Healthcare & Biotech Investments, Premji InvestDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations. 

Biopharma’s weight loss warriors have led the news this week, with Structure Therapeutics and Rhythm Pharmaceuticals announcing new data. Structure delivered a “competitive profile” for its investigational GLP-1 pill compared to Eli Lilly’s orforglipron and Novo Nordisk’s oral Wegovy, BMO Capital Markets wrote to investors, after the candidate elicited 16.3% weight loss after 44 weeks in a Phase 2 trial. Rhythm was not as successful, announcing that Imcivree failed in a Phase 3 basket trial of various genetically driven obesities. Meanwhile, Lilly and Novo made headlines outside of the clinical realm, as Lilly warned the public of the potential safety risks of taking compounded versions of tirzepatide—marketed as Zepbound for obesity and Mounjaro for type 2 diabetes. And Novo was hit with an FDA warning letter for failing to investigate reported adverse events—including three deaths—potentially linked to its own diabetes drug Ozempic. The letter only adds to what has been a challenging recent run for Novo, one that led to a 34% drop in total assets under management for its controlling shareholder Novo Holdings. On the regulatory front, Robert F. Kennedy Jr.’s vaccine agenda is stalled after Massachusetts District Court Judge Brian Murphy found that his efforts to overhaul policies in this area were likely unlawful. Murphy specifically cited Kennedy’s move last June to empty the CDC’s Advisory Committee on Immunization Practices (ACIP). This comes on the heels of a White House crackdown in which officials would like the health secretary to tone down his vaccine skepticism, according to a report by The Wall Street Journal. At the FDA, tensions continue to escalate, with Sen. Ron Johnson (R-WI) launching an investigation into recent rejections of rare disease drugs. And transparency issues have come to light once again regarding the circumstances around biologics chief Vinay Prasad’s imminent departure and recent request to remain anonymous during a media briefing about uniQure’s gene therapy for Huntington’s disease.

In this episode of Denatured, you'll listen to Oxana Iliach, senior director of regulatory strategy at Certara and Vera Pomerantseva, director of product management for risk-based quality management at eClinical Solutions. We speak about how the FDA's latest decision to have one, rather than two pivotal studies, for new drug applications raises the bar for data collection and risk-based management.Host⁠Jennifer C. Smith-Parker⁠, Director of Insights, BioSpaceGuestsOxana Iliach, Senior Director of Regulatory Strategy, CertaraVera Pomerantseva, Director of Product Management for RBQM, eClinical SolutionsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

After Friday’s news that Center for Biologics Evaluation & Research Chief Vinay Prasad will leave the FDA—again—at the end of April, stocks for several rare disease drug developers popped. UniQure, in particular, was up 51% in premarket trading on Monday. Prasad in a meeting last Thursday with select journalists called the biotech’s Huntington’s treatment AMT-130 a “failed” therapy, according to STAT News. Shares of Replimune and REGENXBIO—which have suffered rejections during the past year—also rose.One person who is not impressed with the plethora of rare disease drug rejections of late—H.C. Wainwright said in a note Tuesday that there have been at least five cell and gene therapies they believe could have been approved under prior FDA officials—is Wisconsin Senator Ron Johnson. Tuesday, Bloomberg News reported that Johnson has launched an investigation into these recent denials.Johnson called the FDA’s request that uniQure conduct a sham surgery-controlled trial of AMT-130 “bureaucratic idiocy,” according to the publication. Meanwhile, uniQure and the FDA appear to be on different pages regarding the design of this prospective trial, with uniQure Chief Medical Officer Walid Abi-Saab referring to a 10-12 hour surgery during which [burr] holes would be drilled in patients’ skulls and Prasad claiming on a media call last week that it would require only “one to three nicks in the scalp.”In other news, no episode of The Weekly would be complete without our weekly weight loss segment. Roche and Zealand Pharma’s amylin analog fell short of Eli Lilly’s rival candidate eloralintide; AbbVie reported what analysts called “competitive” results, with its amylin analog eliciting nearly 10% weight loss at 13 weeks in a Phase 1 trial; and Regeneron touted a much-needed Phase 3 win for Hansoh-partnered dual GLP-1/GIPR agonist olatorepatide in China. Beyond data, Novo Nordisk and Hims & Hers are together again, with Novo striking a deal to sell its injectable and oral GLP-1 medicines through the telehealth provider.Elsewhere on the business side of biopharma, experts are reporting a cut-throat atmosphere behind doors on the M&A front as the supply of companies available to buy dwindles.

Stylus Medicine CEO Emile Nuwaysir and Chief Scientific Officer Jason Fontenot speak with BioSpace about the biotech's work on next-generation genetic medicines—and why they think it’s the perfect time to be in the cell therapy game. Stylus Medicine is featured in BioSpace's  list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsEmile Nuwaysir, CEO, Stylus MedicineJason Fontenot, Chief Scientific Officer, Stylus MedicineDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

In this Denatured episode, Jennifer C. Smith-Parker speaks to Ram May-Ron, managing partner at FreeMind Group, and Ravi Kiron, managing director at Biopharma Strategy Advisors. We'll discuss how best to tailor an investment approach of both nondilutive funding and family offices to overcome the drug development valley of death. Host⁠Jennifer Smith-Parker⁠, Director of Insights, BioSpaceGuestsRam May-Ron, Managing Partner, FreeMind GroupRavi Kiron, Managing Director, Biopharma Strategy AdvisorsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

The FDA is dominating the headlines once again thisweek.  Days after FDA Commissioner Marty Makary appeared to question uniQure’s gene therapy candidate for Huntington’s disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO’s gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by issues with the study’s population, controls and use of surrogate markers to measure efficacy, according to the document.  Meanwhile, regulatory experts have expressed concernsthat the FDA’s circle of trust is shrinking, making many decisions feel like “fiat”—both in terms of individual drug applications and policy. The FDA has reportedly initiated a probe into complaints that a toxic workplace is fostered by CBER director Vinay Prasad, who is at the heart of many of these decisions. Finally, the biopharma industry continues to react to the agency’s pivot from a requirement of two pivotal trials to one for approval, asking why now, what are the risks and what exactly the FDA expects from this one trial.   Still on the gene therapy front, Sarepta Therapeutics CEO Doug Ingram stepped down last week to spend more time with family as the company’s muscular dystrophy mission hits home. Also during the company’s fourth quarter earnings call, Sarepta projected that sales of its embattled Duchenne muscular dystrophy gene therapy Elevidys will be flat or down as far as 15% in 2026.  On the obesity front, Eli Lilly topped Novo Nordisk again in a weight loss trial, this time in a Lilly-sponsored study of patients with type 2 diabetes. But don’t count Novo out yet. The company is actively seeking out new obesity assets, according to business development executive Tamara Darsow. Just last week, Novo linked with Boston’sVivtex to advance novel weight loss pills.Finally, check out BioPham Executive this week for a rundown of 2025’s top-selling assets—spoiler: Merck’s Keytruda held onto its crown as number one—and a story on former2seventy exec Chip Baird’s new role as CEO of recently launched Poplar Therapeutics, which secured a $45 million series A extension this week.

In this episode, you'll be listening to Indu Navar, CEO and founder of EverythingALS and Dr. Olga Uspenskaya, chief medical officer at VectorY Therapeutics. We'll be speaking about patient-pharma collaborations accelerating trials and hope, advances in ALS biology understanding and biomarker-driven endpoints.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuests⁠Indu Navar⁠, CEO and Founder, EverythingALSDr. Olga Uspenskaya, Chief Medical Officer, VectorY TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.  Everything is coming up Lilly. The Indianapolis-based pharma bested its chief rival, Novo Nordisk in a head-to-head test. In a Phase 3 trial initiated by Novo itself, Lilly’s Zepbound generated 25.5% weight loss while the Danish pharma’s CagriSema elicited 23%. The results sent Novo’s shares plummeting by an unprecedented 20% to a pre-Wegovy valuation while Lilly’s market cap continues to climb.   Novo attempted a comeback on Tuesday, announcing that its triple-G agonist UBT251 scored almost 20% weight loss after 24 weeks in a Phase 2 trial in China. By comparison, Lilly’s own triple-G competitor retatrutide led to 17.5% weight loss over the same timeframe, according to BMO Capital Markets analysts. Novo also sweetened the pot, announcing that it would slash the prices for all three of its GLP-1 medicines starting in 2027.    Meanwhile, the FDA kicked off Rare Disease Week with draft guidance on the new Plausible Mechanism Pathway for personalized therapies that was first teased in November. Jumping off last summer’s Baby KJ success story, the new pathway is aimed at advancing treatments for ultra-rare diseases. And a bipartisan senate hearing on Thursday will focus on the authorization process for rare disease therapies.  While the rare disease space has enjoyed recent regulatory progress, funding these vital therapies remains a challenge. Companies like the Orphan Therapeutics Accelerator (OTXL), a non-profit biotech, are trying to change this with creative approaches including tax exempt status and unique partnerships with CDMOs and CMOs. Finally, in a move that also has implication for the rare disease space, the FDA’s official pivot from a two clinical trial requirement to just one for new drug applications is lighting up biopharma social media.   And over at the CDC, there is more upheaval on the leadership front as National Institutes of Health Director Jay Bhattacharya replaces acting director Jim O’Neill as head of the agency, and principal deputy director Ralph Abraham steps down, citing “unforeseen family obligations.”    On the business front, Gilead inked the biggest M&A deal of the year so far, acquiring CAR T partner Arcellx for nearly $8B. And Merck’s Keytruda should have a few extra years of dominance thanks to a web of patents, with billions on the line. Check it out in BioPharm Executive, in your inboxes Wednesday.  HostsJef Akst, Managing Editor, BioSpaceHeather McKenzie, Senior Editor, BioSpaceAnnalee Armstrong, Senior Editor, BioSpace

Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care in this special bonus episode. Corsera Health is featured in BioSpace's NextGen: Class of 2026 list, the top startups to watch in the U.S.HostAnnalee Armstrong, Senior Editor, BioSpaceGuestsRena Denoncourt, Chief Operating Officer, Corsera HealthMeredith Kaya, Chief Financial Officer, Corsera HealthDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

In this episode, you'll be listening to Jane Hughes, President of R&D and Co Founder of Verdiva Bio, and Jon Rees, CEO and cofounder of MitoRx Therapeutics. We'll discuss next-generation obesity solutions tackling GLP-1's muscle loss and adherence challenges, through innovative muscle preservation, oral administration and combination therapy.HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsJane Hughes, President of R&D and Co-founder, Verdiva BioJon Rees, CEO and Co-founder, MitoRx TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Last week, the FDA declined to review Moderna’s mRNA-based flu vaccine, with Center for Biologics Evaluation and Research Director Vinay Prasad himself signing the refuse-to-file (RTF) letter. Prasad said Moderna’s comparator group “does notreflect the best-available standard of care,” while Moderna pushed back, saying CBER had previously found a standard-dose flu shot to be an “acceptable” comparator. Despite the shocking turn of events, HHS backed Prasad, saying Moderna didn’t “follow very clear FDA guidance from 2024.”Regardless of the reasons, the development imperilsModerna’s breakeven plans, affecting not just the company’s investigational flu vaccine but also a flu-COVID combo shot and other parts of the company’s pipeline. And for the broader industry, it highlights the regulatory uncertainty that persists into 2026, even as other countries move full speed ahead with novel modalities.That regulatory uncertainty extended this week to DiscMedicine, whose rare disease drug bitopertin was rejectedby the FDA. The company tried to convince investors that its planned Phase 3 trial would pave the way toward a refiling, but analysts raised concerns that the study was developed with oldFDA leadership. Disc’s situation also raises questions about the FDA’s Commissioner’s National Priority Voucher, which bitopertin had received.Meanwhile, Compass Pathways dropped long-awaited data from two Phase 3 trials of its psilocybin-based COMP360, showing strong durability data that “clearly met the Street’s bar for success,” according to Stifel analysts. The company plans to complete a rolling new drug application by the end of the year.Finally, the CDC has been left leaderless, again, with the departure of Jim O’Neill, who had been servingas acting director after the ouster of Susan Monarez last summer. And Sanofi’s Paul Hudson was removed as CEO last week. He’ll be replaced by Merck KGaA’s Belén Garijo, who becomes just the second woman in charge of a Big pharmacompany.

Last year, the FDA announced it would be phasingout animal testing requirements for some therapies. The NIHfollowed suit. According to Thomas Hartung, professor and chair at Johns Hopkins Bloomberg School of Public Health, these policy shifts are an “overdue adaptation to scientific progress.” In this special edition of The Weekly, Hartung discusses howartificial intelligence (AI) and various non-animal models such as human organoids will transform drug development and delivery, especially now that the regulatory side is catching up. The FDA Modernization Act, now making its way through Congress, codifies the FDA’s stated goal of starting to move away from animal testing. And in making that announcement last year, the FDA put out a roadmap for how to do this. In May, Hartung will attend the National Biotechnology Conference in San Diego as a keynote speaker. BioSpace is a media partner of the meeting, and Managing Editor Jef Akst will also attend to moderate the executive track. The 2026 National Biotechnology Conference runs May 11–14.You can find the agenda here.

In this episode of Denatured, Jennifer C. Smith-Parker speaks with Dr. Rob Monroe, Vice President and Chief Scientific Officer of Oncology at Danaher Corporation and Chief Medical Officer at Leica Biosystems, and Jennifer Fakish, Vice President and Franchise Head of Oncology at Danaher Corporation. We'll be discussing how antibody drug conjugates (ADCs) are transforming cancer care and with AI-powered pathology, doctors can now measure her HER2 more precisely to match patients with the best treatments. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestsDr. Rob Monroe, Vice President and Chief Scientific Officer, Oncology, Danaher Corporation; Chief Medical Officer, Leica BiosystemsJennifer Faikish, Vice President and Franchise Head, Oncology, Danaher CorporationDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Last Thursday, Hims & Hers launched a compounded versionof Novo’s oral Wegovy, approved just before Christmas and launched in early January. Novo was, not surprisingly, none too pleased. FDA Commissioner Marty Makary denounced“illegal copycat drugs” in an X post the same day without naming Hims, which then said it would notsell the oral weight loss drug. Novo sued the consumer healthcare company for patent infringement, seeking potentially hundreds of millions in damages. Thenit emerged that FDA hit Hims with a warning letter last year about infestations of vermin at a facility it owns, including rodents, birds and insects, as well as a live spider in a production area.The timing of all the Hims drama is interesting, because BioSpace was already covering Novo, Lilly and their blockbuster GLP weight loss drugs as both companies—and others—reported 2025 fourth quarter and full year earnings. EliLilly and Novo both reported last Wednesday, and both spoke of Novo’s oral Wegovy launch positively. But the calls had two very different tones, as Lilly beat Q4 2025 analyst consensus by more than a billion dollars while Novo projected sales to decline by 5% in 2026.In other recent earnings calls, AbbVie touted strong Skyriziand Rinvoq sales, and the company continues to follow Johnson & Johnson’s lead into the psychedelics space. And Biogen discussed the highly anticipated readout of its tau-targetingtherapy for Alzheimer’s.Finally, in gene therapy, Sarepta struggles to recover from last year’s patient deaths as other DMD contenders near the market; uniQure pauses two arms of a clinical trial for Fabry disease; and Ultragenyx resubmits its in vivo gene therapy UX111 for the treatment of Sanfilippo syndrome type A.