In this webinar, experts from SK pharmteco’s European and North American sites share practical experience addressing these challenges across the linker-payload development lifecycle—from facility and containment strategy through process and analytical development, scale-up, cleaning, and final product release. Case-based examples will illustrate how integrated chemistry, engineering, analytical, and industrial hygiene strategies can reduce technical risk and support the rapid transition of emerging ADC programs into GMP manufacturing.
The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2 study of AMT-130 underestimates disease progression.
Roche’s anti-myostatin therapy emugrobart is unlikely to elicit meaningful weight loss, according to an interim mid-stage analysis, prompting the pharma to return the asset rights to its subsidiary Chugai Pharmaceutical.
The all-stock deal gives Summit Therapeutics enough money to see through Phase 3 trials for the PD-1/VEGF bispecific ivonescimab—but keeps the asset fully in-house without giving up licensing rights.
Investors looking for more transformative business development at Novo will have to wait, but a new partnership with China’s Hengrui Pharma adds a new weekly oral option to the Danish pharma’s early pipeline.
To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved Pasatru and Ipsen’s Sohonos.
Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2 billion.
What drives meaningful employee engagement in today’s life sciences workplace? This BioSpace report explores the factors that shape how employees feel about their organizations and what employers can do to create workplaces where talent wants to stay and thrive.
Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital Markets.
Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when should receive regenerative treatment.
The recent FDA approval of Fayuvi for a rare, childhood neurodegenerative disease was “particularly special” for Ultragenyx CEO Emil Kakkis. It could also, along with an August nod for another gene therapy, help offset recent challenges brought on by two asset failures.
Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about by AbbVie’s Humira and Sanofi and Regeneron’s Dupixent.
Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks.
Nektar Therapeutics has been awarded $90 million in damages after a jury sided with the biotech, which had accused Big Pharma Eli Lilly of “botching” an analysis of their formerly partnered autoimmune drug.
Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year.
Genentech's agreement with Earendil Labs came the same day its parent company, Roche, inked a cardiometabolic and renal deal with Atavistik Bio for up to $2 billion.
FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.”
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as her views on vaccines and abortion drugs.
While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as Lewy body dementia.
Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate.
Kyverna Therapeutics' miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on Thursday. The biotech plans to file for priority review this year.
Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and up to $7.8 billion for Centessa Pharmaceuticals in March.
In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We look at the momentum behind radioligand therapy and how its diagnostic and therapeutic capabilities are improving care for more than 14 million patients worldwide.
While artificial intelligence can help biotech and pharma companies more quickly vet job applicants, it can also turn off the very people they want to employ. Two recruiting experts discuss AI’s role and limitations in the hiring process.
Biotechs that announced series B financing this year and are expanding their workforces include one that raised $2.1 billion and has partnerships with Eli Lilly, Johnson & Johnson and Novartis.
After imeroprubart failed to demonstrate sufficient efficacy in lupus during a Phase 2b trial, Immunovant is moving on from the indication and looking to other high priority programs for the drug in neurology, endocrinology and rheumatology.
Amgen is awaiting another Phase 3 readout for the investigational Sjögren's disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to support an FDA application.
A late-stage test of Roche and Ionis Pharmaceuticals’ sefaxersen showed that the drug reduced protein in the urine, which suggests the RNA-targeting therapy could improve kidney function and delay transplant.
Ulefnersen, an RNA-targeted therapy being developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, improved measurements of functional impairment and survival in patients with a rare, genetic ALS subtype in a Phase 3 trial. The partners plan to approach the FDA with the results to determine potential pathways for approval.
Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the FDA recommended the biotech conduct a new clinical study.
Viking Therapeutics’ VK2735 met Truist’s “best-case scenario,” with robust weight loss that was largely maintained when patients transitioned to less frequent dosing. Viking’s stock popped more than 30% on Tuesday.
While Vertex is laser-focused on an upcoming FDA decision for povetacicept in immunoglobulin A nephropathy, the APOL1 inhibitor inaxaplin has demonstrated potential “best-in-class” data in a different kidney disease.
With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could support the potential of its next-gen GLP-1 and GIP receptor agonist to treat diseases far beyond obesity.
With more than 25 companies debuting on the public markets, 2026 has recorded the highest number of biotech IPOs since 2021. Now, four companies—including Iambic Therapeutics and ADARx Pharmaceuticals—are looking to grow this total even further.
Novo CEO Maziar Mike Doustdar disclosed an additional 4,000 staff departures, which a spokesperson told BioSpace are linked to attrition and other measures.
The mid-stage readout is one link in a chain of catalysts that analysts were watching for this year from Roche’s metabolic pipeline, which features assets from the $2.7 billion acquisition of Carmot Therapeutics as well as partner Zealand Pharma.
Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and T cell engagers.
Novo has “gone shopping” to fill pipeline gaps, with a focus on obesity and diabetes, plus an expansion in blood and endocrine disorders, liver diseases and cardiovascular conditions.
Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendocrine tumors. The asset was rejected by the FDA last month for manufacturing concerns.
Investors and analysts have been hounding Novo to beef up its pipeline and advance new molecules as a majority of the company's sales stem from its semaglutide franchise.
Delivering therapeutics directly to tumors, as in the case of Replimune’s recently approved Tudriqev and Amgen’s Imlygic, holds advantages, especially when cancer is caught early, but challenges remain before the method becomes a mainstay in treatment.
Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by the Senate, will commissioner nominee Heidi Overton stay the course?
As molecule complexity rises, advanced cell line development platforms are giving biopharma companies new tools to overcome expression challenges, improve stability and reach the clinic faster.
A new five-year biotech plan has been released by the Chinese government, revealing ambitious goals such as achieving five blockbuster medicines on the global markets in that time.
Electra Therapeutics has exceeded its initial fundraising plans as it becomes the 26th biotech to debut publicly this year and outlines pivotal development plans for its monoclonal antibody ipsoprubart.
As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, triggering a temporary pause.
The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month.
Bristol Myers Squibb acquired the degrader-antibody conjugate from Orum Therapeutics in 2023 for $100 million upfront and the possibility of up to $80 million more in milestones.
The multi-drug partnership with Orbis Medicines—which Novo Holdings has backed since the biotech's seed rounds—is focused on cardiometabolic targets, but the technology at the center of the deal could deliver oral weight loss candidates. Obesity rival Eli Lilly has also helped fund Orbis.
Learn what manufacturing challenges lie ahead, how to equip your team to protect your program from avoidable manufacturing and regulatory setbacks and forge partnerships that can withstand the next five years of industry turbulence.
While increases in the interest rate from the Federal Reserve are usually bad for biotech, the sector at this moment is poised to withstand the blow, according to analysts, though earlier stage companies may be left in the lurch.
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
With just over $10 million in cash available to fuel operations through the end of the year, Longeveron is undertaking a strategic review after the failure of a cardiovascular study.
In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life.
As biopharma job openings rose this year, opportunities were greatest in Massachusetts and California and in the science/R&D and clinical disciplines, according to BioSpace data. Several other locations and functions have also been going strong.
After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations.
The TREM2 stabilizer failed to show efficacy in a Phase 2 trial of patients with early-stage ALS. This development follows two late-stage trial failures reported by Novartis last week, plus the news that the pharma has paused multiple CAR T cell trials following patient deaths.
Sling Therapeutics is advancing the first late-stage oral drug for thyroid eye disease that, if approved, could compete against Amgen and Viridian Therapeutics.
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
As AI becomes more embedded in biotech R&D, companies are competing for professionals who can bridge biology, machine learning, data and engineering. Recruiting expert Darren Nelson explains which capabilities are becoming hardest to find—and why.
Biopharma professionals are among those delaying retirement, with 52% expecting to leave the workforce later than originally planned, according to a BioSpace LinkedIn poll. A career coach and recruiter discuss why some are pushing out or moving up their exits.
A growing number of biotechs are entering the market with newly launched medicines, a pattern indicative of “improving capital markets,” according to Jefferies’ Andrew Tsai.
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. "The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt said during the meeting, but many other factors will ensure this new drug class can benefit patients.
Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.
After inking a T cell engager pact with Chimagen Biosciences a few years ago, GSK is back for more, this time acquiring a multiple myeloma program from the antibody specialist.
After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.”
This guide explores the evolving role of podcasts, webinars, and thought leadership programs in biopharma and provides practical recommendations for public relations agencies, corporate communications teams, and commercial marketers looking to elevate their visibility and influence.
BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
Positive topline results from a second straight study in generalized anxiety disorder shift the narrative for Definium Therapeutics’ DT120 to commercialization, Jefferies analysts said Monday, while Stifel wrote that the asset is moving towards an FDA submission.
SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.
Scholar Rock’s spinal muscular atrophy drug, now to be called Isembyld, was originally rejected in September 2025, when the FDA cited compliance problems at a third-party manufacturer.
With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still slow progress. Viva Biotech’s experts outlined how hybrid synthesis, ADME/PK modeling and AI‑guided design are expanding what peptide therapeutics can reach.
Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.
Following their blowout win in melanoma last month, Merck and Moderna are leading the way among a new crop of personalized cancer vaccines. Here are five companies with similar therapies hoping to break through where others have previously failed.
A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”
Join BioSpace's Managing Editor, Director of Insights and Vice President of Marketing for an inside look at how PR, communications and marketing teams can successfully leverage webinars, podcasts and integrated content campaigns to elevate executive voices, share industry expertise and engage key biotech and pharma audiences.
