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.
Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results.
FEATURED STORIES
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.
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.
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 about her views on vaccines and abortion drugs.
LATEST PODCASTS
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.
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
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.
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SPECIAL EDITIONS
As Big Pharma adds AI technology to bolster drug development, a cadre of new, upstart biotechs are pushing drug discovery to new heights.
BioSpace takes stock of the psychedelic therapeutics space, which is once again on the cusp of its first FDA approval.
Job postings increase and competition dips, according to BioSpace data.
DEALS
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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. -
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. -
The new partnership follows Roche’s recent R&D expansion in Boston focused on development for cardiovascular, renal and metabolic diseases. -
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.
WEIGHT LOSS
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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.” -
Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday. -
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming. -
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. -
With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
POLICY
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As Chinese companies push beyond “me-too” drugs and the country lays out a new five-year plan targeting a $522 billion–strong biotech industry by 2030, experts say more predictable funding and regulation could help the U.S. maintain its edge. -
Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites. -
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA. -
Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program, representing some 89% of the branded drug market. -
The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China is winning.
A career setback can teach you something useful—or teach you the wrong lesson. Executive coach Angela Justice explains how one difficult experience can quietly shape the choices that follow.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
With U.S. data science jobs projected to grow 35% over the next decade, a recruiter and talent strategy director discuss the qualifications, technical skills and mindset needed to land these coveted positions.
Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.
An executive who is rarely short on ideas needs someone to pull their big ideas through to implementation. Kaye/Bassman’s Michael Pietrack explains why this person, who he calls the implementer, may be the most important hire in the building.
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
HOTBEDS
REPORTS
Gain the latest insights into the biopharma hiring landscape with BioSpace’s Biopharma Job Market Report Q2 2026. Explore the trends shaping talent acquisition, from rising job postings and sustained R&D hiring to the market activity signaling stronger hiring demand ahead.
Opportunities increased by the end of the first quarter, according to BioSpace data.
In this whitepaper, BioSpace reviews the major trends impacting the CDMO sector and the evolving relationship between sponsors and providers. We examine the key qualities pharma and biotech should consider in CDMO selection, and how the macroeconomic and macrodevelopment factors affecting the space play a role in this selection.
CANCER
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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. -
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. -
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. -
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. -
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.
NEUROSCIENCE
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In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control. -
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. -
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. -
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. -
Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
CELL AND GENE THERAPY
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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. -
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. -
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.
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Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies. -
Encoded Therapeutics’ lead asset ETX101 is a gene therapy being tested for Dravet syndrome. Phase 1/2 data showed substantial reductions in seizures.
