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Dan Samorodnitsky

Dan Samorodnitsky

News Editor

Dan Samorodnitsky is the news editor at BioSpace. He has a decade of experience covering biotech, genetics and medicine. Before coming to BioSpace he was an editor at Drug Discovery News and Massive Science, and his writing has appeared in outlets such as Quanta, STAT, GROW and many others. He is based in Minneapolis. You can reach him at dan.samorodnitsky@biospace.com.

FDA Headquarters_Grandbrothers/Adobe Stock
Rare diseases
FDA Overruled Reviewers in Approving Stealth’s Barth Syndrome Treatment
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
November 5, 2025
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2 min read
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Dan Samorodnitsky
Podcast
Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
November 5, 2025
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1 min read
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Heather McKenzie
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Immunology and inflammation
Neurocrine Goes to China To Grow Pipeline in up to $881M TransThera Deal
At the center of the licensing deal is an NLRP3 inhibitor that has shown “encouraging efficacy in acute inflammation models,” according to TransThera, indicating its potential in various metabolic and inflammatory diseases.
November 3, 2025
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1 min read
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Dan Samorodnitsky
South San Francisco, CA, USA - Feb 23, 2024: Exterior view of AbbVie's research facility in South San Francisco. AbbVie is an American pharmaceutical company headquartered in North Chicago, Illinois.
Earnings
AbbVie’s Immunology Dyad Dominates Again in Q3
Skyrizi and Rinvoq made nearly $7 billion combined, almost half of the company’s income for the quarter alone.
October 31, 2025
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2 min read
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Dan Samorodnitsky
Merck & Co. headquarters in Silicon Valley; Merck & Co. Inc. is an American multinational pharmaceutical company
Earnings
Merck Vaccine Sales Drop as US Declines Strike Another Pharma
While the company’s sales outlook was otherwise rosy, Merck took sales hits on Gardisil, Proquad, Varivax and Vaxneuvance.
October 30, 2025
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1 min read
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Dan Samorodnitsky
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).
Biosimilars
FDA Proposes Lower Bar for Biosimilar Approvals in Bid To Lower Drug Prices
Generic versions of biologic drugs could hit the market without human trials and allow the market forces to bring down costs, HHS leaders said while announcing new draft guidance.
October 29, 2025
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3 min read
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Dan Samorodnitsky
Podcast
Novartis’ Big Buy, Q3 Earnings, Regeneron’s Dropped Cell Therapy, More
As third-quarter earnings continue to roll out, Novartis makes headlines with the second biggest acquisition of the year; Novartis’ CEO also downplayed the impact of Big Pharma pricing deals with the Trump administration; Regeneron continued the trend of dropping cell therapy assets; BioSpace takes a look at how the FDA is functioning mid-shutdown.
October 29, 2025
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1 min read
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Heather McKenzie
USA shutdown and United States government closed and american federal shut down due to spending bill disagreement between the left and the right pas a national finance symbol with yellow hazard tape in a 3D illustration style.
Government
FDA Struggles To Keep Lights On Amid Shutdown as Biopharmas Begin To See Delays
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
October 29, 2025
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4 min read
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Dan Samorodnitsky
Creative picture image collage banner of guy worker jump from financial charts determined company success.
Neuroscience
BridgeBio Pops on Late-Stage Limb-Girdle Muscular Dystrophy Data
New interim data from a Phase III trial puts the company on track to file for FDA approval next year in an indication that not only lacks a disease-modifying treatment but suffered significant setbacks after a patient died in a clinical trial for Sarepta’s investigational gene therapy.
October 27, 2025
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2 min read
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Dan Samorodnitsky
Cambridge, USA - 26 July 2024. View of leading global biotechnology company Biogen office exterior banner logo sign, Biotech industry
Immunology and inflammation
Biogen Grows Immunology Pipeline With Vanqua’s Anti-Inflammatory Molecule
The $70 million upfront deal adds to a portfolio of drugs Biogen has been growing in various immunological conditions since 2024.
October 24, 2025
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2 min read
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Dan Samorodnitsky
Hands reach out to each other. Handshake. Halftone retro hands. Body parts cut out of newspaper. Hands tied with thread. Shaking hands. Make a deal. Successful agreement. Modern collage
Mergers & acquisitions
Ipsen Puts Up $1.6B To Absorb ImCheck for Mid-Stage Leukemia Antibody
The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.
October 22, 2025
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1 min read
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Dan Samorodnitsky
Podcast
Novo Board Upended, ESMO Excitement, FDA Awards, Replimune’s U-Turn
Novo Nordisk’s leadership gets another shake-up as President Trump promises to significantly slash prices for its GLP-1 drugs; Summit/Akeso, Exelixis and more present new data at ESMO 2025; Replimune pops as FDA accepts resubmitted BLA; FDA names first winners of Commissioner’s National Priority Voucher program; and more.
October 22, 2025
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1 min read
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Heather McKenzie
Unhappy young woman feel lonely abandoned in crowd suffer from communication lack. Upset girl struggle with depression or mental disorder. Psychological problem. Flat vector illustration.
Neuropsychiatric disorders
Neuphoria’s Social Anxiety Drug Flunks Late-Stage Trial
The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.
October 21, 2025
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2 min read
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Dan Samorodnitsky
Hands holding crystal ball fortune telling collage art. Abstract concept of prophecy and prediction of future illustration
FDA
Krystal Biotech’s FDA Platform Designation Pushes Limits of the Award
The company’s technology, a modified herpes simplex virus used to deliver gene therapies, was given the FDA’s new designation based on its approved topical skin cream. What this will mean for Krystal’s still-in-development eye drop is unclear.
October 21, 2025
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2 min read
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Dan Samorodnitsky
World kidney day. Human hands holding healthy kidney shape made from paper on light blue background.
Autoimmune disease
Roche’s Gazyva Expands Out of Cancer With FDA Approval for Lupus
The anti-CD20 antibody, developed by Roche’s Genentech along with Biogen and already approved for multiple oncology indications, is branching into autoimmune disease. Its B cell–targeting mechanism of action gives it activity in improving kidney conditions in patients with lupus nephritis.
October 20, 2025
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2 min read
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Dan Samorodnitsky
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