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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.

Podcast
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
July 23, 2025
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1 min read
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Jef Akst
A finger presses down on a businessman. Art collage.
Immuno-oncology
Replimmune Plummets Following FDA’s Surprise Rejection of Melanoma Treatment
BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimmune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
July 22, 2025
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1 min read
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Dan Samorodnitsky
Searching for investments for a startup. Fundraising campaigns. Accumulation of funds. Search for investors and lending. New space race. A promising project
Funding
Avalyn Pharma Adds $100M Series D for Inhaled Pulmonary Fibrosis Drugs
The company is pushing inhaled versions of common oral drugs with the hope of avoiding severe side effects.
July 22, 2025
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2 min read
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Dan Samorodnitsky
A brick building with the sign Food and Drug Administration on the entrance
Regulatory
FDA’s CDER Gets New Chief in Biopharma Veteran George Tidmarsh
Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as director of the Center for Drug Evaluation and Research will be his first government position.
July 21, 2025
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2 min read
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Dan Samorodnitsky
Illustration of two syringes in a pop art style with pinks and blues
Vaccines
After Moderna Pulled Its Shot, Combination Flu/COVID Vaccines Hang in Limbo
Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based combination shot that targets both influenza and COVID-19. Now, the entire vaccine sector is sizing up a new regulatory world, companies’ next steps uncertain.
July 21, 2025
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7 min read
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Dan Samorodnitsky
Goal disorientation and lack of vision. Inability to set the right business objectives. Failure to achieve the objectives. Missing the unrealistic and inaccurate company goals.
Rare diseases
AstraZeneca’s Amyloidosis Asset Stumbles in Late-Stage Trials
The antibody anselamimab, which AstraZeneca picked up in its 2021 purchase of Caelum Biosciences, failed to improve survival and reduce hospitalizations, but the company sees promise in data from an unspecified patient subgroup.
July 16, 2025
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1 min read
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Dan Samorodnitsky
Podcast
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
July 16, 2025
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1 min read
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Heather McKenzie
Contemporary art collage. Conceptual design with young woman, motivated employee running forward to reach goal, professional success. Concept of business, career development, achievement
Obesity
Hengrui’s Dual GLP-1/GIP Elicits 17.7% Weight Loss in Phase III
The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application in China and global clinical trials.
July 15, 2025
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2 min read
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Dan Samorodnitsky
3d rendering medical heart in yellow background
Cardiovascular disease
AstraZeneca’s Baxdrostat Pushes Blood Pressure Lower in Phase III Trial
The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines.
July 14, 2025
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1 min read
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Dan Samorodnitsky
Complete response letters
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public insight into the reasons new drug and biologics applications got rejected.
July 10, 2025
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2 min read
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Dan Samorodnitsky
AbbVie's office in South San Francisco, California
Cancer
AbbVie Scoops Up Ichnos Glenmark’s Lead Myeloma Antibody for Nearly $2B
The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.
July 10, 2025
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1 min read
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Dan Samorodnitsky
A hand in a medical or laboratory glove holds a laboratory flask with coins with dollar sign. Investments in laboratory research and science. Concept of profit, making money, business. Modern design. Copy space.
Gene therapy
AstraZeneca Gains More Gene Therapy AAVs in JCR Deal Worth up to $825M
The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR Pharmaceuticals for use in up to five of Alexion’s gene therapies.
July 9, 2025
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1 min read
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Dan Samorodnitsky
Podcast
Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More
H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn.
July 9, 2025
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1 min read
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Heather McKenzie
Creative picture image collage banner of guy worker jump from financial charts determined company success.
Immunology and inflammation
Cogent Jumps on Positive Mid-Stage Mastocytosis Data and NDA Plans
A readout from the company’s SUMMIT trial put its small molecule bezuclastinib on a collision course with rival Blueprint’s Ayvakit, which Leerink analysts said does not sufficiently treat all patients.
July 7, 2025
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1 min read
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Dan Samorodnitsky
Robot and human hand in retro collage style with halftone. Vector illustration, artificial intelligence concept.
Artificial intelligence
Roche’s Chugai Breaks Into Aging via Potential $1B+ Deal With AI Outfit Gero
The partnership will give Chugai access to Gero’s artificial intelligence technology to discover novel targets in aging-related diseases. Chugai will then develop antibody-based drugs based on the findings.
July 7, 2025
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2 min read
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Dan Samorodnitsky
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