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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.

Company downsizing, staff reduction and layoffs. Employee dismissal, firing and unemployment. Business concept.
Layoffs
Heidelberg Pharma Misses Out on Royalty Payment, Plans 75% Workforce Cut
The company was awaiting $70 million from HealthCare Royalty but missed an agreed-upon payment condition.
September 26, 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).
Rare diseases
FDA Approves Crinetics’ Once-Daily Acromegaly Treatment
The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with the rare pituitary condition. It’s the first approval for Crinetics Pharmaceuticals and something CEO Scott Struthers predicted “will transform people’s lives.”
September 25, 2025
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2 min read
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Dan Samorodnitsky
Accumulated problems, contradictions. Dead end, we need to go back. You cannot continue further. Complete impossibility to continue. Rejection of an idea. Hard sanctions. Fatal error.
Rare diseases
Acadia Scraps Prader-Willi Drug After Late-Stage Failure
Acadia Pharmaceuticals was testing the drug, an intranasal formulation of the oxytocin analogue carbetocin, for its potential to ease hyperphagia in the rare neurological condition.
September 24, 2025
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1 min read
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Dan Samorodnitsky
Podcast
FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More
The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss startup Metsera for nearly $5 billion after suffering a hat trick of R&D failures; psychedelics are primed for M&A action and Eli Lilly may be next in line; RFK Jr.’s revamped CDC advisory committee met last week with confounding results; and Stealth secured its Barth approval.
September 24, 2025
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2 min read
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Heather McKenzie
Pictured: Blue Sanofi sign on building in Germany at night
Multiple sclerosis
FDA Action Date for Sanofi’s Oral Multiple Sclerosis Drug Bumped to December
The company was expecting a decision from the FDA by Sept. 28 for its oral drug tolebrutinib, but an update to the drug’s application package convinced the agency to take more time to review.
September 22, 2025
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1 min read
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Dan Samorodnitsky
Black swan theory or a black swan event is a term used to describe a very rare or otherwise unexpected event that has a major effect, such as a financial crash or pandemic. The term is based on an ancient saying which presumed black swans did not exist.
Rare diseases
Rare Disease Experts See Futility in FDA’s Proposed Framework
The FDA’s proposed Rare Disease Evidence Principles review process is a starting point for getting rare disease therapies across the finish line, but industry leaders say there are more concrete steps the regulator could take to help patients.
September 22, 2025
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5 min read
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Dan Samorodnitsky
2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday – Friday, 9 am – 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.
Vaccines
ACIP Day 2 Reveals Confusion, ‘Lack of Knowledge,’ on Revamped Committee
After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
September 19, 2025
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5 min read
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Dan Samorodnitsky
Contemporary art collage of people, employees carrying geometric figures symbolizing team work. Concept of team, business, success, professional growth, career, analytics. Copy space for ad
Neurodegenerative disease
VectorY Bets up to $1.2B+ That Shape’s Brain-Penetrant Capsids Are a Fit
VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments.
September 18, 2025
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2 min read
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Dan Samorodnitsky
Podcast
China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More
The White House is clamping down on pharma’s ability to buy new molecules from Chinese biotechs; Sanofi, Merck and others abandon the U.K. after the introduction of a sizeable levy; Novo CEO Maziar Mike Doustdar lays off 9,000 while the company presents new data at EASD; Capsida loses a patient in a gene therapy trial; and CDER Director George Tidmarsh walks back comments on FDA adcomms.
September 17, 2025
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2 min read
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Heather McKenzie
Novo Nordisk's logo on the facade of its building in Germany
Obesity
Novo’s Amylin Injectable Cagrilintide Hits 11.8% Weight Reduction in Phase III Trial
The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.
September 16, 2025
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2 min read
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Dan Samorodnitsky
U.S. and Chinese flags in concrete, broken in the middle
China
Trump Reportedly Preparing Order Restricting Chinese Drug Licensing Deals
A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
September 11, 2025
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2 min read
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Dan Samorodnitsky
Dollar boat swimming on paper waves
Funding
Odyssey Rebounds Off Failed IPO With $213M Series D
The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.
September 10, 2025
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1 min read
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Dan Samorodnitsky
Podcast
Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More
This week’s release of the Make America Health Again report revealed continued emphasis on vaccine safety; Health Secretary Robert F. Kennedy Jr.’s faceoff with senators last week amounted to political theater; the FDA promises complete response letters in real time and shares details on a new rare disease framework; and Summit disappoints at the World Conference on Lung Cancer in Barcelona.
September 10, 2025
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1 min read
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Jef Akst
Contemporary art collage of woman sitting in the lotus position, cloud, pillows against the background of the night sky. Concept of healthy lifestyle and sport. Good and relaxing sleep. Copy space.
Neuroscience
Alkermes One Ups Takeda in Narcolepsy, Clearing Cognitive Impairments in Mid-Stage Trial
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
September 8, 2025
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2 min read
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Dan Samorodnitsky
graphic pattern with the tablet. topic of drugs. pill with girl and space inside. relax
Psychedelics
With Lykos MDMA Rejection Letter Out, MAPS Founder Decries ‘Change of the Goal Posts’
Rick Doblin, the founder of the Multidisciplinary Association for Psychedelic Studies, which founded Lykos, bemoaned a “moving of the goal posts” in Lykos’ rejection but looked for positives in the newly released complete response letter.
September 5, 2025
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3 min read
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Dan Samorodnitsky
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