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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
Tariff-Triggered Recession Fears, Fallout From HHS Cuts, Knockoff GLP-1s and More
A consumer-driven weight loss market could put pharma at greater risk if a recession hits; the continued turmoil at FDA and other HHS agencies magnifies the uncertainty facing the industry; Lilly files a lawsuit against a med spa selling its drugs; and more.
April 9, 2025
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1 min read
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Heather McKenzie
The factor that changes everything. A critical break. A sudden change in plans. A threat and a danger. Recover from the blow and get back on course. Severe stress. Withstand the blow.
Rare diseases
Rallybio Pivots as Antibody for Rare Bleeding Disorder Flunks Dosing Trial
The company is dropping its former lead molecule in favor of another antibody, RLYB116, which is being developed for a variety of rare autoimmune disorders.
April 8, 2025
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1 min read
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Dan Samorodnitsky
Government
Kennedy Senate Appearance to Address HHS Cuts Won’t Proceed This Week
Senators Bill Cassidy and Bernie Sanders asked HHS Secretary Robert F. Kennedy, Jr. to make good on a pledge to appear before the committee regularly. It is not clear if or when the hearing, which was scheduled for Thursday, will take place.
April 7, 2025
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2 min read
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Dan Samorodnitsky
Woman checking her weight on a measuring device after dieting
Obesity
Rhythm Drug Leads to Reduced BMI in Rare Obesity Indication
Stifel analysts were bullish on the data, which showed a 16.5% drop in body-mass index among patients with damage to the hypothalamus taking Rhythm Pharmaceuticals’ Imcivree.
April 7, 2025
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2 min read
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Dan Samorodnitsky
Courtesy of Sarepta Therapeutics
Duchenne muscular dystrophy
Committee Recommends EU Trials of Sarepta’s Elevidys Continue, Day After Holds
One day after the European Medicines Agency requested that three clinical trials of Elevidys be placed on hold after the death of a U.S. teenager, a data monitoring committee concluded that they should continue unchanged.
April 4, 2025
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2 min read
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Dan Samorodnitsky
FDA
Scott Steele Steps In as FDA’s Interim CBER Head After Marks’ Departure
Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the reins in a department inside an agency beset by cuts, layoffs, and confusion.
April 2, 2025
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3 min read
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Dan Samorodnitsky
Brain , concept idea art of thinking, surreal portrait painting, conceptual artwork, 3d illustration
Neurodegenerative disease
Denali Goes All In on Neuroscience’s Thorniest Hurdle: Crossing the Blood-Brain Barrier
After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, which today began a rolling BLA for accelerated approval.
April 2, 2025
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5 min read
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Dan Samorodnitsky
Podcast
FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio Data, Kisunla’s EU Miss, More
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
April 2, 2025
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1 min read
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Heather McKenzie
Company downsizing, staff reduction and layoffs. Employee dismissal, firing and unemployment. Business concept.
Layoffs
Carisma Lays Off Most of Staff, Eyes Sale of Assets and Company
Cell therapy and oncology–focused Carisma Therapeutics started layoffs late last year. Now the company plans to wind down fully.
April 1, 2025
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1 min read
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Dan Samorodnitsky
Wooden blocks with arrow and error icon. Delays and disruptions, stop the process, critical error concept
Alzheimer’s disease
EU Rejects Lilly’s Alzheimer’s Drug Kisunla, Following Same Path as Rival Leqembi
The European Union’s CHMP said that the benefits of the drug, already approved in the U.S., do not outweigh the risk of potentially fatal brain swelling and bleeding.
March 28, 2025
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2 min read
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Dan Samorodnitsky
Different pills on seesaw weight scale. Comparison, choice, healthcare and medicine concept. Flat design. EPS 8 vector illustration, no transparency, no gradients
Cancer
Merck’s Injectable Keytruda Matches IV Formula in Pivotal Trial
Merck’s new formulation of the mega-blockbuster Keytruda, made in collaboration with Alteogen, could help to keep the drug’s patent cliff at bay.
March 28, 2025
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2 min read
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Dan Samorodnitsky
caute cartoon businesspeople stand on hands with blue backgroound
China
Bayer Jumps on Chinese Partnership Train with Oncology Deal
The German conglomerate announced a licensing agreement with Puhe BioPharma for a PRMT5 inhibitor used in a variety of cancers. Financial details of the deal were not disclosed.
March 26, 2025
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1 min read
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Dan Samorodnitsky
Podcast
Trump’s Pharma Tariffs, Monarez for CDC, Novo’s New Obesity Play, More
President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
March 26, 2025
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1 min read
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Heather McKenzie
Businessmen working together installing gears in human head, business initiative, mindset improvement concept
Vaccines
GSK Builds on Real-World Experiment to Study Shingrix’s Impact on Dementia
The British pharmaceutical giant is working with the U.K. Dementia Research Institute to exploit a “natural randomization” experiment to determine whether 65- and 66-year-olds who received GSK’s shingles vaccine Shingrix have reduced dementia risk.
March 25, 2025
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1 min read
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Dan Samorodnitsky
Online Vertebrologist ,Orthopedics Woman traumatologist Surgeon Doctor.Internet Presentation Seminar.Fracture, Pain in Back Spine Diagnostics.Internet Conference. Digital Medical Hospital Illustration
Immunology and inflammation
Hillstar Bio Nets $67M Series A to Advance Autoimmune and Arthritis Pipeline
Led by alums from Takeda and Boston Pharmaceuticals, Hillstar Bio is working on treatments that remove harmful immune cells to relieve disease.
March 25, 2025
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2 min read
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Dan Samorodnitsky
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