SUBSCRIBE
SUBSCRIBE
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
Q3 Earnings Are Here, Novo Ditches Cell Therapy but Buys Akero, Gov’t Shutdown Hits CDC
Johnson & Johnson has yet to make a drug pricing deal with Trump; Novo makes more moves under new CEO; more than 1,000 laid off from CDC, though many immediately hired back; the BIOSECURE Act is back and more.
October 15, 2025
 · 
1 min read
 · 
Heather McKenzie
illustration of man entering into a painting, surreal virtual meta verse concept
Immuno-oncology
Cartography Pushes Sequencing to the Limit To Find Bananas in 100 Apples
The startup, launched out of CEO Kevin Parker’s grad school idyll during the COVID lockdowns, is primed to find new targets where Big Pharmas won’t dare.
October 15, 2025
 · 
4 min read
 · 
Dan Samorodnitsky
Facade of AstraZeneca's office in Shanghai, China
Drug pricing
AstraZeneca Becomes Second Pharma to Strike DTC Deal With Trump Administration
The British pharmaceutical giant has joined the direct-to-consumer push, following Pfizer and Amgen’s announcements in response to the president’s calls to lower U.S. drug prices.
October 10, 2025
 · 
1 min read
 · 
Dan Samorodnitsky
People determined to be free, freedom and confinement vector art
Rare diseases
Nearly Three Quarters of FDA Breakthrough Designated Drugs Win Approval: Report
New analysis from Jefferies shows that rare disease and cancer drugs granted the status are especially likely to be approved.
October 9, 2025
 · 
3 min read
 · 
Dan Samorodnitsky
Podcast
Shutdown Pauses New Drug Reviews, CDC Issues New COVID Guidance, CGT Meets on Mesa
The U.S. government remains shut down, with the FDA closed for new drug applications until further notice; cell and gene therapy leaders gather for the annual meeting in Phoenix with the field in a state of flux; Pfizer and Amgen will make drugs available at a discount as President Donald Trump’s tariffs still loom; and new regulatory documents show how Pfizer beat out the competition for Metsera.
October 8, 2025
 · 
1 min read
 · 
Heather McKenzie
Tariffs Anxiety and tariff stress due to economic uncertainty and trade war reciprocal taxation as global imports and exports taxed causing fear and panic in the markets.
Tariffs
Most Life Sciences Companies Not Planning New Investments After Tariffs: Report
A new survey from CRB showed that most manufacturing initiatives in the U.S. made in response to tariffs are coming from Big Pharma companies, while smaller biotechs are left to hope “the situation doesn’t get worse.”
October 7, 2025
 · 
3 min read
 · 
Dan Samorodnitsky
Traffic light silhouette and golden sky.
ALS
FDA Lifts Clinical Hold, Clearing Neurizon’s ALS Drug for Human Trials
The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ‘strain’ on its capacity, according to Neurizon.
October 6, 2025
 · 
2 min read
 · 
Dan Samorodnitsky
A man and a wolf stand on a cliff overlooking a surreal floating island with a circular path and a glowing orb in the distance, digital art style, illustration painting
Cell and Gene Therapy
FDA’s New Cell and Gene Therapy Guidances Finally Go a ‘Click Further’ to ‘Game Changing’
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.
October 3, 2025
 · 
5 min read
 · 
Dan Samorodnitsky
Difficult question concept. Big question mark or big problem to solve or finding solution, doubt or uncertainty, thinking to make decision, businessman holds up big question mark.
Drug pricing
Pfizer’s Drug Pricing Deal With Trump Raises Questions About Access
At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.
October 1, 2025
 · 
2 min read
 · 
Dan Samorodnitsky
Podcast
M&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’s
M&A headlined for a second straight week as Genmab acquired Merus for $8 billion; Pfizer strikes most-favored-nation deal with White House; CDER Director George Tidmarsh caused a stir with a now-deleted LinkedIn post; GSK CEO Emma Walmsley will step down from her role; and uniQure’s gene therapy offers new hope for patients with Huntington’s disease.
October 1, 2025
 · 
2 min read
 · 
Heather McKenzie
Pfizer CEO Albert Bourla speaks at the Oval Office, standing in front of a lectern next to President Donald Trump, Mehmet Oz, Robert F Kennedy Jr
Drug pricing
Pfizer To Offer Drugs at a Discount in Agreement with US Government
Pfizer CEO Albert Bourla directly credited the threat of tariffs with leading to the deal, in which the company will offer drugs on a soon-to-be-launched website called TrumpRx.
September 30, 2025
 · 
2 min read
 · 
Dan Samorodnitsky
Company downsizing, staff reduction and layoffs. Employee dismissal, firing and unemployment. Business concept.
Layoffs
Sutro Makes Deeper Cuts To Extend Runway Into 2027, Reach Key Data Readout
After parting with 50% of its employees earlier this year, Sutro Biopharma will lay another third of its staff in a restructuring effort geared toward reaching key inflection points.
September 30, 2025
 · 
1 min read
 · 
Dan Samorodnitsky
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
 · 
1 min read
 · 
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
 · 
2 min read
 · 
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
 · 
1 min read
 · 
Dan Samorodnitsky
Load More