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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.

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Regulatory
FDA Breakthrough Designations Lead to Priority Reviews, Report Finds
A new analysis from Jefferies shows that drugs receiving breakthrough designations sail through the regulatory process more quickly, on top of frequently winning approval.
November 20, 2025
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1 min read
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Dan Samorodnitsky
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Mergers & acquisitions
UPDATE: Avadel Accepts Alkermes’ Revised $2.37B Counteroffer, Besting Lundbeck
Lundbeck had tried to scoop the narcolepsy drug maker out from under Alkeremes with $2.4 billion, but Avadel has elected to go with its original suitor.
November 19, 2025
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3 min read
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Tristan Manalac
Podcast
Billions More in M&A, Another Bidding War and More FDA Drama
Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high between FDA Commissioner Marty Makary and Health Secretary RFK Jr.
November 19, 2025
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1 min read
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Heather McKenzie
Johnson and Johnson sign
Mergers & acquisitions
J&J, Aiming for $50B in Cancer Sales, Buys Halda for $3B in Cash
Halda Therapeutics is developing oral assets for prostate and lung cancer. The deal comes after Johnson & Johnson set an ambitious goal for its oncology sales by 2030.
November 17, 2025
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2 min read
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Dan Samorodnitsky
External view of Bristol Myers Squibb's office California
Cardiovascular disease
BMS Jettisons Coronary Trial for J&J-Partnered Anticoagulant
Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.
November 14, 2025
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1 min read
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Dan Samorodnitsky
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Funding
Biohaven Seeks $150 Million From Wall Street Following FDA Rejection
After the FDA rejected its spinocerebellar ataxia treatment, Biohaven missed out on a $150 million payment from Oberland Capital. Now the company is reshuffling its pipeline to stay alive.
November 12, 2025
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3 min read
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Dan Samorodnitsky
Podcast
Pfizer Wins Metsera, Trump Strikes GLP-1 Pricing Deal, FDA Awards More Priority Vouchers
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
November 12, 2025
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1 min read
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Heather McKenzie
Illustration showing large scissors cutting employees in half
Layoffs
Kezar Loses 70% of Staff After FDA Cancels Meeting on Autoimmune Asset
Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
November 10, 2025
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2 min read
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Dan Samorodnitsky
Obesity
Despite Obesity Drug Pricing Deal, GLP-1 Compounders Continue To Operate in the Shadows
The White House may have struck a deal with Eli Lilly and Novo Nordisk last week to lower the costs of their weight loss drugs for patients, but knockoff versions of Zepbound and Wegovy still permeate the obesity market.
November 10, 2025
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3 min read
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Dan Samorodnitsky
Brussels, Belgium. 21st December 2020. Exterior view of Pfizer Pharmaceutical company's offices.
Mergers & acquisitions
Pfizer Wins Metsera Bidding War Over Novo With Final $10B Price Tag
After a bidding war erupted between Pfizer and Novo Nordisk over the fledgling obesity drugmaker, Metsera sided with its original suitor in a final agreement announced late Friday evening.
November 7, 2025
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1 min read
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Dan Samorodnitsky
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Regulatory
Wegovy, Casgevy Among Latest FDA Priority Review Voucher Recipients
The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
November 6, 2025
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3 min read
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Dan Samorodnitsky
Cambridge, USA - 16 August 2024. View of Moderna office entrance with logo sign, Biotechnology industry
Earnings
Moderna Posts Fourth-Straight Earnings Drop but the Bleeding Is Slowing
The company reported $200 million in net losses for the third quarter, but an aggressive and highly successful cost-cutting campaign is helping to stem the downward trend.
November 6, 2025
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2 min read
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Dan Samorodnitsky
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
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