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Michael Gibney

Michael Gibney is a freelance writer with more than a decade covering the biotech, pharmaceutical and healthcare industries. Most recently he served as senior writer and editor at PharmaVoice.

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Cardiovascular disease
Novo’s IL-6 inhibitor fails in cardiovascular Phase 3, plunging shares more than 9%
Novo Nordisk’s IL-6 inhibitor ziltivekimab failed to reduce the risk of cardiovascular events in the late-stage trial, dashing hopes for an edge in the hyper-competitive cardiometabolic space.
July 31, 2026
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2 min read
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Michael Gibney
complex messy management, bureaucracy,red tape,organization and innovation,business disruption, complicated business process
FDA
Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but trial design was a major sticking point as the panel deliberated.
July 30, 2026
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5 min read
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Michael Gibney
Stacked person head silhouettes. Abstract painting.
Neuroscience
MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb’s Cobenfy is likely to hold its market share.
July 27, 2026
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2 min read
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Michael Gibney
businessman checking mark on checklist with a red marker on dark background
FDA
FDA has recommitted to adcomms—but to what end?
The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings were called at all, while many have questioned the rationale behind them and other adcomms on deck.
July 27, 2026
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5 min read
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Michael Gibney
chain which breaks under pressure with the back wall
Diabetes
Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape with innovative approaches—and experts say there’s room for all of them.
July 20, 2026
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7 min read
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Michael Gibney
Close up shot red darts arrows in the target center on dark blue sky background. Business target or goal success and winner concept.
Lung cancer
Kelun’s Merck-partnered ADC notches late-stage NSCLC win alongside Keytruda
The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.
July 15, 2026
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2 min read
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Michael Gibney
FDA headquarters with a purple psychedelic background.
Psychedelics
Final psychedelics guidance suggests FDA is ‘receptive’ to helping companies succeed
The agency’s finalized recommendations for clinical testing of psychedelic compounds for mental health could pave the way for companies like Compass Pathways, whose psilocybin-based therapy for treatment-resistant depression could win approval as early as this year.
July 14, 2026
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3 min read
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Michael Gibney
Man walking through a glowing upward arrow shaped doorway with light streaming in from the sky outside, hope, success, 3d render
Alzheimer’s disease
AAIC 2026: Tau-targeted Alzheimer’s treatments heat up while amyloid therapies persist
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
July 10, 2026
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6 min read
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Michael Gibney
Businesswoman running arrow path breaking barriers of inequality, feminism, overcoming women's obstacles. and leadership. isometric vector illustration.
Drug Development
5 molecular glues that could stick—and the companies stuck in
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
July 6, 2026
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6 min read
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Michael Gibney
New Opportunity, Businessman Walks Up Stairs Finds Exit Big Door
FDA
FDA’s cell and gene therapy head steps down after 1 year
Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
June 30, 2026
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2 min read
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Michael Gibney
moving up colorful transparent arrows on white background
Psychedelics
Definium’s LSD-based therapy elicits ‘profound’ efficacy in Phase 3 depression trial
Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
June 22, 2026
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2 min read
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Michael Gibney
Purple neon arrow with glowing light trails and dynamic motion effect on dark background
ALS
Nura raises $73.8M to target ALS through a unique target
Nura Bio will use the series B financing to carry two neuroprotective drug candidates through early- to mid-stage clinical studies, one targeting ALS and the other for a broader neurological profile.
June 22, 2026
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4 min read
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Michael Gibney
Crowd of diverse people gather around empty circle in the middle. 3D illustration
Regulatory
FDA’s new voucher program hints at broader policy agenda, making many ‘uncomfortable’
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
June 19, 2026
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7 min read
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Michael Gibney
Pictured: Eli Lilly Campus in San Diego
Metabolic disorders
Lilly maintains deal streak with $1.2B pact for Hanmi’s GLP-2 candidate
Expanding in the metabolic space, Eli Lilly has struck a back-loaded licensing deal with South Korea’s Hanmi Pharm for a mid-stage GLP-2 agonist being trialed for short bowel syndrome.
June 1, 2026
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2 min read
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Michael Gibney