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Tristan Manalac

Tristan Manalac

Contributing Writer | News

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

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Collaboration
Novartis Bets Up to $1.7B in Cardio-Focused Peptide Partnership
Novartis and Unnatural Products did not specify which disease targets they’re going after, only noting that the latter’s macrocyclic platform can generate potentially next-generation therapies that could apply to cardiovascular conditions.
February 19, 2026
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2 min read
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Tristan Manalac
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Government
Cassidy Names Areas of Improvement for FDA’s Regulatory ‘Black Box’
The FDA’s drug review process can often be “unpredictable,” and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.
February 19, 2026
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3 min read
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Tristan Manalac
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Regulatory
It’s Official: FDA Will Now Default to One Clinical Trial for Drug Applications
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from related indications or animal models.
February 19, 2026
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3 min read
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Tristan Manalac
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Alzheimer’s disease
Korsana Joins Alzheimer’s Amyloid Arena With $150M Debut, Next-Gen Antibody
Korsana’s lead program uses a next-generation shuttling technology to improve delivery into the brain and lower the incidence of amyloid-related imaging abnormalities.
February 18, 2026
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2 min read
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Tristan Manalac
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Legal
Court Rejects Two Moderna Defenses in mRNA Vaccine Patent Row With Arbutus
Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
February 18, 2026
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2 min read
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Tristan Manalac
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Collaboration
Lilly Fronts $100M for CSL’s IL-6 Blocker to Bolster I&I, Cardiovascular Pipeline
CSL is advancing clazakizumab for the treatment of cardiovascular events in end-stage kidney disease and will retain rights over the asset in this indication. Lilly will explore other conditions.
February 18, 2026
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2 min read
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Tristan Manalac
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Immunology and inflammation
Ocular’s Hydrogel Beats Regeneron’s Eylea in Wet AMD Study, Plots Path to FDA
Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.
February 17, 2026
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2 min read
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Tristan Manalac
Jim O'Neill
CDC
CDC Left Leaderless Again After Acting Director Departs HHS
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
February 16, 2026
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1 min read
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Tristan Manalac
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Complete response letters
FDA Rejects Disc’s Rare Blood Disease Drug Amid Reports of Prasad’s Skepticism
The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.
February 16, 2026
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3 min read
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Tristan Manalac
Richard Pazdur
Government
‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements
Richard Pazdur had spent 26 years at the FDA before stepping down last year due to disagreements with Commissioner Marty Makary about lowering the number of clinical trials required for a new drug application, Pazdur told the media.
February 16, 2026
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2 min read
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Tristan Manalac
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Obesity
Lilly Prepares $1B+ Orforglipron Stock Ahead of Approval as Novo Brings Wegovy Pill Overseas
Eli Lilly has long been gearing up for the launch of orforglipron, announcing as early as February 2024 that it was ramping up manufacturing investments for the weight-loss pill.
February 13, 2026
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2 min read
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Tristan Manalac
3D illustration of a fatty liver
Earnings
All Eyes on Vertex’s Kidney Franchise, as Painkiller Journavx Tops Half a Million Scripts
Analysts are keeping a close eye on Vertex’s kidney disease portfolio, anchored by the IgAN drug povetacicept, as its nonopioid painkiller Journavx is poised for “incremental” growth in the first half 2026, according to BMO Capital Markets.
February 13, 2026
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2 min read
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Tristan Manalac
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Rare diseases
‘Highly Impressive’ Data Propels BridgeBio’s Achondroplasia Drug Forward
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
February 12, 2026
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2 min read
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Tristan Manalac
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Regulatory
HHS Backs Prasad Amid Moderna Flu Shot Blowback
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
February 12, 2026
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2 min read
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Tristan Manalac
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Legal
AbbVie Sues HHS, CMS for Including Botox in Drug Price Negotiation Program
AbbVie contends that Botox should have been excluded from the IRA drug price negotiation program because it is a plasma-derived product.
February 12, 2026
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1 min read
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Tristan Manalac
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