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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.

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
Poster sketch image artwork photo collage of body language finger showing gesture symbol thumb down dislike dissatisfied minus no opinion.
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
Various white pills and capsules forming a map of the world, illustrating humanity's increasing dependency on medication manufacturing.
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
Achieve goal concept art collage. Rising arrow chart and halftone hand pointing to center of dartboard. Business goal, achieve targets, success. Trendy modern retro vector illustration
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
Pictured: A syringe broken in half with long hallway in background/Nicole Bean for BioSpace
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
Concept of money prize. Vector illustration. Halftone hand holds bouquet of money flowers. Gift prize, donation, earnings, bonus or cashback concept. Retro poster or banner. Creative trend collage.
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
A pill bottle in between two injector pens
GLP-1
Oral Wegovy Brings in Thousands of New GLP-1 Patients
The oral version of Wegovy has made GLP-1 medicines more accessible and acceptable to many patients who had steered clear of injectable versions, healthcare analytics firm Truveta suggests.
February 12, 2026
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1 min read
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Tristan Manalac
3d fatty liver disease isolated on pink background. 3d illustration render
MASH
Madrigal Dives Further Into MASH With up to $4.4B siRNA Deal With Chinese Biotech
The pact between Madrigal Pharmaceuticals and Ruzhou Ribo Life Sciences could complement the former’s Rezdiffra, the first FDA-approved therapy for MASH. That drug made $287.3 million in the third quarter of 2025.
February 11, 2026
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2 min read
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Tristan Manalac
Gilead's headquarters in Silicon Valley
Earnings
Gilead To Stay ‘Proactive And Disciplined’ With Deals But M&A Not Urgent Priority
With 10 launches planned in the coming quarters, Gilead isn’t feeling the same acquisition urgency as its pharma peers—though the prospect of a takeover isn’t off the table.
February 11, 2026
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2 min read
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Tristan Manalac
Close-up of back skin with urticaria
Immunology and inflammation
Nektar’s Rezpeg Differentiates in Atopic Dermatitis With Durable, Deep Responses in Mid-Stage
The percentage of patients achieving total clearance of eczema lesions in a Phase 2b trial increased with prolonged rezpeg treatment.
February 11, 2026
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2 min read
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Tristan Manalac
Syringe and a vial above the map of the USA. Illustration of the concept of the vaccination and immunization in the United States
Vaccines
FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
February 11, 2026
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4 min read
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Tristan Manalac
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Regulatory
Hims & Hers’ Woes Compound as FDA Hits Company With Warning Letter
The agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, birds insects, and other vermin.”
February 10, 2026
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2 min read
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Tristan Manalac
Businessman holding a dart aiming at the target - business targeting, aiming, focus concept. Art collage.
Obesity
Kailera, Hengrui Push Oral GLP-1/GIP Pill to Phase 3 After Clearing Mid-Stage China Study
Kailera will launch a global Phase 2 study of ribupatide this year, while Hengrui will push the asset into Phase 3 in China.
February 10, 2026
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1 min read
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Tristan Manalac
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