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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.

Photo of a GLP-1 injector pen on a blue background
Weight loss
FDA Proposes Draft Guidance for Weight-Loss Therapies as Obesity Space Heats Up
The FDA recommended maintaining a minimum of 5% weight-loss for drug developers seeking to establish the efficacy of their investigational obesity candidates.
January 8, 2025
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2 min read
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Tristan Manalac
Art collage, hands and falling coins in orange circle. Modern design of finance and business.
IPO
Maze Opens 2025 IPO Class to Advance Kidney Disease Programs
Maze’s IPO comes on the heels of its oversubscribed Series D funding round, which infused the biotech with $115 million in funding to support the development of its kidney disease pipeline.
January 8, 2025
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2 min read
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Tristan Manalac
Creative pattern made with a syringe on pastel pink background. Vaccine for Coronavirus infection. Pandemic concept.
Vaccines
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome Warnings
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
January 8, 2025
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2 min read
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Tristan Manalac
Corporate headquarters of Novo Nordisk in Denmark
Collaboration
Novo Puts $4.6B on the Line to Expand Valo Deal, Maintain Cardiometabolic Leadership
The investment continues a Novo dealmaking spree to cement its leadership status in the cardiometabolic space, with partnerships with Photys Therapeutics, Ascendis Pharma and two Flagship-backed start-ups.
January 8, 2025
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2 min read
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Tristan Manalac
Mechanical weight scale, body mass control concept : Bathroom scale on pale blue wood background. Analog scale operated with spring that pressure is calibrated to translate tension into a mass readout.
Obesity
Metsera Touts ‘Powerful’ Weight Loss Results—Again
Months after posting weight loss of 7.5% at 36 days for patients taking MET-097i, Metsera releases mid-stage results of just over 11% average body weight reduction at 12 weeks, with no plateau and a promising safety profile.
January 7, 2025
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Artificial intelligence
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information regarding models’ development and maintenance.
January 7, 2025
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2 min read
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Tristan Manalac
Missed Target
ALS
Denali Suffers Another ALS Fail With Phase II/III Flop
Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and Amylyx have seen similarly disappointing results.
January 7, 2025
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Diabetes
Novo Launches Citizen Petition to Block Compounded Victoza
In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.
January 6, 2025
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2 min read
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Tristan Manalac
Handshake gesture contemporary collage art. Celebrating success, congratulating for financial and business partnership, job contract deal, mutual friendship and respect. Abstract illustration isolated.
Mergers & acquisitions
Higher Biopharma M&A Activity ‘Almost Inevitable’ in 2025, With Viking as Top Candidate: Analysts
Seeking Alpha analyst Terry Chrisomalis regards Viking Therapeutics as the most attractive M&A candidate in 2025, bolstered by its strong obesity candidate VK2735 and largely de-risked MASH therapy VK2809.
January 6, 2025
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Regulatory
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
January 6, 2025
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8 min read
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Tristan Manalac
Multi-directional arrows on yellow background , choose between several potential future options and scenarios,3d rendering
GLP-1
7 Indications for GLP-1s Beyond Weight Loss
Already established as cornerstone therapies in diabetes and obesity, GLP-1 receptor agonists also show potential in several other indications, including cancer, addiction and neurodegenerative diseases.
December 23, 2024
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11 min read
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Tristan Manalac
GSK's headquarters office building in Poznan, Poland
Ovarian cancer
GSK Posts Mixed Survival Data for Jemperli/Zejula Combo in First-Line Ovarian Cancer
First approved in 2021, Jemperli has now become a cornerstone of GSK’s cancer business, earning more than $160 million in the third quarter.
December 20, 2024
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2 min read
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Tristan Manalac
Corporate headquarters of Novo Nordisk in Denmark
Obesity
Novo Nosedives on Underwhelming CagriSema Phase III Weight-Loss Data
Investors appeared disappointed by CagriSema’s Phase III readout, which showed weight loss that fell short of Novo Nordisk’s prior projections for the therapy. Meanwhile, Eli Lilly’s stock rose on the news.
December 20, 2024
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3 min read
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Tristan Manalac
Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Approvals
Ionis’ Tryngolza Becomes First FDA-Approved Therapy for Familial Chylomicronemia Syndrome
Despite securing the industry’s first approval for familial chylomicronemia syndrome, BMO Capital Markets believes that Tryngolza’s regulatory triumph will not be a significant positive for Ionis. Instead, the firm is focusing on olezarsen’s readout in severe hypertriglyceridemia, a much larger market.
December 20, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Drug shortages
FDA Confirms Lilly’s GLP-1s Are Not in Shortage, Gives Compounders Grace Period
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
December 19, 2024
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3 min read
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Tristan Manalac
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