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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.

Thumb up close-up in surgical, medical gloves, gesture, recommendation for a successful operation. Pink background.
Rare diseases
FDA Greenlights First Gene Therapy for Rare Pediatric Disease
Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a non-profit sponsor to win FDA approval.
December 10, 2025
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1 min read
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Tristan Manalac
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).
Vaccines
FDA Launches Probe Into Safety of Approved Anti-RSV Antibodies
The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.
December 10, 2025
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2 min read
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Tristan Manalac
Minimal Clip Art Collage. Pop Vector Design Composition with bright bold geometric shapes, halftone objects for ad, animation etc
Approvals
First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
December 10, 2025
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
FDA
CAR-T Developers Will Need Randomized Trials as FDA Eyes Tighter Approval Requirements
For traditional approval, CAR T therapies will need to establish superiority over current standard treatments, including already-approved CAR T products.
December 9, 2025
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2 min read
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Tristan Manalac
Closeup of businessman give money to robot. Man pass banknote bribe to robotic assistant. AI and technology. Vector illustration.
Immunology and inflammation
Novartis Unites With Relation in $1.7B Inflammatory Skin Disease Pact
At the heart of the deal is Relation’s Lab-in-the-Loop platform, which uses AI models to improve understanding of diseases and guide clinical development programs.
December 9, 2025
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2 min read
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Tristan Manalac
Art collage, coins, and arrow up on the red and paper background. Concept of business and financial growth.
Obesity
Structure Stock Soars as Oral GLP-1 Generates ‘Highly Competitive’ Weight Loss
Structure’s aleniglipron elicited over 11% weight loss in a Phase II trial, sending the biotech’s stock up nearly 103% as markets closed on Monday.
December 9, 2025
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2 min read
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Tristan Manalac
Stand out from the crowd and different creative idea concepts , Longest light ladder glowing and aiming high to goal target among other short ladders on green background with shadows . 3D rendering.
Infectious disease
Assembly’s Antivirals Show ‘Striking’ Drop in Lesions, Viral Shedding in Early Genital Herpes Study
A mid-stage study for ABI-5366 will begin mid next year, while Assembly continues to assess the Phase II potential of ABI-1179.
December 9, 2025
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2 min read
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Tristan Manalac
Orlando, Florida
Cancer
ASH25: CAR-T Leaders Gilead, J&J Show in Multiple Myeloma; Fulcrum Rises on Sickle Cell Data
The 2025 meeting of the American Society of Hematology features some of the newest developments in blood cancers and rare diseases.
December 8, 2025
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5 min read
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Tristan Manalac
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Duchenne muscular dystrophy
Dyne’s Exon Skipper Delivers ‘Best Ever’ Functional Outcomes in Early DMD Study
Dyne’s exon-skipping therapy zeleciment rostudirsen resulted in an approximately sevenfold increase in dystrophin levels at six months and elicited functional improvements that are the “best ever” for this treatment class, Stifel analysts said.
December 8, 2025
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2 min read
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Tristan Manalac
Poznan, Poland – October 29, 2020: The Glaxosmithkline headquarters office building in Poznan. LOGO. GaxoSmithKline also called GSK is a British pharmaceutical company.
Cancer
GSK Cuts Five-Year-Old Cancer Collaboration With Ideaya
GSK and Ideaya first linked up in 2020 to advance novel therapies for solid tumors. It is unclear why the pharma terminated the partnership.
December 8, 2025
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2 min read
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Tristan Manalac
Mental health, illness ,brain development ,medical treatment concept, messy lines of thinks in human head , vector illustration
Neuroscience
Biogen, Stoke Boost Epilepsy Drug’s Blockbuster Potential With Early Seizure Reduction Data
Analysts at Jefferies see blockbuster potential in zorevunersen in Dravet syndrome, with sales potentially reaching $1 billion to $4 billion.
December 8, 2025
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2 min read
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Tristan Manalac
Red round circle with a pause button or icon against yellow background.
Regulatory
FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals
Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.
December 5, 2025
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2 min read
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Tristan Manalac
Brain neuro cell growth or damaging drawing with texture shading illustration isolated on dark background
Neuroscience
Praxis Ends Epilepsy Study Early Due to Strong Results, Heads to FDA
Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026.
December 5, 2025
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2 min read
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Tristan Manalac
Business people shaking hand in China.
Collaboration
Crescent, Kelun-Biotech Swap Therapies in ADC-Bispecific Deal Worth Up To $1.25B
The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.
December 4, 2025
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2 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.
Policy
FDA Eyes Higher User Fees for Companies Holding Phase I Studies Abroad
Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.
December 4, 2025
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2 min read
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Tristan Manalac
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