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Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has 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.

A brain hovers over a hand against a yellow-striped background
Alzheimer’s disease
Roche Is Back in Alzheimer’s as Latest Antibody Clears Amyloid Plaques
Trontinemab lowered amyloid levels below the threshold of positivity in 92% of treated patients.
December 2, 2025
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2 min read
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Tristan Manalac
2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday – Friday, 9 am – 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.
Vaccines
ACIP To Discuss Hep B, Childhood Vaccine Schedule Under New Chair Who Linked COVID Shots to Cancer
This week’s meeting of the Advisory Committee on Immunization Practices will be led by Kirk Milhoan, a physician and pastor who recently claimed that COVID-19 vaccines contained a contamination that causes cancer.
December 2, 2025
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2 min read
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Tristan Manalac
Pictured: AI robot holding biopharma-related items in hands
Artificial intelligence
FDA Rolls Out Agentic Models in Bid to ‘Modernize’ Regulatory Workflows
Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.
December 2, 2025
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1 min read
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Tristan Manalac
A piggy bank crammed with $100 bills on a background of American cash
Series B
Novartis-Backed Protego Eyes Pivotal Amyloidosis Study With $130M Series B
Protego Biopharma is advancing a small-molecule drug that helps light chain proteins fold correctly, in turn addressing the underlying biological cause of AL amyloidosis.
December 1, 2025
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1 min read
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Tristan Manalac
Creative sketch collage of business people handshake gesture approval project development success colleagues cooperation support.
Gene editing
Regeneron Makes $275M Gene Editing Play With Tessera Partnership Targeting AATD
The centerpiece of the deal is the in vivo editor TSRA-196, which in preclinical studies has shown robust editing at SERPINA1, the locus linked to alpha-1 antitrypsin deficiency.
December 1, 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’s Prasad Links 10 Child Deaths to COVID-19 Vaccines, Eyes Stricter Review Guidelines
The alleged deaths were detected by the FDA’s Vaccine Adverse Event Reporting System, reports from which “generally cannot be used to determine” causation or even contribution, according to the agency.
December 1, 2025
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2 min read
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Tristan Manalac
Office worker, employee being late for work, looking untidy. Deadlines and time management. Contemporary art collage. Concept of business, office lifestyle, career, challenges
FDA
FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months
If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.
December 1, 2025
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1 min read
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Tristan Manalac
Businessmen helping their friend climbing the rock, teamwork, partnership in business concept
Cell Therapy
6 Companies Hanging On in Cell Therapy
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
December 1, 2025
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9 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: BMS, GSK, Amgen and More
The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.
December 1, 2025
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5 min read
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Tristan Manalac
Concept World kidney day, handcraft paper blue kidneys and stethoscope on yellow background. Copy space. Banner.
Approvals
Otsuka Secures IgAN Win as FDA Approves First Anti-APRIL Antibody
Analysts at Guggenheim Partners expect Voyxact to see “broad commercial uptake” given its relatively broad label compared with previous accelerated approvals for IgA nephropathy.
November 26, 2025
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2 min read
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Tristan Manalac
Stack of coins balancing on seesaw over a bottle of pills.
Drug pricing
Novo’s GLP-1s Highlight List as CMS Unveils Final Prices For Second Cycle of Drug Negotiations
The discounts should be compared against the drugs’ “ultimate net price” rather than their indicated list price to gauge the true impact of the negotiations, BMO Capital Markets analysts said.
November 26, 2025
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2 min read
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Tristan Manalac
Female hand showing thumbs up gesture on blue background, art collage. Positive hand sign. Fashion collage in the style of Thumbs up magazine. Contemporary art. Modern design.
Approvals
AstraZeneca Notches Another Indication for Imfinzi, Pushing PD-L1 Blocker Into Stomach Cancer
Imfinzi is the first immunotherapy approved for perioperative use to treat gastric and gastroesophageal junction cancers.
November 26, 2025
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2 min read
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Tristan Manalac
Illustration of businessman with flag looking victorious on top of teetering blocks
Obesity
Novo Bounces Back With ‘Competitive’ Mid-Stage Weight Loss Data for Amycretin
Novo Nordisk’s amycretin showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes, suggesting its efficacy could become even stronger with longer follow-up, according to analysts at BMO Capital Markets.
November 25, 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.
Cancer
ASH25: Late-Stage Data For J&J’s Tecvayli/Darzalex Combo Could ‘Shift Paradigm’ in Myeloma
Tecvayli plus Darzalex led to an 83% boost to progression-free survival versus the current standard therapy in relapsed or refractory multiple myeloma, results analysts at Guggenheim Securities called “remarkable.”
November 25, 2025
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2 min read
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Tristan Manalac
Richard Pazdur
FDA
Pazdur Questions Safety, Legality of FDA’s Expedited Drug Approval Programs
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
November 25, 2025
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2 min read
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Tristan Manalac
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