SUBSCRIBE
SUBSCRIBE
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.

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
 · 
2 min read
 · 
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
 · 
2 min read
 · 
Tristan Manalac
Vaccines
FDA To Provide Further Data on 10 Alleged Pediatric Deaths Linked to COVID-19 Vaccines By End of Month
Last week, Center for Biologics Evaluation and Research Director Vinay Prasad claimed in an internal memo—without providing evidence—that COVID-19 vaccines were responsible for the deaths of 10 children between 2021 and 2024.
December 4, 2025
 · 
2 min read
 · 
Tristan Manalac
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
Regulatory
COVID Contrarian Tracy Beth Høeg Named as FDA’s Acting CDER Chief
Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
December 4, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Alzheimer’s disease
BMS Delays Cobenfy Alzheimer’s Psychosis Data After ‘Irregularities’ in Phase III Study
Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”
December 3, 2025
 · 
2 min read
 · 
Tristan Manalac
Mental health, illness ,brain development ,medical treatment concept, messy lines of thinks in human head , vector illustration
Neuroscience
Harmony’s Dravet Drug Halves Monthly Seizures in Late-Stage Study
The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.
December 3, 2025
 · 
2 min read
 · 
Tristan Manalac
FDA signage at its headquarters in Maryland
Regulatory
FDA Moves to Cut Back on Testing Antibodies on Primates
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating the need for six-month testing.
December 3, 2025
 · 
2 min read
 · 
Tristan Manalac
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
 · 
2 min read
 · 
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
 · 
2 min read
 · 
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
 · 
1 min read
 · 
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
 · 
1 min read
 · 
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
 · 
1 min read
 · 
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
 · 
2 min read
 · 
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
 · 
1 min read
 · 
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
 · 
9 min read
 · 
Tristan Manalac
Load More