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.

Illustration showing woman starting down curved path with markers toward goal marked by flag
Rare diseases
New Confirmatory Study Hints at ‘Alignment’ Between Applied Therapeutics, FDA for Rare Disease Drug
Applied Therapeutics has yet to confirm whether the study, posted on Clinicaltrials.gov on Thursday, means it has indeed aligned with the FDA on govorestat’s development.
September 29, 2025
 · 
2 min read
 · 
Tristan Manalac
Creative collage illustration of financial business. Two businessmen shaking hands for partners agreement. Conceptual illustration of success deal, corporate ethic, connection.
Mergers & acquisitions
Genmab Buys Rising Cancer Star Merus for $8B
The centerpiece of the acquisition is petosemtamab, Merus’ bispecific antibody targeting EGFR and LGR5, which in May demonstrated best-in-class potential for head-and-neck cancer.
September 29, 2025
 · 
2 min read
 · 
Tristan Manalac
FDA Sign in front of FDA Buildings
FDA
September’s FDA Action Bolsters Keytruda, Ultra-Rare Disease but Deals Two SMA Defeats
The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and granted approvals in Barth syndrome and for a subcutaneous version of Merck’s Keytruda that could be key to the blockbuster’s future earnings.
September 29, 2025
 · 
10 min read
 · 
Tristan Manalac
Pictured: Exterior view of the headquarters of the
Regulatory
6 FDA Decisions To Watch For in Q4
From more than 30 target action dates in the last three months of the year, BioSpace has narrowed the list to six regulatory decisions that could have far-reaching implications for biopharma and patients.
September 29, 2025
 · 
9 min read
 · 
Tristan Manalac
2D illustration of kidneys
Immunology and inflammation
Hansa Kidney Transplant Drug Aces Phase III Study, Headed to FDA
Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 million, according to William Blair.
September 26, 2025
 · 
2 min read
 · 
Tristan Manalac
Indianapolis, U.S. - April 16, 2016: Eli Lilly and Company World Headquarters. Lilly makes Medicines and Pharmaceuticals VI
Breast cancer
Lilly’s Oral SERD Wins FDA Go-Ahead for Breast Cancer
Phase III data showed that Inluriyo improves progression-free survival versus standard endocrine therapy.
September 26, 2025
 · 
2 min read
 · 
Tristan Manalac
Protection From Tariffs as an An umbrella that shields against import and export tariff taxes as a trade war storm increasing prices and straining supply chains as a business metaphor and a symbol for resilience in times of crisis and economic downturn.
Tariffs
Trump Sets 100% Pharma Tariff Deadline for October 1
Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday.
September 26, 2025
 · 
2 min read
 · 
Tristan Manalac
Stack of coins balancing on seesaw over a bottle of pills.
Drug pricing
Trump Admin Readies Proposed Rule To Lower US Drug Prices
Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries.
September 26, 2025
 · 
2 min read
 · 
Tristan Manalac
Contemporary art collage of target and hands with the megaphone on a ue background with copy space. Concept of reaching a goal and spreading.
Pancreatic cancer
Immuneering Asset Nearly Doubles Overall Survival in Pancreatic Cancer After 9 Months
Truist analysts called the results “encouraging” while pointing out certain unknowns in the data. Immuneering plans to kick off a registrational trial for atebimetinib later this year.
September 25, 2025
 · 
2 min read
 · 
Tristan Manalac
Conceptual business illustration of upcoming business problem metaphor with falling domino and businessman silhouette. Minimalistic vector eps 10 illustration
Weight loss
Lilly Cuts Mid-Stage Obesity Study of Muscle-Sparing Antibody
The decision to stop the Phase IIb study was driven by “strategic business reasons,” according to a federal clinical trials database.
September 25, 2025
 · 
2 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).
FDA
FDA Details Thinking for Streamlining Development of Cell, Gene, Regenerative Therapies
Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.
September 25, 2025
 · 
2 min read
 · 
Tristan Manalac
Wooden blocks with arrow and error icon. Delays and disruptions, stop the process, critical error concept
Rare diseases
Harmony Fails Pivotal Fragile X Syndrome Trial, Blames High Placebo Response
While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.
September 25, 2025
 · 
1 min read
 · 
Tristan Manalac
Pictured: Blue and white Sanofi sign on building/R
Venture capital
Sanofi Fattens Venture Unit With $625M Infusion for Rare Disease, Neuro Innovation
Sanofi Ventures, which now has $1.4 billion in total assets, will focus its investment efforts on early players working in immunology, rare diseases, neurology and vaccines.
September 24, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Johnson & Johnson Sign/iStock, JHVEPhoto
Manufacturing
FDA Hits J&J With Warning Letter Over ‘Significant Violations’ at Korean Production Plant
The issues the regulator found include the failure to comprehensively review complaints and product defects.
September 24, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Manufacturing
Lilly Unveils Second Facility in Manufacturing Push, Naming Texas as Site of New $6.5B Plant
Lilly expects to open 615 high-wage roles in Texas in connection with its new facility, plus around 4,000 construction roles.
September 24, 2025
 · 
2 min read
 · 
Tristan Manalac
Load More