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.

Entrance to the U.S. Department of Health and Human Services in Washington, DC
Layoffs
HHS Begins Formally Laying Off Employees
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.
July 15, 2025
 · 
2 min read
 · 
Tristan Manalac
Wood block with healthcare medical icon on blue background. Health care insurance concept
Infectious disease
Gilead, GSK/ViiV, Merck Present New HIV PrEP Frontiers at IAS25
HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval.
July 15, 2025
 · 
4 min read
 · 
Tristan Manalac
Policy
FDA Commissioner Marty Makary Proposes Lowering Industry User Fees
According to Makary, reducing user fees—which make up just under half of the FDA’s budget—could make it easier for smaller companies, individual investors and academics to participate in the process.
July 15, 2025
 · 
2 min read
 · 
Tristan Manalac
Pictured: Takeda sign at its office in Massachusetts
Neuroscience
Takeda Establishes Lead in Narcolepsy Race With Back-to-Back Phase III Wins
Takeda’s oveporexton improved wakefulness, attention and other key narcolepsy endpoints “with a high degree of statistical significance,” according to Jefferies analysts.
July 14, 2025
 · 
2 min read
 · 
Tristan Manalac
vector illustration arrows miss the target board, concept of lost in focus, failure, fail, mistake
Depression
After Three Strikes, Relmada Abandons Depression Drug Esmethadone 
The development saga for the depression molecule has been rocky for years, unable to ease symptoms in multiple late-stage trials.
July 14, 2025
 · 
2 min read
 · 
Tristan Manalac
Contemporary art collage. Giang hand kicking office worker symbolizing dismissal. Unsuccessful employee. Job reduction. Concept of business, career, failure, success, troubles
Rare diseases
Ultragenyx Takes Second Hit as FDA Rejects Gene Therapy for Sanfilippo Syndrome
The FDA cited manufacturing issues but did not flag problems with Ultragenyx’s data package for UX111, with the biotech noting that the regulator found its neurodevelopmental findings for the gene therapy to be “robust.”
July 14, 2025
 · 
2 min read
 · 
Tristan Manalac
Regulatory
FDA Mulls Speedier Reviews to Companies Willing To Lower Drug Costs
Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that promise to keep prices down.
July 14, 2025
 · 
1 min read
 · 
Tristan Manalac
Pharmaceutical research and new medicine biotechnology or revolutionary medication discovery health concept with prescription pill symbols with 3D illustration elements.
Obesity
Obesity in Focus: ADA Reveals R&D Priorities for Blockbusters-in-Waiting
New data and analyses presented at the American Diabetes Association’s annual meeting highlight the priorities for the next generation of weight loss medicines: muscle preservation, limited side effects and novel targets.
July 14, 2025
 · 
9 min read
 · 
Tristan Manalac
FDA signage at its headquarters in Maryland
FDA
FDA Action Alert: Roche, GSK, Regeneron, More
The FDA has several big-ticket decisions lined up to close out July, including applications in lymphoma, rare diseases and a hormone deficiency, while GSK dares to DREAMM again in multiple myeloma.
July 14, 2025
 · 
7 min read
 · 
Tristan Manalac
Contemporary art collage showing a hand giving a thumbs down surrounded by red arrows pointing down, concept of negative feedback and bad review
Complete response letters
Capricor Plunges on FDA Rejection of DMD Cell Therapy
In its complete response letter, the FDA cited insufficient evidence establish deramiocel’s effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.
July 11, 2025
 · 
3 min read
 · 
Tristan Manalac
Cambridge, USA - 16 August 2024. View of Moderna office entrance with logo sign, Biotechnology industry
COVID-19
Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids
The approval of Moderna’s Spikevax for kids at higher risk of contracting the disease continues the company’s regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.
July 11, 2025
 · 
2 min read
 · 
Tristan Manalac
Business consultant. Hands help a businessman is falling from a graph vector
Rare diseases
Ultragenyx, Mereo Plummet After Late-Stage Trial for Rare Genetic Disorder Appears To Fall Short
Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase II/III study of their osteogenesis imperfecta candidate will proceed to final analysis, implying it did not show sufficiently strong results at an interim analysis.
July 10, 2025
 · 
2 min read
 · 
Tristan Manalac
Government
Kennedy Postpones Preventive Care Panel Meeting After ‘Double-Edged Sword’ Supreme Court Win
The move has sparked concern that the U.S. Preventive Services Task Force could soon be dismissed after a decision by the high court affirmed Health Secretary Robert F. Kennedy Jr.'s power to remove its members at will.
July 10, 2025
 · 
2 min read
 · 
Tristan Manalac
Feb 19, 2020 Foster City / CA / USA - Gilead corporate headquarters in Silicon Valley; Gilead Sciences, Inc. is an American biotechnology company that researches, develops and commercializes drugs
Infectious disease
Gilead to Provide New HIV Drug to Lower-Income Countries Through Novel Philanthropic Partnership
The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
July 10, 2025
 · 
2 min read
 · 
Tristan Manalac
Fund raising Capital Donation. Funds Support Concept. Fundraising. Collecting donations in jar.
Series B
Nuclidium Nets $99M Series B for Copper-Based Radiopharma Platform
Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.
July 10, 2025
 · 
2 min read
 · 
Tristan Manalac
Load More