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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.

Pictured: Blue Sanofi sign on building in Germany at night
Alzheimer’s disease
Sanofi’s Neuro Push Arrives in Seoul With $1B+ Alzheimer’s Play
The star of the agreement targets a specific type of tau protein, helping to prevent toxic accumulation in the brain while also preserving the function of healthy tau.
December 16, 2025
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1 min read
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Tristan Manalac
Sketch image trend artwork montage 3D photo collage of target trader business charts stats young lady hold laptop run up ladder success.
Rare diseases
Kyverna’s CAR T Therapy Delivers ‘Impressive’ Mobility Benefits in Stiff Person Syndrome
Kyverna plans to submit mivocabtagene autoleucel to the FDA for approval in the first half of 2026. If approved, it would be the first CAR T therapy for an autoimmune disease.
December 16, 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, Daiichi Sankyo Move Enhertu to First-Line Metastatic Breast Cancer
Analysts at Jefferies called the approval “highly significant,” estimating it could add $2 billion to $3 billion to peak Enhertu sales.
December 16, 2025
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2 min read
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Tristan Manalac
Johnson and Johnson sign
FDA
J&J Wins Proactive FDA National Priority Voucher for Multiple Myeloma Combo
Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a Phase III study testing Tecvayli plus Darzalex in patients with relapsed or refractory multiple myeloma.
December 16, 2025
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2 min read
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Tristan Manalac
Man jumping, running, and winner holding trophy. Competition, challenge, risk and reward concept. Vector illustration.
Approvals
Milestone’s Long Regulatory Road Ends in Approval for Cardamyst
The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and again in March this year, when it flagged manufacturing issues.
December 15, 2025
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2 min read
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Tristan Manalac
Rheumatoid arthritis (RA) commonly causes inflammation in the hands, leading to pain, swelling, and stiffness in the joints, particularly the small joints of the fingers and wrists. This inflammation results from the immune system attacking the body's own joint tissues, causing the synovium (lining of the joint) to become inflamed and release chemicals that damage nearby tissues.
Mergers & acquisitions
Sobi Makes $1.5B Gout Play With Arthrosi Acquisition
For $950 million upfront, Sobi will gain ownership to pozdeutinurad, an oral URAT1 inhibitor that performed well in Phase II studies.
December 15, 2025
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2 min read
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Tristan Manalac
COVID-19
Prasad’s Claim of 10 Pediatric Deaths From COVID-19 Shots Overblown: Report
The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
December 15, 2025
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2 min read
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Tristan Manalac
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Clinical research
5 of 2025’s Defining Clinical Wins
In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal parts. Here are some of this year’s most glorious clinical trial victories.
December 15, 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: GSK, Aldeyra, Rhythm and More
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
December 15, 2025
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5 min read
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Tristan Manalac
Target, miss the target, target shooting, dart, correct decisions, bow and arrow, dart on target, hits and misses (3d illustration)
Clinical research
The 5 Most Painful Clinical Trial Failures of 2025
Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting neurological diseases. Some failures split up partners, and one particularly egregious case even led to the demise of an entire company.
December 15, 2025
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9 min read
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Tristan Manalac
Pictured: Illustration of antibodies attacking a nerve cell
Approvals
Amgen Scores Uplizna Expansion Into Generalized Myasthenia Gravis
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
December 12, 2025
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2 min read
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Tristan Manalac
Hands in black and white dropping a collection of pills on a pink background
Approvals
GSK’s Blujepa Opens First New Class of Gonorrhea Antibiotic in More Than 30 Years
Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
December 12, 2025
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2 min read
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Tristan Manalac
Close-Up Of Syringe With Bottles Against Blue Background
Vaccines
CDC Highlights Efficacy of COVID-19 Shots in Kids Amid FDA Probe of Alleged Deaths
The 2024–2025 formulations of COVID-19 vaccines had an effectiveness rate of 76% at preventing emergency or urgent care visits in children aged 9 months through four years, according to a new report.
December 12, 2025
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2 min read
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Tristan Manalac
Pictured: Entrance to Pfizer's office in Belgium
Breast cancer
Pfizer Builds Case for Tukysa as ‘New Standard Regimen’ in First-Line Metastatic Breast Cancer
While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”
December 11, 2025
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2 min read
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Tristan Manalac
Creative collage illustration of financial business. Two businessmen shaking hands for partners agreement. Conceptual illustration of success deal, corporate ethic, connection.
Weight loss
Zealand Bets up to $2.5B in Metabolic Pact With Chinese Biotech
Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.
December 11, 2025
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2 min read
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Tristan Manalac
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