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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.

Balance. A business man maintains a balance between life and work. vector
Regulatory
Acting CBER, CDER heads become permanent as FDA works to restore stability
The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner.
September 9, 2026
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2 min read
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Tristan Manalac
Achieve goal concept art collage. Rising arrow chart and halftone hand pointing to center of dartboard. Business goal, achieve targets, success. Trendy modern retro vector illustration
CAR-T
BMS clinches pivotal win for myeloma CAR T in ‘key derisking event’
Bristol Myers Squibb is positioning arlo-cel for quadruple-class exposed patients, which could help reduce competition with an upcoming multiple myeloma CAR T therapy from Gilead Sciences, according to BMO Capital Markets.
September 9, 2026
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2 min read
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Tristan Manalac
Innovation - Think differently - Being different, taking risky, move for success in life -The graphic of rocket also represents the concept of courage, enterprise, confidence, belief, fearless, daring,
Funding
Caspian launches with $50M, Lilly support to advance disease-modifying diabetes bet
Kura Oncology has spun out Caspian around KO-7246, which seeks to increase the number and activity of beta cells in the pancreas, in turn boosting insulin production in patients with diabetes.
September 9, 2026
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2 min read
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Tristan Manalac
3D rendering of a world map with area outlines. 3D illustration of a world map with country outlines.
China
Beyond China: Five other overseas destinations for biopharma dollars
As geopolitical tensions between the U.S. and China grow increasingly complicated, here are five alternative territories for biotech investments.
September 9, 2026
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8 min read
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Tristan Manalac
Success to win in business competition, overcome obstacles or motivation to solve problem and lead company achievement concept, confident businessman leader jump high over 3 hurdles to be winner.
Approvals
AstraZeneca’s SERD pill overcomes adcomm defeat to win FDA nod in breast cancer
The approval opens up a “modest” market for AstraZeneca’s Etcamah, according to Leerink analysts, who nevertheless looked forward to an upcoming late-stage readout that could lead to a “significantly larger opportunity” for the drug.
September 8, 2026
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2 min read
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Tristan Manalac
Conceptual business illustration of upcoming business problem metaphor with falling domino and businessman silhouette. Minimalistic vector eps 10 illustration
Neuroscience
Novartis’ $12B Avidity acquisition hits Phase 3 speedbump as dystrophy drug disappoints
While Novartis’ antibody-oligonucleotide conjugate failed to significantly improve hand function in patients with myotonic dystrophy type 1, the asset nevertheless showed signs of clinical activity in secondary and exploratory measures.
September 8, 2026
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2 min read
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Tristan Manalac
businessman on dollar boat with storm and lightning
Cardiovascular disease
Novartis’ cholesterol-lowering medicine fails Phase 3, clouding Lp(a) horizons
The failure of Novartis’ pelacarsen to translate its Lp(a)-lowering effects to clinical benefits “marks a meaningful setback” for other companies taking a similar approach to cardiovascular risk, analysts say—including Eli Lilly and Amgen.
September 8, 2026
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2 min read
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Tristan Manalac
Human brain with abstract visualization of neuron activity
Funding
BrainChild Bio targets deadly pediatric brain cancer with $116M series A
BrainChild Bio’s lead asset BCB-276 is in pivotal development for diffuse intrinsic pontine glioma, a rare and fatal brain tumor that affects around 300 children in the U.S. every year.
September 8, 2026
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2 min read
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Tristan Manalac
Tension, separation, danger or risk concepts. Frayed rope is about to brake on blue background with copy space.
Antibody-drug conjugate (ADC)
Pfizer punts Seagen ADC, further muddying value of the $43B buyout
The co-development deal comes after Pfizer reported a late-stage failure for a Seagen asset and the discontinuation of another investigational therapy developed by the company as a subsidiary of the pharma.
September 4, 2026
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2 min read
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Tristan Manalac
Businessman holding a dart aiming at the target - business targeting, aiming, focus concept. Art collage.
Cancer
AbbVie’s T cell engager delivers survival benefit in Phase 3 multiple myeloma study
AbbVie’s etentamig has a relatively cleaner safety profile and an administration schedule that could give it an edge over other BCMA-targeting multiple myeloma therapies on the market, according to BMO Capital Markets.
September 4, 2026
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2 min read
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Tristan Manalac
Trustworthy and honesty to believe in work together, integrity or trust for partnership, support and reliable to help success together concept, businessman acrobat hold hand tight by trusted partner.
Deals
GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy
For $110 million upfront, GSK will have the exclusive global right to advance HMPL-A830, which combines an EGFR-targeting antibody with a small-molecule KRAS blocker. The asset will be studied for colorectal, pancreatic and lung cancer.
September 3, 2026
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1 min read
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Tristan Manalac
Market failure, recession. Businessman falling into the trap. vector
Rare diseases
Ultragenyx’s ‘high-risk’ Angelman bet fails, cratering stock and forcing strategic review
The success of apazunersen in a Phase 3 trial for Angelman syndrome was a key driver of Ultragenyx’s value, according to William Blair, and the asset’s failure robs the biotech of any meaningful near-term milestones.
September 3, 2026
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2 min read
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Tristan Manalac
Document checking, agreement or contract validation, financial or budget analysis, search for document files concept, businessman manager holding big magnifying glass checking document paper.
FDA
Replimune’s melanoma drug would have been rejected again if not for senior CBER official
The FDA’s primary review team found that Replimune hadn’t sufficiently addressed deficiencies that had been pointed out in the two prior rejection letters for the melanoma therapy Tudriqev.
September 3, 2026
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Tristan Manalac
Dashed line from pills isolated on white
Regulatory
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA.
September 2, 2026
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2 min read
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Tristan Manalac
Composite photo collage of two players hold chess board game hobby tactic horse queen championship leisure isolated on painted background.
Multiple sclerosis
Novartis’ Rhapsido cuts MS progression in Phase 3 trial, teeing up Roche battle
Novartis is planning to file for remibrutinib’s expanded approval in relapsing multiple sclerosis by next year, putting it just behind Roche’s own BTK inhibitor fenebrutinib.
September 2, 2026
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2 min read
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Tristan Manalac