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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.

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Weight loss
Roche, Zealand’s Amylin Weight Loss Drug Fails To Clear Lilly’s Bar
Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.
March 6, 2026
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3 min read
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Tristan Manalac
Pictured: Johnson & Johnson Business Center in Switzerland
Immuno-oncology
J&J Wins Third National Priority Approval for Multiple Myeloma Combo
The FDA granted Johnson & Johnson a Commissioner’s National Priority Voucher in December 2025 after the combination of Darzalex and Tecvayli improved progression-free survival by 83%. The new approval is for second-line treatment of the blood cancer.
March 6, 2026
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2 min read
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Tristan Manalac
Human brain with abstract visualization of neuron activity
Huntington’s disease
FDA Official Fires Back at UniQure, Doubles Down on Sham-Controlled Trial
UniQure does not have to drill placebo burr holes in the skulls of patients with Huntington’s disease, an unnamed FDA senior official said on Thursday. Instead, the company would anesthetize them and put “one to three nicks” in their scalp.
March 6, 2026
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2 min read
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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.
FDA
FDA’s Hoeg Reportedly Trying To Hire Friend, Fellow Antidepressant Skeptic
Adam Urato, who is currently a vaccine advisor to the CDC, is closely associated with acting CDER director Tracy Beth Høeg and is a fellow skeptic of the use of selective serotonin reuptake inhibitors during pregnancy.
March 5, 2026
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2 min read
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Tristan Manalac
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Regulatory
PepGen’s Mid-Stage Myotonic Dystrophy Study Hit With ‘Surprise’ Pause
The timing of the partial hold is “odd,” according to analysts at Stifel, who noted that the preclinical data the FDA took issue with were filed in mid-2024.
March 5, 2026
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2 min read
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Tristan Manalac
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Collaboration
Roche Broadens Global Clinical Trial Footprint With $480M+ South Korea Pledge
South Korea has attracted increasing investment from the pharmaceutical industry, which is drawn to the Asian country due to its experience in antibody-drug conjugates and cell and gene therapies, according to McKinsey.
March 5, 2026
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1 min read
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Tristan Manalac
Businessman receiving large stacks of money from a giant hand. Concept of funding, venture capital, financial support, dividend, and profitable business.
Funding
Teva Bags $400M Backing From Blackstone To Advance Sanofi-Partnered Drug
The funding comes weeks after TL1A blocker duvakitug maintained clinical remission rates above 50% in patients with ulcerative colitis and Crohn’s disease in a Phase 2b trial.
March 4, 2026
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2 min read
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Tristan Manalac
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Company closure
Bespoke Startup EveryONE Folds 1 Week After Plausible Mechanism Guidance
While an anonymous source tied the closure to shortcomings in the FDA’s new pathway, a spokesperson for the Department of Health and Human Services pushed back on the suggestion.
March 4, 2026
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2 min read
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Tristan Manalac
Composite contemporary collage statue of justice themis femida on the background of the target as the concept and idea of justice and law. High quality photo
Patents
Moderna Notches Much-Needed Win in COVID-19 Patent Spat With Roivant
The settlement, which requires Moderna to pay the plaintiffs $950 million upfront plus up to $1.3 billion in contingent commitments, is an outcome “better than feared,” according to analysts.
March 4, 2026
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2 min read
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Tristan Manalac
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Immunology and inflammation
Sanofi Bets Up to $1.53B in Hong Kong Immuno Pact, Adding to String of Deals
Sanofi will gain global exclusive rights over rovadicitinib, an oral JAK/ROCK blocker that has anti-inflammatory and anti-fibrotic effects.
March 4, 2026
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2 min read
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Tristan Manalac
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Earnings
Keytruda Hangs On to Best Seller Crown as GLP-1s Gain Ground
Merck’s Keytruda will soon lose exclusivity, just as weight-loss giants Eli Lilly and Novo Nordisk press in with their blockbuster GLP-1s.
March 4, 2026
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9 min read
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Tristan Manalac
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MASH
Boehringer Ingelheim Axes MASH Pact With OSE After Disappointing Mid-Stage Data
OSE Immunotherapeutics has kicked off a strategic realignment initiative that involves deprioritizing the AbbVie-partnered OSE-230 and focusing its resources on the late-stage development of its ulcerative colitis candidate lusvertikimab.
March 3, 2026
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2 min read
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Tristan Manalac
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Gene therapy
Intellia’s CRISPR Gene Therapy Free To Move Forward After FDA Fully Lifts Hold
The FDA last October paused Intellia Therapeutics’ late-stage CRISPR studies after detecting life-threatening enzyme elevations in one patient, who died a few days later.
March 3, 2026
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2 min read
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Tristan Manalac
Illustration showing hurdles along a path ending in an arrow
Complete response letters
REGENXBIO’s Hunter Rejection Hinged on Inadequate Controls, Surrogate Endpoint
In a complete response letter published by the FDA on Monday, the agency said a resubmission for REGENXBIO’s Hunter syndrome gene therapy should provide evidence of normalized or improved biomarker levels or neurodevelopmental outcomes.
March 3, 2026
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2 min read
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Tristan Manalac
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Rare disease
Aardvark Tanks After Pausing Prader-Willi Study on ‘Surprise’ Safety Signals
Aardvark Therapeutics is down 54% since Friday after the biotech said it detected “reversible cardiac observations” in a healthy volunteer study of its drug to treat extreme hunger in patients with the rare genetic disease.
March 2, 2026
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2 min read
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Tristan Manalac
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