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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.

Amgen sign at its headquarters in Thousand Oaks, California, USA.
FDA
Amgen Contests J&J’s Stelara with FDA Approval for Interchangeable Biosimilar
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.
November 2, 2023
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3 min read
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Tristan Manalac
Pictured: GSK laboratories in Dresden, Germany
Business
GSK Touts Strong Q3 Performance on the Back of Arexvy, Shingrix Sales
The British biopharma company reported 10% sales growth in the third quarter, driven mainly by robust sales of its respiratory syncytial virus shot Arexvy and shingles vaccine Shingrix.
November 1, 2023
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
FDA Lifts Hold on Mersana’s Antibody-Drug Conjugate Following Patient Death
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.
November 1, 2023
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2 min read
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Tristan Manalac
Pictured: Three doctors holding their thumbs up/iS
Policy
FDA Adcomm Sides with Vertex, CRISPR on Safety Testing for SCD Gene Therapy
The regulator’s advisory committee on Tuesday found Vertex Pharmaceuticals and CRISPR Therapeutics’ off-target analysis for its sickle cell disease candidate exa-cel to be sufficient.
November 1, 2023
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2 min read
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Tristan Manalac
Pictured: Facade of Novartis building in Switzerland
Drug Development
Novartis’ $3.2B Chinook Buy Pays Off with Promising Phase III IgAN Data
Following the recent Chinook Therapeutics acquisition, the Novartis experimental IgA nephropathy therapeutic atrasentan significantly reduced protein in the urine of patients compared to placebo.
October 31, 2023
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2 min read
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Tristan Manalac
Pictured: Boy in a wheelchair looking out the window
Drug Development
Sarepta Fails Confirmatory Trial for DMD Therapy, Still Eyes Label Expansion
Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.
October 31, 2023
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2 min read
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Tristan Manalac
CRISPR-Cas9 genome editing enzyme, 3d illustration
Policy
FDA Flags Off-Target Effects of Vertex, CRISPR’s Sickle Cell Therapy Ahead of Adcomm
In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.
October 30, 2023
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2 min read
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Tristan Manalac
Pictured: Girl student having trouble concentratin
Drug Development
Otsuka’s Centanafadine Shows Promise in Phase III Pediatric ADHD Studies
The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.
October 30, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's biotechnology center in San Diego, California
FDA
Lilly’s Ulcerative Colitis Therapy Mirikizumab Finally Snags FDA Approval
Following an FDA rejection and a previous discontinuation in psoriasis, Eli Lilly’s anti-IL-23 antibody has finally won an approval in ulcerative colitis, joining a crowded inflammatory bowel disease market.
October 27, 2023
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2 min read
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Tristan Manalac
Merck Research Laboratories headquarters in Silicon Valley
Business
Merck Touts Strong Growth in Keytruda Sales, ADC Business in Q3
The company’s blockbuster cancer asset Keytruda brought in more than $6.3 billion in the third quarter, a 17% increase from the same period last year, while bolstering its antibody-drug conjugate portfolio.
October 27, 2023
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2 min read
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Tristan Manalac
Pictured: Boy sitting in a wheelchair on a beach/i
FDA
FDA Approves Novel Corticosteroid Treatment Option for DMD Patients
Santhera Pharmaceuticals and partner Catalyst Pharmaceuticals got the FDA’s greenlight for their Duchenne muscular dystrophy drug Agamree, which is expected to launch in the first quarter of 2024.
October 27, 2023
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2 min read
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Tristan Manalac
A scientific analysis of Alzheimer's disease/istoc
Drug Development
BioXcel Alzheimer’s Trial Shows No Signs of Misconduct, Finds Independent Audit
A third-party audit found no integrity and reliability problems with data from BioXcel Therapeutics’ Phase III trial. The company intends to file a supplemental New Drug Application for its candidate BXCL501.
October 26, 2023
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2 min read
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Tristan Manalac
Pictured: 3D rendering of amyloid-beta oligomers
Drug Development
Eisai, Biogen Build Case for Subcutaneous Leqembi for Alzheimer’s at CTAD
Subcutaneous injections of Eisai and Biogen’s Leqembi led to numerically greater amyloid removal than the intravenous version of the Alzheimer’s disease therapy, though risks of brain swelling and bleeding remained.
October 26, 2023
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2 min read
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Tristan Manalac
Pictured: Alnylam headquarters in Massachusetts/iS
Drug Development
Alnylam Publishes Phase III ATTR-CM Data for Patisiran After FDA Rejection
Following the regulator’s denial of patisiran’s label expansion, Alnylam has published late-stage data for the RNAi therapeutic in The New England Journal of Medicine demonstrating its efficacy in ATTR-cardiomyopathy.
October 26, 2023
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2 min read
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Tristan Manalac
Pictured: GSK's office in Poznan, Poland/iStock, W
Drug Development
GSK Looks to Push RSV Vaccine to Younger Seniors with New Phase III Data
The company’s respiratory syncytial virus vaccine Arexvy can elicit similar levels of immune protection in adults aged 50 to 59 as in its approved population, finds results from a late-stage study.
October 25, 2023
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2 min read
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Tristan Manalac
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