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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.

Pictured: J&J's building in Switzerland
Drug pricing
HRSA Threatens J&J With Sanctions Over Planned 340B Rebate Scheme
If Johnson & Johnson refuses to scrap its proposed changes to the 340B drug pricing for hospitals, it risks the termination of participation in the program and monetary fines, the Health Resources and Services Administration warned.
September 18, 2024
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2 min read
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Tristan Manalac
3D illustration of an antibody-drug conjugate
Antibody-drug conjugate (ADC)
Merck, Daiichi Score Late-Stage NSCLC Win for ADC, Flag Two Deaths
Despite meeting the primary endpoint in a Phase III study, two patients treated with Merck and Daiichi Sankyo’s experimental antibody-drug conjugate died in a Phase III non-small cell lung cancer study, though the deaths have not been linked to patritumab deruxtecan.
September 17, 2024
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2 min read
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Tristan Manalac
Photo of a GLP-1 injector pen on a blue background
GLP-1
GLP-1s Can Potentially Cut Cirrhosis, Related Complications in MASLD: Study
In metabolic dysfunction-associated steatotic liver disease, a retrospective analysis shows that patients on GLP-1 receptor agonists are 14% less likely to progress to cirrhosis.
September 17, 2024
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2 min read
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Tristan Manalac
Pictured: Boehringer Ingelheim sign on a building/
Phase III
Boehringer Aces Phase III Pulmonary Fibrosis Trial, Plans FDA Application
Boehringer Ingelheim’s investigational compound nerandomilast, which targets the PDE4B enzyme involved in fibrosis and inflammation in the lungs, met its primary endpoint in a late-stage study.
September 17, 2024
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2 min read
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Tristan Manalac
Pictured: Infant in the hospital wearing a ventila
RSV
Sanofi, AstraZeneca Get FDA Approval of New Manufacturing Line to Bolster US Supply of RSV Antibody
The newly approved filling line will be able to provide both 50-mg and 100-mg doses of the respiratory syncytial virus antibody Beyfortus to help meet demand ahead of the 2024/2025 RSV season.
September 17, 2024
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2 min read
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Tristan Manalac
External view of Eli Lilly's world headquarters in Indianapolis
Approvals
Lilly Secures FDA Nod for Eczema Therapy, Eyes Launch in ‘Coming Weeks’
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
September 16, 2024
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2 min read
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Tristan Manalac
Pictured: AstraZeneca building in Gothenburg/iStoc
Bladder cancer
AstraZeneca’s Perioperative Imfinzi ‘Significantly Extends Survival’ in Type of Bladder Cancer
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.

September 16, 2024
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2 min read
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Tristan Manalac
GSK's headquarters in West London
Lung cancer
GSK, iTeos Score Phase II Win for Jemperli-TIGIT Combo in NSCLC
High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.
September 16, 2024
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
FDA
FDA Action Alert: BMS, Merck, Sanofi/Regeneron and More
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
September 16, 2024
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6 min read
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Tristan Manalac
Pictured: Roche tower in Basel, Switzerland
Approvals
Roche Gains PD-1 Edge on Merck With FDA Nod for Subcutaneous Tecentriq
Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
September 13, 2024
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2 min read
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Tristan Manalac
Concept art to depict schizophrenia and split personality disorder
Neuropsychiatric disorders
Neurocrine Scraps Schizophrenia Candidate After Phase II Failure
BMO Capital Markets analyst Evan Seigerman said luvadaxistat’s inconsistencies between mid-stage trials raise questions about Neurocrine Biosciences’ developmental efforts moving forward.
September 13, 2024
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2 min read
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Tristan Manalac
Gilead's headquarters in Silicon Valley
Infectious disease
Gilead Touts 96% HIV Risk Reduction With Twice-Yearly PrEP, Eyes Regulatory Filings
Armed with readouts from the PURPOSE 1 and 2 trials, Gilead Sciences is now gearing up for global regulatory submissions for lenacapavir as a pre-exposure prophylactic option for human immunodeficiency virus.
September 13, 2024
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2 min read
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Tristan Manalac
Astellas' headquarters for the Americas
FDA
Astellas’ Hot Flash Drug Veozah Slapped With Another FDA Warning for Liver Injury
One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label.
September 13, 2024
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Approvals
J&J Positions Tremfya as Stelara Successor With FDA Nod for Ulcerative Colitis
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
September 12, 2024
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Adcomms
Intercept’s Ocaliva in Jeopardy as FDA Questions Efficacy, Safety Ahead of Adcomm
With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
September 12, 2024
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2 min read
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Tristan Manalac
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