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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.

Merck & Co. headquarters in Silicon Valley; Merck & Co. Inc. is an American multinational pharmaceutical company
Regulatory
FDA Approves Merck’s Keytruda for First-Line Treatment of Pleural Mesothelioma
The mesothelioma approval for the Keytruda combination regimen potentially unlocks a $12 billion market opportunity, according to a recent report from research firm IMARC Group.
September 18, 2024
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Tristan Manalac
The United States Capitol building with the dome lit up at night.
Drug pricing
Sanders Says Generics Companies Can Make, Sell Ozempic for Less Than $100 a Month
Ahead of a Senate health committee hearing next week with Novo Nordisk CEO Lars Jørgensen, Sen. Bernie Sanders claims he has secured assurances from generics developers that they will charge a significantly lower monthly price than the $969 Americans currently pay for the Danish drugmaker’s diabetes blockbuster.
September 18, 2024
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Tristan Manalac
Novartis' office building in Marburg, Germany
Approvals
Novartis Pushes Kisqali Into Earlier Stages of Breast Cancer, Nearly Doubles Eligible Patient Population
The FDA’s approval of Kisqali in combination with an aromatase inhibitor allows Novartis to target patients with earlier breast cancer who are at risk of recurrence.
September 18, 2024
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2 min read
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Tristan Manalac
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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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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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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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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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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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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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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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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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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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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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
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