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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.

Novo Nordisk's corporate headquarters in Denmark
Complete Response Letters
FDA Rejects Novo’s Once-Weekly Insulin Injection, Cites Manufacturing Process
The FDA’s Complete Response Letter turned down Novo Nordisk’s Biologics License Application for its once-weekly basal insulin icodec injection for diabetes mellitus, with “requests” related to the manufacturing process and the type 1 diabetes indication.
July 11, 2024
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Business
VC Firm Flagship Raises $3.6B to Create, Support 25 ‘Breakthrough’ Companies
Biotech venture capital firm Flagship Pioneering is looking to fund companies focused on artificial intelligence, human health and sustainability, bringing the total raised since 2021 to $6.4 billion.
July 10, 2024
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Tristan Manalac
Pictured: Amgen's office in Tampa, Florida
Drug Development
Amgen Axes Development of Early-Stage Bispecific T-Cell Engager for Solid Tumors
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
July 10, 2024
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Tristan Manalac
3D illustration of a T cell killing a cancer cell
CAR-T
Interius Gets Go-Ahead for Phase I Trial of In Vivo CAR-T Therapy in Australia
Interius BioTherapeutics has received approval from Australia’s Human Research Ethics Committee to begin the first-in-human trial of an investigational in vivo CAR-T therapy designed to treat B-cell malignancies.
July 10, 2024
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Tristan Manalac
Woman scratching her arm while sitting in bed
Approvals
FDA Approves Atopic Dermatitis Label Expansion for Arcutis’ Zoryve Cream
The regulator Tuesday added atopic dermatitis to the label of Arcutis Biotherapeutics’ topical PDE4 inhibitor Zoryve for the treatment of patients six years of age and older.
July 10, 2024
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Tristan Manalac
Man preparing his GLP-1 injection
Obesity
Lilly’s Mounjaro Helps Patients Lose More Weight Than Novo’s Ozempic: Study
Eli Lilly’s Mounjaro outperformed Novo Nordisk’s Ozempic at inducing weight loss in obese or overweight adults, according to an observational study published Monday in JAMA Internal Medicine.
July 9, 2024
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Regulatory
Roche Reintroduces Wet AMD Eye Implant Nearly Two Years After Voluntary Recall
Roche’s eye implant Susvimo for patients with neovascular age-related macular degeneration is re-entering the U.S. market after the FDA approved updates to the components of the product.
July 9, 2024
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Tristan Manalac
Gilead's corporate headquarters in Silicon Valley
Policy
US Government Files Appeal in High-Stakes HIV PrEP Patent Battle Against Gilead
The Biden administration is appealing a 2023 jury decision that declared invalid its patent protections over Gilead Sciences’ HIV prevention regimen of Truvada and Descovy.
July 9, 2024
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Tristan Manalac
Pictured: uniQure headquarters in Amsterdam
Huntington’s Disease
UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data
Following a disappointing readout last year, uniQure on Tuesday posted promising Phase I/II data for its investigational gene therapy AMT-130 and nabbed the first-ever Regenerative Medicine Advanced Therapy designation from the FDA in Huntington’s disease.
July 9, 2024
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Tristan Manalac
Photo of a GLP-1 injector pen on a blue background
Cancer
GLP-1s May Cut Risk of 10 Obesity-Related Cancers in Type 2 Diabetes Patients: Study
GLP-1 receptor agonists could reduce the risk of 10 obesity-associated cancers, such as meningioma, multiple myeloma and colorectal cancer, according to an analysis of electronic health records.
July 8, 2024
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Tristan Manalac
External view of Boehringer Ingelheim's headquarters in Silicon Valley
Legal
Boehringer Ingelheim Loses Legal Challenge to IRA in Connecticut Federal Court Ruling
A federal judge ruled last week that the U.S. government can use its economic standing as a bulk purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act.
July 8, 2024
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Business
Lilly Pays $3.2B to Buy Morphic and Deepen Immunology, Gastro Portfolio
Eli Lilly on Monday announced a $3.2 billion all-cash deal to purchase Morphic and its pipeline of oral integrin therapies in a move to expand the pharma’s presence in the autoimmune diseases space.
July 8, 2024
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Tristan Manalac
Roche's signage at its office in France
Drug Development
Roche Axes Phase II/III NSCLC Study as TIGIT Drug Loses to Keytruda-Chemo Combo
Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.
July 8, 2024
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Tristan Manalac
Photo of a GLP-1 injector pen on a blue background
Drug Pricing
Biden, Sanders Call on Novo Nordisk and Eli Lilly to Lower Weight-Loss Drug Prices
President Joe Biden and Sen. Bernie Sanders in a Tuesday op-ed in USA Today called on Novo Nordisk and Eli Lilly to “stop ripping off Americans” with “unconscionably high prices” for their GLP-1 medicines.
July 3, 2024
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Tristan Manalac
Johnson & Johnson's business center in Switzerland
Drug Development
J&J, Legend’s Phase III Win Cements Carvykti as Earlier-Line Multiple Myeloma Treatment
Johnson & Johnson and Legend Biotech’s Carvykti cell therapy significantly improved survival in patients with multiple myeloma when used in the second-line setting, the companies announced on Tuesday.
July 3, 2024
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Tristan Manalac
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