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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: 3D illustration of a damaged liver/iStoc
FDA
Madrigal’s Rezdiffra Energizes MASH Space, Sets Bar for Future Therapies
With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.
March 18, 2024
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3 min read
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Tristan Manalac
Pictured: Merck office building in Canada
Drug Development
Merck’s Keytruda Pushes Towards Earlier Stages of Cervical Cancer with Phase III Data
The PD-1 inhibitor Keytruda significantly improved overall survival in a late-stage trial when used with chemoradiotherapy to treat patients with newly diagnosed advanced cervical cancer.
March 15, 2024
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2 min read
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Tristan Manalac
3D illustration of blood cells being produced in the bone marrow
Policy
FDA Adcomm Backs Geron’s Anemia Drug for Blood Cancer
Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.
March 15, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
FDA
BeiGene’s Tevimbra Wins First US Approval Following Tough Regulatory Path
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.
March 15, 2024
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2 min read
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Tristan Manalac
External view of AstraZeneca's headquarters building in Silicon Valley
Deals
AstraZeneca Boosts Rare Disease Portfolio with $1.05B Amolyt Acquisition
At the center of the deal is Amolyt Pharma’s late-stage candidate eneboparatide for the rare disease hypoparathyroidism. AstraZeneca also gains ownership of AZP-3813, which is being assessed for acromegaly in a Phase I trial.
March 14, 2024
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2 min read
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Tristan Manalac
Pictured: Sign above the entrance to a U.S. courthouse
Policy
PhRMA Loses Another Legal Battle as Court Sides with Arkansas Over Drug Discount Program
A lawsuit filed by the Pharmaceutical Research and Manufacturers of America failed to block an Arkansas law that empowers hospitals to use outside pharmacies to dispense discounted drugs.
March 14, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
Mirum Secures Livmarli’s Expansion into Familial Intrahepatic Cholestasis
Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.
March 14, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Policy
BIO Separates from China’s WuXi AppTec Amid National Security Concerns
In a change of position as congressional scrutiny of WuXi AppTec grows, the Biotechnology Innovation Organization announced it is taking steps to separate from the China-based biotech.
March 14, 2024
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3 min read
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Tristan Manalac
Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace
Policy
FDA Action Alert: Orchard, ITF, Merck and More
The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
March 13, 2024
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8 min read
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Tristan Manalac
Pictured: Eli Lilly's biotechnology center in San Diego, California
Drug Development
Lilly Makes Weight-Loss Drug Zepbound Available Through Amazon Pharmacy
Eli Lilly has partnered with Amazon Pharmacy to help fill online orders of its obesity drug Zepbound—as well as migraine and diabetes medicines—placed through the pharma’s online portal LillyDirect.
March 13, 2024
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2 min read
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Tristan Manalac
3D illustration of a T cell killing a cancer cell
Business
Allogene, Arbor Team to Develop Off-the-Shelf CAR-T Therapies with CRISPR
Allogene Therapeutics and Arbor Biotechnologies will use their allogeneic CAR T and next-generation gene-editing platforms to develop novel off-the-shelf CAR-T therapies for autoimmune diseases.
March 13, 2024
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
FDA Questions Benefit, Risk Profile of Geron’s MDS Candidate Ahead of Adcomm
In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
March 13, 2024
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2 min read
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Tristan Manalac
Pictured: Entrance to Pfizer's office in Belgium
Drug Development
Pfizer’s $43B Seagen Buy Starts to Pay Off with Adcetris Phase III Data in DLBCL
Antibody-drug conjugate Adcetris, when used with rituximab or lenalidomide, improved overall survival in patients with relapsed or refractory diffuse large B-cell lymphoma. Pfizer secured access to Seagen’s ADC in March 2023.
March 12, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Updates Use of Biomarkers in Draft Guidelines for Alzheimer’s Drug Development
The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals.
March 12, 2024
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2 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Drug Development
Roche Plots Neuro Comeback with Promising Mid-Stage Alzheimer’s Data
In Monday’s neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.
March 12, 2024
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2 min read
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Tristan Manalac
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