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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.

A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Travere, Avadel and Roche
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
September 3, 2024
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3 min read
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Tristan Manalac
Pictured: Alnylam headquarters in Massachusetts/iS
Rare diseases
Alnylam Builds ATTR-CM Case for Vutrisiran With Strong Phase III Survival Data
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
August 30, 2024
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Regulatory
J&J Poised to Challenge Argenx With Myasthenia Gravis Filing for Nipocalimab
J&J gained rights to the FcRn blocker nipocalimab when it acquired Momenta Pharmaceuticals in August 2020 for $6.5 billion.
August 30, 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
Legal
Siding With Novo and Lilly, Court Agrees to First Tackle ‘Cross Cutting Issues’ in GLP-1 Litigations
In agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects.
August 30, 2024
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2 min read
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Tristan Manalac
Gloved hand holding a vial of mpox vaccine
Regulatory
Emergent Wins FDA Approval for Mpox Vaccine as Outbreak Rages On
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
August 30, 2024
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2 min read
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Cancer
Merck Axes Two Keytruda Phase III Cancer Trials Due to Disappointing Data
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.
August 29, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Pharmacy benefit managers
House Oversight Chair Calls on PBM Execs to Correct Testimonies
The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings.
August 29, 2024
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2 min read
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Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Legal
Regeneron Sues Sandoz in Federal Court to Block Eylea Biosimilar
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
August 29, 2024
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Cardiovascular disease
Novartis Plots Leqvio Expansion After Lowering Cholesterol in Phase III Study
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
August 29, 2024
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2 min read
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Tristan Manalac
Sign in front of Pfizer in Quebec, Canada
Collaboration
Pfizer Partners With Flagship’s Quotient to Leverage Genetics Against Heart, Renal Diseases
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
August 28, 2024
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2 min read
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Tristan Manalac
3D illustration of antibodies
Series A
Navigator Closes $100M Series A, Targets Autoimmune Market With Potential Best-in-Class Bispecific Antibody
Navigator Medicine is looking to push its lead asset NAV-240 targeting immune-mediated diseases through to clinical studies “in the coming months,” which the startup in-licensed from a South Korean biotech for $20 million upfront.
August 28, 2024
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2 min read
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Tristan Manalac
Nurse inserts an IV line into a patient with a mask
COVID-19
FDA Limits Use of Invivyd’s COVID-19 Prophylactic as New Variants Dominate
The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.
August 28, 2024
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2 min read
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Tristan Manalac
Signage at Pfizer's world headquarters in New York City
Business
Pfizer Launches Direct-to-Consumer Portal for Migraine, Flu, COVID-19 Products
The company joins Eli Lilly in offering its own digital platform to more directly connect to patients, allowing them easier access to healthcare providers and prescription drugs.
August 28, 2024
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2 min read
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Tristan Manalac
External view of Eli Lilly's world headquarters in Indianapolis
Obesity
Lilly Looks to Expand Zepbound Supply by Offering Single-Dose Vials
Through its online pharmacy LillyDirect, Eli Lilly announced Tuesday it will allow patients to purchase single-dose vials of Zepbound—without the autoinjector—at a 50% discount or more versus other incretin obesity treatments.
August 27, 2024
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3 min read
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Tristan Manalac
3D illustration of tow GLP-1 therapy autoinjectors
Drug pricing
Medicare Coverage of Novo’s Semaglutide for CVD Could Cost $145B Annually: Study
The number of patients who will be eligible for Novo Nordisk’s blockbuster GLP-1 under new Medicare Part D plan guidelines will vary depending on how cardiovascular disease is defined, according to researchers.
August 27, 2024
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2 min read
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Tristan Manalac
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