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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.

Hand holding a nasal spray bottle against a white background
Complete response letters
Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time
Citing the need for another human factor study and more technical data for the final product, the FDA denied approval of Orexo’s nasal spray rescue medication for opioid overdose.
July 17, 2024
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2 min read
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Tristan Manalac
A team of research scientists in protective equipment working in a lab
Manufacturing
CordenPharma Expands GLP-1 Manufacturing Footprint in US and Europe with $980M Commitment
To help keep pace with the demand for GLP-1 therapies, CordenPharma has announced a sizeable $980 million investment in its U.S. and European sites.
July 16, 2024
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Cell therapy
FDA Eyes Site Tours of Cell and Gene Therapy Manufacturers
To improve its reviewers’ understanding of cell and gene therapy manufacturing, the agency has launched a program that will involve a tour of manufacturing facilities and daily workshops for its staffers.
July 16, 2024
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2 min read
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Tristan Manalac
Corporate headquarters of Novo Nordisk in Denmark
Government
Democratic Senators to Meet with Novo Nordisk After Withdrawal of Levemir: Reuters
After discontinuing its long-acting insulin product Levemir, Novo has again found itself under legislative scrutiny, with three Democratic senators seeking a sit-down with the pharma.
July 16, 2024
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2 min read
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Legal
Vertex Sues US Government Over Fertility Services for Casgevy Treatment
Vertex has filed a complaint against the Department of Health and Human Services, seeking to make its fertility preservation program available to federally insured patients needing Casgevy treatment.
July 16, 2024
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1 min read
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Tristan Manalac
Boy sitting in a wheelchair
Friedreich’s ataxia
Lexeo’s Gene Therapy Shows Early Promise for Friedreich’s Ataxia Cardiomyopathy
Lexeo Therapeutics’ investigational gene therapy reduces left ventricular volume and wall thickness in patients with Friedreich’s ataxia, according to a small study.
July 15, 2024
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2 min read
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Tristan Manalac
Businessmen grasping cardboard box full of office supplies on a desk in an office
IPO
Metagenomi CSO Steps Down Shortly After IPO, Moderna Exit
Following a disappointing IPO and the loss of Moderna’s gene editing contract, Metagenomi’s Chief Scientific Officer Luis Borges is departing the biotech.
July 15, 2024
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Neuropsychiatric disorders
Ozempic Tied to Lower Risk of Dementia, Nicotine Misuse: Study
Despite recent concerns about suicidality and other neuropsychiatric issues, a recent study has found that Novo Nordisk’s Ozempic (semaglutide) is associated with lower risks of dementia, cognitive deficit and nicotine misuse.
July 15, 2024
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2 min read
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Tristan Manalac
Businessman rejecting money in white envelope offered by his partner in the dark, anti bribery concept - panoramic banner
Drug Pricing
Akebia Ends Deal With CSL Vifor, Unveils Hefty Price Tag for CKD Anemia Drug Vafseo
Akebia Therapeutics on Thursday said it regained full U.S. rights to its chronic kidney disease anemia drug Vafseo, which the biotech has priced at around $15,500 per year.
July 12, 2024
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2 min read
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Tristan Manalac
Doctor performing an ultrasound scan on the neck of a woman/iStock, Roman Chekhovskoy
Cancer
Immutep Aces Phase IIb in First-Line Head and Neck Cancer, Eyes Regulatory Path Ahead
Immutep shares jumped nearly 20% on Friday after data showed its LAG-3 therapy—plus Keytruda—elicited strong response rates in head and neck squamous cell carcinoma patients in the front-line setting.
July 12, 2024
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2 min read
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Tristan Manalac
AbbVie's office in South San Francisco, California
Business
AbbVie’s Humira Continues to Lose Market Share as Biosimilars Gain Ground: Report
CVS Caremark’s recent decision to take AbbVie’s Humira off its major formularies has caused the blockbuster to lose more market share to biosimilars, according to the latest report from Samsung Bioepis.
July 12, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Patents
Senate Unanimously Passes Bill to Reduce Big Pharma Patent Thickets, Increase Competition
The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.
July 12, 2024
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1 min read
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Tristan Manalac
Pictured: Pfizer office in Brussels, Belgium/iStoc
Weight Loss
Pfizer Moves Forward With Obesity Pill, Plans Dose Optimization Studies This Year
Pfizer said Thursday it is pushing ahead with a once-daily, modified-release formulation of its oral GLP-1 obesity therapy danuglipron, with dose optimization studies in the second half of 2024.
July 11, 2024
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2 min read
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Tristan Manalac
3D illustration of a tumor on a brain/iStock, wildpixel
Brain Cancer
Kazia Offers Secondary OS Data to Build FDA Case for Glioblastoma Drug
Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial.
July 11, 2024
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2 min read
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Tristan Manalac
Entrance of the FTC in Washington, DC
Drug Pricing
FTC to Sue ‘Big Three’ PBMs for Setting Insulin, Other Drug Prices: WSJ
The Federal Trade Commission plans to file lawsuits against the three largest pharmacy benefit managers over allegedly steering patients away from less expensive drugs, according to The Wall Street Journal.
July 11, 2024
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2 min read
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Tristan Manalac
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