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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.

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Earnings
Vertex Shrugs Off Q1 Miss With ‘Strong’ Journavx Launch, Encouraging Pipeline Position
Vertex has recorded some 25,000 prescriptions for Journavx since its January approval and is in the process of getting big PBMs to cover the non-opioid pain drug.
May 6, 2025
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2 min read
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Tristan Manalac
Sign outside BioNTech's building in Germany
Earnings
BioNTech’s Ambitious PD-L1/VEGF Plans Currently Rely on Chinese Manufacturing
BNT327, a PD-L1/VEGF therapy, is still currently being manufactured in China, but BioNTech is working to establish a diversified supply chain, executives said during the company’s Q1 investor call.
May 5, 2025
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3 min read
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Tristan Manalac
©Vertex Pharmaceuticals Incorporated. All Rights Reserved.
Gene therapy
Vertex Abandons AAV as Gene Therapy Space Weathers Difficulties
The cell and gene therapy space in recent months has hit several speedbumps, including layoffs, dropped drugs and discontinued partnerships.
May 5, 2025
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2 min read
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Tristan Manalac
Open white medication bottle tipped over with red capsules scattered on a plain background, highlighting modern healthcare and medication management.
GLP-1
Novo’s Wegovy Inches Closer to Becoming First FDA-Approved GLP-1 Weight-Loss Pill
The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year.
May 5, 2025
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2 min read
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Tristan Manalac
fire,business,laid off
Policy
FDA Rehires User Fee Negotiators After Mass Employee Layoffs: Reuters
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
May 5, 2025
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: GSK, Sanofi, Merck and More
On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.
May 5, 2025
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6 min read
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Tristan Manalac
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Government
FDA to Rehire Some Travel Staff as Lapses Begin to Show: AP
Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.
May 2, 2025
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2 min read
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Tristan Manalac
Geneva, Switzerland - November 16, 2024: Exterior view of the headquarters of the World Health Organization (WHO), the specialized agency of the United Nations responsible for global public health
Obesity
WHO Leaning Toward Adding Obesity Drugs for Adults to Essential Medicines List: Reuters
In an internal memo, the World Health Organization signaled its support for anti-obesity drugs like Wegovy and Zepbound, which the agency decided against listing in 2023, the last time the Essential Medicines list was updated.
May 2, 2025
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2 min read
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Tristan Manalac
Pictured: Amgen's office in Massachusetts/iStock,
Earnings
Amgen Advocates For ‘Pro-Growth Tax Policy’ Instead of Tariffs to Boost Domestic Manufacturing
Like fellow Big Pharmas Eli Lilly and Johnson & Johnson, Amgen is urging the Trump administration to consider tax policy instead of tariffs to promote domestic pharma manufacturing.
May 2, 2025
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2 min read
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Tristan Manalac
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Multiple sclerosis
Immunic Talks Up Disability Gains as Phase II MS Therapy Fails on Primary Endpoint
According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug development in multiple sclerosis.
May 1, 2025
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2 min read
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Tristan Manalac
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Approvals
J&J Steps Into Crowded Myasthenia Gravis Market With FDA Nod
With Imaavy, J&J will go toe-to-toe with fellow Big Pharma AstraZeneca, which owns Soliris and Ultomiris.
May 1, 2025
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2 min read
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Tristan Manalac
complex business management or organization, distraction and complicated business process
Government
FDA Misses Another Deadline Amid Staff Exodus, Structural Disruptions
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two decades.
May 1, 2025
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2 min read
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Tristan Manalac
Mergers & acquisitions
Novartis Drops up to $1.7B to Bolster Oligo Pipeline With Regulus Buy
At the heart of the acquisition is Regulus’ farabursen, an miRNA-targeting oligonucleotide in early-stage development for rare autosomal dominant polycystic kidney disease.
April 30, 2025
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2 min read
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Tristan Manalac
Poznan, Poland - 5 October 2024: GSK -Glaxosmithkline headquarters office building in Poznan.
Earnings
GSK Optimistic About M&A Prospects Despite Trump Tariff Threats
GSK’s dealmaking will be “cautious and disciplined” under the current trade war, but the pharma will focus on looking for “opportunities created” amid these tensions, according to CEO Emma Walmsley. The company also reported a 4% earnings bump for the quarter.
April 30, 2025
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2 min read
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Tristan Manalac
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Mergers & acquisitions
Major Shareholder Opposes Acelyrin’s Merger With Alumis, Prefers Wind-Down
It’s been a fraught road for the proposed merger between Acelyrin and Alumis, with Tang Capital’s Concentra Biosciences in February threatening to upend the deal with a proposed $3-per-share acquisition of Acelyrin.
April 30, 2025
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2 min read
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Tristan Manalac
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