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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.

Magnifying glass and various business graphs on light blue background
Regulatory
FDA To Publish Drug-Related Adverse Event Reports Daily
The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
August 25, 2025
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2 min read
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Tristan Manalac
Miles of lava rocks and hardened lava flow on the Big Island of Hawaii after a recent volcanic eruption
Obesity
Weight-Loss Wasteland: 5 Obesity Assets That Failed
The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and losers. Here are five molecules that never made it to the market.
August 25, 2025
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9 min read
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Tristan Manalac
Minimal Clip Art Collage. Pop Vector Design Composition with bright bold geometric shapes, halftone objects for ad, animation etc
Approvals
Ionis Wins Approval For First RNA-Targeted Prophylactic for Rare Swelling Disease
The drug, for hereditary angioedema, is Ionis’ second wholly owned asset.
August 22, 2025
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2 min read
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Tristan Manalac
Contemporary art collage. Human hand holding megaphones and spreading fake news. Concept of information, creativity, social issues, rumors. Copy space for ad
Regulatory
After Court Win, Vanda Asks Makary To Review ‘Unacceptable’ Approval of Rival Generics
Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.
August 22, 2025
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2 min read
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Tristan Manalac
Contemporary art collage of a hand holding scissors. Copy space for ad. Modern design.
Regulatory
Krystal Cuts Melanoma Study of Viral Immunotherapy as FDA ‘Uncertainty’ Muddies Approval Pathway
Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.
August 22, 2025
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2 min read
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Tristan Manalac
Close-up of medical ampoule production line/iStock
Manufacturing
Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds
Among the problems cited were cat hair, bacterial contamination and instrument defects.
August 22, 2025
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2 min read
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Tristan Manalac
Johnson & Johnson's business center in Switzerland
Manufacturing
J&J Adds $2B to US Manufacturing Commitment Amid Trump’s Protracted Tariff Threats
President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.
August 21, 2025
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2 min read
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Tristan Manalac
Pictured: CDC signage at its headquarters in Georg
Government
Hundreds of HHS Staffers Accuse RFK Jr. of ‘Sowing Public Mistrust’ Against CDC After Shooting at HQ
In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health misinformation, particularly about vaccines, infectious diseases and federal health agencies.
August 21, 2025
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2 min read
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Tristan Manalac
Trendy halftone collage. A hand holds a ringing alarm clock. Time, hurry up. Vector business concepts for graphic and web design, marketing and print materials, social media. Vector illustration
Regulatory
Two FDA Decisions for Regeneron’s Eylea HD Delayed Into Q4
The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
August 21, 2025
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2 min read
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Tristan Manalac
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).
Cancer
FDA Looks To Raise Survival Bar for Cancer Drug Approvals in New Draft Guidance
The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new guidance follows the surprising return of CBER Head Vinay Prasad, who has previously argued for prioritizing OS.
August 20, 2025
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2 min read
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Tristan Manalac
Arrows lead to a graph of a downward trend, then c
Layoffs
CSL Overhauls Business With Vaccine Spinout, 15% Layoffs
With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.
August 20, 2025
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1 min read
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Tristan Manalac
Healthcare, medical and doctor with kid patient and father holding baby for shot in hospital. Girl, children and family clinic nurse with vaccine for covid, virus or flu shot.
Vaccines
American Academy of Pediatrics Contradicts CDC, Recommends COVID-19 Shot for Kids
The CDC no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, a position that has been opposed by leading medical societies.
August 20, 2025
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2 min read
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Tristan Manalac
Choosing between two distinct paths, leading to different outcomes and destinations. Visual metaphor.
Business
5 Biotechs Taking the Pipeline-in-a-Product Approach to Drug Development
The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges.
August 20, 2025
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10 min read
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Tristan Manalac
Abstract creative art collage, market declines in the stock market. The concept of collapse or bankruptcy.
Weight loss
Viking Crashes as Obesity Pill Delivers Over 12% Weight Loss
Viking Therapeutics’ VK2735 achieves a 10.9% placebo-adjusted weight loss at 13 weeks, but a less than ideal safety profile marred the results.
August 19, 2025
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2 min read
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Tristan Manalac
Time elapses in achieving the goal. Deadline. Get off schedule. Make it before the end of the term. Overdue work. Loss of relevance. Decrease in achievements, obsolescence of tasks.
Gene therapy
Regenxbio’s Hunter Syndrome Gene Therapy Hit With 3-Month PDUFA Delay
The FDA has postponed its decision date for Regenxbio’s Hunter syndrome gene therapy to review additional longer-term clinical data for the asset.
August 19, 2025
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2 min read
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Tristan Manalac
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