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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.

FDA CDER director George Tidmarsh speaking in an FDA video
FDA
UPDATE: Tidmarsh Waffles on Resignation, Will Fight To Clear Name
Less than 24 hours after resigning his post as the FDA’s head drug regulator, George Tidmarsh is reportedly reconsidering his decision and vowing to fight for his name and credibility amid a probe into his “personal conduct” at the agency.
November 3, 2025
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3 min read
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Tristan Manalac
Legal battle lawsuit concept as two justice scales hitting each other as a justice court fight symbol representing a lawyer or attorney representation services with 3D illustration elements.
Mergers & acquisitions
UPDATE: Pfizer Files Lawsuits Against Novo Nordisk, Metsera To Stop Rival Bid
Pfizer has filed two separate lawsuits in an effort to stop Novo Nordisk’s unsolicited bid to acquire obesity biotech Metsera.
November 3, 2025
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4 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).
Gene editing
FDA Eyes Accelerated Reviews for Gene Editing Therapies
Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking on accelerating gene editing reviews.
November 3, 2025
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2 min read
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Tristan Manalac
Eli Lilly's biotechnology center in California
Pain
Lilly Refines Pain Pipeline Again, Scrapping Mid-Stage Program
Before being discontinued, the P2X7 receptor blocker had cleared a master protocol study in chronic pain, though Eli Lilly said that results were not sufficient for advancement of the Asahi Kasei–partnered asset.
October 31, 2025
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2 min read
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Tristan Manalac
Contemporary digital collage art. Modern trippy design. Hands holding fork and spoon
Earnings
Gilead Still Hungry for Deals as HIV Portfolio Grows, Veklury Crashes
Gilead is actively looking for late-stage and de-risked assets for potential deals across various therapeutic spaces, including liver disease, cancer and immunology.
October 31, 2025
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2 min read
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Tristan Manalac
Concept art showing a money icon and human hands
IPO
Evommune Joins IPO Class With Planned $160M Raise for Immuno Pipeline
With the shutdown ongoing, Evommune plans to close its IPO on Nov. 5 via a Securities Act clause that allows registrations to come into effect after a certain window has passed.
October 31, 2025
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2 min read
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Tristan Manalac
Investment mistakes, taxes, expenses, and unknown costs drain money, concept of Businessman carries a money bag with a big hole, banknotes falling out
Manufacturing
Lilly Continues Manufacturing Push With $1.2B Puerto Rico Facility for GLP-1 Pill
The investment, which will expand Eli Lilly’s existing campus in Puerto Rico, is slated to create 100 new jobs, on top of around 1,000 construction-related roles.
October 30, 2025
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2 min read
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Tristan Manalac
Stand out from the crowd and different creative idea concepts , Longest light ladder glowing and aiming high to goal target among other short ladders on green background with shadows . 3D rendering.
CAR-T
Kyverna’s CAR T Therapy Sets ‘New Efficacy Standard’ in Myasthenia Gravis, De-Risking Phase III Trials
With a 100% response rate in a Phase II study, KYV-101 sets a new efficacy bar in generalized myasthenia gravis, according to analysts at William Blair.
October 30, 2025
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2 min read
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Tristan Manalac
Contemporary art collage showing a hand giving a thumbs down surrounded by red arrows pointing down, concept of negative feedback and bad review
Regulatory
Life-Threatening Liver Toxicity Triggers FDA Freeze on Two Intellia Gene Therapy Studies
The clinical hold comes days after Intellia voluntarily paused enrollment and dosing in the same two studies.
October 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 Points to ‘Macro Factors’ To Explain US Shingrix Demand Crash
Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.
October 29, 2025
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2 min read
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Tristan Manalac
Poster sketch image artwork photo collage of body language finger showing gesture symbol thumb down dislike dissatisfied minus no opinion.
Earnings
FDA Formally Rejects Regeneron’s Eylea HD Over Manufacturing Issues
Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing troubles for the franchise.
October 29, 2025
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2 min read
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Tristan Manalac
The factor that changes everything. A critical break. A sudden change in plans. A threat and a danger. Recover from the blow and get back on course. Severe stress. Withstand the blow.
Immunology and inflammation
Aldeyra Cans RASP Asset, Brings Forward Two Others in Pipeline Shakeup
The reprioritization initiative extends Aldeyra’s cash runway into the second half of 2027.
October 29, 2025
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2 min read
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Tristan Manalac
People And Robots Handshake Modern Human And Artificial Intelligence Futuristic Mechanism Technology Vector Illustration
Artificial intelligence
J&J, Lilly Crest AI Wave With Nvidia Partnerships
Eli Lilly and Johnson & Johnson are joining fellow Big Pharma peers in upping their investment in AI, with Lilly looking to create the industry’s ‘most powerful supercomputer’ and J&J building a virtual operating room.
October 29, 2025
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2 min read
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Tristan Manalac
Blue human kidneys with a red surface. Kidney disease, medical diagnosis, technology, artificial intelligence, treatment concept. Low-poly futuristic digital style. Wireframe structure. Vector.
Autoimmune disease
Cabaletta’s CAR T Therapy Spurs Remissions in Small Lupus Trial
Phase I/II data for rese-cel point to its therapeutic potential in systemic lupus erythematosus and lupus nephritis, as well as other autoimmune conditions.
October 28, 2025
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2 min read
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Tristan Manalac
Sep 21, 2020 Brisbane / CA / USA - BioMarin headquarters in Silicon Valley; BioMarin Pharmaceutical Inc. is an American biotechnology company
Earnings
BioMarin Abandons Gene Therapy Roctavian, Cuts Revenue Guidance as Voxzogo Faces Competitors
BioMarin no longer expects to hit its $4 billion revenue target by 2027, citing various market factors such as impending competition for achondroplasia therapy Voxzogo and the divestment of the gene therapy Roctavian.
October 28, 2025
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4 min read
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Tristan Manalac
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