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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.

Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
FDA
FDA Names Psychedelic Proponent as CDER Deputy Director, Top Spot Remains Open
Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
June 25, 2025
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2 min read
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Tristan Manalac
Artwork magazine collage picture of serious confident lady looking big enlargement glass isolated drawing background.
Immunology and inflammation
Nektar Declares Phase IIb Eczema Win for Rezpeg—But Analysts Unconvinced
Despite Nektar’s share price shooting up as much as 175% on Tuesday, William Blair maintained that “there is an absence of clear differentiation” for rezpegaldesleukin in the atopic dermatitis space.
June 25, 2025
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3 min read
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Tristan Manalac
Illustration showing scientist climbing up DNA spiral staircase
Gene therapy
Sangamo’s ‘Positive’ Phase I/II Data for Fabry Gene Therapy Opens Path to FDA
Isaralgagene civaparvovec is a “potential best-in-class gene therapy for Fabry disease,” according to analysts at H.C. Wainwright. Sangamo plans to use pivotal Phase I/II data to build an accelerated approval case for the asset.
June 24, 2025
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3 min read
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Tristan Manalac
People And Robots Handshake Modern Human And Artificial Intelligence Futuristic Mechanism Technology Vector Illustration
Artificial intelligence
In latest AI Play, Sanofi Bets $630M+ for Formation Bio’s JAK/SYK Blocker
The star of Monday’s deal is gusacitinib, a small-molecule drug that Formation is developing for chronic hand eczema. Sanofi will explore additional indications for gusacitinib in a Phase I study.
June 24, 2025
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2 min read
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Tristan Manalac
Novo Nordisk and Eli Lilly buildings
Weight loss
Lilly’s Antibody Protects Patients From Losing Muscle While Taking Novo’s Wegovy
Eli Lilly’s bimagrumab led to weight loss that was due almost entirely to fat reduction when combined with semaglutide, marketed by rival Novo Nordisk as Wegovy. BMO Capital Markets called the data “impressive” while raising concerns about the antibody’s safety profile.
June 24, 2025
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2 min read
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Tristan Manalac
leader crossed forbidden line, leadership vector concept, finish line and winner
Cancer
Exelixis Beats Bayer in Colorectal Cancer as Zanzalintinib Delivers ‘First Pivotal Success’
In combination with Roche’s PD-L1 blocker Tecentriq, zanzalintinib bested Bayer’s Stivarga. Exelixis is positioning the drug candidate as a successor to cabozantinib, which is set to lose patent exclusivity in 2030.
June 23, 2025
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2 min read
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Tristan Manalac
Corporate headquarters of Novo Nordisk in Denmark
Obesity
Novo Leans on CagriSema’s Safety as Amycretin Moves Forward to Phase III
After consistently failing to meet investor expectations, Novo Nordisk touted a safety profile for CagriSema in line with the GLP1-RA class, while reporting mid-stage data for its GLP1- and amylin-targeting drug amycretin that raised dosing questions.
June 23, 2025
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2 min read
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Tristan Manalac
Man walking on a boardwalk in the fog
Depression
Compass Plots Path to FDA With ‘Meaningful’ Phase III Data for Psilocybin Drug in Depression
Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.
June 23, 2025
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2 min read
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Tristan Manalac
©Vertex Pharmaceuticals Incorporated. All Rights Reserved.
Diabetes
Vertex’s Cell Therapy Could Be ‘Functional Cure’ for Diabetes, but Market Prospects Uncertain
While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential.
June 23, 2025
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2 min read
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Tristan Manalac
Weigh scales on pink background, top view with space for text. Overweight concept
Obesity
Zealand’s GLP-1/GLP-2 Drug Elicits Over 11% Weight-Loss—With the Potential for More
Analysts at William Blair say dapiglutide’s 11.6% weight reduction at 28 weeks could still be better, given that Zealand’s study predominantly included men and enrolled patients with lower BMI at baseline.
June 20, 2025
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2 min read
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Tristan Manalac
Set your goals is shown using the collage with aim and the hand. Business targeting, aiming, focus concept and way to achieve a goal
Rare diseases
Cycle Wins First FDA Nod for Ultra-Rare Genetic Disease
Harliku is the only FDA-approved drug for alkaptonuria, a rare condition characterized by skin discoloration, arthritis and heightened risks of heart failure and stroke.
June 20, 2025
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1 min read
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Tristan Manalac
A pill with the Amercan and Chinese flag wrapped around it
Government
FDA Freezes Trials Shipping Cells to China, ‘Other Hostile Countries’
Exemptions to new export control policies have allowed companies to ship patients’ biological materials to foreign laboratories, including those in China and other adversarial nations, according to the FDA.
June 20, 2025
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2 min read
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Tristan Manalac
3d illustration of a black dragon flying on an extraterrestrial world with mountains beneath.
Neuropsychiatric disorders
Draig Takes Flight With $140M Series A To Advance Neuropsych Drugs
The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.
June 18, 2025
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2 min read
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Tristan Manalac
screenshot of Marty Makary speaking on the Megyn Kelly Show
Regulatory
Makary Doubles Down on Push To ‘Modernize’ FDA, Eyes Speedier Reviews
Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.
June 18, 2025
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Drug pricing
Senate Republicans Drop Orphan Drug Exemptions From ‘One Big Beautiful Bill’
The new version of the bill will still need to go through the entire House and Senate.
June 18, 2025
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2 min read
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Tristan Manalac
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