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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.

Pictured: Biogen's headquarters in Cambridge, Massachusetts
Spinal muscular atrophy
Biogen Receives Surprise FDA Rejection for High Dose Spinraza
The regulatory action marks the second rejection for a spinal muscular atrophy therapy this week after Scholar Rock’s apitegromab was issued a complete response letter on Tuesday, similarly on manufacturing grounds.
September 24, 2025
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2 min read
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Tristan Manalac
Drug or medicine dose adjustment. Dose regulation and overdose. Titration of medicine dosage. Overmedication and prescribed dose. Drug rejection.
Spinal muscular atrophy
Much Maligned Manufacturing Site Trips Up Scholar Rock’s Spinal Muscular Atrophy Drug
In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned by Novo Nordisk. Issues at this site have previously been investigated by the regulator.
September 23, 2025
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2 min read
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Tristan Manalac
JHVEPhoto/GettyImages
Government
FDA Revives Decades-Dormant Drug as Potential Autism Treatment
The agency also pointed to the use of Tylenol and other acetaminophen products during pregnancy as being potentially linked to neurological and developmental defects in children, following a press conference Monday in which President Donald Trump did the same.
September 23, 2025
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2 min read
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Tristan Manalac
Illustration showing hurdles along a path ending in an arrow
Regulatory
After FDA Rejection, Lexicon’s Type 1 Diabetes Drug Hit With Another Regulatory Delay
An advisory committee last year found that Zynquista’s benefit-risk profile in type 1 diabetes was unfavorable due to cases of diabetic ketoacidosis.
September 23, 2025
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1 min read
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Tristan Manalac
Modern halftone collage. Concept of teamwork, problem solving together, business direction, collaborate to win,achieve success. Business creative illustration for web banner, marketing material, business presentation. Vector illustration
Rare diseases
Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease
By improving gait stability, Ionis’ zilganersen could be “potentially disease modifying,” according to analysts at William Blair.
September 23, 2025
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2 min read
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Tristan Manalac
Pictured: Entrance to Pfizer's office in Belgium
Mergers & acquisitions
Pfizer Stages Obesity Comeback With $4.9B Metsera Acquisition
The acquisition of breakout obesity star Metsera should pump new life into Pfizer’s portfolio, which over the last two years has suffered from three discontinued assets.
September 22, 2025
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Tristan Manalac
Cairo, Egypt, October 31 2024: Novartis CO building in Egypt, Novartis AG is a Swiss multinational pharmaceutical corporation based in Basel, Switzerland, manufactures the drugs
Drug pricing
Novartis Looking for Constructive Ways To Bring Down Drug Costs in US
In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries.
September 22, 2025
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2 min read
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Tristan Manalac
Feb 2, 2020 South San Francisco / CA / USA - Merck & Co. headquarters in Silicon Valley; Merck & Co. Inc. is an American multinational pharmaceutical company
Cancer
As Exclusivity Loss Looms, Merck Wins Subcutaneous Approval for Keytruda
For the last two years, Keytruda has reigned as the world’s top-selling drug—a distinction under threat with key patent protections expiring in 2028.
September 22, 2025
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2 min read
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Tristan Manalac
Close-Up Of Syringe With Bottles Against Blue Background
Vaccines
Reformed ACIP Recommends Delaying MMRV Combo Vaccination, Forecasts Changes to Hep B, COVID
BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.
September 19, 2025
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2 min read
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Tristan Manalac
Problems and Challenges. Businessman stands on question mark
Immuno-oncology
Replimune Crashes as Uncertainty Clouds Regulatory Path for Tumor Destroyer
Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets.
September 19, 2025
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Rare diseases
Hope for Rare Pediatric Disease Voucher Reignited as House Bill Passes Committee
The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.
September 19, 2025
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2 min read
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Tristan Manalac
Creative trend collage of hand take education read book pile programmer coding studying billboard comics zine minimal.
Immunology and inflammation
Nektar Provides More Data for Dermatitis Drug, but Key Questions Remain Unanswered
Nektar Therapeutics still needs to establish what differentiates rezpeg from other atopic dermatitis therapies, according to analysts at William Blair.
September 19, 2025
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2 min read
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Tristan Manalac
Company downsizing, staff reduction and layoffs. Employee dismissal, firing and unemployment. Business concept.
Layoffs
Novo, BMS Layoffs Hit New Jersey Hard With More Than 500 Left Jobless
Both BMS and Novo Nordisk have, in recent months, announced steep layoffs as they strive to cut back on costs.
September 18, 2025
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Tristan Manalac
Joint pain anatomy medical concept
Immunology and inflammation
Roivant, Pfizer’s Therapy Shows ‘Patient-Centered Benefit’ in Rare Inflammatory Condition
Brepocitinib remains “ahead of competition” in the dermatomyositis space, according to analysts at Leerink, who projected that the drug candidate could hit $2 billion in sales in 2032.
September 18, 2025
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Tristan Manalac
Creative artwork strange collage of woman touch head suffer terrible tension ache.
Pain
Lexicon Backs Phase III Go Decision for Non-Opioid Pain Med With Post-Hoc Analysis
Supporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is an “improving” regulatory environment for non-addictive options for chronic pain, according to analysts at Jefferies.
September 18, 2025
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2 min read
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Tristan Manalac
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