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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.

A scientist with pill bottles in front of FDA headquarters
FDA
7 FDA decisions to watch for in Q3
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
July 2, 2026
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7 min read
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Tristan Manalac
Trendy halftone collage. Concept of contracting, negotiation, contracting, favorable terms. Trendy modern retro illustration on business theme. Concept of teamwork. Vector illustration
China
AstraZeneca taps China’s CSPC again, betting up to $1.77B to target kidney diseases
AstraZeneca and CSPC Pharmaceutical Group have already inked two other agreements this year, including an obesity-focused deal in January and one focused on chronic diseases in June.
July 2, 2026
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2 min read
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Tristan Manalac
Axe holding in hand man lumberjack. Woodman, carpenter, joiner, icon. Template hard work. Vector illustration flat design.
Alzheimer’s disease
Merck axes Alzheimer’s study, adding to partner Neuphoria’s mounting woes
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed.
July 2, 2026
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2 min read
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Tristan Manalac
A contemporary artistic collage featuring a hand holding a trophy. The concept of victory and achievement.
Approvals
Vertex’s Casgevy becomes first approved gene therapy for young kids with rare blood disorders
The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program.
July 2, 2026
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2 min read
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Tristan Manalac
Business and financial crisis vector concept with businessman falling down the hole. Symbol of market crash, recession, risk, bankruptcy and loss. Eps10 illustration.
Neuropsychiatric disorders
Vistagen in freefall as social anxiety drug fails Phase 3
Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
July 1, 2026
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2 min read
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Tristan Manalac
Man walking on a long wavy path with flag at the end, persistence, determination and ultimate business success - 3D Render
Duchenne muscular dystrophy
Sarepta secures early 2027 FDA decision for Duchenne drugs, pushing past confirmatory fail
Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a confirmatory trial.
July 1, 2026
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2 min read
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Tristan Manalac
Accumulated problems, contradictions. Dead end, we need to go back. You cannot continue further. Complete impossibility to continue. Rejection of an idea. Hard sanctions. Fatal error.
Immunology and inflammation
Evommune ends development of lead asset in chronic hives after mid-stage efficacy woes
With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
June 30, 2026
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2 min read
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Tristan Manalac
Cancer of the brain as tumor growth diagnosis and symptoms of gliomas meningiomas astrocytomas and oligodendrogliomas as diagnosis of symptoms as a paper sculpture.
Regulatory
FDA hits Praxis with 3-month delay for epilepsy drug verdict
The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.
June 30, 2026
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2 min read
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Tristan Manalac
Set of crumpled lumps of different paper isolated on yellow background. Gritty dusty dotted effect, vector elements with jagged edges, old notebook sheets.
Regulatory
Amgen’s Tavneos troubles continue as NEJM retracts pivotal publication
Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
June 30, 2026
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2 min read
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Tristan Manalac
Business handshake trendy halftone art collage banner template. Partnership concept, successful agreement, closing a deal, securing a contract. Modern retro cut out vector illustration
Mergers & acquisitions
Ipsen makes up to $1.75B blood cancer bet with Kartos buyout
The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
June 29, 2026
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2 min read
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Tristan Manalac
Innovation - Think differently - Being different, taking risky, move for success in life -The graphic of rocket also represents the concept of courage, enterprise, confidence, belief, fearless, daring,
Approvals
Viridian debuts on market with FDA greenlight for thyroid eye disease drug
Viridian Therapeutics’ Lumvoa is the first FDA-approved treatment for thyroid eye disease that includes data for both active and chronic forms of the illness.
June 29, 2026
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2 min read
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Tristan Manalac
Illustration of businessman with flag looking victorious on top of teetering blocks
Rare diseases
BridgeBio’s achondroplasia pill shows ‘compelling’ growth and body proportionality benefit
BridgeBio Pharma plans to file for approval in the third quarter. If granted, the oral drug could present a “highly differentiated” option over current achondroplasia therapies, according to Jefferies.
June 29, 2026
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2 min read
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Tristan Manalac
Pointing up with fingers number three. Close up, isolated on white background.
Cancer
Replimune gets early August decision date for twice-rejected melanoma drug
Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
June 26, 2026
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3 min read
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Tristan Manalac
Digital overload and its impact on the human brain, showcasing fragmented thoughts, information overload. Abstract design art collage. Social media digital addiction, mental health, stress, anxiety
Neuropsychiatric disorders
Otsuka’s drug eases symptom burden, anxiety in ADHD as FDA verdict nears
The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.
June 26, 2026
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2 min read
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Tristan Manalac
Businessmen look at the city from the outskirts.
Pipeline
Moderna looks out to R&D ‘horizons’ as 2028 break-even goal looms
Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.
June 26, 2026
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2 min read
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Tristan Manalac
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