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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.

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Lung cancer
Summit shares descend as PD-1/VEGF asset misses early survival mark
Summit Therapeutics planned an early interim progression-free survival readout for HARMONi-3 in the hope of enabling earlier regulatory engagement—but the early analysis delivered disappointment for the company and shareholders.
May 4, 2026
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2 min read
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Tristan Manalac
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Approvals
FDA clears Pfizer, Arvinas’ novel breast cancer therapy despite mixed data
Veppanu, the first PROTAC therapy approved by the FDA, improved progression free survival by 43% versus AstraZeneca’s Faslodex but showed no such significant benefit in the intention-to-treat analysis.
May 4, 2026
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2 min read
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Tristan Manalac
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Mergers & acquisitions
UCB captures Candid in $2.2B autoimmune deal as pharma’s M&A train chugs along
Candid Therapeutics follows closely behind Neurona Therapeutics, which UCB acquired in mid-April in a potential $1.15 billion deal.
May 4, 2026
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Argenx, AstraZeneca/Daiichi Sankyo, Biogen/Eisai and Cingulate
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
May 4, 2026
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4 min read
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Tristan Manalac
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Earnings
Amgen positions MariTide as potential ‘best monthly’ obesity drug
Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.
May 1, 2026
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2 min read
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Tristan Manalac
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Approvals
Axsome wins first non-antipsychotic FDA approval for Alzheimer’s agitation
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
May 1, 2026
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2 min read
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Tristan Manalac
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Breast cancer
AstraZeneca’s breast cancer drug fails to earn backing of FDA advisory committee
Members of the FDA’s Oncologic Drugs Advisory Committee questioned the design of AstraZeneca’s Phase 3 trial of camizestrant, which involved switching treatments at the point of mutation detection, as opposed to the current practice of changing regimens upon disease progression.
May 1, 2026
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3 min read
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Tristan Manalac
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Earnings
BMS positions Cobenfy as safer alternative ahead of pivotal Alzheimer’s psychosis readout
After delaying a late-stage readout last year due to “irregularities” at certain study sites, pivotal data for Bristol Myers Squibb’s Cobenfy appear set to arrive later this year.
April 30, 2026
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2 min read
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Tristan Manalac
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Schizophrenia
Patient death prompts FDA pause on Newron’s Phase 3 schizophrenia study
The patient death occurred outside the U.S. and was deemed unrelated to Newron Pharmaceuticals’ investigational schizophrenia drug.
April 30, 2026
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2 min read
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Tristan Manalac
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Pipeline
AstraZeneca prunes asthma, rare disease pipeline, cultivates cancer portfolio
While AstraZeneca has discontinued work on four assets—including one in asthma and another in acromegaly—the pharma has also elected to take forward a bispecific antibody that destroys the EGFR protein.
April 30, 2026
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2 min read
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Tristan Manalac
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Alzheimer’s disease
GSK-partnered Alector hit with third neuro failure as Alzheimer’s asset disappoints
Over the last two years, Alector has suffered three setbacks for its neurodegenerative disease pipeline, often forcing the company to downsize.
April 30, 2026
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2 min read
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Tristan Manalac
A flower in the middle of the desert
Adcomms
First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.
April 30, 2026
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9 min read
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Tristan Manalac
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Earnings
GSK’s Shingrix strategy shift drives sales beat even as vaccines slow
While sales for most of GSK’s shots slumped as vaccine skepticism continues to climb in the U.S., Shingrix jumped 20% to almost $1.4 billion in the first quarter, emerging as the pharma’s top-selling product.
April 29, 2026
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2 min read
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Tristan Manalac
Businessman pushing boulder uphill vector concept of Sisyphus. Symbol of hard work, futile effort, strength, struggle, challenge but also motivation and ambition. Eps10 vector illustration.
Adcomms
AstraZeneca faces uphill battle at upcoming adcomm in face of FDA questions
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
April 29, 2026
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3 min read
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Tristan Manalac
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Regulatory
Amgen, AstraZeneca join FDA effort harnessing cloud for real-time clinical trials
The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the cloud—a system that could “compress drug development timelines,” Jefferies analysts said.
April 29, 2026
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3 min read
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Tristan Manalac
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