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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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Obesity
Foundayo’s liver failure blip weighs down Lilly shares but analysts unconcerned
The selloff in Eli Lilly’s shares was “overdone,” according to RBC Capital Markets, which noted that the overall safety profile of Foundayo remains favorable.
May 5, 2026
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2 min read
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Tristan Manalac
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Government
FDA uncertainty persists as search for Prasad successor at CBER drags on
The FDA is reportedly down to a handful of final candidates to lead CBER, with a potential selection expected in the coming month or two. For now, the appointment of acting director Katherine Szarama has not allayed the industry’s concerns.
May 5, 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.
May 4, 2026
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9 min read
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Tristan Manalac
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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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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
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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
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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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