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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.

Pictured: FDA signage at its office in Washington, DC
FDA
Sanofi, Regeneron Win Dupixent Label Expansion to Treat Eosinophilic Esophagitis
With the FDA’s approval on Thursday, Dupixent can now be used for the treatment of children aged 1 to 11 years who have eosinophilic esophagitis, a chronic disease that can severely impact their ability to eat.
January 26, 2024
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Tristan Manalac
External view of the U.S. Capitol building
Policy
Sanders Confident of Senate Panel’s Support for Subpoenaing J&J, Merck CEOs
Ahead of a Jan. 31 vote, Senate health committee chair Sen. Bernie Sanders on Thursday said he has the votes needed to subpoena the CEOs of Johnson & Johnson and Merck to testify on drug pricing.
January 26, 2024
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Tristan Manalac
Pictured: Large yellow sign boards hoisted on meta
Deals
CG Oncology’s Upsized $380M IPO is First Biotech to Go Public in 2024
The bladder cancer-focused company’s larger-than-expected Nasdaq debut on Thursday opens this year’s batch of planned initial public offerings, which include at least half a dozen biotechs.
January 25, 2024
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Tristan Manalac
Pictured: Man prepares his GLP-1 receptor agonist injection
Policy
Suspected Fake Ozempic Tied to Three Severe U.S. Cases of Hypoglycemia: Reuters
More than 3,000 people in the U.S. suffered from side effects of Ozempic in 2023, according to exclusive reporting on Wednesday from Reuters citing data from America’s Poison Centers.
January 25, 2024
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Tristan Manalac
Pictured: A girl cupping her ear/iStock, AaronAmat
Drug Development
Chinese Gene Therapy Restores Hearing in Five of Six Treated Children
After 26 weeks of follow-up, five of six children treated with an experimental gene therapy developed in China showed strong improvements in speech perception and could hold normal conversations.
January 25, 2024
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Reveals More Details on 22 CAR-T Secondary Cancer Cases
The FDA’s Peter Marks and Nicole Verdun in the NEJM Wednesday disclosed that more than 27,000 CAR-T doses have been administered in the U.S. as of the end of 2023, of which there are 22 cases of T-cell cancers.
January 25, 2024
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Tristan Manalac
FDA signage at its office in Maryland
Policy
Theratechnologies Gets FDA Rejection for Concentrated Formulation of Tesamorelin
The regulator’s Complete Response Letter flagged issues with the new formulation of tesamorelin’s chemistry, manufacturing and controls and sought more information about its immunogenicity risk.
January 24, 2024
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Policy
J&J, Legend to Face Adcomm for Carvykti’s Push as Earlier Line MM Treatment
An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
January 24, 2024
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly’s Investigational Gene Therapy Restores Hearing in First Treated Patient
In a Phase I/II trial, an 11-year-old boy gradually regained hearing—eventually reaching normal range for some frequencies at 30 days—following treatment with Eli Lilly’s dual adeno-associated viral vector-delivered gene therapy.
January 24, 2024
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Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Calls for Boxed Warnings on CAR-T Therapies Regarding Secondary Cancer Risks
Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.
January 23, 2024
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Tristan Manalac
Pictured: Illustration showing sickle cells in the
Sickle Cell Gene Therapies Seen as Cost Effective Below $2M Threshold: Study
While gene therapies for treating sickle cell disease are promising, they will only be cost effective in the U.S. if priced below $2 million, according to a new modeling analysis.
January 23, 2024
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Business
Coherus Offloads Lucentis Biosimilar to Sandoz for $170M in Pivot to Oncology
Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.
January 23, 2024
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Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Drug Development
BMS Builds First-Line Case for Opdivo-Yervoy Combo in mCRC with Phase III Data
The immunotherapy combination reduced the risk of disease progression or death by 79% versus chemotherapy in certain metastatic colorectal cancer patients, according to Bristol Myers Squibb.
January 22, 2024
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Tristan Manalac
Pictured: J&J's building in Switzerland
FDA
J&J Secures Full FDA Approval for Bladder Cancer Drug Balversa
Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.
January 22, 2024
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Tristan Manalac
Pictured: Amgen's office in Tampa, Florida
Policy
Amgen’s Osteoporosis Drug Gets FDA Boxed Warning for Hypocalcemia Risk
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
January 22, 2024
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2 min read
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Tristan Manalac
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