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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.

Gilead's headquarters in Silicon Valley
Breast cancer
Gilead’s Trodelvy, With Keytruda, Slows Disease Progression in Triple-Negative Breast Cancer
Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in metastatic triple-negative breast cancer, according to analysts at Truist Securities.
April 22, 2025
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Tristan Manalac
Breast Cancer awareness month card illustration. Pink ribbon and hand fist up power in retro collage craft style. Design concept for disease prevention or october support campaign.
Breast cancer
AstraZeneca, Daiichi Sankyo Push Enhertu to Frontline Breast Cancer With Phase III Data
Analysts at Leerink Partners said in a Monday note that DESTINY-Breast09’s findings “could support an approval” for Enhertu in first-line HER2+ metastatic breast cancer.
April 22, 2025
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2 min read
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Tristan Manalac
Novo Nordisk advertising flags and logo on facade
Obesity
Novo Seeks FDA Nod for Semaglutide Pill as Oral Obesity Space Heats Up
Novo Nordisk filed for approval of an oral, 25-mg formulation of its weight loss blockbuster “earlier this year,” according to a company spokesperson.
April 22, 2025
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Tristan Manalac
Immunology and inflammation
Following Rejection, FDA Okays Sanofi/Regeneron’s Dupixent for Chronic Hives
Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.
April 21, 2025
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Tristan Manalac
factory of the pharmaceutical industry. pills on the conveyor
Manufacturing
After Phase III Win, Lilly Promises to Manufacture Weight-Loss Pill in US
President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.
April 21, 2025
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Tristan Manalac
FDA
Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview
In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that autism could potentially be driven by certain environmental factors.
April 21, 2025
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Tristan Manalac
Reduce risk level or decrease stress anxiety meter, lower danger indicator or scale, reduce from red alert meter to be green chart concept, businesswoman pull meter to reduce risk or stress level.
Business
Elevation Mulls Strategic Alternatives, Including Closure, Amid Activist Pressure
BML Capital Management, an activist investor that owns 9.9% of Elevation’s shares, is urging the company to wind down operations given “the current state of the public equity market.”
April 18, 2025
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Tristan Manalac
Rug pull crypto, scam coin, trading problem, investment risk in unstable and uncertainty stock market concepts. Unknown people pull carpet and make businesspeople who standing on money falling down.
FDA
FDA’s User Fee Negotiation Teams Gutted by Layoffs: Reuters
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
April 18, 2025
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Tristan Manalac
Food and Drug Administration building
FDA
FDA Moves to Restrict Industry Influence on Advisory Committees
Industry representatives will still be allowed at these meetings, but they will no longer have a spot on the advisory committee.
April 18, 2025
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Tristan Manalac
Profit and Money Concept, Financial and Business Graph
GLP-1
Lilly Skyrockets on ‘Injectable-Like Efficacy’ for Oral GLP-1 in Phase III Diabetes Trial
Eli Lilly’s shares shot up 11% pre-market on Thursday after orforglipron became the first small-molecule GLP-1 drug to ace a late-stage study in type 2 diabetes, eliciting significant reductions in body weight and improvements in glucose control.
April 17, 2025
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Tristan Manalac
Vaccines
HHS Pulls Funding for GeoVax’s Next-Gen COVID-19 Vaccine
GeoVax was using its HHS contract to develop its next-generation multi-antigen COVID-19 vaccine, which is in Phase IIb development.
April 17, 2025
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2 min read
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Tristan Manalac
Entrance to the U.S. Department of Health and Human Services in Washington, DC
Government
Trump Eyes $40 Billion Budget Cut for HHS: Reports
Despite these cuts, the FDA should be able to stay above a “trigger” level that would prevent it from collecting fees from the pharma industry and deprive it of approximately half of its annual funding, according to The Washington Post.
April 17, 2025
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
RFK Jr. Eyes Changes to Vaccines Injury Surveillance System to Deduce ‘Culprit’
Kennedy is planning modifications to the Vaccines Adverse Event Reporting System to identify whether vaccines contribute to an unstated problem. The reporting system is at the heart of the departure of CBER head Peter Marks.
April 17, 2025
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2 min read
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Tristan Manalac
Lungs health and pulmonology as a respiratory medicine conept for pulmonary science and lung cancer or respiration disease and bronchi breathing or asthma symbol in a 3D illustration style.
Clinical research
Sanofi’s $1.4B Kymab Bet Falters as Asthma Drug Stumbles in Phase II
Analysts at Leerink agreed with Sanofi that, despite falling short of statistical significance in the Phase II TIDE-Asthma trial, amlitelimab warrants further development in this indication.
April 16, 2025
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Tristan Manalac
European Union flags in front of the blurred European Parliament in Brussels, Belgium
Europe
With Tariffs Looming, EU and US Pharmas Make Demands of European Commission
Playing both sides of trade war, pharma companies are asking for certain compensations for scientific innovation and a smoother regulatory framework.
April 16, 2025
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2 min read
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Tristan Manalac
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