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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.

Pictured: FDA signage at its office in Washington, DC
Policy
FDA Hits Defender with Complete Response Letter, Rejects Motion Sickness Gel
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
January 31, 2024
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Drug Development
Vertex Secures Three Phase III Wins for Non-Opioid Pain Candidate, Plans NDA
After VX-548 demonstrated significant pain relief in surgical and non-surgical settings, Vertex Pharmaceuticals is preparing to file a New Drug Application for the non-opioid candidate by mid-2024.
January 30, 2024
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Tristan Manalac
Pictured: Sign of U.S. Department of Health & Huma
Policy
Analysts Expect CMS to Ask for Steep Drug Discounts in Initial IRA Proposal: Reuters
The Centers for Medicare and Medicaid Services’ initial proposed drug price cuts, due to pharma companies by Thursday under the Inflation Reduction Act, could range from 25% to 60%, analysts told Reuters.
January 30, 2024
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Tristan Manalac
Pictured: WHO headquarters in Geneva, Switzerland/
Drug Development
Shortage of GLP-1 RAs Tied to Rise in Counterfeit Products: WHO
The persistent shortage of genuine glucagon-like peptide 1 receptor agonist products has led to an increase in fake versions, the World Health Organization warned on Monday.
January 30, 2024
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Tristan Manalac
Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto
Drug Development
BMS’s Opdivo Fails for Second Time in Late-Stage Kidney Cancer Trial
Bristol Myers Squibb’s PD-1 inhibitor was unable to outperform the placebo arm in improving disease-free survival in renal cell carcinoma patients at high risk of relapse after surgery.
January 29, 2024
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Tristan Manalac
Syringe resting on top of a vaccine vial, with more vaccine bottles in the background
Drug Development
Biopharma Invested Just $6.5B in Vaccine Development in Last Decade: Report
The clinical development pipeline for vaccines is broad but shallow with a large proportion of programs dedicated to COVID-19, according to a new report by industry group Biotechnology Innovation Organization.
January 29, 2024
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Tristan Manalac
Pictured: U.S. Capitol Building, Washington DC
Policy
J&J, Merck CEOs Agree to Testify Before Senate Panel and Dodge Subpoena
The CEOs of J&J and Merck have finally committed to testifying before the Senate health committee regarding the high prices of drugs in the U.S. The hearing is set for Feb. 8.
January 29, 2024
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Drug Development
Merck’s Keytruda Gets Back-to-Back Phase III Wins in Kidney, Bladder Cancer
The blockbuster immunotherapy secured separate late-stage victories as an adjuvant-setting treatment in renal cell carcinoma and muscle-invasive urothelial carcinoma.
January 29, 2024
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Tristan Manalac
Pictured: Nasdaq signage and building in New York City
Deals
ArriVent’s $175M Upsized IPO Builds Momentum on Heels of CG Oncology Offering
Late Thursday, ArriVent Biopharma announced its upsized initial public offering to support the development of its EGFR inhibitor furmonertinib, following CG Oncology going public earlier in the day.
January 26, 2024
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Tristan Manalac
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
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