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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.

U.S. and Chinese flags in concrete, broken in the middle
China
House Lawmakers Raise Alarm About US Biopharma Companies Working With Chinese Military on Trials
In a letter to FDA Commissioner Robert Califf, a House committee flagged several U.S. companies—including Eli Lilly and Pfizer—that have allegedly worked with the People’s Liberation Army on clinical trials in Xinjiang, raising ethical and intellectual property concerns.
August 21, 2024
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Tristan Manalac
A Walgreens' retail location in Indiana
Decentralized trials
Walgreens, BARDA Team in $100M Partnership to Boost Decentralized Clinical Trials
The retail pharmacy giant and the Biomedical Advanced Research and Development Authority hope to make decentralized clinical trials more accessible and representative of the U.S. population.
August 20, 2024
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Tristan Manalac
AbbVie's office in South San Francisco, California
Approvals
AbbVie, Genmab Secure European Label Expansion for Tepkinly in Follicular Lymphoma
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
August 20, 2024
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Tristan Manalac
Eli Lilly's biotechnology center in California
Diabetes
Lilly’s Tirzepatide Cuts Type 2 Diabetes Risk by 94% in Overweight, Obese Adults
Eli Lilly released topline Phase III data on Tuesday showing that after more than three years of follow-up, pre-diabetic patients treated with tirzepatide were less likely to progress to type 2 diabetes.
August 20, 2024
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Tristan Manalac
Entrance to the U.S. Department of Health and Human Services in Washington, DC
Drug pricing
More Than Half of IRA Negotiation Savings to Come From Three Drugs: Report
Amgen’s Enbrel, Bristol Myers Squibb’s Eliquis and Johnson & Johnson’s Stelara will account for 51.4% of the Inflation Reduction Act’s drug price negotiation savings in 2026, according to the Brookings Institution.
August 20, 2024
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Tristan Manalac
FDA signage at its headquarters in Maryland
Regulatory
Liquidia Misses Full Approval for Pulmonary Hypertension Drug as Competitor Retains Market Exclusivity
The FDA on Monday only granted Liquidia’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.
August 19, 2024
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Tristan Manalac
Bavarian Nordic's sign outside its facility in Germany
Infectious disease
Bavarian Nordic Accelerates Mpox Vaccine Production to Respond to Global Emergency
The Danish company on Saturday announced plans to increase production of its vaccine Jynneos on the heels of the World Health Organization last week declaring mpox a global health emergency.
August 19, 2024
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Tristan Manalac
A child's hands with blisters and painful rashes
Infectious disease
Mid-Stage Study Finds Only Mpox Drug Ineffective Against Current Outbreak
SIGA Technologies’ TPOXX did not outperform placebo at resolving lesions in patients with clade I mpox, the new strain that has spread through parts of Africa and is reaching beyond the continent.
August 19, 2024
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Tristan Manalac
Signage outside Genentech's headquarters in Silicon Valley
Business
Genentech Shutters Cancer Immunology Group Amid Wider R&D Reprioritization
The unit’s closure comes as Genentech’s parent Roche rethinks its cancer business, an effort that has included the discontinuation of three early-stage candidates and a T-cell partnership with Adaptimmune.
August 19, 2024
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Tristan Manalac
Syringe resting on top of a vaccine vial, with more vaccine bottles in the background
Infectious disease
Pfizer, BioNTech’s Mixed Phase III Data Sets Back COVID-Flu Vaccine Candidate
The companies’ late-stage stumble could allow Moderna to widen its lead, with its mRNA-based combination vaccine eliciting superior immune responses against COVID-19 and three influenza strains.
August 16, 2024
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Tristan Manalac
External view of AstraZeneca's production plant in Sweden
Regulatory
AstraZeneca’s Imfinzi Scores Lung Cancer Wins With FDA’s NSCLC Approval, SCLC Priority Review
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
August 16, 2024
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Tristan Manalac
Healthcare worker draws from a vial of an mpox vaccine
Vaccines
Bavarian Nordic Sees Potential Windfall Opportunity Amid Global Mpox Emergency
The company can make 10 million doses available next year, with $600 million to $1 billion in revenue potential into 2025, “albeit perhaps lower on price, discounts and donations,” according to Jefferies analyst Peter Welford.
August 16, 2024
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Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Patents
Delaware Judge Throws Out Pfizer’s $107.5M Tagrisso Patent Win Over AstraZeneca
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
August 16, 2024
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Tristan Manalac
Gilead's corporate headquarters in Silicon Valley
Approvals
Gilead’s $4.3B Bet on CymaBay Pays Off With FDA Nod for Autoimmune Liver Disease Drug
The regulator’s approval of Livdelzi for primary biliary cholangitis under the accelerated pathway is a boost to Gilead Sciences’ liver disease business. Analysts expect the drug to reach more than $1 billion in sales.
August 15, 2024
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Tristan Manalac
Incyte's logo on its building in Delaware
Approvals
Incyte Wins Second Graft-Versus-Host Disease FDA Approval
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.
August 15, 2024
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Tristan Manalac
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