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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.

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Drug Development
AbbVie, J&J Pull Two Accelerated Approvals for Imbruvica
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
April 10, 2023
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2 min read
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Tristan Manalac
Sarah Silbiger/Getty Images
FDA
FDA Action Alert: Alvotech, Otsuka and More
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
April 7, 2023
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4 min read
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Tristan Manalac
Kirkland, Quebec, Canada - September 3, 2021: Merck Canada head office in Kirkland, Quebec, Canada. Merck is an American multinational pharmaceutical company.
Drug Development
Merck/Eisai Drops Melanoma Program for Keytruda-Lenvima Combo After Phase III Fail
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.
April 7, 2023
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2 min read
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Tristan Manalac
Courtesy of JHVEPhoto/Getty Images
Drug Development
Pfizer Publishes Phase III RSV Data Ahead of May Decision
Phase III data for Pfizer’s respiratory syncytial virus vaccine candidate showed high levels of protection for older adults and infants.
April 6, 2023
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2 min read
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Tristan Manalac
Courtesy Bodo Marks/Picture Alliance via Getty Ima
Drug Development
AstraZeneca’s Imfinzi/Lynparza Combo Boosts Survival in Ovarian Cancer
AstraZeneca’s Imfinzi and Lynparza met primary endpoint markers in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to data released Wednesday.
April 5, 2023
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2 min read
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Tristan Manalac
Pictured: Medical professional giving COVID Test/C
Drug Development
FDA Grants EUA to InflaRx’s Anti-Inflammatory COVID-19 Treatment
The FDA has granted emergency use authorization to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.
April 5, 2023
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2 min read
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Tristan Manalac
Pictured: A corporate building overlooking a freew
Business
Cure Ventures Launches with $350M to De-Risk Innovation
With an inaugural $350 million fund, Cure Ventures launched Tuesday to support early-stage companies with cutting-edge curative technologies and help them de-risk their science
April 4, 2023
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2 min read
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Tristan Manalac
Physician holds up hand in a stop sign signal_Shut
Drug Development
Gossamer Cuts Lymphoma Drug After Two Fatalities
Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate, GB5121, following two patient deaths in the Phase Ib/II STAR-CNS study.
April 4, 2023
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2 min read
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Tristan Manalac
Drug Development
FDA Approves Keytruda/Padcev Combo in Advanced Urothelial Cancer
The FDA has approved the combination regimen of Merck’s Keytruda and Seagen and Astellas’ Padcev for the first-line treatment of locally advanced or metastatic urothelial carcinoma.
April 4, 2023
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2 min read
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Tristan Manalac
Pictured: Vedere Bio II CEO Cyrus Mozayeni/company
Business
Vedere Bio II Closes Doors After Preclinical Studies Fall Short
Almost two years after its launch, eye-focused gene therapy start-up Vedere Bio II is closing its doors, company leaders announced through a LinkedIn post over the weekend.
April 3, 2023
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2 min read
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Tristan Manalac
Pictured: FDA sign at headquarters/Courtesy of Get
Drug Development
Phase III Failure Leaves Cytokinetics with One Last Late-Stage Hopeful
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
April 3, 2023
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2 min read
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Tristan Manalac
Drug Development
HUTCHMED Completes FDA Submission for High-Potential Colorectal Cancer Drug
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
March 31, 2023
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2 min read
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Tristan Manalac
Business
Mathai Mammen Finds New Home at FogPharma
Nearly eight months after leaving his post as head of R&D at Johnson & Johnson, Mathai Mammen has found a new job as CEO of cancer focused FogPharma.
March 31, 2023
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2 min read
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Tristan Manalac
Courtesy Niels Wenstedt/BSR Agency via Getty Image
Drug Development
J&J Drops Out of RSV Race, Cuts Late-Stage Vaccine Candidate
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
March 30, 2023
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2 min read
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Tristan Manalac
Business
Bluebird Faces Another Delay with BLA for Sickle Cell Gene Therapy
In an earnings call Wednesday, bluebird bio revealed it is unlikely to meet its first-quarter goal to submit a Biologics License Application for sickle cell disease (SCD) gene therapy lovo-cel.
March 30, 2023
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2 min read
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Tristan Manalac
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