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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.

AstraZeneca's sign on its office in California
FDA
AstraZeneca, Ionis Get FDA Approval for hATTR-PN Therapy
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
December 22, 2023
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Policy
Merck’s Chronic Cough Drug Fails to Secure FDA Approval for Second Time
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
December 21, 2023
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Tristan Manalac
Facade of the FDA's office in Maryland
FDA
Calliditas Therapeutics Nabs Full FDA Approval for IgAN Therapy Tarpeyo
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
December 21, 2023
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Tristan Manalac
Pictured: Illustration showing a downward graph tr
Drug Development
Argenx Nixes Efgartigimod’s Development in Pemphigus After Phase III Flop
Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.
December 20, 2023
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Tristan Manalac
FDA signage at its office in Maryland
FDA
Chiesi’s $1.25B Amryt Buy Pays Off with FDA Approval of Filsuvez
Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
December 20, 2023
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Tristan Manalac
Pictured: Magnetic resonance imaging scans of the brain
Policy
Biogen Secures Tecfidera Exclusivity in EU Until Early 2025
The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
December 20, 2023
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Tristan Manalac
Pictured: American cash shaped into a funnel/iStoc
Bluebird Looks to Raise $250M After Lukewarm Reception of SCD Gene Therapy
Cash-strapped bluebird bio is aiming to raise a quarter of a billion dollars through two funding vehicles—a public offering and a deal with finance firm Alterna—to support its general and commercialization operations.
December 19, 2023
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3 min read
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Tristan Manalac
Pictured: GSK laboratories in Dresden, Germany
Drug Development
GSK’s Jemperli-Zejula Combo Aces Phase III Trial in Endometrial Cancer
The combination of Jemperli and chemotherapy followed by Zejula improved progression-free survival in a late-stage study of patients with advanced or recurrent endometrial cancer.
December 19, 2023
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Tristan Manalac
Pictured: Wall sign of the Novo Nordisk Foundation and Novo Holdings in Denmark
Novo Nordisk Foundation Pumps $260M into Vaccines for Respiratory Diseases
The new research and vaccine initiative seeks to develop immunizations against influenza, tuberculosis and other deadly respiratory diseases.
December 19, 2023
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Tristan Manalac
Pictured: San Francisco's Golden Gate Bridge/iStoc
In Second Fund, Pivotal Raises $389M to Create and Support Transformative Companies
The new fund brings Pivotal bioVenture Partners’ total capital to $689 million, which the venture capital firm intends to pump into young biotechs developing “innovative and impactful therapeutics.”
December 18, 2023
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Tristan Manalac
Pictured: Facade of Moderna's building in Massachusetts
Policy
FDA Finds Quality Control Problems at Moderna’s Vaccine Facility: Reuters
There is no evidence that the lapses have harmed patients who received Spikevax or clinical trial participants who received investigational shots.
December 18, 2023
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Tristan Manalac
Pictured: Illumina headquarters in California/iSto
Policy
Illumina Loses Long Antitrust Battle, Readies to Divest GRAIL
Following a U.S. appeals court decision, the company said it is preparing to divest GRAIL through a third-party sale or capital markets transaction.
December 18, 2023
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Tristan Manalac
Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto
Business
Pfizer Inks Potential $1B ADC Deal with Nona, Closes Seagen Acquisition
Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.
December 15, 2023
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
FDA Approves First Oral High-Risk Neuroblastoma Maintenance Therapy
Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.
December 15, 2023
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Tristan Manalac
Syringe resting on top of a vaccine vial, with more vaccine bottles in the background
Policy
Sanofi, AstraZeneca Promise 230K More Doses of RSV Infant Shots for US
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
December 15, 2023
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Tristan Manalac
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