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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.

Pictured: Gloved hand holding a collection tube for a triglyceride test
Drug Development
Ionis Notches Phase III Win in Rare Genetic Disease, Plans to Submit NDA
The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.
September 26, 2023
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Tristan Manalac
Pictured: Facade of Takeda's office in Massachusetts
Business
Takeda Puts Nearly $600M on the Line for AcuraStem’s ALS Program
The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.
September 26, 2023
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Tristan Manalac
Pictured: Novartis' logo outside its building in S
Drug Development
Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer
The Swiss pharma is one step closer to bringing Lutathera into the front-line setting, with data from the Phase III NETTER-2 study showing that the radiotherapy met its primary endpoint.
September 26, 2023
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Tristan Manalac
Update: AbbVie headquarters building in California
Business
AbbVie Ends I-Mab Deal for CD47 Antibody Compounds, Products
After dropping an early-stage study more than a year ago, AbbVie has finally terminated its CD47 collaboration with I-Mab, leaving up to $1.3 billion in potential milestone payments on the table.
September 25, 2023
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Tristan Manalac
Pictured: Merck building and sign in Silicon Valley
Drug Development
Merck, Eisai Post Back-to-Back Phase III NSCLC Failures for Keytruda-Lenvima Combo
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
September 25, 2023
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Tristan Manalac
Pictured: Woman grasping her stomach in pain/iStoc
Drug Development
Morphic’s Ulcerative Colitis Pill Misses Expectations in Mid-Stage Study, Stock Falls
Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.
September 25, 2023
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Policy
Roche Claims Another Legal Victory Over Takeda in Hemophilia Patent Case
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
September 22, 2023
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Tristan Manalac
Pictured: People in suits with their thumbs down/i
Policy
Intarcia’s Diabetes Drug-Device Implant Unanimously Rejected by Adcomm
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
September 22, 2023
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Tristan Manalac
Pictured: A yellow line pointing the way out of a
Policy
Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting
Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.
September 21, 2023
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Tristan Manalac
Pictured: Capsules in a production line at a pharm
Civica Rx’s Unique Business Model Improves Drug Supply Security, Cuts Costs: Study
A new study provides the first empirical evidence that the not-for-profit manufacturer’s business model can lead to robust drug supplies and lower medicine costs.
September 21, 2023
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
September 21, 2023
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Tristan Manalac
FDA signage at its office in Maryland
Policy
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
September 20, 2023
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Tristan Manalac
Pictured: Closed sign being flipped over/iStock, S
Business
Fresh Tracks, Histogen to Shutter Businesses in Absence of Viable Options
The companies have announced the impending closures of their respective businesses. Histogen will lay off most of its employees by the end of September. Fresh Tracks will do so by early October.
September 20, 2023
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Tristan Manalac
3D illustration of an RNA molecule
ReCode Raises $260M in Series B Financing to Advance Lead Programs
Bringing in an additional $50 million in a Series B extension, ReCode Therapeutics’ total haul for the funding round totaled $260 million, which it will use to further its experimental mRNA therapies.
September 20, 2023
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Tristan Manalac
External view of Novartis' office in Canada
Business
Novartis Returns Cancer Asset Tislelizumab to BeiGene
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
September 19, 2023
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Tristan Manalac
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