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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: FDA signage at its office in Washington, DC
FDA
Sandoz Nabs FDA Approvals for First Two Biosimilars for Amgen’s Denosumab
Sandoz’s two interchangeable biosimilars, Jubbonti and Xgeva, are poised to challenge Amgen’s blockbuster bone drug denosumab. However, no launch details were announced Tuesday due to ongoing patent litigation.
March 6, 2024
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2 min read
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Tristan Manalac
Pictured: NHS sign on a building/iStock, TkKurikaw
Policy
UK’s NICE Rejects AstraZeneca, Daiichi Sankyo’s Enhertu for NHS Use
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.
March 6, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's corporate headquarters in Denmark
Drug Development
Novo’s Ozempic Poised for Cardiometabolic Expansion with New Phase III Data
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease.
March 5, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
Eyenovia, Formosa Win FDA Approval for Anti-Inflammatory Eye Drops
The regulator has approved Eyenovia and Formosa’s ophthalmic clobetasol propionate solution to ease eye inflammation and pain after surgery, with a potential $1.3 billion market.
March 5, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor injecting Botox into the forehead
FDA
Hugel Challenges Botox with FDA Approval for Neurotoxin Injection for Frown Lines
Hugel America has won the FDA’s approval for Letybo, authorized for the treatment of frown lines in adults, which is poised to challenge AbbVie’s blockbuster Botox.
March 5, 2024
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2 min read
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Tristan Manalac
Pictured: 3D illustration of a damaged liver/iStoc
Drug Development
Akero Bounces Back in MASH, Posts Positive Mid-Stage Fibrosis Data
New 96-week data show Akero Therapeutics’ efruxifermin can improve fibrosis by at least one stage without metabolic dysfunction-associated steatohepatitis worsening in more patients versus placebo.
March 4, 2024
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2 min read
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Tristan Manalac
Pictured: Illustration of a motor neuron being deg
Drug Development
ALS Treatment Landscape ‘Primed’ with Over 100 Candidates: GlobalData
Amid the limitations of current therapies for amyotrophic lateral sclerosis, a new GlobalData report points to novel disease-modifying drug approaches that could transform the space.
March 4, 2024
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
FDA
J&J Wins Full FDA Approval for Rybrevant, Chemo Combo in NSCLC
Rybrevant has been approved for use with carboplatin and pemetrexed in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with exon 20 insertion mutations in the EGFR gene.
March 4, 2024
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2 min read
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Tristan Manalac
Pictured: Elderly man getting vaccinated by a heal
Policy
RSV Shots May Slightly Raise Risk of Rare Autoimmune Disorder in Older Adults
The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.
March 1, 2024
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2 min read
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Tristan Manalac
Pictured: Gilead's headquarters in Silicon Valley/
Business
Gilead Secures $210M from VC to Build Trodelvy’s Clinical Case in NSCLC
Retaining the full rights to Trodelvy, Gilead now has access to $210 million in financing from venture capital firm Abingworth to help push the antibody-drug conjugate into non-small cell lung cancer studies.
March 1, 2024
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2 min read
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Tristan Manalac
Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto
Pfizer Focuses on Four Main Cancer Types, Eyes Eight Blockbusters by 2030
At Thursday’s Oncology Innovation Day, Pfizer laid out its business strategy which includes building up its biologics business, specifically antibody-drug conjugates and bispecific antibodies.
March 1, 2024
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2 min read
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Tristan Manalac
Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace
Policy
FDA Action Alert: Vanda, Eyenovia and Viatris/Mapi
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
February 29, 2024
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3 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly Looks to India Launch of Mounjaro in 2025: Reuters
Eli Lilly is planning to launch its blockbuster diabetes drug Mounjaro next year in India, the world’s most populous nation, ahead of its main competitor Novo Nordisk which is eyeing an Indian launch of Wegovy in 2026.
February 29, 2024
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2 min read
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Tristan Manalac
Pictured: Sarepta sign on a brick building/courtes
Business
Sarepta’s Duchenne Gene Therapy Elevidys Nabs $200M on Strong Demand
Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool.
February 29, 2024
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2 min read
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Tristan Manalac
Pictured: Anxious man with his head in his hands/i
Drug Development
Incannex’s Psilocybin Clears Phase II Trial in Generalized Anxiety Disorder
Incannex Healthcare on Wednesday said its investigational psychedelic psilocybin met the primary endpoint, demonstrating it can reduce Hamilton anxiety scores by more than nine points versus placebo.
February 29, 2024
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2 min read
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Tristan Manalac
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