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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.

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People
Lykos CEO to Resign After FDA Rejection of MDMA Therapy, Layoffs
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
September 6, 2024
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Approvals
Travere Wins Full FDA Approval for IgAN Treatment Filspari
With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
September 6, 2024
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Tristan Manalac
Cigna Healthcare office in Delaware
Pharmacy benefit managers
Cigna Continues Biosimilar Push, Targets J&J’s Stelara With No Out-of-Pocket Cost
Thursday’s announcement comes after the insurance giant last week said it would remove AbbVie’s Humira from its major formularies starting in 2025, replacing the blockbuster with more affordable biosimilars.
September 6, 2024
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Tristan Manalac
Eli Lilly's world headquarters in Indianapolis
Diabetes
Lilly Gains Ground on Novo With Positive Phase III Readouts for Weekly Insulin
Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
September 5, 2024
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Obesity
Amgen Plans Phase III Program for Next-Gen Obesity Drug Targeting Liver and Kidney Diseases
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
September 5, 2024
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Tristan Manalac
3D illustration of tow GLP-1 therapy autoinjectors
GLP-1
UK’s MHRA Finds No Risk of Suicidal Ideation, Self-Harm With GLP-1 Drugs
Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.
September 5, 2024
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Tristan Manalac
Pictured: Novartis' logo outside its building in S
Manufacturing
Novartis Starts Construction on Two US Sites to Bolster Radioligand Therapy Manufacturing
The company is building a new facility in California, its third U.S.-based radioligand therapy production site, and expanding an Indianapolis site for producing isotopes for cancer treatment.
September 5, 2024
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Tristan Manalac
Roche's signage at its office in France
Multiple sclerosis
Roche Touts Phase II MS Data on Heels of Sanofi’s Late-Stage Stumbles
Days after Sanofi reported back-to-back failures for its BTK inhibitor, Roche’s fenebrutinib on Wednesday scored a mid-stage win in relapsing multiple sclerosis, demonstrating near-total elimination of disease activity.
September 4, 2024
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Tristan Manalac
Pictured: Nasdaq headquarters in New York/iStock,
IPO
Lilly Partner BioAge Files for IPO to Advance Obesity Candidate
BioAge will use the proceeds from the initial public offering to move its oral apelin receptor agonist azelaprag past its Phase III STRIDES study and into a registrational Phase III trial.
September 4, 2024
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Tristan Manalac
3D illustration of neurons
Alzheimer’s disease
Athira’s Small Molecule Injection for Alzheimer’s Flops in Phase II/III Study
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
September 4, 2024
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Tristan Manalac
MRI scans of a human brain
Neuroscience
Recursion Reports Thin Mid-Stage Efficacy Data for Rare Brain Disease Therapy
Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
September 4, 2024
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Tristan Manalac
Pictured: Boy in a wheelchair looking out the window
Duchenne muscular dystrophy
Dyne Touts ‘Unprecedented’ Dystrophin Expression in Phase I/II DMD Trial for Exon-Skipping Therapy
The highly anticipated results come as the company makes significant changes to its C-suite. Despite the turnover, Dyne said it is looking toward expedited approval pathways for its DMD treatment.
September 3, 2024
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3 min read
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Tristan Manalac
Sanofi's Distribution Center in Quebec, Canada
Multiple sclerosis
Sanofi’s Tolebrutinib Misses Two of Three Late-Stage Multiple Sclerosis Readouts
The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”
September 3, 2024
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Tristan Manalac
Exterior of Novo Nordisk's location in Mainz, Germany
Supply chain
Novo’s Ozempic to Remain in Shortage Into Q4 as Supply Woes Continue
Novo Nordisk’s continuing supply problems for semaglutide come as the pharma tries to expand the drug’s indication, opening it up to more patients—and potentially to heavier production pressures.
September 3, 2024
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Tristan Manalac
Healthcare worker administers a vaccine to a patient
COVID-19
Novavax Catches Up to Competitors With FDA Approval for Updated COVID-19 Boosters
Unlike Pfizer/BioNTech and Moderna, Novavax does not use mRNA technology for its COVID-19 vaccine, instead opting for a recombinant version of the virus’ spike protein to elicit protection.
September 3, 2024
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Tristan Manalac
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