SUBSCRIBE
SUBSCRIBE
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.

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
 · 
2 min read
 · 
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
 · 
3 min read
 · 
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
 · 
3 min read
 · 
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
 · 
2 min read
 · 
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
 · 
2 min read
 · 
Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Travere, Avadel and Roche
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
September 3, 2024
 · 
3 min read
 · 
Tristan Manalac
Pictured: Alnylam headquarters in Massachusetts/iS
Rare diseases
Alnylam Builds ATTR-CM Case for Vutrisiran With Strong Phase III Survival Data
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
August 30, 2024
 · 
2 min read
 · 
Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Regulatory
J&J Poised to Challenge Argenx With Myasthenia Gravis Filing for Nipocalimab
J&J gained rights to the FcRn blocker nipocalimab when it acquired Momenta Pharmaceuticals in August 2020 for $6.5 billion.
August 30, 2024
 · 
2 min read
 · 
Tristan Manalac
Photo of a GLP-1 injector pen on a blue background
Legal
Siding With Novo and Lilly, Court Agrees to First Tackle ‘Cross Cutting Issues’ in GLP-1 Litigations
In agreeing with Novo Nordisk and Eli Lilly, Pennsylvania judge Karen Spencer Marston said the court should first settle questions of gastroparesis diagnosis and sufficient warnings for side effects.
August 30, 2024
 · 
2 min read
 · 
Tristan Manalac
Gloved hand holding a vial of mpox vaccine
Regulatory
Emergent Wins FDA Approval for Mpox Vaccine as Outbreak Rages On
Emergent BioSolutions joins Bavarian Nordic on pharma’s frontline in the fight against the ongoing mpox emergency.
August 30, 2024
 · 
2 min read
 · 
Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Cancer
Merck Axes Two Keytruda Phase III Cancer Trials Due to Disappointing Data
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.
August 29, 2024
 · 
2 min read
 · 
Tristan Manalac
External view of the U.S. Capitol building
Pharmacy benefit managers
House Oversight Chair Calls on PBM Execs to Correct Testimonies
The chair of the House Committee on Oversight and Accountability wants the CEOs of CVS Caremark, Express Scripts and Optum Rx to fix statements they made in a hearing last month that contradicted the committee’s and Federal Trade Commission’s findings.
August 29, 2024
 · 
2 min read
 · 
Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Legal
Regeneron Sues Sandoz in Federal Court to Block Eylea Biosimilar
In its legal complaint, filed in the District Court for New Jersey, Regeneron alleges that Sandoz failed to provide it with relevant information required under the Biologics Price Competition and Innovation Act.
August 29, 2024
 · 
2 min read
 · 
Tristan Manalac
Novartis' office building in Marburg, Germany
Cardiovascular disease
Novartis Plots Leqvio Expansion After Lowering Cholesterol in Phase III Study
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
August 29, 2024
 · 
2 min read
 · 
Tristan Manalac
Sign in front of Pfizer in Quebec, Canada
Collaboration
Pfizer Partners With Flagship’s Quotient to Leverage Genetics Against Heart, Renal Diseases
Quotient Therapeutics’ platform targets somatic mutations, which the startup contends can help identify a broader scope of genes potentially associated with disease phenotypes. Wednesday’s agreement is part of an existing partnership between Pfizer and Flagship Pioneering.
August 28, 2024
 · 
2 min read
 · 
Tristan Manalac
Load More