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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.

Roche's tower in Shanghai, China
Policy
FDA Puts Clinical Hold on Roche BTK Inhibitor Multiple Sclerosis Program
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
December 5, 2023
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2 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Deals
Roche Jumps into Lucrative Weight-Loss Space with $2.7B Carmot Buy
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity.
December 4, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's biotechnology center in San Diego, California
FDA
Lilly Wins Second Accelerated Approval for Reversible BTK Inhibitor
Lilly’s Jaypirca (pirtobrutinib) can now be used to treat chronic lymphocytic leukemia or small lymphocytic leukemia that had progressed from at least two prior lines of therapy, in addition to its previously-approved indications.
December 4, 2023
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Drug Development
J&J Hires Thousands, Invests Millions in AI-Powered Drug Discovery
Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.
December 4, 2023
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2 min read
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Tristan Manalac
Pictured: FDA sign at Washington D.C. headquarters
Drug Development
FDA Action Alert: Vertex/CRISPR, Arcutis and Optinose
This week, the FDA could approve the first CRISPR-edited therapy in the U.S., while two other companies await decisions on topical drugs.
December 1, 2023
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4 min read
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Tristan Manalac
Pictured: GSK's office in Poznan, Poland/iStock, W
GSK Pulls Ahead of Pfizer in RSV Vaccine Market as Arexvy Nears Blockbuster Status
CEO Emma Walmsley projects that the British biopharma’s Arexvy sales will exceed £1 billion in its first year on the market, leaving Pfizer’s Abrysvo respiratory syncytial virus vaccine far behind in the race.
December 1, 2023
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Tristan Manalac
Pictured: Woman stepping on a weighing scale/iStoc
Drug Development
Altimmune Joins Weight-Loss Race with Phase II Win, Stock Jumps on News
Patients treated with Altimmune’s investigational GLP-1/glucagon dual receptor agonist saw up to 15.6% weight loss, and nearly a third of those taking the highest dose lost at least 20% of their body weight.
December 1, 2023
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2 min read
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Tristan Manalac
Pictured: Image of an MRI brain scan/iStock, sudok
Policy
Karuna Secures FDA Decision Date for Schizophrenia Candidate KarXT
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
November 30, 2023
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Tristan Manalac
FDA signage at its office in Maryland
Policy
Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
November 30, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Business
Lilly Puts Potential $660M on the Line for Protein-Protein Interaction Blockers
In a deal with Tokyo-based PRISM BioLab, Eli Lilly will gain access to the Japanese biotech’s proprietary platform to develop small molecule inhibitors of protein-protein interactions.
November 29, 2023
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Tristan Manalac
Pictured: Man prepares his GLP-1 receptor agonist injection
Drug Development
Real-World Data Shows Lilly’s Tirzepatide Beats Novo’s Semaglutide at Weight Loss
Using electronic health records, healthcare analytics firm Truveta contends that Eli Lilly’s Mounjaro (tirzepatide) could achieve stronger and faster weight loss than Novo Nordisk’s Ozempic (semaglutide).
November 29, 2023
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2 min read
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Tristan Manalac
Pictured: Facade of Novartis building in Switzerland
Novartis Raises Growth Target, Trims Pipeline Under ‘Pure-Play’ Strategy
The Swiss pharma is adopting a more streamlined strategy focusing on core therapeutic areas: cardiovascular, immunology, neuroscience and oncology, as well as renal and metabolic diseases.
November 29, 2023
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2 min read
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Tristan Manalac
Pictured: Syringe drawing from a series of vials/i
Drug Development
Acelyrin Flags CRO Errors in Izokibep Program After Late-Stage Failure
The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
November 28, 2023
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2 min read
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Tristan Manalac
Pictured: Person applies eye drops/iStock, megaflo
Policy
FDA Rejects Aldeyra’s Dry Eye Drug, Cites Need for Additional Trial
Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
November 28, 2023
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
SpringWorks Wins First FDA Approval for Non-Cancerous Desmoid Tumors
The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
November 28, 2023
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2 min read
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Tristan Manalac
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