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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.

FDA Action Alert logo/© Nicole Bean for BioSpace
Policy
FDA Action Alert: Sarepta, Protalix, Otsuka/Lundbeck and More
The FDA’s agenda includes an advisory committee meeting for Sarepta’s delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
May 5, 2023
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6 min read
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Tristan Manalac
A Novo Nordisk flag flies in the wind/Courtesy jor
Drug Development
Novo Nordisk’s Hemophilia Hopeful Hits FDA Roadblock, Company Cuts Wegovy Supply
During a first-quarter earnings call, Novo revealed its hemophilia candidate had been blocked by the FDA, and that the company is reducing the U.S. supply of lower doses of weight-loss drug Wegovy.
May 5, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Drug Development
Lilly’s Donanemab Data Energizes Alzheimer’s Sector, Safety Concerns Remain
While donanemab showed impressive results in Phase III TRAILBLAZER-ALZ 2, concerns regarding its safety remain compared with Biogen’s and Eisai’s Leqembi.
May 4, 2023
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3 min read
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Tristan Manalac
Pictured: ImmunoGen President and CEO Mark Enyedy/
Drug Development
ImmunoGen’s Elahere Aces Confirmatory Trial, Poised to Win Full Approval
Data from Phase III confirmatory MIRASOL trial show antibody-drug conjugate boosts survival in platinum-resistant ovarian cancer, setting the stage for full approval by the FDA.
May 4, 2023
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2 min read
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Tristan Manalac
Pictured: Photomicrograph of a Lendrum-stained kid
Drug Development
Travere’s Sparsentan Stumbles in Phase III Rare Kidney Disease Study
Despite the Phase III failure, Travere and partner CSL Vifor will explore potential regulatory paths for sparsentan as a treatment for focal segmental glomerulosclerosis.
May 3, 2023
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3 min read
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Tristan Manalac
Pictured: Red and white Lilly sign on building/Mic
Drug Development
Lilly’s Donanemab Slows Cognitive, Functional Decline in Phase III Alzheimer’s Study
The amyloid plaque targeting therapy met primary endpoint and all secondary endpoints, which Lilly will use in its submission to the FDA this quarter.
May 3, 2023
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3 min read
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Tristan Manalac
Pictured: Blue and white Pfizer sign on building/c
Business
Pfizer Cuts Mid-Stage Candidates Amid Declining Revenues
The company’s pipeline changes come as it weathered a nearly 30% decline in first-quarter revenues due to a slowdown in its COVID-19 business.
May 3, 2023
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3 min read
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Tristan Manalac
Pictured: J&J sign/Cristina Arias/Getty Images
J&J Makes $245M Play to Develop Next-Gen CAR-T Therapies
The partnership with Chinese biotech Cellular Biomedicine Group will cost J&J $245 million upfront and give it access to two differentiated CAR-T therapies for diffuse large B-cell lymphoma.
May 2, 2023
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2 min read
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Tristan Manalac
Pictured: Sanofi sign/courtesy of AUFORTJérome_Ado
Sanofi Deepens Pompe Disease Focus with $150M Maze Partnership
For $150 million upfront, Sanofi will gain access to Maze’s lead asset MZE001, which inhibits the GYS1 protein in the rare genetic disorder.
May 2, 2023
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2 min read
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Tristan Manalac
FDA Headquarters_Grandbrothers/Adobe Stock
FDA
FDA Panel Supports Narrow Lynparza Label for Prostate Cancer
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
May 1, 2023
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3 min read
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Tristan Manalac
Pictured: Lundbeck sign on a building_Longfin Medi
FDA
FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
May 1, 2023
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2 min read
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Tristan Manalac
Pictured: Blue and white Pfizer sign on building/T
FDA
FDA Greenlights Pfizer’s Pneumococcal Vaccine in Infants and Children
Prevnar 20 is indicated for the prevention of invasive pneumococcal disease and otitis media in children.
April 28, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Drug Development
Lilly’s Mounjaro Poised to Challenge Novo’s Wegovy in Obesity
In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese.
April 28, 2023
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2 min read
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Tristan Manalac
Courtesy Jeremy Moeller/Getty Images
Business
Caforio Out, Boerner In as BMS Sees Slight Decline with Generic Competition
The leadership shuffle comes as BMS is facing one of the steepest patent cliffs in biopharma, with exclusivity of three of its top drugs lapsing this decade.
April 27, 2023
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2 min read
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Tristan Manalac
FDA
Seres’ Vowst Wins FDA First-Ever Approval for Oral Microbiome Therapeutic
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
April 27, 2023
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2 min read
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Tristan Manalac
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