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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: Gene therapy illustration showing an inj
Policy
FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
September 19, 2023
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2 min read
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Tristan Manalac
Pictured: Blue Sanofi sign on building in Germany at night
Business
Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal
The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.
September 19, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration of a blood clot in a blood
Drug Development
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy
After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: U.S. Chamber of Commerce/Courtesy of Ado
Policy
DOJ, Chamber of Commerce Tussle in Court Over IRA’s Drug Price Negotiations
The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: GSK's office in Poznan, Poland/iStock, W
FDA
FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: Exterior of an FDA building
FDA
FDA Action Alert: ARS Pharma, Appili, Ocuphire and BrainStorm
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
September 15, 2023
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5 min read
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Tristan Manalac
Pictured: 3D rendering of amyloid-beta oligomers
Drug Development
Anavex’s Blarcamesine Slows Cognitive Decline in Alzheimer’s Patients
Following a controversial Rett Syndrome trial last year, Anavex Life Sciences’ blarcamesine has claimed another clinical victory—this time in an Alzheimer’s disease Phase IIb/III study.
September 15, 2023
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2 min read
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Tristan Manalac
Pictured: Alexion headquarters in California/iStoc
Policy
AstraZeneca’s Alexion Reaches $125M Settlement in Soliris Sales Lawsuit
After nearly seven years, the company’s rare diseases arm Alexion has reached a settlement in an investors’ lawsuit over alleged unethical sales practices for its hemoglobinuria therapy Soliris.
September 15, 2023
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2 min read
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Tristan Manalac
Pictured: Pile of money/iStock, Ihor Lukianenko
Generate Raises $273M in Series C Financing with New Investors Amgen, NVIDIA
In the largest biotech Series C financing so far this year, Generate:Biomedicines picked up new investors including Amgen and NVIDIA’s venture capital arm to advance its pipeline of 17 programs.
September 14, 2023
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2 min read
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Tristan Manalac
Pictured: AbbVie Corporate Office/iStock, vzphotos
Business
AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program
The company declined to exercise the license option for Harpoon Therapeutics’ TriTAC HPN217 program for multiple myeloma, which targets B cell maturation antigen, or BCMA.
September 14, 2023
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2 min read
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Tristan Manalac
Pictured: Facade of Moderna's building in Massachusetts
Drug Development
Moderna Axes Four Clinical Development Programs, Two AstraZeneca Had Dropped
During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.
September 14, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration of liver surrounded by hepa
Drug Development
Eiger Discontinues Phase III Hepatitis Study Due to Safety Concerns
Following cases of hepatobiliary toxicity leading to liver decompensation, Eiger has decided to drop its Phase III LIMT-2 trial of peginterferon lambda in chronic hepatitis delta.
September 13, 2023
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2 min read
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Tristan Manalac
Update: AbbVie headquarters building in California
Drug Development
AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial
Continuing its clinical win streak, AbbVie’s Skyrizi showed signs of superiority against Johnson & Johnson’s Stelara in topline data from a head-to-head Phase III Crohn’s disease study.
September 13, 2023
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2 min read
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Tristan Manalac
Pictured: X-ray illustration with the adrenal glan
Drug Development
Neurocrine’s Congenital Adrenal Hyperplasia Candidate Clears Phase III
Topline data for the company’s CRF1 antagonist crinecerfont showed a significant drop in daily glucocorticoid dose, while maintaining androgen control in adult patients with the genetic disorder.
September 13, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration depicting large layoffs/iSt
Business
2seventy to Lay Off 40% of Workforce, CEO to Depart in Reorganization
Citing a challenging macro environment, 2seventy bio is launching a sweeping strategic reorganization that will see 40% of its staff laid off and CEO Nick Leschly stepping down.
September 12, 2023
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3 min read
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Tristan Manalac
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