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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.

Pictured: The U.S. Supreme Court building in Washi
Policy
Supreme Court Denies Vanda’s Petition in Hetlioz Patent Case Against Teva
The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
April 23, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
April 23, 2024
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2 min read
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Tristan Manalac
Pictured: 3D concept art showing a bladder surrounded by cancer cells
FDA
ImmunityBio Wins FDA Approval for First IL-15 Superagonist for NMIBC
Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
April 23, 2024
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2 min read
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Tristan Manalac
3D illustration of an RNA molecule
Business
Ipsen, Skyhawk Ink Potential $1.8B Deal to Target RNA in Neuro Diseases
Ipsen is looking to deepen its expertise in movement disorders in a research collaboration with Skyhawk Therapeutics to develop small molecule drugs for RNA targets in neurological diseases.
April 22, 2024
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2 min read
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Tristan Manalac
AbbVie's office in South San Francisco, California
AbbVie Tops Doctor Ranking of Immunology Companies, Handily Beating Pfizer and J&J
Bolstered by its portfolio of “revolutionary” therapies, AbbVie remains the top pharma company in the immunology space, according to a new survey of doctors by ZoomRx.
April 22, 2024
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2 min read
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Tristan Manalac
Pictured: Vifor Pharma's office in Switzerland/iSt
Policy
CSL Vifor Offers Marketing Campaign to Reverse Alleged Anti-Competitive Practices
Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival.
April 22, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor looking at a patient's MRI brain scan
Drug Development
AbbVie, NeuroDerm Heat Up Levodopa Competition with New Data at AAN24
As AbbVie and NeuroDerm race toward potential U.S. approvals later this year, the companies presented strong data at last week’s American Academy of Neurology 2024 annual meeting for their respective continuous subcutaneous levodopa infusions.
April 22, 2024
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2 min read
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Business
Alvotech, Teva Enlist New Partner to Expand Access to Humira Biosimilar in US
Ahead of launching its Humira biosimilar Simlandi, Alvotech and Teva on Friday announced they have signed a long-term agreement with an undisclosed strategic partner to help boost patient access to the drug.
April 19, 2024
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2 min read
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Tristan Manalac
Pictured: Facade of Sanofi's headquarters in Franc
Business
Sanofi Cuts Jobs in US Vaccines Division as Part of Restructuring
French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.
April 19, 2024
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2 min read
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Tristan Manalac
Signage outside Genentech's headquarters in Silicon Valley
FDA
Genentech Wins FDA Approval for First Adjuvant Therapy for ALK-Positive, Early NSCLC
Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
April 19, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
FDA Requires Boxed Warning for Secondary Cancers on CAR-T Therapies
Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
April 19, 2024
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2 min read
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Tristan Manalac
Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace
Policy
FDA Action Alert: ImmunityBio, Aquestive, XOMA and More
The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
April 18, 2024
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6 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Drug Development
Roche’s Ocrevus Achieves Near-Complete Reduction of Relapse, Lesions in MS
Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.
April 18, 2024
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
Teva, Alvotech Secure FDA Approval for Stelara Biosimilar with Early 2025 Launch
Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.
April 18, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Most Doses of Lilly’s Zepbound and Mounjaro in Short Supply Through Q2: FDA
Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.
April 18, 2024
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2 min read
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Tristan Manalac
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