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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.

Roche's tower in Shanghai, China
Business
Roche Trims Four Early Assets as Q1 Sales Slip 6% on Currency, COVID Headwinds
Despite being hit with a continuing decline in COVID-19 sales and a strong Swiss franc, Roche on Wednesday reported first-quarter sales were up 2% at constant exchange rates.
April 24, 2024
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Tristan Manalac
Pictured: Anxious man with his head in his hands/i
Drug Development
Neurocrine’s Takeda-Partnered Drug Candidate Aces Phase II Depression Study
An undisclosed once-daily oral dose of Neurocrine Biosciences’ Takeda-partnered investigational drug significantly reduced symptom severity in adults with major depressive disorder.
April 24, 2024
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2 min read
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Tristan Manalac
Pictured: The front entrance to the FDA headquarters/iStock, Grandbrothers
FDA
Day One’s Ojemda Gets FDA Accelerated Approval for Pediatric Brain Tumor
The FDA on Tuesday approved Day One Biopharmaceuticals’ type II RAF inhibitor Ojemda, which is designed to penetrate the blood-brain barrier, for the treatment of relapsed or refractory pediatric low-grade glioma.
April 24, 2024
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Tristan Manalac
Pictured: Sanofi Distribution Center
Drug Development
Sanofi’s $3.7B Principia Buy Starts to Pay Off with Phase III Rilzabrutinib Win
Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
April 23, 2024
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Tristan Manalac
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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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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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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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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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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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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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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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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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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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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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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Tristan Manalac
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