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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: Novartis Building/iStock, JHVE Photo
Business
Novartis Confirms Sandoz Spin-Off Plans, Sets Oct. 4 Completion Date
The company Tuesday posted Sandoz’s financial performance for the first half of 2023, as it looks to secure the approval of shareholders this month for the generics and biosimilars spin-off.
September 5, 2023
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Policy
Novartis Latest to Join Lawsuits Against IRA Drug Negotiation Program
The Swiss pharmaceutical company filed a suit Friday joining a growing group of legal complaints by Big Pharma seeking to block the Inflation Reduction Act’s Drug Price Negotiation Program.
September 5, 2023
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2 min read
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Tristan Manalac
Pictured: 3D illustration of antibody-drug conjugates with their toxic payloads
Drug Development
Genmab, Seagen Notch Late-Stage Victory in Metastatic Cervical Cancer
The companies are moving closer to traditional approval for the antibody-drug conjugate Tivdak, which met its primary endpoint for overall survival in an interim analysis.
September 5, 2023
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building
Policy
Lawmakers Press Lilly, Novo, Sanofi for Details on Insulin Assistance Programs
Two Democratic senators on Thursday sent a letter to the companies’ CEOs informing them that they have until Sept. 15 to disclose the application processes for their insulin assistance programs.
September 1, 2023
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
Alvotech Tries Again for FDA Interchangeable Designation for Humira Biosimilar
After shoring up quality control at its Reykjavik manufacturing facility, the biotech has resubmitted a BLA to the FDA seeking an interchangeability designation for its Humira biosimilar.
September 1, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration depicting large layoffs/iSt
Business
Sage Cuts Staff by 40% After FDA’s MDD Rejection
Following the FDA’s recent rejection of zuranolone in major depressive disorder, Sage Therapeutics has launched a strategic reorganization initiative including a 40% reduction in headcount.
August 31, 2023
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2 min read
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Tristan Manalac
Pictured: A sign in front of a Takeda building/iSt
FDA
FDA Approves Generics of Takeda’s ADHD, Binge Eating Drug Vyvanse
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
August 31, 2023
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Business
J&J Earns $13.2B from Kenvue Spinout, Lowers Guidance
Johnson & Johnson on Wednesday reported multi-billion earnings from its Kenvue consumer health spinout, with updated 2023 revenue guidance down from its previously announced range.
August 31, 2023
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2 min read
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Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Denies Outlook’s Wet AMD Bid, Issues Complete Response Letter
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Pfizer office in Brussels, Belgium/iStoc
Policy
Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Sign at FibroGen's headquarters in Calif
Drug Development
FibroGen Continues Losing Streak with Phase III DMD Failure
The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Sign of U.S. Department of Health & Huma
Policy
CMS Names First 10 Drugs for Medicare Drug Price Negotiations
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
August 29, 2023
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3 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study
Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.
August 29, 2023
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2 min read
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Tristan Manalac
Pictured: Magnifying glass focusing on a tumor in
Drug Development
Novocure Fails Phase III Ovarian Cancer Trial for Tumor Treating Fields Therapy
The company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.
August 29, 2023
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2 min read
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Tristan Manalac
Pictured: Ultrasound machine showing a heart scan
Drug Development
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data
The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.
August 28, 2023
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2 min read
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Tristan Manalac
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