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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: Astellas' Americas headquarters in Illin
Policy
Astellas Withdraws IRA Lawsuit After Xtandi Avoids Drug Price Negotiations
The company has withdrawn a suit against the Department of Health and Human Services after its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list.
September 7, 2023
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2 min read
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Tristan Manalac
External view of AstraZeneca's production plant in Sweden
Policy
FDA Rejects AstraZeneca’s Ultomiris Label Expansion in NMOSD
Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.
September 6, 2023
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2 min read
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Tristan Manalac
Pictured: Medicines on dollar bills/iStock, Julia_
Policy
CMS Should Monitor Effects of Drug Rebates with Eye Towards IRA: GAO
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
September 6, 2023
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3 min read
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Tristan Manalac
Pictured: Illustration of a base nucleotide being
Drug Development
Beam Launches Early-Stage Study of Allogeneic, Base-Edited CAR-T Therapy
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
September 6, 2023
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2 min read
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Tristan Manalac
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
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