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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: Illustration of an antibody molecule/iSt
Business
Seagen, Nurix Team to Create New Class of Antibody Conjugates for Cancer
The companies have started a collaboration worth up to $3.4 billion to develop a portfolio of degrader-antibody conjugates, a potentially new class of antibodies that selectively kill cancer cells.
September 8, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration of a virus vector/iStock, p
Business
Otsuka, Shape Ink Potential $1.5B Deal to Develop Eye AAV Gene Therapies
To build its ophthalmology portfolio, Japan’s Otsuka Pharmaceuticals has teamed with RNA editing biotech Shape Therapeutics to develop adeno-associated virus gene therapies for ocular diseases.
September 8, 2023
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Drug Development
FDA Action Alert: GSK and Alnylam
After a three-month delay, GSK expects an FDA verdict for its myelofibrosis candidate, while Alnylam gears up for an advisory committee meeting discussing patisiran in cardiomyopathy of ATTR amyloidosis.
September 7, 2023
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3 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Drug Development
J&J Terminates Phase III Study of Cardio Asset in Pulmonary Hypertension
At the recommendation of an independent data monitoring committee, J&J decided to stop the MACiTEPH trial in chronic thromboembolic pulmonary hypertension due to futility.
September 7, 2023
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2 min read
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Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Policy
BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly
Blue Cross and Blue Shield of Louisiana has filed a case against Bristol Myers Squibb alleging the company conducted patent fraud to extend protections for its multiple myeloma drug Pomalyst.
September 7, 2023
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2 min read
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Tristan Manalac
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
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