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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.

Bodo Marks/picture alliance via Getty Images
Drug Development
AstraZeneca Notches Back-to-Back Late-Stage Wins in Lung Cancer
AstraZeneca reported positive data from both the Phase III ADAURA trial studying Tagrisso (osimertinib) and the Phase III AEGEAN studying Imfinzi (durvalumab) in NSCLC patients.
March 9, 2023
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Tristan Manalac
Courtesy of Cristina Arias/Getty Images
Drug Development
Lilly’s Alzheimer’s Struggles Continue as Preclinical Disease Asset Fails Phase III
Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
March 9, 2023
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Tristan Manalac
BioMarin HQ/courtesy of BioMarin
Drug Development
BioMarin Answers BridgeBio’s Challenge with sNDA for Achondroplasia
BioMarin announced Tuesday that the FDA has accepted its supplemental New Drug Application to expand Voxzogo for children younger than five years with achondroplasia.
March 8, 2023
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Tristan Manalac
Young team during virus lab tests. Multi ethnic scientists focused on work. Wearing protective workwear
Business
Lilly-Backed Volastra Enters Clinic with Amgen’s KIF18A Inhibitor
Volastra Therapeutics has in-licensed Amgen’s sovilnesib, a KIF18A inhibitor being studied for high-grade ovarian cancer, triple-negative breast cancer and other solid tumors.
March 7, 2023
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Tristan Manalac
Pictured: Merck building/courtesy Michael Vi/Getty
Drug Development
Merck Preps Potential First Oral PCSK9 Inhibitor for Phase III
Merck presented Phase IIb data at ACC Monday showing that its hypercholesterolemia hopeful met the primary endpoint.
March 7, 2023
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Tristan Manalac
Maddie Meyer/Getty Images
Drug Development
Moderna Eyes Accelerated Approval for mRNA Cancer Vaccine
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
March 7, 2023
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Tristan Manalac
Courtesy of Sarah Silbiger/Getty Images
Policy
FDA Action Alert: Roche and Acadia
The FDA’s Oncologic Drugs Advisory Committee will meet March 9 to discuss Roche’s sBLA for Polivy in first-line DLBCL, while Acadia awaits potential approval of the first therapy for Rett Syndrome.
March 4, 2023
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Tristan Manalac
Sen. Bernie Sanders/Courtesy of Gage Skidmore, Cre
Policy
Sanders Calls on Sanofi, Novo to Follow Lilly in Cutting Insulin Prices
Sen. Bernie Sanders (I-VT), chairman of the Senate’s Health, Education, Labor and Pensions Committee, sent a letter to Sanofi and Novo Nordisk urging them to lower insulin prices.
March 3, 2023
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Tristan Manalac
Pictured: Exelixis headquarters/Company courtesy
Drug Development
Roche, Exelixis Suffer Another Late-Stage Cancer Combo Failure
Phase III data showed the combination of Roche’s Tecentriq and Exelixis’ Cabometyx fell short of its primary endpoint in renal cell carcinoma.
March 3, 2023
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Tristan Manalac
Yichuan Cao/NurPhoto via Getty Images
Business
FDA Rejected Human Trial for Elon Musk’s BCI Tech - Reuters
In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
March 3, 2023
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Tristan Manalac
Courtesy of joreks/Getty Images
Job Trends
Novo Boosts Boston R&D Operations, Adds 200+ Jobs with New R&D Site
Novo Nordisk announced Thursday it plans to expand its research and development operations in the greater Boston area and add over 200 new jobs this year.
March 2, 2023
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Tristan Manalac
Stan Wang, M.D., Ph.D., founder and CEO, Thymmune
Business
George Church-Backed Thymmune Launches to Target Overlooked Organ
Thymmune is backed by an A-list team of investors including Pillar VC, former Alnylam CEO John Maraganore and famed geneticist George Church.
March 2, 2023
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Tristan Manalac
Courtesy of Merck & Co. Inc.
Drug Development
Keytruda Offsets Back-to-Back Flops with Phase III NSCLC Win
Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.
March 1, 2023
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Tristan Manalac
Pictured: Stop sign in front of FDA headquarters/S
Drug Development
FDA Rejects Cytokinetics’ Heart Failure Drug, Requests Another Trial
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
March 1, 2023
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Tristan Manalac
Al Drago/CQ Roll Call
Drug Development
GSK’s RSV Vaccine Wins Adcomm Backing One Day after Pfizer
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.
March 1, 2023
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Tristan Manalac
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