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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.

Kirkland, Quebec, Canada - September 3, 2021: Merck Canada head office in Kirkland, Quebec, Canada. Merck is an American multinational pharmaceutical company.
FDA
Merck Pushes Keytruda into Perioperative NSCLC Setting with FDA Approval
The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.
October 17, 2023
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Deals
Novo in $1.3B Deal Buys Late-Stage Hypertension Drug from Singapore Biotech
The Danish pharma announced Monday that it is buying a Phase III hypertension candidate from Singapore-based KBP Biosciences. It is Novo Nordisk’s third high-value purchase in as many months.
October 16, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly’s Tirzepatide Shows Strong Weight Loss Efficacy in Phase III Study
Patients in a late-stage trial treated with Eli Lilly’s GIP and GLP-1 receptor agonist saw a 21.1% mean body weight reduction over 72 weeks following an intensive lifestyle intervention program.
October 16, 2023
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2 min read
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Tristan Manalac
Pictured: Pfizer's signage outside its office in Canada/iStock, JHVEPhoto
Business
Pfizer Kicks Off $3.5B Cost-Cutting Program as COVID Revenues Decline
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
October 16, 2023
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2 min read
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Tristan Manalac
Pictured: MRI scans of the brain/iStock, Nomadsoul
Drug Development
Cassava Defends Alzheimer’s Asset in Response to Data Manipulation Allegations
The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor.
October 13, 2023
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2 min read
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Tristan Manalac
Sign outside BioNTech's building in Germany
Business
BioNTech Inks Potential $1B Deal with MediLink for Cancer-Focused ADCs
The German biotechnology company has teamed with Suzhou-based biotech MediLink Therapeutics to develop next-generation antibody-drug conjugates for cancer.
October 13, 2023
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2 min read
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Tristan Manalac
Pictured: Entrance to DaVita's headquarters in Col
DaVita Casts Doubt on Novo’s Chronic Kidney Disease Results for Ozempic
Dialysis giant DaVita on Thursday raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.
October 13, 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
Drug Development
FDA Action Alert: Merck, Ardelyx, BioMarin and More
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
October 12, 2023
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6 min read
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Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue
The regulator issued a Complete Response Letter citing “deficiencies” at the company’s Reykjavik plant, this time for its Stelara biosimilar AVT04. It’s the fourth FDA rejection for Alvotech since last year.
October 12, 2023
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2 min read
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Tristan Manalac
Pictured: Blue upward trendline showing rising sto
Drug Development
Tempest’s Stock Skyrockets 4,000% on Early Data for Hepatocellular Carcinoma
In a Phase Ib/II study, Tempest Therapeutics’ investigational PPAR⍺ antagonist—combined with Roche’s Avastin and Tecentriq—showed strong signs of survival benefits in liver cancer patients.
October 12, 2023
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2 min read
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Tristan Manalac
John Tlumacki/The Boston Globe via Getty Images
Business
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition
The layoffs, set to take effect in late November, will impact about a third of Reata’s headcount. The workforce reduction comes just weeks after Biogen completed its $7.3 billion Reata buy.
October 12, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration depicting large layoffs/iSt
Business
Sana Downsizes Staff by 29%, Refocuses on Ex Vivo Cell Therapy Platform
The biotech is laying off about 29% of its employees and will focus its resources on the company’s hypoimmune platform. The latest downsizing follows a previous round of layoffs in August 2023.
October 11, 2023
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2 min read
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Tristan Manalac
Pictured: Illumina signage outside its office in California
Policy
EU Orders Illumina to Divest Grail After Years of Regulatory Challenges
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
October 11, 2023
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3 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Drug Development
Novo Ends Semaglutide Kidney Study Early Due to Strong Efficacy Signals
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
October 11, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration of a damaged liver/iStock,
Drug Development
Akero’s Phase IIb NASH Data Disappoints, Sends Stock Plummeting
Both low and high doses of Akero Therapeutics’ lead candidate efruxifermin failed to significantly outperform placebo at improving liver fibrosis without worsening non-alcoholic steatohepatitis.
October 10, 2023
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3 min read
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Tristan Manalac
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