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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: Test-tube containing a blood sample for
FDA
Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD
The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.
October 18, 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 Sees Nearly 7% Growth in Q3, Increases Full-Year Guidance
In its first financial report since the Kenvue consumer health spinoff, Johnson & Johnson beat analyst expectations fueled by strong pharmaceutical sales including Darzalex, Erleada and Stelara.
October 17, 2023
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2 min read
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Tristan Manalac
Pictured: A dry eye/Kryuchka Yaroslav_Adobe Stock
Policy
Aldeyra Anticipates FDA Rejection of Dry Eye Drug Following Regulatory Meeting
Months after a denial of its rare eye cancer injection, Aldeyra Therapeutics is bracing for another potential rejection by the regulator, this time for its investigational dry eye disease treatment.
October 17, 2023
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2 min read
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Tristan Manalac
Pictured: AbbVie Corporate Office/iStock, vzphotos
Drug Development
AbbVie’s Skyrizi Beats Remission Rates of J&J’s Stelara in Crohn’s Disease
In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
October 17, 2023
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2 min read
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Tristan Manalac
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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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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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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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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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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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
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