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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: Eli Lilly's biotechnology center in San
Policy
EU to Review Lilly’s Multi-Dose Pen for Mounjaro on Heels of UK Launch
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.
February 20, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's corporate headquarters in Denmark
Business
Novo Licenses to Almirall Potential First-in-Class Antibody Candidate
Almirall will have exclusive global rights to develop and commercialize the anti-IL-21 monoclonal antibody NN-8828 in several fields, including immune inflammatory dermatological indications.
February 19, 2024
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2 min read
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Tristan Manalac
Pictured: Sanofi Distribution Center
Drug Development
Sanofi, Denali ALS Candidate Flops in Mid-Stage Trial
In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients.
February 19, 2024
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2 min read
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Tristan Manalac
AstraZeneca's sign on its office in California
FDA
AstraZeneca Expands Tagrisso’s NSCLC Label, FDA Allows Use with Chemo
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
February 19, 2024
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2 min read
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Tristan Manalac
Pictured: Male patient getting an ultrasound/iStoc
Policy
Inventiva Pauses Late-Stage NASH Trial, Keeps Field Open for Madrigal
Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.
February 16, 2024
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2 min read
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Tristan Manalac
Pictured: Sign above the entrance to a U.S. courthouse
Policy
Karuna CEO, Board Sued by Shareholder over $14B BMS Acquisition
Claiming that Karuna Therapeutics’ board of directors withheld crucial information, a shareholder has filed a lawsuit seeking to block the $14 billion merger with Bristol Myers Squibb.
February 16, 2024
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2 min read
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Tristan Manalac
Astellas' headquarters for the Americas
Business
Astellas Inks Potential $800M Deal with Kelonia for In Vivo Gene Delivery Tech
Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.
February 16, 2024
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2 min read
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Tristan Manalac
Gilead's corporate headquarters in Silicon Valley
Drug Development
Gilead Suspends Patient Enrollment for Magrolimab in Solid Tumor Trials
While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.
February 16, 2024
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2 min read
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Tristan Manalac
FDA Headquarters_Grandbrothers/Adobe Stock
Policy
FDA Action Alert: Alvotech and Minerva
In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.
February 15, 2024
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3 min read
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Tristan Manalac
Pictured: Healthcare worker draws blood from a pat
Drug Development
Roche-Backed Freenome Continues Industry’s Funding Rally with $254M Raise
Freenome announced Thursday a fundraising round of more than a quarter of a billion dollars, led by Roche, to advance its blood-based cancer tests as pivotal readouts approach.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Facade of the U.S. Patent and Trademark
Drug Development
Otsuka’s Longer-Acting Schizophrenia Injection to Offset Abilify Patent Loss
A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Unhappy woman with her head in her hands
Business
Sage Touts Strong Launch for Postpartum Depression Drug Zurzuvae
Despite missing out on an FDA approval for major depressive disorder, Zurzuvae appears to be a strong asset for Sage Therapeutics, with high growth potential in 2024.
February 15, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
FDA Approves First Treatment for Severe Frostbite, Reduces Risk of Amputation
Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Biogen's headquarters in Cambridge, Massachusetts
Policy
DOJ, SEC Subpoenas Add to Biogen’s Compounding Problems
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
February 14, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Pushes Back PDUFA Data for Rocket’s Gene Therapy for Rare Blood Disorder
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
February 14, 2024
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2 min read
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Tristan Manalac
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