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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.

External view of AstraZeneca's production plant in Sweden
Regulatory
AstraZeneca’s Imfinzi Scores Lung Cancer Wins With FDA’s NSCLC Approval, SCLC Priority Review
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
August 16, 2024
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2 min read
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Tristan Manalac
Healthcare worker draws from a vial of an mpox vaccine
Vaccines
Bavarian Nordic Sees Potential Windfall Opportunity Amid Global Mpox Emergency
The company can make 10 million doses available next year, with $600 million to $1 billion in revenue potential into 2025, “albeit perhaps lower on price, discounts and donations,” according to Jefferies analyst Peter Welford.
August 16, 2024
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2 min read
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Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Patents
Delaware Judge Throws Out Pfizer’s $107.5M Tagrisso Patent Win Over AstraZeneca
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
August 16, 2024
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2 min read
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Tristan Manalac
Gilead's corporate headquarters in Silicon Valley
Approvals
Gilead’s $4.3B Bet on CymaBay Pays Off With FDA Nod for Autoimmune Liver Disease Drug
The regulator’s approval of Livdelzi for primary biliary cholangitis under the accelerated pathway is a boost to Gilead Sciences’ liver disease business. Analysts expect the drug to reach more than $1 billion in sales.
August 15, 2024
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2 min read
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Tristan Manalac
Incyte's logo on its building in Delaware
Approvals
Incyte Wins Second Graft-Versus-Host Disease FDA Approval
Nearly two weeks ahead of its target action date, the regulator on Wednesday has signed off on Incyte and Syndax’s Niktimvo for the third-line treatment of graft-versus-host disease.
August 15, 2024
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2 min read
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Tristan Manalac
Concept art of a gene therapy showing a syringe injecting into a 3D DNA helix
Gene therapy
Bluebird Hit With Slow Uptake of Sickle Cell, Beta-Thalassemia Gene Therapies
Likely to miss its initiation target, bluebird bio has renegotiated the loan deals of its agreement with Hercules Capital, giving it until June 30 next year—at the latest.
August 15, 2024
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2 min read
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Tristan Manalac
Front view of the White House
IRA
White House Expects IRA’s Negotiated Drug Prices to Save Medicare $6B in 2026
The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation.
August 15, 2024
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3 min read
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Tristan Manalac
Facade of AstraZeneca's office in Shanghai, China
Approvals
AstraZeneca’s Imfinzi-Lynparza Combo Wins Landmark EU Nod for Endometrial Cancer
The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
August 14, 2024
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2 min read
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Tristan Manalac
Illumina's signage at its headquarters in San Diego, California
Business
Illumina Lays Out Growth Roadmap After Grail Divestment
In a bid to win back investor confidence, Illumina on Tuesday unveiled a three-year growth plan focused on easier DNA sequencing and improved data analysis for customers.
August 14, 2024
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2 min read
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Tristan Manalac
Lilly's newly opened Seaport Center in Boston
Gene therapy
Lilly Opens $700M R&D Center in Boston for Genetic Medicines
Eli Lilly’s new research and development facility in Boston’s Seaport district will focus on DNA- and RNA-based therapies, as well as other priority areas such as diabetes and obesity.
August 14, 2024
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2 min read
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Tristan Manalac
Feet of a person with red-painted toenails as the person steps onto a weight scale.
Cardiovascular disease
Rivus Targets Weight-Loss Drug Market With Mid-Stage Win in Obesity-Related Heart Failure
Rivus Pharmaceuticals will push HU6 into Phase III development and is looking to engage with regulatory authorities and launch a late-stage study next year in obesity-related heart failure with preserved ejection fraction.
August 14, 2024
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2 min read
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Tristan Manalac
Skin lesions of prurigo nodularis, including
Immunology and inflammation
Galderma’s IL-31 Injection Wins FDA Approval for Skin Disorder Prurigo Nodularis
The Swiss company’s monoclonal antibody Nemluvio is also undergoing regulatory review for atopic dermatitis, which is a potentially larger market for the first-in-class IL-31 blocker.
August 13, 2024
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2 min read
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Tristan Manalac
External view of Novartis' office in Canada
Legal
Novartis Loses Court Case to Block Entresto Generics After FDA Denies Petition
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
August 13, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's logo on the facade of its building in Germany
Diabetes
Novo Refuses to Give Up on Insulin Icodec, Eyes Combo Filing With Semaglutide
By the end of the year, Novo Nordisk intends to make a regulatory filing for the combination of its icodec and semaglutide, keeping its once-weekly insulin program afloat.
August 13, 2024
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2 min read
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Tristan Manalac
Business partners shaking hands after closing a deal
Mergers & acquisitions
Crown Laboratories to Buy Botox Rival Revance Therapeutics for $924M
The acquisition announced Monday will give Crown access to Revance’s Daxxify, a competitor to AbbVie’s Botox, which is indicated for frown lines and for cervical dystonia.
August 13, 2024
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2 min read
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Tristan Manalac
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