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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 headquarters in Indianapolis
Drug shortages
Lilly’s Tirzepatide Could Land Again on FDA Drug Shortage List, Opens Door for Compounders
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
October 14, 2024
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2 min read
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Tristan Manalac
Pictured: Pfizer office at its South San Francisco
Approvals
Pfizer Wins FDA Nod for Hemophilia Therapy Amid Activist Investor Challenge
The approval makes Pfizer’s Hympavzi the first once-weekly subcutaneous prophylactic injection for hemophilia B in the U.S., according to the company, which is currently embroiled in a row with activist investor Starboard Value.
October 14, 2024
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Amgen, Camurus, Iterum and Lexicon
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
October 14, 2024
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4 min read
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Tristan Manalac
Outside view of an empty meeting and a city view in the window beyond
Adcomms
Stealth Wins Adcomm’s Unexpected Support for Ultra-Rare Disease Drug Candidate
Despite substantial variability in the presented data and no well-controlled trial, the FDA advisory committee voted in favor of Stealth BioTherapeutics’ Barth syndrome therapy elamipretide, citing the urgent unmet need.
October 11, 2024
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2 min read
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Tristan Manalac
Roche's signage at its office in France
Approvals
Roche Wins First-Line Breast Cancer Nod for Oral PI3K Blocker, Projects $2.3B in Peak Sales
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.
October 11, 2024
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2 min read
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Tristan Manalac
Pictured: Teva Pharmaceuticals USA headquarters in
Legal
Teva to Pay $450M in Settlement With DOJ Over Kickback and Price-Fixing Allegations
The U.S. Department of Justice alleged that Teva violated the Anti-Kickback Statute and the False Claims Act. The payment is in addition to the criminal penalty paid by Teva USA under its deferred prosecution agreement.
October 11, 2024
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2 min read
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Tristan Manalac
Sanofi's Distribution Center in Quebec, Canada
Multiple sclerosis
Sanofi, Denali Abandon Mid-Stage Multiple Sclerosis Study on Disappointing Data
Oditrasertib, which blocks the inflammatory RIPK1 protein, earlier this year also failed a Phase II trial in amyotrophic lateral sclerosis, forcing the company to discontinue its development a few months later.
October 11, 2024
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2 min read
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Tristan Manalac
Sign in front of Pfizer in Quebec, Canada
Prostate cancer
Pfizer Phase III Prostate Cancer Win Builds Case for Broader Label for Talzenna-Xtandi Combo
The overall survival data from the late-stage trial will help Pfizer in its bid to expand the label for Talzenna and Xtandi, potentially covering all patients with metastatic castration-resistant prostate cancer regardless of biomarker status.
October 10, 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
7 Children Receiving Bluebird’s Gene Therapy Developed Blood Cancers: Study
The pediatric patients, with a rare neurodegenerative disease, were treated with bluebird bio’s Skysona to slow the progression of neurologic dysfunction. Six patients developed myelodysplastic syndrome and one patient developed acute myeloid leukemia.
October 10, 2024
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2 min read
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Tristan Manalac
GSK's headquarters office building in Poznan, Poland
Legal
GSK Settles Zantac Lawsuits for $2.2B, Analysts Now Shift Focus to Vaccines
The settlement, which is at the low end of Jefferies analysts’ $2 billion to $3.5 billion estimate, will resolve 93% of the product liability cases regarding allegations that GSK’s heartburn drug could cause cancer. Analysts say separate concerns remain about its vaccines business.
October 10, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Artificial intelligence
Lilly, Insitro Ink Unique AI Deal, Eye Novel Treatments for Metabolic Diseases
In a departure from most deals, startup insitro will in-license Lilly’s delivery technology for its investigational liver-targeted siRNA therapies. The pharma will be eligible for milestones and royalties down the line.
October 9, 2024
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2 min read
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Tristan Manalac
Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.
Adcomms
Stealth’s Ultrarare Disease Candidate Might Not Meet Bar for Approval: FDA
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
October 9, 2024
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2 min read
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Tristan Manalac
A closeup of a doctor taking a blood sample from a newborn's foot
Complete response letters
Zealand Hit With CRL for Ultrarare Genetic Disease Treatment
The rejection is related to the timing of the FDA’s reinspection of Zealand’s third-party manufacturer, which previously had deficiencies.
October 9, 2024
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2 min read
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Tristan Manalac
Pictured: 3D rendering of amyloid-beta oligomers
Alzheimer’s disease
Sage Suffers Third Neuro Stumble in Six Months With Disappointing Mid-Stage Alzheimer’s Readout
Sage has decided to discontinue the development of dalzanemdor in Alzheimer’s disease. A study of the candidate in Huntington’s is ongoing, with early data expected later this year.
October 8, 2024
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Patents
Novo, Viatris Settle Ozempic Patent Row
Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents.
October 8, 2024
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2 min read
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Tristan Manalac
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