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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.

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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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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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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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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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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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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Tristan Manalac
Signage at Pfizer's world headquarters in New York City
Business
Activist Investor Starboard Carves $1B Stake in Pfizer, Enlists Former CEO for Help
Pfizer in recent months has implemented aggressive cost-cutting measures to help it weather the steep decline in sales of its COVID-19 products.
October 8, 2024
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Tristan Manalac
Boy sitting in a wheelchair
Neurodegenerative disease
Scholar Rock’s Shares Soar 300% After Phase III Win in Spinal Muscular Atrophy
With Monday’s data from SAPPHIRE, Scholar Rock is building toward regulatory submissions for apitegromab in spinal muscular atrophy in the first quarter of 2025.
October 8, 2024
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Tristan Manalac
Facade of AstraZeneca's office in Shanghai, China
Cardiovascular disease
AstraZeneca Puts $2B On The Line for Preclinical Heart Disease Drug
For an exclusive license to the preclinical Lp(a) disruptor, AstraZeneca is paying CSPC Pharmaceutical Group $100 million upfront and offering up to $1.92 billion in regulatory and commercial milestones.
October 7, 2024
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Infectious disease
J&J Discontinues Phase II Dengue Study as it Retreats from Infectious Disease
J&J has recently pulled back from the infectious diseases space, including winding down R&D activity in this area in August 2023.
October 7, 2024
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Tristan Manalac
Man holds up his hand to signify a pause or stop
Regulatory
Kezar’s Lupus Trial Paused After Four Patient Deaths
The clinical hold doesn’t cover its drug’s Investigational New Drug application for autoimmune hepatitis, for which the Phase IIa PORTOLA trial is ongoing.
October 7, 2024
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2 min read
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Tristan Manalac
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