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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: Roche Diagnostics building in California
Policy
Roche Claims Another Legal Victory Over Takeda in Hemophilia Patent Case
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
September 22, 2023
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2 min read
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Tristan Manalac
Pictured: People in suits with their thumbs down/i
Policy
Intarcia’s Diabetes Drug-Device Implant Unanimously Rejected by Adcomm
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
September 22, 2023
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2 min read
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Tristan Manalac
Pictured: A yellow line pointing the way out of a
Policy
Mesoblast Sees Path Forward for Twice-Rejected Cell Therapy After FDA Meeting
Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.
September 21, 2023
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2 min read
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Tristan Manalac
Pictured: Capsules in a production line at a pharm
Civica Rx’s Unique Business Model Improves Drug Supply Security, Cuts Costs: Study
A new study provides the first empirical evidence that the not-for-profit manufacturer’s business model can lead to robust drug supplies and lower medicine costs.
September 21, 2023
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
Policy
Third Time Might Be a Charm for Alvotech as FDA Accepts BLA for Humira Biosimilar
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
September 21, 2023
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
FDA Rejects ARS’ Epinephrine Nasal Spray Despite Adcomm Support
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
September 20, 2023
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2 min read
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Tristan Manalac
Pictured: Closed sign being flipped over/iStock, S
Business
Fresh Tracks, Histogen to Shutter Businesses in Absence of Viable Options
The companies have announced the impending closures of their respective businesses. Histogen will lay off most of its employees by the end of September. Fresh Tracks will do so by early October.
September 20, 2023
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2 min read
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Tristan Manalac
3D illustration of an RNA molecule
ReCode Raises $260M in Series B Financing to Advance Lead Programs
Bringing in an additional $50 million in a Series B extension, ReCode Therapeutics’ total haul for the funding round totaled $260 million, which it will use to further its experimental mRNA therapies.
September 20, 2023
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2 min read
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Tristan Manalac
External view of Novartis' office in Canada
Business
Novartis Returns Cancer Asset Tislelizumab to BeiGene
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
September 19, 2023
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2 min read
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Tristan Manalac
Pictured: Gene therapy illustration showing an inj
Policy
FDA Accepts Orchard’s BLA for Rare Disease Gene Therapy Behind EU Approval
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.
September 19, 2023
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2 min read
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Tristan Manalac
Pictured: Blue Sanofi sign on building in Germany at night
Business
Sanofi Sells 11 CNS Assets to Pharmanovia including Frisium and Gardenal
The French pharma company continues to pare down its central nervous system business by divesting 11 brands to U.K.-based Pharmanovia, which is expanding its neurology portfolio.
September 19, 2023
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2 min read
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Tristan Manalac
Pictured: Illustration of a blood clot in a blood
Drug Development
Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy
After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: U.S. Chamber of Commerce/Courtesy of Ado
Policy
DOJ, Chamber of Commerce Tussle in Court Over IRA’s Drug Price Negotiations
The legal battle over the Inflation Reduction Act’s price negotiation program moved to federal court in Ohio with the Department of Justice and U.S. Chamber of Commerce sparring about the law.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: GSK's office in Poznan, Poland/iStock, W
FDA
FDA Approves GSK’s Momelotinib for Myelofibrosis Patients with Anemia
Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continued its oncology winning streak with an FDA approval for momelotinib in adult myelofibrosis patients with anemia.
September 18, 2023
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2 min read
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Tristan Manalac
Pictured: Exterior of an FDA building
FDA
FDA Action Alert: ARS Pharma, Appili, Ocuphire and BrainStorm
The FDA will finish September with three action dates and one of the year’s most highly-anticipated advisory committee meetings.
September 15, 2023
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5 min read
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Tristan Manalac
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