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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.

A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Biofrontera, BMS and Zealand
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.
September 30, 2024
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4 min read
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Tristan Manalac
AbbVie's office in South San Francisco, California
Parkinson’s disease
AbbVie’s $8.7B Cerevel Buy Starts to Pay off With Phase III Parkinson’s Win
Results from TEMPO-1, which showed that tavapadon significantly improved motor symptoms in patients with Parkinson’s disease, will help AbbVie as it builds a regulatory case for the D1/D5 dopamine receptor agonist.
September 27, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Securities and Exchange Commission in Washington, DC
Alzheimer’s disease
Cassava Agrees to Pay $40M Fine to Resolve SEC Probe as Company Hit With New Lawsuit
Despite the settlement, the Securities and Exchange Commission on Thursday sued Cassava Sciences in the Western District Court of Texas, claiming that the company misled investors regarding the Phase IIb performance of its Alzheimer’s disease drug candidate.
September 27, 2024
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2 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Immunology and inflammation
Roche Looks to Push Gazyva Into Lupus Nephritis With Promising Late-Stage Data
In the Phase III REGENCY study, Gazyva elicited superior complete renal response rates in patients with lupus nephritis versus placebo, positioning Roche’s therapeutic antibody for expansion into the indication.
September 27, 2024
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2 min read
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Tristan Manalac
Corporate headquarters of Novo Nordisk in Denmark
Collaboration
Novo, Evotec Ink Stem Cell Partnership as Drugmaker Looks to Expand Pipeline
While the companies did not reveal the financial details of the deal, Novo Nordisk will provide funding for two Evotec sites in Germany and Italy to support the development of next-generation cell therapies.
September 26, 2024
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2 min read
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Tristan Manalac
Sign in front of Pfizer in Quebec, Canada
Sickle cell disease
Pfizer Takes Sickle Cell Drug Oxbryta Off Global Market, Cites Risk of Death
Based on new safety signals, Pfizer on Wednesday announced that Oxbryta’s overall benefit “no longer outweighs the risk” in patients with sickle cell disease. Guggenheim Securities analysts said the setback increases investor frustrations with the company’s business development track record.
September 26, 2024
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Drug Development
Novo’s Ozempic Potentially Linked to Lower Opioid Overdose Risk in Diabetics
A retrospective cohort study of more than 33,000 patients with type 2 diabetes showed that Novo Nordisk’s GLP-1 may lower the risk of opioid overdose by 42% to up to 68%.
September 26, 2024
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2 min read
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Tristan Manalac
3D illustration of neurons
Multiple sclerosis
Study Casts Doubt on Benefit of Anti-CD20 Therapies in Multiple Sclerosis
New research has found that MS patients treated with anti-CD20 antibodies, such as Roche’s Ocrevus, do not experience significantly slower progression of disability.
September 26, 2024
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2 min read
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Tristan Manalac
Pictured: Merck building and sign in Silicon Valley
Cancer
Merck’s Keytruda Combo Fails in Phase III Colorectal Cancer Study
Merck follows in the footsteps of Bristol Myers Squibb, which in December 2023 also failed to secure a late-stage victory for its combo regimen of a PD-1 blocker and an anti-LAG-3 antibody.
September 25, 2024
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2 min read
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Tristan Manalac
Pictured: Amgen's office in Tampa, Florida
Phase III
Amgen Scores Late-Stage Wins in Eczema and Myasthenia Gravis, But Analysts See Mixed Results
Jefferies analyst Michael Yee in a note to investors called rocatinlimab’s atopic dermatitis data “modest,” noting that the OX40 receptor blocker “came in at the lower end of efficacy and expectations,” but found Uplizna’s performance in generalized myasthenia gravis “better than expected.”
September 25, 2024
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2 min read
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Tristan Manalac
3D illustration of a stomach tumor
Regulatory
FDA Considers Narrowing Label of PD-1 Drugs in Stomach Cancer Ahead of Adcomm Meeting
If approved, the potential restrictions would impact Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, which are marketed for the first-line treatment of several types of stomach cancer regardless of PD-L1 expression.
September 25, 2024
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Approvals
IntraBio Wins FDA Nod for Ultra-Rare Neurodegenerative Disease on Heels of Competitor’s Approval
IntraBio’s Aqneursa is the second drug within a week approved by the regulator for treating Niemann-Pick disease type C, just days behind Zevra Therapeutics’ Miplyffa.
September 25, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Capitol building at sunset
Drug pricing
Amgen, Lilly Are Part of Ongoing Senate Probe Into Pharma’s Restrictions on 340B Program
A senior senator has asked the CEOs of both companies to provide information about the limits they are putting on 340B drug pricing for hospitals.
September 24, 2024
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2 min read
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Tristan Manalac
Pictured: Boy in a wheelchair looking out the window
Neurodegenerative disease
Biohaven Sets Stage for Comeback With Pivotal Study Results in Spinocerebellar Ataxia
The FDA previously refused to review Biohaven’s candidate in the indication due to a failed late-stage trial. However, the company is now planning to file an NDA in the fourth quarter of 2024.
September 24, 2024
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2 min read
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Legal
Amgen Gets Legal Win in Eylea Patent Row With Regeneron
Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
September 24, 2024
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2 min read
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Tristan Manalac
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