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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.

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Immunology and inflammation
Amgen, Kyowa Kirin’s Rocatinlimab Picks Up Steam With Late-Stage Atopic Dermatitis Win
In September 2024, a readout from a separate trial of rocatinlimab elicited mixed reactions from analysts, who found the antibody’s efficacy in that study to be underwhelming.
March 10, 2025
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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: GSK, Alnylam, Sanofi and More
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
March 10, 2025
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7 min read
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Tristan Manalac
Pictured: AstraZeneca's manufacturing facility in
Stomach cancer
AstraZeneca Builds Stomach Cancer Case for Imfinzi With Strong Phase III Data
Imfinzi is one of AstraZeneca’s key growth drivers for 2025, with potential approvals in stomach and bladder cancers. The PD-L1 blocker brought in over $4.7 billion in sales last year.
March 7, 2025
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2 min read
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Tristan Manalac
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Regulatory
Biogen, Eisai’s Leqembi Suffers Overseas Setbacks as UK Denies Coverage, Australia Denies Approval
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
March 7, 2025
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2 min read
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Tristan Manalac
Marty Makary speaks on a panel at the New America Foundation
Government
Makary Shows Soft Support for FDA Vaccines Committee at Confirmation Hearing
Analysts at Jefferies see Makary as a positive for the rare disease space, given his support for accelerated approvals and openness to “customizing regulatory pathways for rare diseases.”
March 7, 2025
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Depression
J&J Axes Late-Stage Depression Trial After Underwhelming Efficacy
Analysts do not believe the Phase III stumble for aticaprant will derail J&J’s broader neuroscience strategy, particularly given its recent $14.6 billion acquisition of Intra-Cellular Therapeutics and the success of Spravato for treatment-resistant depression.
March 7, 2025
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2 min read
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Tristan Manalac
Hand holding a nasal spray bottle against a white background
Approvals
ARS Wins FDA Approval for Neffy Spray for Children in Anaphylaxis
Neffy 1 mg is the “first significant innovation” for epinephrine delivery in small children aged 4 years and up in over 35 years, according to ARS Pharmaceuticals.
March 6, 2025
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2 min read
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Tristan Manalac
Capitol in Washington
Government
Anxious Industry Awaits Makary’s Hearing Amid Disruptions, Layoffs at FDA
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
March 6, 2025
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2 min read
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Tristan Manalac
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Mergers & acquisitions
Jazz Expands Cancer Expertise With $935M Chimerix Buy
At the heart of the deal is the drug candidate dordaviprone, which is months away from a regulatory verdict for its use in H3 K27M-mutated diffuse glioma.
March 5, 2025
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2 min read
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Tristan Manalac
Sign outside BioNTech's building in Germany
Vaccines
FDA Pauses Study of BioNTech’s Malaria Shot as Problems for Vaccine Space Mount
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
March 5, 2025
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2 min read
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Tristan Manalac
Illustration of two hands, one thumbs up and one thumbs down
Mergers & acquisitions
Acelyrin Rejects Concentra’s Buyout Offer in Favor of Alumis Merger
Acelyrin and Alumis plan to close their merger in the second quarter of 2025, pending clearances and shareholder approval.
March 5, 2025
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2 min read
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Tristan Manalac
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Regulatory
Novo, Sanofi Hit With Anti-Competitive Probe in South Africa: Bloomberg
The last few years have been tough for the insulin market, with recent policies and high-level pressure forcing companies to lower drug prices.
March 5, 2025
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2 min read
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Tristan Manalac
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Drug pricing
10 Best-Selling Drugs of 2024 Rake in Billions Amid Exclusivity Threats
Merck’s Keytruda holds on to the top spot while AbbVie’s Humira—once the world’s top-selling drug—continues to cede its market share to biosimilar competitors.
March 5, 2025
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11 min read
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Tristan Manalac
Roche's tower in Shanghai, China
Approvals
Roche Continues Regulatory Run With Acute Stroke Expansion for Heart Attack Drug
TNKase is the first stroke drug to win FDA approval in nearly three decades.
March 4, 2025
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2 min read
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Tristan Manalac
Signage at Pfizer's world headquarters in New York City
Manufacturing
Pfizer Prepared to Reshore Manufacturing if Trump Makes Good on Tariff Threats
Last week, Eli Lilly also responded to the President’s tariff warnings by investing $27 billion to construct four manufacturing facilities across the U.S. in five years.
March 4, 2025
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2 min read
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Tristan Manalac
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