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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.

3D illustration of tow GLP-1 therapy autoinjectors
Diabetes
GLP-1 Prescriptions for Type 1 Diabetes Spike Despite Lack of FDA Approval: Study
While the regulator has not approved their use in type 1 diabetes, off-label prescribing for GLP-1 receptor agonists has sharply increased, according to researchers, who warn about the risk of serious side effects such as ketoacidosis.
October 24, 2024
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2 min read
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Tristan Manalac
GLP-1 injector pens and pills against colorful background
Weight loss
Viking to Accelerate Development of Obesity Drug With Two Q4 Catalysts
Following an end-of-Phase II meeting with the FDA in the fourth quarter, Viking Therapeutics plans to push its subcutaneous obesity therapy VK2735 into late-stage development and to start a Phase II trial for an oral formulation.
October 24, 2024
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2 min read
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Tristan Manalac
CDC approved vaccines for adults to boost the immu
Vaccines
CDC Panel Recommends Merck and Pfizer Pneumococcal Vaccines for Adults Aged 50–64
The CDC’s Advisory Committee on Immunization Practices on Wednesday backed the use of Merck’s Capvaxive and Pfizer’s Prevnar 20 in adults between 50-64 years of age, opening a bigger market for the respective companies.
October 24, 2024
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2 min read
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Tristan Manalac
Roche's tower in Shanghai, China
Earnings
Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings’ Catalent Buyout
Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo.
October 23, 2024
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3 min read
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Tristan Manalac
Pictured: Pfizer's signage at its world headquarters in New York
RSV
Pfizer Wins FDA Approval of RSV Vaccine for Broader Adult Population
Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.
October 23, 2024
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Regulatory
Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
October 23, 2024
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2 min read
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Tristan Manalac
Sangamo's headquarters in Silicon Valley
Regulatory
Sangamo’s Fabry Gene Therapy Could Hit Market 3 Years Earlier With FDA Accelerated Approval Pathway
The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.
October 23, 2024
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Complete response letters
FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems
The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.
October 22, 2024
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Legal
Lilly Ups Legal Offensive Against Tirzepatide Copycats as FDA Mulls Shortage Status
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
October 22, 2024
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2 min read
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Tristan Manalac
An empty conference room overlooking a city
Business
Activist Investor Starboard Takes Aim at J&J Spinoff Kenvue on Heels of $1B Stake in Pfizer
Starboard Value contends that Kenvue, with strong consumer health brands like Tylenol and Listerine, is underperforming its rivals, according to The Wall Street Journal.
October 22, 2024
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2 min read
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Tristan Manalac
A team of research scientists in protective equipment working in a lab
Manufacturing
Radiopharma-Focused CDMO Nucleus Unveils Two New Plants, Looks to Create 100 Jobs
Nucleus RadioPharma’s two sites are meant to help address the industry’s lack of manufacturing and development capabilities, as well as geographic limitations associated with the short half-life of many radioactive components.
October 22, 2024
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2 min read
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Pain
Vertex Unveils Full Phase III Data for Non-Opioid Pain Candidate, Touts Safety Profile
BMO Capital Markets analyst Evan Seigerman in a note to investors said the late-stage data for Vertex’s experimental non-opioid pain medication “reaffirms our confidence in the strength of suzetrigine’s profile.” However, William Blair analysts view these data as “an incremental positive” as the company faces challenges in targeting the acute pain market.
October 21, 2024
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3 min read
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Tristan Manalac
Pictured: Novartis' logo outside its building in S
Drug pricing
NJ Court Tosses Novartis’ Lawsuit Against Drug Negotiation Program in Latest Setback for Big Pharma
With Friday’s ruling by New Jersey District Judge Zahid Quraishi, Novartis joins a growing list of pharmaceutical companies that have failed in their legal challenges to the Inflation Reduction Act.
October 21, 2024
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2 min read
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Tristan Manalac
Pictured: Astellas' Americas headquarters in Illin
Approvals
Astellas’ First-in-Class, Claudin-Targeted Therapy Wins FDA Nod for Certain Gastric Cancers
The regulator’s approval on Friday of Vyloy for gastric or gastroesophageal junction cancer makes it the first and only claudin 18.2–targeted therapy approved in the U.S. for these indications, according to Astellas.
October 21, 2024
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2 min read
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Tristan Manalac
Pictured: Wall sign of the Novo Nordisk Foundation and Novo Holdings in Denmark
Mergers & acquisitions
Unions, Public Interest Groups Call on FTC to Challenge Novo Holdings-Catalent Acquisition
Pressure has been mounting for the Federal Trade Commission to take action, with Senator Elizabeth Warren last week urging FTC Chair Lina Khan to block the merger if it violates antitrust laws.
October 18, 2024
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2 min read
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Tristan Manalac
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