SUBSCRIBE
SUBSCRIBE
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.

US Capitol_Andrea Izzotti_Adobe Stock
Policy
US Senate Kicks Off Fresh Round of Drug Pricing Control Legislation
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
April 26, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Novartis/Courtesy of Adobe Stock, Yingko
Business
Novartis Culls 10% of Pipeline, Doubles Down on Five Core Therapeutic Areas
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
April 26, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: A pile of $100 bills/ElenaR/Adobe Stock
Drug Development
Vedanta Raises $106.5M to Advance New Class of C. diff Therapeutics
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
April 25, 2023
 · 
3 min read
 · 
Tristan Manalac
FDA/Courtesy: Grandbrothers, Adobe Stock
Drug Development
Applied Therapeutics Seeks NDA for Rare Pediatric Disease Drug Despite Phase III Failure
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
April 25, 2023
 · 
3 min read
 · 
Tristan Manalac
Al Drago/CQ Roll Call
Drug Development
FDA Presses Pause on Another Foghorn Program
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
April 25, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: FDA Headquarters/Courtesy of Grandbrothe
FDA
FDA Delays Verdict for Daiichi Sankyo’s Quizartinib
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
April 24, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Graphic showing two people facing each o
Policy
Supreme Court Maintains Mifepristone Access
Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process.
April 24, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Red and black graphic that reads "FDA Ac
FDA
FDA Action Alert: Biogen/Ionis, Seres, Otsuka/Lundbeck and More
This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
April 21, 2023
 · 
5 min read
 · 
Tristan Manalac
Aerial view of Skyscrapers_courtesy of Getty Image
Business
Abdera Debuts with $142M to Develop Precision Radiopharmaceuticals
Abdera Therapeutics will use the money to fund its ROVEr platform and advance its lead asset ABD-147 for small-cell lung cancer.
April 20, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Genentech Headquarters/iStock, Sundry Ph
FDA
FDA Greenlights Roche’s Polivy in First-Line DLBCL
Polivy is approved for front-line DLBCL as part of a combination regimen including Rituxan, cyclophosphamide, doxorubicin and prednisone.
April 20, 2023
 · 
3 min read
 · 
Tristan Manalac
Courtesy of Michael Vi/Getty Images
Drug Development
Data Leak Shows J&J and Legend’s Carvykti Exceeds Expectations
The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens.
April 19, 2023
 · 
2 min read
 · 
Tristan Manalac
AbbVie_© AbbVie Inc. All rights reserved.
FDA
AbbVie Wins FDA Approval for New Migraine Indication
Qulipta’s label expansion makes it the first oral CGRP receptor antagonist approved for episodic and chronic migraine.
April 19, 2023
 · 
2 min read
 · 
Tristan Manalac
Leon Neal/Getty Images
Business
GSK Makes $2B Play to Challenge Merck in Chronic Cough Market
The acquisition of Bellus Health will give GSK access to camlipixant, a potentially best-in-class P2X3 antagonist for chronic cough.
April 18, 2023
 · 
3 min read
 · 
Tristan Manalac
Pictured: Exterior view of the headquarters of the
FDA
Gamida’s Long Regulatory Road Ends in Approval of Blood Cancer Cell Therapy
Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.
April 18, 2023
 · 
2 min read
 · 
Tristan Manalac
Pictured: Pneumonia patient on a ventilator/Courte
Drug Development
FDA Adcomm Backs Innoviva’s Pneumonia Antibiotic
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
April 18, 2023
 · 
2 min read
 · 
Tristan Manalac
Load More