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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: Healthcare working holding an injection/
FDA
Lupin Launches Generic Thiamine Hydrochloride Injection in US
Following the FDA’s approval in March, India-based Lupin is launching its generic thiamine hydrochloride injection USP in the U.S. for treating vitamin B1 deficiency.
June 20, 2023
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2 min read
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Tristan Manalac
Pictured: Chinese flags in a row/iStock
Business
AstraZeneca Mulls China Unit Spin-Off Amid Rising Tensions
As geopolitical tensions rise in the region, AstraZeneca is looking at potentially spinning off its China unit into its own independent business.
June 20, 2023
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2 min read
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Tristan Manalac
Pictured: Healthcare worker examining a hand X-ray
Drug Development
BioSenic Puts Fracture Cell Therapy Program on Hold After Mid-Stage Failure
Following disappointing Phase IIb results, BioSenic is pausing the development of its tibial fracture cell therapy ALLOB derived from mesenchymal stem cells.
June 19, 2023
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2 min read
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Tristan Manalac
Pictured: Eli Lilly Campus in San Diego
Drug Development
Lilly’s Migraine Drug Emgality Fails to Outperform Pfizer’s Nurtec
In the first head-to-head trial of CGRP antagonists, Lilly’s Emgality failed to demonstrate that it was significantly better than Pfizer’s Nurtec ODT at easing migraine headaches.
June 19, 2023
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2 min read
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Tristan Manalac
Pictured: Bristol Myers Squibb office in California
Policy
BMS Follows Merck’s Lead, Sues Government Over Drug Pricing Negotiation
On the heels of a legal challenge to the Inflation Reduction Act by Merck, Bristol Myers Squibb on Friday filed its own lawsuit claiming that the law’s drug price negotiation provision is unconstitutional.
June 19, 2023
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2 min read
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Tristan Manalac
Clene President and CEO Rob Etherington/Courtesy C
Drug Development
Clene Reports Promising NfL Biomarker Data for ALS Hopeful
In the latest HEALEY trial readout, Clene’s CNM-Au8 significantly reduced plasma neurofilament light chain levels in ALS patients, which could be a strong and reliable signal of its clinical benefit.
June 16, 2023
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2 min read
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Tristan Manalac
Pictured: Syringe pulling vaccine from a vial / Ad
Policy
After Adcomm’s Vaccine Recommendation, Can Novavax Make a Covid Comeback?
In a unanimous 21-0 vote, an FDA advisory committee recommended an updated monovalent formulation of the COVID-19 vaccine targeting the now-dominant XBB.1.5 subvariant.
June 16, 2023
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2 min read
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Tristan Manalac
FDA Headquarters_Grandbrothers/Adobe Stock
Policy
FDA Action Alert: Argenx, Aldeyra, Intercept and Sarepta
The FDA has four target action dates this week, including ones for Argenx’s subcutaneous efgartigimod in generalized myasthenia gravis and Sarepta’s gene therapy for Duchenne muscular dystrophy.
June 15, 2023
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5 min read
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Tristan Manalac
Pictured: Front of FDA headquarters/Grandbrothers/
Drug Development
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold
Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.
June 15, 2023
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2 min read
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Tristan Manalac
Pictured: Merck building and sign in Silicon Valley
Policy
Merck Secures Bridion Patent Protection Through January 2026
The company won a patent ruling from a New Jersey court, which extends protections from generic competition for its muscle relaxant reversal drug Bridion.
June 15, 2023
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2 min read
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Tristan Manalac
Pictured: Blue and white Pfizer sign on building/c
Policy
Texas Orders Pfizer to Turn Over Meta Advertising Records
In a subpoena filed Monday, the state of Texas asked Pfizer to turn over all communications with Meta regarding the tech company’s advertising practices.
June 15, 2023
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2 min read
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Tristan Manalac
PictureDesignSwiss / Shutterstock
Business
Biogen Teams with NeuroSense to Explore ALS Neurofilament Biomarker
The biotech company is collaborating with Israel’s NeuroSense to study how the latter’s amyotrophic lateral sclerosis candidate affects plasma neurofilament levels in patients.
June 14, 2023
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2 min read
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Tristan Manalac
Pictured: A sign with the Merck logo surrounded by
Drug Development
Merck Gets FDA Fast Track for Efinopegdutide, Previews NASH Data Versus Novo’s Semaglutide
The company teased data for efinopegdutide, a GLP-1/glucagon receptor co-agonist, in nonalcoholic steatohepatitis compared to Novo Nordisk’s semaglutide, which is not yet approved for NASH.
June 14, 2023
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2 min read
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Tristan Manalac
Pictured: Syringe pulling vaccine from a vial / Ad
Drug Development
Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race
Valneva’s chikungunya vaccine candidate VLA1553 showed that the shot safely and rapidly induced high rates of seroprotection. Merck earlier in 2023 discontinued its chikungunya program.
June 13, 2023
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2 min read
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Tristan Manalac
Pictured: J&J sign/Cristina Arias/Getty Images
Policy
J&J Settles Stelara Issue with Teva, Alvotech
Following a May 2023 settlement with Amgen, J&J has also signed an agreement with Teva and Alvotech, allowing their Stelara biosimilar to enter the U.S. no later than February 21, 2025.
June 13, 2023
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2 min read
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Tristan Manalac
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