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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: Analyst pointing to stock chart / iStock
Business
Bluebird Pins Hopes on Zynteglo Uptake, FDA Verdict Amid Cash Constraints
The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.
August 9, 2023
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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 Wegovy Protects Heart Health in Overweight, Obese Adults
Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
August 8, 2023
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2 min read
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Tristan Manalac
Pictured: Man feeling anxious while in a group/iSt
Drug Development
VistaGen Stock Soars 1,000% After Phase III Social Anxiety Win
Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
August 8, 2023
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2 min read
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Tristan Manalac
Pictured: Sign at FibroGen's headquarters in Calif
Business
FibroGen Looks to Regroup After Rocky Q2 Results, Ongoing Challenges
Following a handful of clinical failures and changes to its leadership, FibroGen is trying to chart a more positive path forward by focusing on four strategic areas.
August 8, 2023
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3 min read
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Tristan Manalac
Pictured: Astellas' Americas headquarters in Illin
FDA
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas
Friday, Iveric Bio scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.
August 7, 2023
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Policy
EU Pulls Authorization of Novartis’ Sickle Cell Disease Drug
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
August 7, 2023
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2 min read
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Tristan Manalac
Pictured: Rejected stamp/iStock, Pavel Muravev
Policy
FDA Blocks Mesoblast Cell Therapy Again, Asks for More Data
For the second time, the regulator has blocked Mesoblast’s attempt to have remestemcel-L approved for pediatric steroid-refractory acute graft versus host disease, citing the need for adult data.
August 4, 2023
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2 min read
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Tristan Manalac
Pictured: CDC signage at its headquarters in Georg
Policy
AstraZeneca, Sanofi Win CDC Support for Preventive RSV Antibody for Infants
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
August 4, 2023
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2 min read
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Tristan Manalac
Amgen sign at its headquarters in Thousand Oaks, California, USA.
Drug Development
Amgen Clinches Clinical Wins in SCLC and Colorectal Cancer
The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.
August 4, 2023
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2 min read
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Tristan Manalac
Pictured: Financial graph overlaid on stacks of co
Business
Regeneron Eyes Earlier FDA Decision on Higher-Dose Eylea
During Regeneron’s second-quarter earnings call Thursday, the company said that the regulator could make its decision on 8-mg Eylea in the third quarter—much earlier than market expectations.
August 3, 2023
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3 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
FDA Clears Taiho’s Lonsurf in Metastatic Colorectal Cancer Ahead of Takeda, Hutchmed
The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
August 3, 2023
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2 min read
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Tristan Manalac
Pictured: Entrance to the U.S. Department of Healt
Policy
IRA’s Drug Price Negotiation Program Could Save Medicare $1.8B in First Year
Savings from just four of 10 drugs covered by the Inflation Reduction Act’s Drug Negotiation Program could reach $1.8 billion during the first year of implementation, according to research.
August 3, 2023
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2 min read
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Tristan Manalac
FDA sign outside its office in Maryland
Policy
Cancer Drug Manufacturer Intas Slapped with FDA Warning Letter
Following reports of destroyed and discarded data, the U.S. regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice.
August 2, 2023
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2 min read
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Deals
Revolution to Buy EQRx in All-Stock Deal, Add $1B in Cash to Balance Sheet
Following difficult recent months for EQRx, the biotech is being bought by Revolution Medicines in an all-stock transaction that secures $1 billion in additional capital for the oncology company.
August 1, 2023
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2 min read
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Tristan Manalac
Pictured: Quest Diagnostics headquarters in New Je
Drug Development
Quest Launches Alzheimer’s Beta-Amyloid Blood Test for Consumers
Amid a re-energized Alzheimer’s disease space, Quest Diagnostics offers what the company contends is the first direct-to-consumer blood-based biomarker test to assess disease risk.
August 1, 2023
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2 min read
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Tristan Manalac
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