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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.

FDA signage at its office in Maryland
FDA
Vanda Gets FDA Approval for Fanapt Antipsychotic, Expands into Bipolar Disorder
After sustaining a regulatory defeat in insomnia, Vanda Pharmaceuticals on Tuesday won the FDA’s approval for its atypical antipsychotic Fanapt for the treatment of manic or mixed episodes in adults with bipolar I disorder.
April 3, 2024
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2 min read
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Tristan Manalac
Pictured: Businessmen shaking hands after closing a deal
Deals
Genmab Leans into Hot ADC Space with $1.8B ProfoundBio Acquisition
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
April 3, 2024
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2 min read
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Tristan Manalac
Pictured: Healthcare worker holding up a vial for an LDL-C test
Drug Development
Verve Halts Trial for Lead Gene Editing Program Due to Safety Concerns
Verve Therapeutics is pausing enrollment in the Phase Ib Heart-1 study for its gene editor VERVE-101 after a patient developed grade 3 laboratory abnormalities, the company announced Tuesday.
April 2, 2024
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2 min read
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Drug Development
Vertex Pushes Oral Drug into Phase III Kidney Disease Trial, Eyes Accelerated Approval
Following promising Phase IIa data, Vertex Pharmaceuticals will now evaluate its oral drug candidate inaxaplin in a late-stage study of APOL-1 mediated kidney disease.
April 2, 2024
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2 min read
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Tristan Manalac
Pictured: A U.S. federal bankruptcy courthouse building
Deals
Eiger Files for Bankruptcy, Plans to Shutter Operations After Difficult Year
Following a series of rejections and clinical failures, Eiger BioPharmaceuticals has declared bankruptcy and will sell all its assets as the company winds down operations.
April 2, 2024
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2 min read
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Tristan Manalac
Pictured: Sign above the entrance to a U.S. courthouse
Policy
Teva, Viatris Again Challenge J&J Patent for Schizophrenia Drug with Appeals Court Win
A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna.
April 2, 2024
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2 min read
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Tristan Manalac
Pictured: Magnetic resonance imaging scans of the brain
Policy
Biogen and Eisai Fall Behind on Leqembi’s Subcutaneous BLA for Alzheimer’s
The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
April 1, 2024
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2 min read
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Tristan Manalac
Pictured: Man prepares his GLP-1 receptor agonist injection
Policy
Lack of Medicare Coverage for GLP-1 Drugs Tied to Lower Prescription Rates: Study
Despite strong demand for weight-loss drugs, the lack of Medicare coverage is potentially interfering with prescription and dispensing rates of anti-obesity medications for elderly adults, according to a new study.
April 1, 2024
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2 min read
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Tristan Manalac
Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto
Drug Development
BMS Pulls Ahead of Amgen, Aces Confirmatory Phase III NSCLC Trial for Krazati
Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.
April 1, 2024
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2 min read
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Tristan Manalac
Pictured: A close-up of the U.S. Capitol dome/iSto
Policy
WuXi AppTec Shared Client IP with Beijing, Say US Intelligence Officials: Reuters
U.S. intelligence officials have informed senators that China-based biotech WuXi AppTec transferred an American client’s intellectual property to the Chinese government without consent, reports Reuters.
March 29, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Extends Review Period for Applied Therapeutics’ Govorestat by Three Months
Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
March 29, 2024
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2 min read
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Tristan Manalac
Pictured: Gilead's headquarters in Silicon Valley/
FDA
Gilead Wins Label Expansion for Vemlidy to Treat Hepatitis B Virus in Kids
Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
March 29, 2024
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2 min read
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Tristan Manalac
Pictured: Bristol Myers Squibb in NJ/iStock, arlut
Drug Development
BMS’ Zeposia Fails to Meet Primary Endpoint in Phase III Crohn’s Trial
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
March 29, 2024
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2 min read
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Tristan Manalac
Pictured: A scientist with pill bottles in front o
Policy
FDA Action Alert: Vanda, Basilea and J&J/Legend
April kicks off with three FDA target action dates, including one that could potentially set the stage to move CAR-T therapies into earlier lines of treatment.
March 28, 2024
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4 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
Akebia’s CKD Anemia Drug Ends Tough Regulatory Path with FDA Approval
After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
March 28, 2024
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2 min read
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Tristan Manalac
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