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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.

Pictured: CDC signage at its headquarters in Georg
Policy
CDC Advisory Panel Backs Valneva’s Chikungunya Vaccine for Certain Groups
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
February 29, 2024
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2 min read
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Tristan Manalac
Update: AbbVie headquarters building in California
Business
AbbVie Puts Potential $713M on the Line for OSE’s Inflammation Antibody
AbbVie continued its dealmaking spree Wednesday by partnering with OSE Immunotherapeutics to develop its early-stage, first-in-class antibody for chronic and severe inflammation.
February 28, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
Theratechnologies’ HIV Therapy Trogarzo Denied FDA Review
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
February 28, 2024
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2 min read
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Tristan Manalac
AstraZeneca's sign on its office in California
Business
AstraZeneca Returns to FibroGen the Rights to Roxadustat in US, Other Territories
More than two years after an FDA rejection, AstraZeneca has given back to FibroGen U.S. and rest-of-world rights to the HIF-PH inhibitor, though the companies will maintain their contract in China and South Korea.
February 28, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Ramps Up Manufacturing Inspections in India: Reuters
Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.
February 28, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor measures waistline of obese patie
Drug Development
Viking Scores Mid-Stage Win for Obesity Candidate, Eyes Lucrative Weight-Loss Market
Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
February 27, 2024
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2 min read
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Tristan Manalac
Facade of Novo Nordisk's office in Fremont, California
Business
Novo Inks Potential $1.46B Deal to Tap Neomorph’s Molecular Glue Platform
Under the collaboration and licensing agreement, Novo Nordisk and Neomorph are looking to discover, develop and commercialize novel molecular glue degraders for cardiometabolic and rare diseases.
February 27, 2024
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2 min read
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Tristan Manalac
Pictured: BioMarin headquarters in California/iSto
Policy
BioMarin Hit with DOJ Subpoena on Sponsored Testing for Rare Diseases
The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.
February 27, 2024
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2 min read
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
Policy
Merck’s Bridion Could Face Generic Pressure from Hikma Ahead of Patent Expiry Date
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
February 27, 2024
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2 min read
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Tristan Manalac
Pictured: Boehringer Ingelheim's office in California
Drug Development
Boehringer’s Obesity Candidate Survodutide Shows Strong Potential in MASH
Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.
February 26, 2024
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2 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Drug Development
Roche’s Asthma Drug Xolair Shows Promise Against Food Allergies on Heels of FDA Approval
Approved earlier this month for children and adults with one or more food allergies, Xolair in a Phase III study reduced severe allergic reactions in patients suffering from multiple food allergies.
February 26, 2024
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2 min read
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Tristan Manalac
Pictured: J&J's building in Switzerland
Policy
EU Panel Backs J&J, Legend’s Carvykti for Second-Line Multiple Myeloma
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
February 26, 2024
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
Alvotech, Teva End Rough Road for Humira Biosimilar with FDA Approval
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
February 26, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Policy
Sanofi, Regeneron Secure FDA Priority Review for Dupixent in COPD
The FDA’s target decision date is June 27, 2024, the companies announced Friday. Sanofi and Regeneron are looking to expand blockbuster Dupixent into chronic obstructive pulmonary disease.
February 23, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor showing a patient their lung scan
Business
Blueprint’s Cancer Drug Gavreto Finds New Home at Rigel after Roche Split
A year after Roche returned Gavreto’s global rights to Blueprint Medicines, Rigel Pharmaceuticals has acquired the U.S. rights to the FDA-approved treatment for non-small cell lung cancer.
February 23, 2024
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2 min read
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Tristan Manalac
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