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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.

Photo of a GLP-1 injector pen on a blue background
GLP-1
Viking Takes Obesity Candidate into Phase III to Rival Lilly, Novo
With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday.
July 25, 2024
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2 min read
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Tristan Manalac
External view of Novartis' office in Massachusetts
Collaboration
Novartis, Dren Bio Ink Potential $3B Deal for Anti-Myeloid Bispecific Antibodies for Cancer
Novartis continues its dealmaking spree with a bet on Dren Bio’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies in oncology.
July 25, 2024
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2 min read
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Tristan Manalac
FDA sign outside its office in Maryland
Regulatory
FDA Issues Final Guidance for Using Real-World Data in Drug Applications
The regulator on Wednesday provided recommendations to drugmakers for assessing the use of electronic health records and medical claims data to support their applications.
July 25, 2024
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2 min read
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Tristan Manalac
Hand shaking while holding a glass
Clinical research
Biogen, Sage Scrap Essential Tremor Study After Phase II Failure
Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday.
July 24, 2024
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2 min read
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Tristan Manalac
External view of AstraZeneca's headquarters building in Silicon Valley
Adcomms
FDA Flags Potential ‘Overtreatment’ for NSCLC With AstraZeneca’s Imfinzi Ahead of Adcomm
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
July 24, 2024
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Tristan Manalac
External view of the U.S. Capitol Building
Pharmacy benefit managers
PBM Execs Point Fingers at Pharma Industry in House Hearing on Rising Drug Prices
Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges.
July 24, 2024
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Tristan Manalac
A 3D illustration of an antibody binding to human cell receptors
Series A
J&J Alums Raise $165M Series A for Startup to Develop Biologics for Cancer, Autoimmune Diseases
Third Arc Bio, led by three former Johnson & Johnson executives, is advancing a portfolio of multifunctional antibodies for cancer and inflammatory and immune-mediated diseases.
July 24, 2024
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Tristan Manalac
Merck Research Laboratories in South San Francisco, California
RSV
Merck Challenges AstraZeneca, Sanofi With Phase IIb/III Data for RSV Antibody
Merck’s clesrovimab lowered the risk of medically attended lower respiratory infections associated with RSV infection when used in infants, according to topline results announced Tuesday.
July 23, 2024
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Tristan Manalac
Agilent's signage at its office in California
Mergers & acquisitions
Agilent Pays $925M to Buy CDMO Biovectra to Boost Biologics, CRISPR Capabilities
The acquisition of the contract development and manufacturing organization will allow Agilent Technologies to provide a one-stop source for gene-editing services for its customers.
July 23, 2024
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2 min read
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Tristan Manalac
External view of the U.S. Securities and Exchange Commission in Washington, DC
Regulatory
SEC Hits Allarity With Wells Notice, Flags Alleged Violations in FDA Meeting
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
July 23, 2024
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Tristan Manalac
Entrance to the U.S. Department of Health and Human Services in Washington, DC
Gene therapy
HHS Issues Negative Opinion on Bluebird’s Fertility Support Program for Gene Therapies
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
July 23, 2024
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Tristan Manalac
Photo of a GLP-1 injector pen on a blue background
Diabetes
Innovent’s Lilly-Partnered Type 2 Diabetes Drug Aces Phase III in China, Inches Closer to Approval
Innovent Biologics’ dual GLP-1/glucagon receptor agonist mazdutide is also being developed for chronic weight management. China’s regulator accepted Innovent’s drug application for this indication in February 2024.
July 22, 2024
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Tristan Manalac
Eli Lilly's headquarters in Indianapolis
Regulatory
Lilly Wins Chinese Approval for Tirzepatide in Obesity on Heels of Novo’s Semaglutide
Eli Lilly’s tirzepatide, which has previously been approved in China for diabetes, can now also be used for chronic weight management in the world’s second most populated country.
July 22, 2024
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Tristan Manalac
GSK's office in Dresden, Germany
Regulatory
GSK Plots Blenrep’s Path Back to Market With EU Filing
GSK is seeking to relaunch Blenrep after its market withdrawal in 2022. The pharma is eyeing a second-line niche for the antibody-drug conjugate in the treatment of relapsed or refractory multiple myeloma.
July 22, 2024
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Tristan Manalac
Doctor in rubber gloves examining rashes a child's legs
Infectious disease
SIGA, US Government Ink $113M Procurement Deal for Smallpox, Mpox Drug
Oral doses of SIGA Technologies’ antiviral drug Tpoxx will help the U.S. maintain its reserves of the vaccine in preparation for future potential outbreaks, according to the company.
July 22, 2024
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1 min read
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Tristan Manalac
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