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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.

FDA Headquarters_Grandbrothers/Adobe Stock
FDA
FDA Panel Supports Narrow Lynparza Label for Prostate Cancer
The Oncologic Drugs Advisory Committee voted 11–1 supporting Merck’s and AstraZeneca’s PARP inhibitor for metastatic castration-resistant prostate cancer patients with BRCA mutations.
May 1, 2023
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3 min read
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Tristan Manalac
Pictured: Lundbeck sign on a building_Longfin Medi
FDA
FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder
Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
May 1, 2023
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2 min read
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Tristan Manalac
Pictured: Blue and white Pfizer sign on building/T
FDA
FDA Greenlights Pfizer’s Pneumococcal Vaccine in Infants and Children
Prevnar 20 is indicated for the prevention of invasive pneumococcal disease and otitis media in children.
April 28, 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 Mounjaro Poised to Challenge Novo’s Wegovy in Obesity
In the Phase III SURMOUNT-2 study, Mounjaro reduced body weight by 29.8 lbs. on average in adult type 2 diabetes patients who were overweight or obese.
April 28, 2023
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2 min read
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Tristan Manalac
Courtesy Jeremy Moeller/Getty Images
Business
Caforio Out, Boerner In as BMS Sees Slight Decline with Generic Competition
The leadership shuffle comes as BMS is facing one of the steepest patent cliffs in biopharma, with exclusivity of three of its top drugs lapsing this decade.
April 27, 2023
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2 min read
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Tristan Manalac
FDA
Seres’ Vowst Wins FDA First-Ever Approval for Oral Microbiome Therapeutic
Vowst, the first-ever oral fecal microbiome-based therapeutic, is indicated for preventing C. diff recurrence in adults following antibacterial treatment.
April 27, 2023
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2 min read
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Tristan Manalac
Pictured: Front of FDA headquarters/Grandbrothers/
Drug Development
FDA Questions Efficacy of Merck-AstraZeneca’s Lynparza Ahead of Adcomm
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
April 27, 2023
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2 min read
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Tristan Manalac
Pictured: Close up of $100 bills/Nomad_Soul/Adobe
Business
Beam Spin-Out Orbital Therapeutics Raises $270M to Advance RNA Portfolio
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
April 26, 2023
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2 min read
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Tristan Manalac
US Capitol_Andrea Izzotti_Adobe Stock
Policy
US Senate Kicks Off Fresh Round of Drug Pricing Control Legislation
The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022.
April 26, 2023
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2 min read
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Tristan Manalac
Pictured: Novartis/Courtesy of Adobe Stock, Yingko
Business
Novartis Culls 10% of Pipeline, Doubles Down on Five Core Therapeutic Areas
Novartis is scaling back its pipeline to focus on higher-value assets with stronger commercial potential.
April 26, 2023
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2 min read
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Tristan Manalac
Pictured: A pile of $100 bills/ElenaR/Adobe Stock
Drug Development
Vedanta Raises $106.5M to Advance New Class of C. diff Therapeutics
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
April 25, 2023
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3 min read
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Tristan Manalac
FDA/Courtesy: Grandbrothers, Adobe Stock
Drug Development
Applied Therapeutics Seeks NDA for Rare Pediatric Disease Drug Despite Phase III Failure
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
April 25, 2023
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3 min read
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Tristan Manalac
Al Drago/CQ Roll Call
Drug Development
FDA Presses Pause on Another Foghorn Program
The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609.
April 25, 2023
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2 min read
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Tristan Manalac
Pictured: FDA Headquarters/Courtesy of Grandbrothe
FDA
FDA Delays Verdict for Daiichi Sankyo’s Quizartinib
To give the FDA more time to evaluate updates to quizartinib’s proposed REMS program, the regulator is pushing the target action date to July 24.
April 24, 2023
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2 min read
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Tristan Manalac
Pictured: Graphic showing two people facing each o
Policy
Supreme Court Maintains Mifepristone Access
Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process.
April 24, 2023
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2 min read
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Tristan Manalac
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