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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: A sign in front of a Takeda building/iSt
FDA
FDA Approves Generics of Takeda’s ADHD, Binge Eating Drug Vyvanse
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
August 31, 2023
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2 min read
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Tristan Manalac
Pictured: J&J's office in Madrid, Spain
Business
J&J Earns $13.2B from Kenvue Spinout, Lowers Guidance
Johnson & Johnson on Wednesday reported multi-billion earnings from its Kenvue consumer health spinout, with updated 2023 revenue guidance down from its previously announced range.
August 31, 2023
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2 min read
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Tristan Manalac
Pictured: FDA sign at its office in Washington, DC/iStock, JHVEPhoto
Policy
FDA Denies Outlook’s Wet AMD Bid, Issues Complete Response Letter
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Pfizer office in Brussels, Belgium/iStoc
Policy
Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Sign at FibroGen's headquarters in Calif
Drug Development
FibroGen Continues Losing Streak with Phase III DMD Failure
The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.
August 30, 2023
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2 min read
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Tristan Manalac
Pictured: Sign of U.S. Department of Health & Huma
Policy
CMS Names First 10 Drugs for Medicare Drug Price Negotiations
The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.
August 29, 2023
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3 min read
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Tristan Manalac
Pictured: Eli Lilly's headquarters in Indianapolis
Drug Development
Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study
Data from the first-in-human trial showed that Eli Lilly’s muvalaplin is safe and can cut significant levels of lipoprotein(a), a risk factor for atherosclerosis and related cardiovascular diseases.
August 29, 2023
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2 min read
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Tristan Manalac
Pictured: Magnifying glass focusing on a tumor in
Drug Development
Novocure Fails Phase III Ovarian Cancer Trial for Tumor Treating Fields Therapy
The company’s investigational electric field therapy was unable to elicit significant survival benefits in patients with platinum-resistant ovarian cancer.
August 29, 2023
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2 min read
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Tristan Manalac
Pictured: Ultrasound machine showing a heart scan
Drug Development
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data
The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.
August 28, 2023
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2 min read
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Tristan Manalac
Pictured: FTC sign above a doorway/iStock, Gromit7
Policy
FTC Temporarily Withdraws Challenge to $27.8B Amgen-Horizon Deal
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
August 28, 2023
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Business
Novartis Abandons Xoma-Partnered Antibody for Pancreatic Cancer
The Swiss pharma is returning the anti-TGFβ antibody NIS793 to Xoma Corporation, from which it bought the asset in 2015 for $37 million upfront.
August 28, 2023
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2 min read
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Tristan Manalac
Pictured: Exelixis headquarters/Company courtesy
Drug Development
Exelixis Ends Phase III Trial Early Due to ‘Dramatic’ Benefits in Neuroendocrine Tumors
Following a late-stage victory on Monday, Exelixis on Thursday reported another Phase III win for its tyrosine kinase inhibitor Cabometyx—this time in advanced neuroendocrine tumors.
August 25, 2023
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2 min read
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Tristan Manalac
Pictured: Facade of Novartis building in Switzerland
FDA
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
August 25, 2023
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
FDA Action Alert: BMS, Outlook and BiolineRx
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
August 24, 2023
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4 min read
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Tristan Manalac
Update: AbbVie headquarters building in California
AbbVie Removes Two Early-Stage Cancer Assets from Pipeline
The company appears to be terminating the development of two Phase I antibody-drug conjugates in cancer, ABBV-011 and the Pfizer-partnered ABBV-647.
August 24, 2023
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2 min read
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Tristan Manalac
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