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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.

Gilead's corporate headquarters in Silicon Valley
Drug Development
Gilead Suspends Patient Enrollment for Magrolimab in Solid Tumor Trials
While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.
February 16, 2024
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2 min read
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Tristan Manalac
FDA Headquarters_Grandbrothers/Adobe Stock
Policy
FDA Action Alert: Alvotech and Minerva
In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.
February 15, 2024
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3 min read
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Tristan Manalac
Pictured: Healthcare worker draws blood from a pat
Drug Development
Roche-Backed Freenome Continues Industry’s Funding Rally with $254M Raise
Freenome announced Thursday a fundraising round of more than a quarter of a billion dollars, led by Roche, to advance its blood-based cancer tests as pivotal readouts approach.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Facade of the U.S. Patent and Trademark
Drug Development
Otsuka’s Longer-Acting Schizophrenia Injection to Offset Abilify Patent Loss
A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Unhappy woman with her head in her hands
Business
Sage Touts Strong Launch for Postpartum Depression Drug Zurzuvae
Despite missing out on an FDA approval for major depressive disorder, Zurzuvae appears to be a strong asset for Sage Therapeutics, with high growth potential in 2024.
February 15, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
FDA
FDA Approves First Treatment for Severe Frostbite, Reduces Risk of Amputation
Eicos Sciences’ injectable vasodilator Aurlumyn is the first FDA-approved medication for severe frostbite to reduce the risk of finger or toe amputation by opening blood vessels and preventing clotting.
February 15, 2024
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2 min read
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Tristan Manalac
Pictured: Biogen's headquarters in Cambridge, Massachusetts
Policy
DOJ, SEC Subpoenas Add to Biogen’s Compounding Problems
The Department of Justice is seeking more information regarding Biogen’s overseas operations, while the Securities and Exchange Commission is looking into the launch of the now-defunct Alzheimer’s disease therapy Aduhelm.
February 14, 2024
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2 min read
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Tristan Manalac
Facade of the FDA's office in Maryland
Policy
FDA Pushes Back PDUFA Data for Rocket’s Gene Therapy for Rare Blood Disorder
Citing the need for more time to review additional Chemistry, Manufacturing and Controls information, the FDA has extended its target action date for Rocket Pharmaceuticals’ investigational gene therapy by three months.
February 14, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor aspirating a patient's bone marro
Drug Development
Roivant to Shutter MDS-Focused ‘Vant’ After Disappointing Phase I/II Trial Results
Roivant Sciences will wind down operations for Hemavant, which was formed two years ago to advance RVT-2001 as a potential first-in-class treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes.
February 14, 2024
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2 min read
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Tristan Manalac
Pictured: FDA signage at its office in Washington, DC
FDA
FDA Approves Ipsen’s Onivyde as First-Line Treatment in Metastatic Pancreatic Cancer
Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.
February 14, 2024
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2 min read
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Tristan Manalac
Pictured: Roche Diagnostics building in California
Business
Roche Returns Solid Tumor Asset to Repare Weeks After $40M Milestone Payment
Citing a pipeline review and “evolving” external factors, Roche has returned the potentially best-in-class camonsertib to Repare Therapeutics, which will continue to evaluate the asset in various tumor types.
February 13, 2024
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2 min read
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Tristan Manalac
Pictured: Biogen's headquarters in Cambridge, Massachusetts
Policy
Biogen Reaps Rewards of Reata Buyout with EU Approval for Skyclarys in Friedreich’s Ataxia
Following Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals in July 2023, the drug on Monday was approved in the European Union for treating the rare genetic disorder that causes progressive damage to the nervous system.
February 13, 2024
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2 min read
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Tristan Manalac
Pictured: Doctor holding a brain scan with an elde
Drug Development
Otsuka Drug Candidate Fails Phase III Alzheimer’s Agitation Study
AVP-786 was unable to significantly reduce total scores in the Cohen-Mansfield Agitation Inventory versus placebo, Otsuka Pharmaceuticals reported Monday. The company is evaluating the next steps for the drug combination.
February 13, 2024
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2 min read
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Tristan Manalac
Pictured: The inside of a federal courtroom/iStock
Policy
Texas Court Dismisses PhRMA IRA Lawsuit Against Biden Administration
On Monday, the Biden administration got an early victory in pharma’s legal challenge to the Inflation Reduction Act, with a Texas judge dismissing a complaint from the Pharmaceutical Research and Manufacturers of America.
February 13, 2024
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2 min read
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Tristan Manalac
Pictured: CSL's building in Prague, Czech Republic
Drug Development
CSL Heart Attack Hopeful Fails to Meet Primary Endpoint in Phase III Trial
CSL’s investigational cholesterol efflux enhancer CSL112 failed to reduce major adverse cardiovascular events within 90 days in patients who had just suffered a heart attack.
February 12, 2024
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2 min read
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Tristan Manalac
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