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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.

3D illustration of the thyroid gland with nodules inside human body
Rare diseases
Ascendis’ Hypoparathyrodism Drug Secures FDA Approval Following Tough Regulatory Path
Ascendis Pharma’s palopegteriparatide was previously rejected by the regulator due to manufacturing problems, and the review period for its resubmitted application was extended by three months.
August 12, 2024
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2 min read
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Tristan Manalac
Illistration of a broken head figure to symbolize psychological stress
Psychedelics
MDMA Papers Retracted for ‘Unethical Conduct’ on Heels of Lykos’ FDA Rejection
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication.
August 12, 2024
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2 min read
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Tristan Manalac
FDA signage at its headquarters in Maryland
Regulatory
FDA Needs More Time to Review Humacyte’s Blood Vessel Implant
Humacyte’s stock price dropped 18% in after-hours trading Friday after the company announced the FDA requires additional time to review its Biologic License Application. No reason was given for the delay or an updated decision date.
August 12, 2024
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1 min read
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Tristan Manalac
Hand holding a nasal spray bottle against a white background
Approvals
ARS Pharma Gets FDA Green Light for First Nasal Spray for Severe Allergic Reactions
ARS Pharma’s neffy on Friday became the first FDA-approved nasal spray to address severe allergic reactions, including those that might lead to life-threatening anaphylaxis.
August 12, 2024
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2 min read
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Tristan Manalac
A scientist with pill bottles in front of FDA headquarters
Regulatory
FDA Action Alert: Ascendis, Gilead and Regeneron
In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.
August 12, 2024
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3 min read
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Tristan Manalac
Merck Research Laboratories headquarters in Silicon Valley
Mergers & acquisitions
Merck Puts Up Potential $1.3B to Acquire Curon’s B Cell Depletion Therapy
Merck is paying $700 million upfront to buy Curon Biopharmaceutical’s bispecific antibody which depletes B cells and is being investigated for non-Hodgkin’s lymphoma and B cell acute lymphocytic leukemia.
August 9, 2024
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2 min read
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Tristan Manalac
Photo of a judge's gavel, a balance and a stack of papers
Legal
Federal Judge Tosses Chamber of Commerce Challenge to IRA’s Drug Price Negotiation Program
In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.
August 9, 2024
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2 min read
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Tristan Manalac
Gilead's headquarters in Silicon Valley
Earnings
Gilead Beats Q2 Wall Street Estimates on Strong HIV, Cancer, Liver Disease Sales
Gilead Sciences’ liver disease portfolio delivered surprisingly robust performance in the second quarter, jumping 17% as the company awaits next week’s potential FDA approval of seladelpar in primary biliary cholangitis.
August 9, 2024
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2 min read
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Tristan Manalac
FDA sign in front of its building in Maryland
Approvals
Citius Scores FDA Approval in Cutaneous T Cell Lymphoma
Citius Pharmaceuticals’ Lymphir is a reformulated version of denileukin diftitox—an FDA-approved cancer therapy—and the only treatment for cutaneous T cell lymphoma that targets the IL-2 receptor located on malignant T cells and Tregs.
August 9, 2024
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2 min read
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Tristan Manalac
Eli Lilly's Biotechnology Center in California
Earnings
Lilly Beats Q2 Expectations as Tirzepatide Supply Stabilizes, Raises Full-Year Revenue Guidance by $3B
Eli Lilly comfortably cleared analyst estimates in the second quarter after improving supply of its blockbuster tirzepatide brands Mounjaro and Zepbound, which together generated more than $4 billion in sales.
August 8, 2024
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
IgA nephropathy
Novartis’ Fabhalta Gets FDA Accelerated Approval, Becomes First Complement Inhibitor for IgAN
Fabhalta is approved for the treatment of IgAN patients who are at risk of rapid disease progression, which is indicated by a urine protein-to-creatinine ratio of at least 1.5 g/g.
August 8, 2024
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2 min read
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Tristan Manalac
MRI scans of the brain
Parkinson’s disease
Amneal Wins FDA Approval for Extended-Release Oral Parkinson’s Drug
Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.
August 8, 2024
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2 min read
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Tristan Manalac
Entrance to Vertex's office in Boston, Massachusetts
Government
Vertex Reaches Reimbursement Deal with UK for Casgevy Gene Therapy in Thalassemia
Patients in the U.K. with transfusion-dependent beta-thalassemia will have access to Vertex Pharmaceuticals’ gene editing therapy Casgevy, thanks to an agreement with the National Health Service on the price.
August 8, 2024
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2 min read
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Tristan Manalac
Novo Nordisk headquarters in Silicon Valley
Earnings
Novo Lowers Full-Year Profit Guidance Amid Disappointing Q2 Semaglutide Sales
Novo Nordisk’s semaglutide brands Ozempic and Wegovy fell short of analyst expectations in the second quarter, mainly held back by supply headwinds. The company’s shares dropped more than 7% in Wednesday morning trading.
August 7, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's corporate headquarters in Denmark
Supply chain
Novo Nearly Catches Up to Lilly, Clears Ozempic and Wegovy from FDA Drug Shortage List
A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages.
August 7, 2024
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2 min read
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Tristan Manalac
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