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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 signage at its headquarters in Maryland
Adcomms
FDA Questions Strength of Evidence Backing Zevra’s Rare Disease Therapy Ahead of Adcomm
The Genetic Metabolic Diseases Advisory Committee will meet on Friday to discuss Zevra’s modified scale to describe the efficacy of its drug candidate for the treatment of Niemann-Pick disease type C.
August 1, 2024
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2 min read
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Tristan Manalac
Novo Nordisk's corporate headquarters in Denmark
IRA
Novo Loses IRA Case as NJ Judge Asserts Price Negotiations Are Voluntary
Reiterating his ruling in a prior Inflation Reduction Act case, New Jersey District Court Judge Zahid Quraishi ruled that Novo Nordisk’s participation in the Medicare Drug Price Negotiation Program is of its own free will.
August 1, 2024
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2 min read
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Tristan Manalac
Sanofi's Distribution Center in Quebec, Canada
Legal
Sanofi Sues Sarepta Over Elevidys DMD Gene Therapy, Alleges Patent Infringement
Sarepta has been hit with another patent infringement lawsuit, this time from Sanofi and its subsidiary Genzyme alleging that the biotech used protected technology related to AAV vectors.
August 1, 2024
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2 min read
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Tristan Manalac
GSK's headquarters office building in Poznan, Poland
Vaccines
GSK Lowers Full-Year Vaccine Guidance After Disappointing Q2 Sales, CDC RSV Guidelines
Systemic administrative and policy challenges, including updated CDC guidelines regarding the use of RSV shots in seniors, have forced GSK to lower its 2024 outlook for its vaccines business.
July 31, 2024
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2 min read
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Tristan Manalac
Entrance to the Vertex's headquarters building in Boston, Massachusetts
Pain
Vertex Nabs Priority Review for Non-Opioid Pain Drug, Awaits January 2025 Decision
The FDA will have six months to review Vertex Pharmaceuticals’ suzetrigine, potentially the first new class of drugs for acute pain in more than 20 years, according to the company.
July 31, 2024
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2 min read
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Tristan Manalac
Incyte's logo on its building in Delaware
Pipeline
Incyte Trims Early-Stage Pipeline Amid Strategic Shift in R&D
Incyte announced Tuesday it is realigning its research and development priorities to focus on dermatology and inflammatory assets obtained from the $750 million acquisition of Escient Pharmaceuticals.
July 31, 2024
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2 min read
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Tristan Manalac
Novartis' office building in Marburg, Germany
Patents
FDA Denies Novartis’ Petition to Block Entresto Generics
In addition to facing generic competition, Entresto is among the initial 10 drugs selected for the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, with the maximum fair prices to be published by Sept. 1.
July 31, 2024
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2 min read
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Tristan Manalac
Sign outside BioNTech's building in Germany
Cancer
BioNTech, Regeneron’s mRNA Cancer Vaccine Combo Clears Phase II in Melanoma
BioNTech and Regeneron will face off against Merck and Moderna, which are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda, in advanced melanoma.
July 30, 2024
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2 min read
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Tristan Manalac
Boy breaking a cigarette in half
GLP-1
Novo Nordisk’s Ozempic Could Help Curb Cigarette Use in Diabetics: Study
Adding to growing evidence of its benefits beyond glucose control and weight loss, Novo Nordisk’s Ozempic could also potentially help diabetics quit smoking, according to new research.
July 30, 2024
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2 min read
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Tristan Manalac
AstraZeneca's sign on its office in California
Cancer
AstraZeneca’s Calquence Aces Phase III CLL Trial, Eyes Fixed-Duration Approval
AstraZeneca is seeking a fixed-duration approval for Calquence, which will allow patients with chronic lymphocytic leukemia to take breaks from the therapy and prevent excessive toxicities and drug resistance.
July 30, 2024
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2 min read
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Tristan Manalac
Doctor holding an endoscope in preparation for a colonoscopy.
Inflammatory bowel disease
Ventyx Ends Development of TYK2 Inhibitor After Phase II Flop in Crohn’s Disease
Back-to-back failures in psoriasis and Crohn’s disease have forced Ventyx Biosciences to abandon the development of its investigational oral TYK2 inhibitor VTX958.
July 30, 2024
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2 min read
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Tristan Manalac
FDA signage at its office in Maryland
Obesity
FDA Flags Safety Risks of Compounded Versions of Novo’s Semaglutide, Reports Hospitalizations
The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.
July 29, 2024
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2 min read
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Tristan Manalac
AbbVie's office in South San Francisco, California
Regulatory
AbbVie’s Skyrizi Wins EU Nod for Ulcerative Colitis, Helps to Weather Humira Patent Cliff
Friday’s European Commission approval is a boost to AbbVie as the company looks to lean on its immunology assets, including Skyrizi, to soften the blow of Humira’s loss of exclusivity.
July 29, 2024
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2 min read
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Tristan Manalac
The EMA's former headquarters in London
Regulatory
Merck’s Keytruda in Combo With Padcev Granted CHMP Positive Opinion in Urothelial Carcinoma
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe.
July 29, 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: Adaptimmune, Zevra, Lykos and scPharma
The FDA has four big events in the coming two weeks, including an advisory panel meeting for an ultra-rare disease.
July 29, 2024
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5 min read
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Tristan Manalac
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