Frank Vinluan on Muck Rack

Frank Vinluan

Verified
North Carolina
As seen in: MedCity News, Above the Law, EIN News, BioXconomy, NewsBreak, American Institute of Certified Public Accountants, WRAL TechWire, DealBreaker, BioProcess International Magazine, Timmerman Report
Business journalist based in #RTP, covering pharma and biotech (almost) everywhere. 71% free throw shooter. Genesis: Album 9, track 11.
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Articles

EMA: Amgen, Vifor Inflammatory Drug’s Benefits No Longer Outweigh Risks

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By Frank Vinluan Verified
| MedCity News Verified
Regulatory pressure is mounting on Amgen’s inflammatory disorder drug, Tavneos, with the European Medicines Agency recommending revocation of the product’s approval in its territory. The move follows an FDA proposal to pull U.S. approval of the product due to safety risks and alleged manipulation of clinical trial data. The Committee for Medicinal Products for Human Use (CHMP), an EMA body, conducted its own review of Tavneos.
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A Metabolic Disease Posing Severe Pancreatic Risks Gets Its First FDA-Approved Therapy

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By Frank Vinluan Verified
| MedCity News Verified
A metabolic disorder that leads to high levels of fat in the blood and life-threatening pancreatic complications now has its first FDA-approved medicine, an RNA-targeting therapy developed by Ionis Pharmaceuticals. The Wednesday regulatory decision for the drug, olezarsen (brand name Tryngolza), covers its use alongside diet and exercise to treat adults with severe hypertriglyceridemia, or sHTG.
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New FDA Nod Keeps Gilead Drug Competitive With AstraZeneca & Daiichi in Breast Cancer

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By Frank Vinluan Verified
| MedCity News Verified
The FDA has expanded the approval of a targeted Gilead Sciences therapy as a new first-line treatment for triple-negative breast cancer, tightening competition with a rival drug from the same class that also recently received approval as an earlier treatment for this cancer. Gilead’s Trodelvy first reached the market in 2020 as a third-line treatment for triple-negative breast cancer.
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