Fiercepharma | June 09, 2020
Consumers are on edge as the COVID-19 pandemic casts doubts on the quality of drugs reaching shelves around the world. On U.S. shores, experts say those issues are warranted—and a wave of Pfizer recalls for menopause drug Duavee won't help build confidence. Pfizer voluntarily recalled two batches of Duavee––marketed as Duavive abroad––from U.K. shelves after identifying faulty packaging that may have reduced the drug's efficacy, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) said Monday. Pfizer launched the recall after manufacturers identified a flaw in the drug's foil laminate pouch that introduced oxygen and lowered the dissolution rate of active pharmaceutical ingredient bazedoxifene acetate, the MHRA said.
Lantern Pharma | June 30, 2020
Lantern Pharma, a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic data to streamline the drug development process and to identify the patients that will benefit from its targeted oncology therapies, announced today that it surpassed the milestone of 450 million curated data points being utilized in its proprietary A.I. and machine learning-powered platform, RADR® (Response Algorithm for Drug Positioning and Rescue).
RADR® leverages genomic, transcriptomic, clinical and drug sensitivity data points across more than 145 drug-tumor interactions to predict the potential response cancer patients will have to potential drugs, therefore enabling a more personalized approach to therapy that is aimed at better outcomes. Lantern is establishing collaborations and partnerships to expand the functionality of RADR®, including algorithms that can operate 200 to 300 percent faster than its existing algorithms, enabling the company to develop robust gene signatures that can be used to guide patient enrollment in trials and as a companion diagnostic (CDx). During the most recent data enrichment campaign, Lantern focused on significantly increasing the depth and amount of data for: non-small cell lung cancer, ovarian cancer, glioblastoma, and gliomas. Reaching this milestone of over 450 million curated data points for oncology drug development will bring greater precision and speed in helping Lantern with its objective of personalizing oncology therapy with reduced risk and cost.
Fiercepharma | May 04, 2020
Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. With less than six months to go until the U.S. elections, the pharma industry finds itself in a different position than expected at the start of the year. While many predicted a tense year as candidates went on the attack, the pandemic has taken the spotlight. And instead of being an easy target, pharma companies have found a chance to shine. On Gilead Sciences' first-quarter conference call, Mizuho analyst Salim Syed pointed out that rhetoric around pharmaceuticals and drug pricing has been “pretty negative” in recent years. So, the analyst wondered aloud whether that has changed as Gilead and other drugmakers charge forward with potential COVID-19 therapies.