Partnership Creates Region’s Largest Biotech CRO Platform to Meet Demand for Clinical Trials in Asia-Pacific SYDNEY, and SHANGHAI, 4 December 2019 – Novotech and PPC Group (PPC), two leading, Asia-Pacific contract research organisations (CROs), announced today that they have formed…
J&J Taps the Brakes on COVID-19 Vaccine Trial After “Unexplained Illness”
Johnson & Johnson paused the clinical trial of its COVID-19 vaccine due to “an unexplained illness in a study participant.” The company began its Phase III trial of JNJ-78436735 on September 23. The vaccine was developed by J&J’s Janssen Pharmaceutical…
BMS bulks up in cardio with $13.1bn takeover deal for MyoKardia
Bristol-Myers Squibb has said it will buy biotech MyoKardia in a $13.1 billion takeover that marks a step up in its development of cardiovascular drugs. The all-cash deal is mainly about MyoKardia’s mavacamten drug that BMS thinks could be a…
Eli Lilly and Gilead’s combination cuts COVID-19 recovery time
Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government. The findings came from additional safety and efficacy data harvested…
Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody
Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the spotlight by being used to treat President Trump. The request for emergency use authorization (EUA)…
Amgen & Cytokinetics’ Cardiovascular Drug Disappoints in Phase III
Cytokinetics‘ stocks plummeted Thursday after they released topline results from their Phase III cardiovascular clinical trial with partners Amgen and Servier. While primary endpoints were met, the secondary endpoint to prove potential to save lives failed. The trial, GALACTIC-HF, was intended to show that treatment…
Pfizer’s Ibrance Unsuccessful in Phase III Breast Cancer Trial
Pfizer’s Phase III study assessing Ibrance as a potential treatment for early breast cancer patients who have residual invasive disease following neoadjuvant chemotherapy failed to meet its primary endpoint. This morning, the pharma giant announced the PENELOPE-B study failed to…
Pharm-Olam Selected as a CRO for Department of Defense Support to Operation Warp Speed Vaccine Trials, Partnering with Geneva Foundation
HOUSTON, Sept. 23, 2020 /PRNewswire/ — Pharm-Olam International, a global mid-sized clinical research organization (CRO), has been selected by the U.S. Department of Defense (DOD) to build capability at military treatment facilities in order to support Phase III clinical trials of…
J&J’s One-Dose COVID-19 Vaccine Candidate Begins Phase III Trial
In the U.S., most of the attention to the COVID-19 vaccine race has been on Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, which are leading the way. There are a number of other major biopharma companies…
Novavax Begin Phase III Study of COVID-19 Vaccine Candidate in the U.K.
Maryland’s Novavax initiated a Phase III study of its COVID-19 vaccine candidate in the United Kingdom. The late-stage study is part of an agreementstruck between the company and the U.K. government last month that includes providing 60 million doses of…
