Will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased, with approximately 200,000 doses expected to ship 3Q21.
The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.
Garrett Perry, Technical Services Specialists at Teknova09.14.21
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
LION-101 is a recombinant adeno-associated virus based vector being developed as a one-time intravenous infusion for Limb-Girdle Muscular Dystrophy Type 2I/R9.
Case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.
Bamlanivimab and etesevimab agreement modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased.
Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.
Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.
Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius03.09.21
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
Lilly expands BLAZE-4 trial to evaluate bamlanivimab with VIR-7831, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patients
The first oral treatment in three distinct types of advanced prostate cancer –non-metastatic and metastatic castration-resistant prostate cancer (CRPC).
U.S.-based, state-of-the-art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic.
JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.