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NanoMab Technology has signed heads of terms with a supplier of Tungsten-188/Rhenium-188 generators, OncoBeta.

NanoMab Technology Signs Heads of Terms with OncoBeta

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

Novavax COVID-19 Vaccine Trial Expands Enrollment

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

FDA Approves Remdesivir for Hospitalized Patients

Donald Singer is senior microbiology technical consultant at Ecolab Life Sciences.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions. 

Refining Microbiological Control for Non-Sterile Products

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.  

Orgenesis Completes Koligo Acquisition and Gains Icellator Technology in Related Transaction

The company was selected because of its nucleic acid platform which, when combined with virotherapy, has the potential to treat liver cancer by using a lipid nanoparticle delivery system.

MilliporeSigma Awards Combined Therapeutics with Advance Biotech Grant

Regeneron will distribute Inmazeb treatment doses over the course of six years to BARDA.

FDA Approves Regeneron’s Inmazeb as the First Treatment for Ebola

The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.

Merck’s Keytruda Approved for Expanded Indication in Classical Hodgkin Lymphoma

The partnership aims to provide a platform of hiPSC-based assays, drug discovery technologies, high-throughput screening, and high-content screening.

Fujifilm Cellular Dynamics and Axxam Team Up for Drug Discovery Platform 

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.

FDA Approves GSK’s New Drug for Rare Blood Disorders 

Cellnest will join Fujifilm Irvine Scientific’s PRIME-XV portfolio which consists of xeno-free and chemically defined media for stem cell culture. 

Fujifilm Irvine Scientific Becomes Worldwide Distributor of Cellnest

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19. 

Novavax Begins Phase III Efficacy Trial of COVID-19 Vaccine 

The companies plan to increase the production output of Ligand’s Captisol for the formulation of Gilead’s COVID-19 treatment Veklury (remdesivir).

Hovione and Ligand Partner to Increase Production of Captisol for Use in Remdesivir

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents. 

Johnson & Johnson Launches Multi-Country Phase III Trial of Janssen’s COVID-19 Vaccine Candidate

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

Lilly and Amgen in Manufacturing Collaboration for COVID-19 Antibody Therapies

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

BioNTech to Receive Funding from BMBF for its COVID-19 Vaccine Program

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

Merck Announces Two Oncology Collaborations with Seattle Genetics

The companies have signed an agreement for the production of two plasmids needed for the manufacture of CG01, a gene therapy for the treatment of drug-resistant focal epilepsy. 

Bio/Pharma News