Bio/Pharma News

The transgenic mouse R&D platform will support the discovery of fully-human monoclonal antibodies.

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

The company announced the status of new and ongoing clinical trial activities during the COVID-19 pandemic.

Novartis will donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

Through the agreement, Emergent will manufacture the vaccine, which is formulated based on Novavax’s proprietary recombinant protein nanoparticle technology platform and its Matrix-M adjuvant to boost immune responses.

The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy

The company is using its LEAPS peptide technology to develop the immunotherapy, which may be able to reduce COVID-19 viral load and tissue damage.

The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.

The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.

GW Pharmaceuticals and Bayer have revealed that GW will regain the exclusive commercialization rights for Sativex (delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD]) in the UK.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

The companies are entering into a development and manufacturing collaboration for the advancement and production of human monoclonal antibodies for the potential treatment of novel coronavirus.

Takeda announced the acquisition after the conclusion of a Phase 1 study of the investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

The partnership will begin in the second half of 2020.

FDA has granted breakthrough therapy designation to padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy keytruda (pembrolizumab).

The companies aim to develop novel cell therapies for treating multiple cancers.

Bio-chromatography development and manufacturing company, BIA Separations, has signed a license agreement with the University of Zagreb to commercialize a novel elution method for virus and viral vector purification.

Sanofi will use a recombinant DNA platform that produces a genetic match to proteins found on the surface of COVID-19 to formulate the vaccine.

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.

ERS Genomics revealed that the European Patent Office (EPO) has rejected arguments filed in opposition to patent EP2800811, which is directed to the single-guide CRISPR/Cas9 gene editing system and covers uses in cellular and non-cellular settings.

The Native Antigen Company has commercially introduced antigens that have been specifically derived from the Wuhan strain of novel coronavirus, now named Covid-19.

Through the agreement, Catalent will offer process optimization and drug substance manufacturing services for the drug candidate at its Madison, WI site.

New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.

A growing number of pharma executives see investment in machine learning and big data as a top priority, according to a 2020 GlobalData survey.

Aimmune plans to introduce the antibody as an adjunctive treatment with its Characterized Oral Desensitized ImmunoTherapy programs to research treatment outcomes in patients with food allergies.

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.