Development

The collaboration will focus on novel therapeutics targeting RNA-modifying proteins for cancer treatment.

Achieving herd immunity will require testing, data, a vaccine, and public support.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

Merck will acquire Themis Bioscience and collaborate with IAVI and Ridgeback Bio on COVID-19 vaccines and therapies.

The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.

CanSinoBIO will license-in Precision NanoSystems' proprietary RNA vaccine platform technology while the latter leads the development of the RNA vaccine formulation.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

Regulators have exaggerated expectations for simulated media fills.

The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.

Santen Pharmaceutical has concluded a licensing agreement with jCyte for the development, registration, and commercialization rights to jCell, an investigational retinitis pigmentosa therapy, in Japan, Asia, and Europe.

Boehringer Ingelheim will use the partnership to reveal novel insights into the complexities of various inflammatory diseases, which opens the potential for a clearer understanding of potential candidate biomarkers.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

The companies will work to accelerate the development of CytoAgents’ lead COVID-19 drug candidate, GP168, into human clinical trials.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

Medical dermatology company based in Denmark, Leo Pharma, has entered into a license agreement with two Eastern-Asian companies for the development and commercialization of FB825, a novel atopic dermatitis and allergic asthma drug candidate.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.

Late-stage pharmaceutical company based in San Diego, MEI Pharma, and Japanese drug discovery company, Kyowa Kirin, have entered into a global license, development, and commercialization agreement for ME-401.

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

The partners have formed a joint venture to produce muscle-derived mesenchymal stem cells as a source of exosomes and other cellular products to develop related therapies and advance clinical trials.