Drug Development

FDA Commissioner Hahn commits to a science-based review and approval process.

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.

Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit-a deep tech company-and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research.

The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.

Find connections to suppliers of the materials, equipment, and services you need to develop, manufacture, and distribute crucial therapies, treatments, and vaccines in the 2020 Pharmaceutical Technology Buyers' Guide.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

Full results from the Phase III ETHOS trial have demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations in patients with moderate to very severe COPD after treatment with triple-combination therapy Breztri Aerosphere.

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.

The agency will be waiving fees for scientific advice for academia developing orphan drugs.

Leo Pharma, medical dermatology specialist, has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

The Biomedical Catalyst has been relaunched, meaning that innovative biotech companies will have the opportunity to access a share of £30 million (US$38 million) in grant funding.

The companies have entered into a development and manufacturing agreement for Anthos Therapeutics’ abelacimab for treating thrombotic disorders.

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?