News

FDA report says drug shortages are underappreciated and patients pay a price.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

On the last day of CPhI Worldwide (Thursday Nov. 7, 2019), several experts will examine the potential role of three-dimensional printing within medicines, particularly in light of the shift in the industry from volume to value.

Avantor’s Senior Vice-President of Business Development and Commercial Operations (Claudia Berrón) will be presenting trends in raw material data mining and sharing within biopharma on the last afternoon of CPhI Worldwide (Thursday Nov. 7, 2019).

On Wednesday Nov. 6, 2019, Dr. Derek Duncan from Lighthouse Instruments will summarize the current state of container closure integrity testing (CCIT) in the bio/pharma industry and will outline a framework for the development of a holistic testing strategy.

Contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has revealed its investment of $1.5 million into a phased expansion of its facility based in North Carolina, United States.

A number of experts will be examining investment opportunities within the evolving cell and gene therapy sector, in a panel discussion on Wednesday morning (Nov. 6, 2019) during CPhI Worldwide in Frankfurt, Germany.

Swiss-based company, BioVersys, has been granted funding worth up to $8.92 million by CARB-X to support the development of anti-virulence small molecule drugs that disarm bacteria, which could offer a paradigm shift in antimicrobial resistance (AMR) therapy.

The second part of CPhI’s annual report has projected that the biologic manufacturing capacity of Europe will exceed that of the United States by 2023, as a result of the rising number of commercially approved biologics.

Dassault Systèmes has announced the completion of its acquisition of Medidata Solutions, which will connect the 3DEXPERIENCE platform with a clinical trial platform and opens up virtual twin experiences for healthcare.

Intertek has announced that it has expanded its center of excellence for biopharmaceutical services in Manchester, United Kingdom, to support the development of biologics and gene therapies.

According to the third part of the CPhI annual report, a lack of cell and gene expertise may be a drag factor on the sector and a spike in biological therapeutics development is driving bio demand in China.

Start-up company, SeraNovo, has revealed that it has signed a license agreement with Carna Biosciences to expand the existing collaboration and jointly develop an oral formulation of Carna’s kinase inhibitor with increase bioavailability.

Published on Oct. 29, 2019, the study focuses on the multidrug-resistant bacterium Pseudomonas aeruginosa (P. aeruginosa) and how it can be used to develop new and sustainable antibiotic treatments.

The report focuses on information from stakeholders, published research, and economic analysis of market conditions from an analysis of drug shortage data and development of recommendations by the inter-agency Drug Shortage Task Force led by FDA.

The partnership will center on the development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase I clinical development, using its proprietary RNAi platform technology.

The project will seek to deliver treatments for the underlying cause of cystic fibrosis through submitted proposals from potential collaborators.

Showing gains of 54% compared with 2018, results from a 2019 study showed that nearly three-quarters of pharma barcodes meet Drug Supply Chain Security Act requirements.

The companies will develop innovative formulations for drugs to treat rare diseases using Catalent’s oral disintegrating tablet technologies.

FDA has approved Vumerity (diroximel fumarate), a new oral drug for relapsing forms of multiple sclerosis.

The new Javené, France-based facility is expected to increase the company’s production capacity of injectable grade sodium hyaluronate obtained by fermentation by 2.5 times.

Ashland will be presenting new devices at booth 102B13 at CPhI Worldwide.

Dr. Ger Brophy, executive vice president, Biopharma Production for Avantor, will deliver the keynote address at the conference and Claudia Berrón, senior vice president, Business Development and Commercial Operations for Avantor, will discuss on leveraging biopharma 4.0 to reconstruct the biopharma supply chain and manufacturing practices.

Breaking with tradition, a compounding facility won for overall operational excellence, while biopharma facilities took home awards in various categories.

The company will showcase its RayDyLyo all-plastic capping solution, which works in conjunction with SCHOTT’s adaptiQ ready-to use (RTU) vials and groninger Nestfillers by providing maximum flexibility for fill/finish operations.

The company is expanding its bioanalytical capacity and capabilities to support biologic drug development, cell and gene therapy development, and biomarker analysis.

Clear Advantage is a product line of multichannel reagent reservoirs to be used for creating a next-gen sequencing library