Pharmaceutical Technology Editors

Flywheel reported, in a Nov. 22, 2021 press release, that Roche and Genentech have successfully integrated its platform for ingestion, classification, standardization, curation, and analysis of medical imaging data.

The cloud-scale informatics platform is secure and allows the aggregation and management of medical imaging and associated data to advance drug discovery. Data are organized and processed via automated pipelines, which is time efficient and reduces the potential for human error in drug development.

“Manual processes to curate data at the terabyte and petabyte levels are historically costly, time-consuming and prone to human error. With our platform in place, Roche and Genentech researchers can access high-quality images for complex analysis and machine learning, ultimately speeding the development of innovative therapies,” said Jim Olson, CEO of Flywheel, in the press release. “Before using the platform, this level of collaboration and analysis was simply not possible.”

“At Roche we envision a future where data, analytics and digital technologies routinely enable more targeted, efficient research and development and more integrated, personalized care,” added James Sabry, head of Roche Pharma Partnering, in the press release. “The Flywheel platform enables rapid access to highly-curated imaging data, enhancing our ability to answer key scientific questions that are critical to advancing better patient care experiences and outcomes.”

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Flywheel's platform will aid Roche and Genentech in the aggregation and management of medical imaging data.

Roche and Genentech Successfully Integrate Flywheel Platform

ACG, provider of integrated solutions for the pharmaceutical and nutraceutical industries, has signed a memorandum of understanding (MoU) with the government of Maharashtra for investment into a capsule manufacturing plant and R&D center to be set up in Aurangabad.

The plans, which were announced in a Nov. 22, 2021 press release, are for the plant to be the largest in Asia, capable of producing 40 billion capsules per year, serving both Indian and international pharmaceutical and nutraceutical companies. Additionally, the plant will be significantly powered by green, renewable energy, and will use industry 4.0 technologies.

“Our vision to be a future-ready solutions provider to the pharma industry anywhere in the world and our proposed investment of approximately US$100 million (over INR 600 crores) in this state-of-the-art plant is an integral part of ACG’s mission to double our capsule manufacturing capacity to 240 billion capsules a year,” said Karan Singh, managing director, ACG, in the press release. “This plant will play a key role in further cementing India’s position as the global hub of capsule manufacturing and will add to improved access to high quality, safe, and affordable medicines and nutraceuticals globally.”

“We have a long history of operating in Maharashtra and are privileged to sign this MoU with [the] government of Maharashtra for this mega project which, when ready by 2023, will create around 1000 direct and indirect jobs in the region,” added Nitin Desai, senior vice-president, ACG, in the press release.

ACG plans to open a capsule manufacturing plant and R&D center in Aurangabad, India.

ACG to Set Up Vast Capsule Manufacturing Plant in Asia

Global biopharmaceutical company, UCB, has announced, in a Nov. 19, 2021 press release, positive top-line interim analysis results from the Phase III study evaluating the efficacy and safety of BIMZELX (bimekizumab) as a treatment for active psoriatic arthritis in adults.

The primary endpoint of the study was met, meaning that significantly more patients who had been treated with bimekizumab achieved 50% or greater improvement in signs and symptoms of psoriatic arthritis from baseline when compared with placebo. Additionally, the study met all ranked secondary endpoints for the interim analysis, which included significant improvements at week 16 versus placebo, skin clearance, and joint radiographic progression.

“Psoriatic arthritis causes painful debilitating joint and skin inflammation, which impacts mobility and quality of life for patients. At UCB, our aim is to support more patients in achieving control of their symptoms and we set high treatment goals in BE OPTIMAL [Phase III study],” said Emmanuel Caeymaex, executive vice-president, Immunology Solutions and head of US, UCB, in the press release. “The clinically meaningful improvements seen in both joint and skin symptoms strengthen our belief that bimekizumab can address the unmet needs of patients with psoriatic arthritis.”

“[The] encouraging findings from the BE OPTIMAL study show the potential of bimekizumab to improve a range of signs and symptoms in people with active psoriatic arthritis, and suggest that targeting IL-17F, in addition to IL-17A, may be a promising therapeutic approach for this disease,” added Professor Iain McInnes, vice principal and head of College, University of Glasgow, Scotland, in the press release.

The study found that patients treated with BIMZELX (bimekizumab) achieved 50% or greater improvement in arthritis signs and symptoms relative to those treated with placebo.

UCB Announces Positive Top-Line Results from Study Evaluating Bimekizumab

The United Kingdom’s regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has granted marketing authorization for Biogen’s VUMERITY (diroximel fumarate) as an oral treatment for relapsing-remitting multiple sclerosis (RRMS).

According to a Nov. 18, 2021 press release, the authorization by MHRA, which comes shortly after that of the European Commission (EC), has been based on data from pharmacokinetic bridging studies comparing diroximel fumarate and dimethyl fumarate, as well as data from clinical trials assessing the tolerability, safety, and efficacy of the therapy in RRMS patients. Diroximel fumarate has already been approved by the US FDA in October 2019.

“Everyone’s experience of MS is unique, it can be unpredictable and emotionally and physically challenging,” said Dr Mihaela Vlaicu, head of Medical Affairs, Biogen UK and Ireland, in the press release. “It is important that people have MS treatment options available to them that can be easily integrated into their daily life. This new option provides flexibility for people living with MS, to be treated without having to think about dietary restrictions or when to take a dose in relation to mealtimes.”

“The approval of diroximel fumarate by the MHRA, and [previously] by the EC, highlights the importance of treatment adherence, which can make a meaningful difference on treatment outcomes when living with a chronic disease,” added Jonathan Randell, senior director, Value & Access, Biogen UK and Ireland, in the press release. “It provides a new oral treatment option for patients with low gastrointestinal discontinuation rates, that may help patients to start and adhere to treatment. This is another milestone in our ambition as a company to advance treatment and improve outcomes for people living with MS and we are working towards ensuring access across the UK and Ireland.”

Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).

MHRA Grants Marketing Authorization for Biogen’s MS Treatment

Benchling, developer of R&D Cloud software for the biotechnology industry, has raised $100 million in Series F funding, which it will use to continue its European expansion and further develop its cloud-based R&D platform, the company reported in a Nov. 18, 2021 press release.

The latest investment round was co-led by new investor Franklin Templeton and existing investor Altimeter Capital. Other new investors to join the existing ones in the financing round were Tiger Global and Lone Capital. As a result of the latest round of funding, Benchling is now valued at $6.1 billion.

“Biotechnology is rewriting life as we know it. Europe is at the forefront of cutting-edge R&D, and we are honored to work with nearly 100 companies there, after establishing a presence in Zurich last year. We are excited to double down our investment in this important market,” said Sajith Wickramasekara, CEO and co-founder of Benchling, in the press release. “Our customers, spanning nearly every major industry, are engineering more effective medicines, nutritious foods, and sustainable crops, materials, and fuels to address humanity’s most pressing issues. These challenges are global, so growth outside of the US is a strategic priority for us as we power modern, data-driven, and collaborative R&D.”

Benchling raised $100 million to expand in Europe and further develop it's cloud-based R&D platform.

Benchling Raises $100 Million in Funding and Continues European Expansion

AstraZeneca has unveiled a new £1 billion (US$1.33 billion) facility in Cambridge, United Kingdom, that has been designed to high environmental standards and with the space to accommodate 2200 research scientists. The formal unveiling took place in the presence of His Royal Highness The Prince of Wales.

According to a Nov. 23, 2021 press release, the new facility, The Discovery Centre (DISC) includes advanced robotics, high-throughput screening, and artificial intelligence (AI)-driven technology. Additionally, it was specified that DISC will be used to support AstraZeneca’s focus on precision and specialized medicines while also fostering collaboration for the discovery and development of next generation therapeutics, such as nucleotide-based, gene-editing, and cell therapies.

“Our ambition […] is to not only unveil a building, but to also drive the next wave of scientific innovation,” said Pascal Soriot, CEO, AstraZeneca, in the company press release. “Our new Discovery Centre in Cambridge raises the bar for sustainable R&D and global collaboration across our industry. It will allow us to break new boundaries in the understanding of disease biology, bring life-changing medicines to patients and power the next stage of our company’s growth.”

AstraZeneca has unveiled its new facility, The Discovery Centre, which will be used to support the company's focus on precision and specialized medicines, and to foster industry collaboration.