Pharmaceutical Technology Editors

Novo Nordisk and Echosens, a liver diagnostics company, announced a partnership on June 22, 2022 to advance early diagnosis of non-alcoholic steatohepatitis (NASH) and increase awareness of the disease NASH is a chronic metabolic liver disease that causes progressive damage to the liver, potentially resulting in end-stage liver disease and death.

According to an Echosens press release, the companies will collaborate to support additional clinical validation, generate real-world evidence, and promote adoption of non-invasive diagnostic tests for NASH. They are hoping to double diagnostic rates for people living with advanced to severe NASH by 2025.

“We are committed to driving change in NASH, to develop new treatment options and advance care for this serious, chronic disease. An important step towards realizing that ambition is to ensure that we can identify the people in need of care,” said Camilla Sylvest, executive vice-president, Commercial Strategy and Corporate Affairs, Novo Nordisk, in the press release. “But we cannot solve this challenge alone and through our partnership with Echosens, we hope to leverage our complementary skills to meet the needs of patients, healthcare providers and other stakeholders striving to address this ‘silent’ epidemic.”

According to the release, while the disease affects approximately 115 million individuals, it is estimated that nine out of 10 people living with NASH go undiagnosed. This is because NASH is a “silent” disease that lacks symptoms in the early stages.

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The partnership between Echosens and Novo Nordisk is intended to increase awareness and early diagnosis of non-alcoholic steatohepatitis (NASH).

Echosens and Novo Nordisk Announce Partnership to Combat NASH

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance concerning decentralized procedure (DCP) and mutual recognition procedures (MRP) on June 24, 2022. The guidance details how MHRA handles products already approved or pending in ongoing DCPs and MRPS, while the new updates detail how to convert a Great Britain Product Licenses (GBPL) or Northern Ireland (PLNI) license to a UK-wide license.

The update concerning GBPL and PLNI excludes products that are already the subject of an EU Community Marketing authorization in Northern Ireland or those that fall within the mandatory scope of the European Medical Agency’s centralized procedure. A full breakdown of the updated guidelines can be found on the 

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP

Novartis has endorsed the Kigali Declaration on neglected tropical diseases (NTDs) and is committing to an investment of $250 million towards research and development (R&D) to fight against NTDs and malaria.

The Kigali Declaration was adopted to reaffirm commitments to end NTDs and malaria and aims to mobilize political will and secure commitments to achieve the SDG3 target on NTDs and to deliver the targets set out in the World Health Organization’s Neglected Tropical Disease Roadmap (2021–2030).

Novartis’ investment will span over five years (2021–2025) and will fund the advancement of R&D of new treatments to combat NTDs and malaria. $100 million will go towards R&D of its neglected tropical disease program, and $150 million will go to the advancement of its 3 novel drug candidates to combat malaria.

“Over the past decade, great progress has been made against NTDs, but there is still a lot more work to be done. Novartis will continue progressing our longstanding commitment to helping realize a world free of NTDs,” said Vas Narasimhan, CEO of Novartis, in a press release. “Today, by endorsing the Kigali Declaration and pledging to invest USD 250 million, we aim to accelerate progress toward elimination of these diseases, which continue to cause suffering and stigma for millions of people around the globe.”

Novartis will endorse the Kigali Declaration on neglected tropical diseases and invest $250 million for R&D. 

Novartis to Invest $250 Million for R&D of Neglected Tropical Diseases

GlaxoSmithKline (GSK) announced on June 23, 2022 an investment of £1 billion (approximately US$1.2 billion) over 10 years to accelerate research and development (R&D) toward infectious diseases that disproportionately impact lower-income countries. The focus of the investment will be on malaria, tuberculosis, HIV, neglected tropical diseases, and anti-microbial resistance, which account for more than 60% of the disease burden in many lower-income countries.

GSK Global Health R&D Hubs are progressing more than 30 potential new vaccines and medicines that will target 13 high-burden infectious diseases. The commitment supports the company’s goal to positively impact the health of more than 2.5 billion people in the next 10 years.

“I am delighted to renew our commitment to global health research for the coming decade, consistent with our purpose to unite our science, technology, and talent to get ahead of disease together and our ambition to deliver health impact at scale,” said Thomas Breuer, chief global health officer at GSK, in a press release. “Through our focus on scientific innovation in Global Health, we have delivered the first malaria vaccine, RTS,S, the first radical cure of vivax malaria, tafenoquine, and a new tuberculosis vaccine candidate. GSK now has more than 30 potential new vaccines and medicines (including pre-clinical assets) in 13 high-burden infectious diseases to accelerate, and we must work collectively with urgency to bring these potentially life-saving innovations to people that need them.”

GSK will invest £1 billion in furthering R&D in malaria, tuberculosis, and HIV, as well as neglected tropical diseases.

GSK Announces £1 Billion R&D Investment in Fighting Infectious Diseases in Lower-Income Countries

Kindeva Drug Delivery, a contract manufacturing and development organization (CDMO), completed its acquisition of iPharma Labs, a CDMO focused on inhaled medicines, on June 16, 2022. The entire team at iPharma has joined Kindeva and will continue to operate at their existing location.

iPharma specializes in inhalation formulation and the development of liquid, dry powder, and propellant-based therapies. According to a company press release, iPharma has worked with dry powder inhalation, soft mist inhalers, and nebulizers for both small and large molecules, including biologics, in the early stages of drug development.

“We’re pleased to offer this combination to our customers and their patients: a complete portfolio of respiratory delivery expertise all in one global team,” said Arron Mann, CEO, Kindeva, in the press release. “[The team at iPharma] will help Kindeva accelerate our one-stop CDMO approach: addressing our customers’ desire for a single partner to support feasibility through commercialization without lengthy and risky hand-offs.”

“Joining Kindeva strengthens our ability to craft the best product development strategy for delivery to the patient to and through the lungs,” said Keith Ung, CEO and co-founder, iPharma, in the press release. “Our customers are already excited to benefit from a more complete product development and manufacturing offering. I look forward to leading efforts at Kindeva to expand our clinical and commercial support for dry powder and nebulized respiratory therapies.”

Kindeva’s acquisition of iPharma will increase the company’s inhalation formulation outsourcing capabilities.

Kindeva Drug Delivery Completes Acquisition of iPharma Labs

Aizon, an artificial intelligence and advanced analytics platform company, announced the launch of its good practice compliant data processing product, Aizon Digitize (AD), on June 21, 2022. AD converts data from paper to data with the goal of increasing productivity and avoiding time-consuming, error-prone manual data inputs.

According to a company press release, the product automatically uploads paper records and commonly used file formations to begin the creation of an audit trail; it then immediately enables tracking of changes to the data. It is designed for integration with electronic batch records, laboratory information management systems, quality management systems, and manufacturing execution systems.

“Many pharmaceutical manufacturers still rely on manual entries and processes to perform critical tasks. This very common approach exponentially increases the risk of introducing errors and hindering their ability to optimize the entire development and manufacturing process,” said John Vitalie, CEO, Aizon, in the press release. “[AD] helps [users] avoid unnecessary manual entry and transfer of information which can create volumes of erroneous data resulting in increasing levels of risk. By shifting the manual workload to an automated digital process, our customers can leverage all of the valuable data trapped in paper-based records and spreadsheets. This is the on-ramp to realizing the benefits that compliant Pharma 4.0 technology can bring to any biopharma manufacturing operation.”

Aizon Digitize is designed to help life science manufacturers transition data from paper to digital.