Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

The United Kingdom and Switzerland have kicked off negotiations on a modern free trade agreement (FTA), it has been revealed in a May 15, 2023 press release issued by the UK government.

Such a deal will boost trade between the two countries, which are both high service economies. The current FTA between the two countries is based on a deal made more than 50 years ago, prior to any digital or electronic services even being available.

“As two of the world’s leading service economies, there’s a huge prize on offer to both the UK and Switzerland by updating our trading relationship to reflect the strength of our companies working in [numerous] areas,” said Kemi Badenoch, Business and Trade secretary, UK Government, in the press release. “The UK and Switzerland are natural trading partners and today’s launch will play to our strengths as services superpowers, while also boosting investment in emerging technologies, data innovation, and digital trade.”

In terms of the life sciences sector, a new trade deal could provide significant opportunities for innovation and will strengthen the relationship the countries already have within the field. Additionally, the new FTA should open up greater opportunities for the countries to enhance their research and innovation offerings, furthering the work started in 2022 when a memorandum of understanding was signed to encourage cooperation in science and technology.

“Negotiation of an Enhanced Trade Agreement between the UK and Switzerland provides a pivotal opportunity for a world-leading agreement between two life science superpowers,” said Claire Machin, executive director, International Policy, Association of the British Pharmaceutical Industry, in a press release issued in response to the government news.“Prioritization of life sciences in negotiations could help to boost the growth of our two innovation-intensive economies and set world-leading standards to encourage the creation and adoption of the next wave of scientific technologies.”

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The UK and Switzerland are negotiating a modern free trade agreement.

Negotiations Between UK and Switzerland are Underway

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced, in a May 18, 2023 press release, that the United Kingdom’s National Institute for Heath and Care Excellence (NICE) has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

The recommendation from NICE follows from the authorization made by the Medicines and Healthcare products Regulatory Agency in April 2022 and has been based on positive data from two Phase III trials. Additionally, data from 32 clinical studies have been used to support the regulatory decisions on Kapruvia.

“The recommendation of Kapruvia by NICE is a key step on our journey to bring this breakthrough treatment to in-center hemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK,” said Fabio Dorigotti, head Global Medical Affairs of CSL Vifor, in the press release. “We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible.”

“We are pleased that Kapruvia will be available to CKD patients in England, Wales, and Northern Ireland who are undergoing hemodialysis and suffering from moderate-to-severe CKD-associated pruritus,” added Christopher Posner, president and CEO of Cara Therapeutics, in the press release. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed.”

“Chronic kidney disease-related itch is common for people on hemodialysis and represents a significant unmet need; leading to poor sleep and reduced quality of life for patients,” said Kieran McCafferty, consultant nephrologist, Barts Health NHS Trust, in the press release. “We now have an option to help reduce the burden of CKD-related itch.”

UK’s NICE has recommended Kapruvia as a treatment for adult patients with moderate-to-severe chronic kidney disease (CKD)-associated pruritus.

NICE Gives Nod to Kapruvia for Moderate-to-Severe CKD-Associated Pruritus

The National Institute for Health and Care Excellence (NICE) in the United Kingdom has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease (CD). With this recommendation, upadacitinib becomes the first janus kinase inhibitor available for CD treatment in England and Wales.

According to a May 18, 2023 press release, the positive final draft guidance from NICE has been based on data from three Phase III trials, providing statistically significant efficacy and consistent safety profiles of the drug in treated patients. Patients that have either not responded well enough, who have lost response, or who are intolerant to previous biological treatment, as well as patients who are contraindicated for treatment with tumor necrosis factor-alpha inhibitors, will be eligible for treatment with RINVOQ in England and Wales.

“We are pleased that NICE has recommended upadacitinib for eligible people with Crohn’s disease on the NHS [National Health Service] in England and Wales. This is another important milestone for the inflammatory bowel disease community, as it follows NICE’s recommendation for upadacitinib in ulcerative colitis last year,” said Belinda Byrne, medical director, AbbVie UK, in the press release. “We are committed to using our extensive immunology experience and working tirelessly to ensure as many people as possible with this debilitating condition can find a treatment that has the potential to have a significant impact on their life.”

“The pain, physical symptoms, and complications of Crohn’s disease should not be underestimated. Often starting at a pivotal time during young adulthood, it can lead to low quality of life and have a significant impact on people’s daily activities and work, as well as having mental health consequences including depression and anxiety,” added Sarah Sleet, CEO, Crohn’s and Colitis UK, in the press release. “It can be difficult for people with Crohn’s disease to find a suitable treatment that works for them or continues to work for them, so new options are of vital importance.”

“As a progressive disease, it is imperative that we help people with Crohn’s disease to achieve disease control and improve their quality of life,” said Alexandra Kent, consultant gastroenterologist at King's College Hospital NHS Trust, in the press release. “There has been a lack of new advanced therapies made available on the NHS to treat Crohn’s disease for over half a decade. Being able to offer eligible people an additional treatment option that is available as a once daily pill is a positive step forward.”

UK's NICE has recommended RINVOQ (upadacitinib) as a treatment option for adult patients in England and Wales with moderately to severely active Crohn’s disease. 

AbbVie Gains Access to UK Crohn’s Disease Market with NICE Recommendation

Waters Corporation has acquired Wyatt Technology, a specialist in light scattering instrumentation and software, which is expected to boost Waters’ growth in bioanalytical characterization for new modalities.

The acquisition, which was announced in a May 16, 2023 press release, will marry Wyatt’s analytical technologies with Waters’ global reach, to better serve the demands of the companies’ global customers. It is projected that revenue growth and margin profile for Waters will be positively impacted immediately, with estimates provided in the release that annual revenue growth worth more than $70 million will be seen by Waters within five years of the acquisition transaction being completed.

“We are pleased to complete the acquisition of Wyatt, which is a significant milestone for Waters as we advance our strategy to accelerate value creation and generate faster growth,” said Udit Batra, president and CEO, Waters Corporation. “With Wyatt, we are even better positioned to solve our customers’ critical challenges with differentiated bioanalytical characterization techniques. We welcome the Wyatt team to Waters and look forward to facilitating a smooth integration process and working together to deliver an unmatched set of bioanalytical characterization solutions to our global customers.”

Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.

Waters Set for Growth in Bioanalytical Characterization with Wyatt Acquisition

Oral solid dosage (OSD) forms are a mainstay for the pharmaceutical industry, providing a convenient, cost-effective solution to drug delivery. The outlook for the OSD market remains positive with estimates of growth reaching a compound annual rate of 6.4% between 2022 and 2032 (1).

If you enjoyed this article, do listen to the podcast interview from the Pharmaceutical Technology Group, featuring Andy Dumelow from I Holland, discussing tablet tooling maintenance, available 

Within this market, tablets account for the largest share, and the segment is forecast to continue to expand during the aforementioned analyzed period. The manufacture of tablets, although cost effective (particularly at scale), still requires specialist equipment and tools, which, if not maintained correctly, can cause defects in the finished product and ultimately harm the manufacturer’s bottom line.

Pharmaceutical Technology's May 2023 Trends in Manufacturing eBook

Keeping Up with Tablet Tooling Maintenance

Felicity Thomas, European/senior editor, Pharmaceutical Technology Group

When referring to this article, please cite it as Thomas, F. Keeping Up with Tablet Tooling Maintenance. 

Pharmaceutical Technology's Trends in Manufacturing eBook 

A good understanding of tablet tooling and how to properly maintain these key parts will maximize lifespan of tools.

The European Commission (EC) has granted marketing authorization to Chiesi Global Rare Diseases, a business unit of Chiesi Group, and Protalix BioTherapeutics, for PRX-102 (pegunigalsidase alfa) as a treatment for adult patients with Fabry disease in the European Union (EU).

According to a May 5, 2023 press release, the EC’s authorization was based on the results from a comprehensive clinical development program that assessed PRX-102 in a group of more than 140 patients over a treatment period of 7.5 years. As PRX-102 is a PEGylated enzyme replacement therapy (ERT), the study was performed in both ERT-naïve and ERT-experienced patients, and included a head-to-head that met its primary endpoint, whereby PRX-102 demonstrated non-inferior efficacy to agalsidase beta in controlling kidney disease.

“People living with Fabry disease often perceive their disease as burdensome and still experience unmet medical needs,” said Giacomo Chiesi, head of Chiesi Global Rare Diseases, in the press release. “Our deepest gratitude to all patients and patient advocates who have stood shoulder-to-shoulder with clinical researchers, scientists, and regulators during the clinical development program, providing the data needed for this approval. I believe this is a vital ingredient in bringing innovation to the real lives of patients and enabling hope and definitive, integrated solutions.”

“We are delighted that the [EC] has approved PRX-102 for the treatment of adult patients with Fabry disease. The EU authorization is a testament to our commitment to deliver innovative therapies and solutions for people affected by rare diseases,” added Diego Ardigò, head of research and development of Global Rare Diseases at the Chiesi Group, in the press release. “As a certified B Corp, we are committed to ensuring access to PRX-102 to as many people living with Fabry disease as possible and thank those who participated in our extensive clinical research program. It is important to deliver this new treatment option to reduce the burden of this chronic disease on patients, their families, and the healthcare system.”

“The [EC’s] approval of PRX-102 is a significant milestone for patients with Fabry disease and their families, providing a new therapeutic option,” said Dror Bashan, Protalix's president and CEO, in the press release. “We are proud of this achievement and believe that this approval further validates our science and technology. Based on solid results from our robust clinical programs, PRX-102 has the potential to be widely used for many years to come. Together with Chiesi, we remain committed to meeting the needs of patients with Fabry disease and bringing this new treatment option to market.”

The therapy is not currently approved by the US FDA, but the safety and effectiveness of pegunigalsidase alfa is under review.

EC has granted marketing authorization to Chiesi Global Rare Diseases and Protalix BioTherapeutics for PRX-102 (pegunigalsidase alfa).