This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
in 2022 to 1% in 2023 due to the “tightening of monetary and financial conditions”. Furthermore, for months, several financial institutions such as Bank of America and JP Morgan have been talking of a “mild recession” in 2023 for the US. by the end of 2023 and may continue to rise in 2024 to 5%.
Untamed inflation is a top concern for the pharmaceutical industry globally in 2023. This could evolve into pharmaceuticalcompanies dealing with semi-permanent higher input costs and other interlinked challenges for longer than current baseline predictions.
Untamed inflation is a top concern for the pharmaceutical industry globally in 2023. This could evolve into pharmaceuticalcompanies dealing with semi-permanent higher input costs and other interlinked challenges for longer than current baseline predictions.
We will also address the ways in which these approaches can help to improve adherence to new Annex 1 and the overall quality and safety of pharmaceutical products. During the 2023 ISPE Europe Annual Conference , you will have the opportunity to explore all these topics in details.
Like many industries, the pharmaceutical labour market has felt and will continue to feel the impacts of the COVID-19 pandemic moving into 2023 and beyond. A new operating model for pharma shifted priorities and forced companies to rethink their organisational strategies. Recruiting.
Trudy Patterson Mon, 03/06/2023 - 11:50 iSpeak Blog iSpeak Operations Data Challenges Limit the Value Realized from Pharma 4.0 Michael Krause 6 March 2023Pharmaceutical and biotech portfolios continue to transition from high volume blockbusters to a diversified set of lower volume, targeted therapeutics.
While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023. Register your details to read more The post How ready are you?
In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023. Fresenius Kabi is a global healthcare company specialising in medicines and technologies for infusion, transfusion and clinical nutrition.
LAUSANNE, Switzerland, June 20, 2023 – Viseven, a leading global MarTech services provider for the Pharma and Life Sciences industries, is thrilled to announce its partnership with SpotMe, an enterprise event platform tailored to high-touch industries. SpotMe provided technological assistance on online meetings with healthcare providers.
Innovator oligonucleotide-based drugs targeting central nervous system (CNS) indications witnessed a 339% ($2.17bn) increase in total licensing agreement deal value from 2023 to 2024, reaching a total deal value of $2.81bn, according to GlobalData’s Pharma Intelligence Center Deals Database. Credit: Kateryna Kon via Shutterstock.
APAC Pharma Challenges — The Viseven Event Summary, April 2023 Digital maturity, personalized customer engagement, and data-driven marketing have been accepted and implemented in Europe and the US for a few years. However, it’s not the case for most pharma companies in the Asia-Pacific region.
7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 The responsibility of printing paper leaflets is currently a key regulatory obligation for pharmaceuticalcompanies. References European Commission, (26 April 2023).
On top of that, the global pharmaceutical market has grown plenty in recent years, reaching an estimated $1.6 trillion in 2023. Because of these changes, pharmaceuticalcompanies are rethinking how they do business. In 2023, the market size was valued at $4,156 million, reaching $4,356 million in 2024.
Navigating Life Sciences Construction in California Trudy Patterson Thu, 09/28/2023 - 11:40 iSpeak Blog iSpeak Navigating Life Sciences Construction in California Gul Dusi 28 September 2023 Few industries have as deep a footprint in California, USA as life sciences. billion a year.
By GlobalData Learn more about Strategic Intelligence In light of the approvals of Leqembi and Kisunla, large pharmaceuticalcompanies are increasingly investing in Alzheimer’s disease through high-value acquisitions. Stay proactive with real-time data and expert analysis.
The ISPE OSD Community of Practice formed a working team in 2017 to advance the use of continuous manufacturing in the pharmaceutical industry and to increase the long-term efficiency and affordability of the manufacture of OSD products. Meet Heather Patterson, Human Resources Manager.
In the midst of tough predictions for 2023 due to inflation and a difficult funding environment, Pliant Therapeutics closed an oversubscribed $287.5 Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. In 2020, the company had raised $165.6
These include the pharmacy’s pricing, the patient’s geographical location, and any applicable pharmaceuticalcompany discount programs or patient assistance programs,” Dr. Foxman says. When BCBS covers Ozempic, the out-of-pocket costs will vary based on the drug tier it falls in.
Management Responsibilities and Management Review : ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.”. Internal Communication. Valid 18 November 2022 – 31 January 2023. Quality Planning.
Randstad Sourceright’s 2022 Talent Trends report found that a third of C-suite and human capital leaders in the life sciences and pharmaceuticalscompanies say talent scarcity is a major pain point for the sector. In particular, the industry is scrambling for people to fill marketing roles.
UV 222 Booth: Far UV-C Light for Decontamination of Gowned Personnel Trudy Patterson Mon, 05/01/2023 - 06:00 Sponsored Content UV 222 Booth: Far UV-C Light for Decontamination of Gowned Personnel 1 May 2023 Contamination within pharmaceutical facilities can arise from different sources.
In the presentation, GlobalData’s analysts pointed out that, in Q1 2023, the global market access risk score has significantly risen by 14.9%. Thus, a higher risk score reflects a more hostile market access environment and drug launch in a geographical area. Please check your email to download the Report.
The letter itself is pretty typical of what we would expect to see from OPDP – prioritizing a communication that includes no safety information despite numerous efficacy claims, calling out an efficacy claim as misleading, and failing to submit promotional material on Form 2253. So, what gives?
To keep within this limit, pharmaceuticalcompanies have had to pay rebates on their sales back to the NHS on all expenditures above the capped limit. Companies that choose not to take part in the voluntary scheme must partake in a statutory scheme. This will replace the current scheme which ends on 31 December 2023.
RudaCure hopes to launch phase 1 and 2 trials for RCI002 in 2023. Further on the horizon, the company is investigating treatments for wet age-related macular degeneration, metastatic cancer and complex regional pain syndrome, a rare disease. Everyone in our team is very valuable,” he said. “I Moving to the global stage.
Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Trudy Patterson Tue, 03/07/2023 - 09:14 Features March / April 2023 Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Guy Wingate, PhD Ylva Ek Patricia M. The risks are equally applicable to both privately owned and publicly traded companies.
For many years, the pharmaceutical industry has been accused of overlooking this patient population by instead targeting investments toward more prevalent indications. First established in 2008, Rare Disease Day is observed every 28 February, with events set up across more than 100 countries in 2023 to unite the world in raising awareness.
Improved communication channels also mean that patients can share health data and feedback directly with researchers, creating a more collaborative experience. In 2023, these advances enabled faster data collection, more efficient processes, and enhanced patient experience, signaling a promising future for patient-centric innovation.
Celnova Pharma is an Argentina-based pharmaceuticalcompany that centres its work around rare diseases, oncology, central nervous system, diabetes and critical care. The company currently has operations in Argentina, Colombia, Chile, Peru, and Uruguay. million pesos ($224,218) in the same period.
According to a new GlobalData report, 27% of healthcare professionals believe that data will trend as the second most disruptive emerging technology in the pharmaceutical sector in 2023, meaning the time to embrace the data revolution is now. Please check your email to download the Whitepaper.
Pfizer, in addition to promising carbon neutrality by the same date via a 46% reduction in direct emissions and 100% renewable electricity purchasing, says its North American operations will be entirely solar powered by the end of 2023. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”.
This guidance has driven many pharmaceuticalcompanies to revaluate their approach to CCIT. According to Lukas Engel, market manager pharma CCIT at Pfeiffer Vacuum, companies are increasingly looking to perform high throughput testing with sophisticated, deterministic methods.
A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceuticalcompany with regard to quality. This facilitates launching the new medicine with the desired packaging and meeting the sustainability objectives.
CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. You may unsubscribe from these ISPE communications at any time.
Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. This study showed that only 9% of the companies currently have targets aligned with a 1.5°C Finalized 9 August 2021.
ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Trudy Patterson Mon, 07/10/2023 - 15:37 Technical July / August 2023 ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma Martin Heitmann, FRM Stefan MÜNCH Brandi M. Published 6 February 2023. Pharmaceutical Engineering 43, no.
Taking more time and effort to deliver comprehensive analysis on country and site selection, as well as more open and honest communication with investigative sites during this process, is essential for providing speed, efficiency and cost-effectiveness. cited 2023 Apr 4]. 2019 [cited 2023 Apr 4]. cited 2023 Apr 4].
In the 1990s, generic pharmaceuticalcompanies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says.
Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Trudy Patterson Tue, 05/09/2023 - 09:34 Features May / June 2023 Research Triangle: Building a Foundation for Pharmaceutical and Biotechnology Excellence Scott Fotheringham, PhD 1 May 2023 North Carolina’s Research Triangle is the largest of its kind in the US.
RSV researchers at major pharmaceuticalcompanies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceuticalcompanies are pushing to develop drugs and vaccines for RSV with these populations in mind.
Today, software companies know there is a growing market to meet demand for supply chain visibility platforms. The question for pharmaceuticalcompanies is how they can best deploy their data to make supply chains more efficient. Please check your email to download the Report.
Tue, 01/03/2023 - 07:38. 1 January 2023. A landmark project for a major international pharmaceuticalcompany was the starting point for a series of follow-up projects in Switzerland and Germany. . You may unsubscribe from these ISPE communications at any time. Seamless Integration with Any Automation Environment.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content