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A new industry survey from the Biotechnology Innovation Organization (BIO) highlights the vulnerability of supply that proposed tariffs would put on medicines, and its impact on patient access. This makes supply of medicines vulnerable especially to proposed tariffs on the EU, China, and Canada, according to BIO.
. | Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to bolster production networks across industries.
Drastic steps need to be taken if the UK is to reverse a steep decline in medicinesmanufacturing in recent years, according to a cross-industry coalition. Over the same period, similar countries – including Ireland, France, and Germany – have been moving to boosting manufacturing productivity, output, and exports.
Johnson & Johnson Innovative Medicine is planning to invest a total of €580 million in Italy over the next five years. A portion of the investment, €125 million, is intended to support greater production capacity at its Latina site, which is a key part of the firm’s worldwide supply chain network, the company stated.
The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU).
Lonza has agreed to acquire one of the world’s largest biologics manufacturing sites (by volume), for a total of $1.2 The acquisition of the manufacturing facility will significantly increase Lonza’s capacity of the manufacture of large-scale biologics, to meet demand for commercial mammalian contract manufacturing.
Sandoz] has the only major remaining vertically-integrated production network for penicillins in Europe” Penicillins are the leading category of antibiotics worldwide, Sandoz highlighted. This represents a significant upgrade of penicillin active pharmaceutical ingredient (API) manufacturing, Sandoz declared.
The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. The EMA set up a task force in 2016 in light of issues concerning medicine availability and supply chain.
billion and another 200 new jobs is planned for Eli Lilly and Company’s two new pharmaceutical manufacturing sites in Boone County, US. Eli Lilly’s investment here is the largest manufacturing investment at a single location in its history. These positions will use advanced technology to help create innovative medicines.
Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. In April 2023, the European Commission (EC) approved the Sandoz biosimilar Hyrimoz ® (adalimumab) high-concentration (HCF) formulation for all indications of the reference medicine Humira ®.
AstraZeneca has announced a $300 million investment in a US-based manufacturing facility in Rockville, Maryland, which will focus initially on T-cell therapies for oncology indications. Currently, AstraZeneca’s manufacturing sites in the US focus on producing small molecules and biologics, the company highlighted.
billion parenteral (injectable) manufacturing site in Alzey, Rhineland-Palatinate, Germany. This includes automation and high-speed manufacturing lines. With the planned additional manufacturing facility in Alzey, the company will operate a total of six manufacturing sites in Europe.
It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen.
Through its investment of approximately £600 million, Takeda plans to build a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan. This is Takeda’s largest ever investment in manufacturing capacity expansion and will be the largest facility of its kind in Japan.
It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000. 1 It is estimated that only 4,000 doses of chimeric antigen receptor T cell (CAR-T) were manufactured in 2021, despite an eligible patient population of 450,000.
It pledges to benefit key industry sectors across life sciences including R&D, innovation, manufacturing and medicine. Over the last five years Made Smarter has transformed countless SME manufacturers,” stated Donna Edwards, Director of Made Smarter’s North West adoption programme.
New analysis from Teva Pharmaceuticals Europe has reported concerning statistics regarding the security of critical medicines supply in the region is at risk. For instance, in the EU, 46 percent of generic medicines from the EU Critical List of Medicines are provided by a single supplier.
Ginkgo Bioworks builds its drug discovery toolkit again, making three acquisitions and launching a partner network in AI, genetic medicines, manufacturing and other areas
With 20 years of leadership experience in the life sciences and biopharma sector, Pedersen has previously had senior leadership positions in quality assurance (QA) and quality control ( QC ), regulatory affairs as well as external manufacturing. There, she oversaw the entire CDMO network.
A report from the Advanced Therapies Treatment Centre (ATTC) Network has highlighted urgent need for rapid change and improvement in the field to maximise patient access to advanced therapies. It was compiled based on expertise gathered at the ATTC Network’s UK Advanced Therapies Adoption Challenge event in October.
Through a new agreement, Eli Lilly and Company and contract development and manufacturing organisation (CDMO) Cambrex will enable external biotech collaborators to accelerate their product development. Collaborators can also access additional support will be provided by Cambrex’s network.
By remaining compliant, medicines are manufactured in line with their pre-defined and approved specifications, in order to ensure the delivery of safe and effective products to consumers. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.
As the world now looks to a post-pandemic future, despite the counterfeit medicine trade showing no signs of slowing, industry bodies must come together to tackle the production and trade of fake products. There is also the challenge of falsified medicines – the fake, unauthorised medical products that make their way into the market.
For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The next wave of medicine is well on course to be cell and gene-based. Meanwhile, the pharma industry is undergoing somewhat of a transformation itself.
ViiV Healthcare and the Medicines Patent Pool (MPP) have signed a new voluntary licensing agreement to increase access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) in least developed, low-income, lower middle-income and Sub-Saharan African countries.
The shortlisted finalists of the CPHI awards for 2023 include companies that led by example in sustainable manufacturing, manufacturers and innovators that developed new technologies to advance drug discovery, development and manufacturing.
In this article, Research Partnership reviews why the path to commercialisation for the half a dozen approvals in Europe over the last few years has not been smooth, and shares feedback gathered from our payer network on the outlook for gene therapy market access in Europe, especially considering the shift to more prevalent diseases.
Sandoz , a leading antibiotics producer has announced its €50 million investment to increase Europe’s manufacturing capacity of finished dosage form (FDF) penicillin, the most common form of antibiotic worldwide, to enhance global manufacturing capacity of amoxicillin and other major penicillin products.
And delays in the supply chain, even for short periods of time can potentially affect the efficacy of medicines, lead to longer-term supply bottlenecks, and ultimately prevent people from getting access to the critical medicines they need. Pharma manufacturing can also be affected by extreme weather events, such as storms.
Personalized Medicine AI can help develop precision medicine by analyzing patient data , including demographic, clinical, and genetic information, as well as information about their metabolism and microbes, environmental exposures, and lifestyle factors, to predict how different patients will respond to various therapies.
Uniting the global supply chain CPHI Barcelona serves as a vital platform for unrivalled networks and access to the global supply chain. The market space offers various benefits, including promotion as a show feature, access to start-up mentors, and a dedicated start-up networking lounge. Manufacturing Excellence 5.
The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. Specifically, an additional four years of funding for the Advanced Therapy Treatment Centre (ATTC) Network is available through the programme. What key solutions will the investment in the Advanced Therapy Treatment Centre Network provide?
Cell One Partners has announced a strategic collaboration with the Center for Breakthrough Medicines (CBM) to expedite the development and commercialisation of cell and gene therapies. Cell One Partners offers virtual company creation and management to its clients for complete aspects of the development and commercialisation of drugs.
Located in Kigali, Rwanda, the mRNA manufacturing facility will be the first of three planned sites across the continent, with further factories to come in Senegal and South Africa. Together this network of factories will supply therapies and vaccines solely for people residing in member states of the African Union.
It is being supported by several patient advocacy groups, including the AIDS Institute, the National Oncology State Network, and the HIV + Hepatitis Policy Institute. The case is Johnson & Johnson Healthcare Systems v. Save On SP, LLC, 2:22-cv-02632, being heard in the US District Curt for the District of New Jersey.
Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Long production times and high energy costs in manufacturing are additional considerations.
The investment is part of the company’s global effort to implement the most innovative technologies and most sustainable processes at its manufacturing sites. Dr Thomas Wozniewski, Global Manufacturing and Supply Officer, added: “For 50 years, this site has been transforming human plasma into life-saving and life-sustaining medicines.
“With cell and gene therapy, not only does it offer the management of symptoms like other conventional medicines, but it also offers the potential of a cure. RoslinCT began as a spin-out from the Roslin Institute – now part of the University of Edinburgh – in 2006, providing expertise in regenerative medicine.
A pharmaceutical tablet is a 3D sample that comprises a mixture of components in which some are arranged as a network of agglomerated particles. Therefore, 2D imaging and mapping approaches may not provide a true representation of these networks throughout a tablet matrix.
For companies that manufacture globally marketed products, the journey towards implementing rFC is a slow one” There are two possibilities for rFC implementation, depending on the pharmacopeial guidance. However, for companies that manufacture globally marketed products, the journey towards implementing rFC is a slow one.
Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. Jiangsu Hengrui Medicine overview Jiangsu Hengrui Medicine (Jiangsu Hengrui) is a biopharmaceutical company that focuses on the research, development, manufacture, and distribution of novel pharmaceutical products.
MZmine also supports IMS-MS addressing the introduction of more IMS-enabled instruments by multiple instrument manufacturers Free to use – an MIT license means MZmine is open-source and free for commercial and non-commercial use, facilitating optimal collaboration.
US radiopharmacy network RLS Radiopharmacies is expanding its radiopharmaceutical contract development and manufacturing (rCDMO) capabilities by establishing a partnership with global isotope technology company Eckert & Ziegler.
Rezvilutamide is under clinical development by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). The company offers products through its sales and distribution network in China, the US, Japan, Germany Switzerland, and Australia.
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