R21/Matrix-M Malaria Vaccine Awarded WHO ‘Stamp of Approval’
The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, has been awarded prequalification status by the World Health Organization (WHO). This milestone represents a key step in making the vaccine accessible…
AstraZeneca and Ionis’ Wainua Granted first-ever Regulatory Approval in the US
AstraZeneca and Ionis’ Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN. Wainua is the only approved medicine for the treatment of ATTRv-PN that can be…
Novo Nordisk Foundation Commits $260 million to Establish Vaccine Initiative
The Novo Nordisk Foundation is committing up to DKK 1.8 billion (USD 260 million) to establish a research and vaccine development initiative. The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis…
Tower Cold Chain Partnership Unveiled in China
Tower Cold Chain has reinforced its global availability by partnering with a Shanghai-based organisation, Tower & Winner Solutions (TWS), to drive the growth of Tower’s temperature-controlled passive containers across the Chinese market. TWS has been created specifically to provide the…
Organon & Lilly Enter Commercialisation Agreement in Europe
Organon, a global healthcare company with a focus on women’s health, announced an agreement with Eli Lilly and Company (Lilly) to become the sole distributor and promoter for the migraine medicines Emgality (galcanezumab) and RAYVOW (lasmiditan) in Europe. Emgality, a humanised…
Shionogi Announces Agreement With SOBI
Shionogi B.V., the European subsidiary of SHIONOGI & Co., Ltd. have announced that they have signed a distribution agreement with Swedish Orphan Biovitrum AB, Sobi, for Fetcroja (cefiderocol) in Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Cyprus, Estonia, Greece, Latvia…
Q&A: Sharp’s Alison Dillon – European Pharmaceutical Manufacturer
As we close off this year at EPM, we look back at one of our standout interviews with Alison Dillon, Director of Marketing Communications and Strategy at Sharp. We sat down at CPHI Barcelona to look back at this year for…
Recipharm Harmonises Global Quality Operations with Veeva Vault Quality
Veeva Systems have announced that Recipharm, a global contract development and manufacturing organisation (CDMO), will use Veeva Vault QMS, Veeva Vault QualityDocs, and Veeva Vault Training to streamline its quality operations. Veeva quality applications will help Recipharm achieve greater quality oversight, use resources more effectively, accelerate…
Leanbio Invests Additional €20m In Barcelona GMP Biologics Plant
Leanbio is adding an additional €20M in investment to its plant, currently under construction, in Sant Quirze del Vallès, Barcelona. Spanning over 3500m2, the facility will house three production lines capable of manufacturing recombinant proteins and antibodies in different expression systems, as well as…
The Missing Piece in Liver Disease Trials
Tim Jobson, MD PhD, Medical Director of Predictive Health Intelligence. As liver cancer awareness month drawers to a close we reflect on the future treatment outlook for patients’ poor liver health. Liver disease can often be the unwanted third wheel…
InvestEU Belgium: €20m EIB Venture Debt Financing to Support Microbiome R&D
The EIB has signed €20 million in venture debt financing with Belgian microbiome health company The Akkermansia Company. With the venture debt, the company will accelerate the R&D and commercial activities around the Akkermansia muciniphila bacteria, which has been the subject of scientific…
Rhenus Air & Ocean Certified for Pharmaceutical Logistics in Italy
The Rhenus Group announces the successful certification of the Good Distribution Practice (GDP) for its Air & Ocean Division in Italy. This notable achievement underscores the company’s unwavering dedication to upholding elevated operational standards and adherence to regulatory frameworks within…
A Revolution in Pharmacovigilance – European Pharmaceutical Manufacturer
Signal detection in post-market drug monitoring has changed little in 70 years, but now that shake-up is coming in the form of advanced AI technology combined with democratised access to standardised real-world data. The result will be a rapid and…
Pfizer Completes $43 billion Acquisition of Seagen
Pfizer have announced the successful completion of its acquisition of Seagen Inc, a global biotechnology company that discovers, develops and commercialises transformative cancer medicines. Pfizer completed its acquisition of all outstanding common stock of Seagen for $229 in cash per share,…
Fujifilm to Invest $200 Million to Expand in US
FUJIFILM Corporation announces the investment of USD 200 million in two subsidiaries to significantly expand global cell therapy contract development and manufacturing (CDMO) capabilities. The investment will enable Fujifilm to support the expanding cell therapy market which is anticipated to grow…
When ADCs Team Up with Immune Modulators to Fight Cancer
Campbell Bunce, Chief Scientific Officer (CSO) and Cambridge Site Head at Abzena Antibody-drug conjugates (ADCs) already sit close to the top of oncological treatments because, unlike many other therapies, they can selectively target and eradicate tumour cells. As the industry…
Getinge Launch Fully Automated Load System for GEV Sterilisers
Getinge has introduced a modular and fully automated load handling solution for seamless integration with the company’s GEV terminal sterilisers. In addition to the safety benefits for operators, the new Getinge Roller Conveyor System (GRCS) optimises throughput performance in pharmaceutical production….
Striving to Be Sustainable: How Can Pharma Manufacturing Go Green?
In the dynamic landscape of pharmaceutical manufacturing, striving for sustainable practices has transitioned from a choice to an imperative. The pharma industry significantly contributes to greenhouse gas emissions, primarily due to energy-intensive manufacturing processes and global supply chains. With universal…
Asahi Kasei Develop Novel Membrane System to Dehydrate Organic Solvents Without Heat or Pressure
Asahi Kasei has developed a novel membrane system for dehydrating organic solvents for pharmaceutical applications without the application of heat or pressure. This system can contribute to the optimisation of manufacturing processes in the pharmaceutical industry. The company has now…
The MedTalk Podcast: Providing an Engine in a World of Horse and Carriages
Ian Bolland and Olivia Friett caught up with Arjun Luthra, commercial director of BioInteractions at COMPAMED 2023. At COMPAMED, BioInteractions relaunched its Astute coating, its coating which can unclot blood. Luthra explains how the product fits into its range, how…
ANTABIO Raises €25 Million in Series B Financing
Antabio SAS, a clinical stage biopharmaceutical company developing novel treatments for severe drug-resistant bacterial infections, announced that it has raised €25m in a series B financing round with subscriptions from the AMR Action Fund, the EIC Fund and from the…
Techbio Talent Migration: Why 2024 Will Be The Year AI and Software Engineers Move to Pharma
Stef van Grieken, co-founder and CEO of genAI biotech startup Cradle. Until now, the field of biological research has largely been limited to those with science degrees or PhDs. However, the rise of AI has the potential of making protein…
Naobios Receives €1.7M in Support of Vaccine Development
Naobios have announced the receipt of a $1.87M (€1.7M) grant from the Bill & Melinda Gates Foundation in support of vaccine development. Naobios will manufacture a human viral challenge agent that will be used to evaluate the effectiveness of vaccines in preventing…
DeepMirror Launches Early Access Programme for Intuitive Molecular Drug Design Software
DeepMirror, a University of Cambridge spin-out company developing intuitive design software for the discovery of novel therapeutic drugs, have announced the launch of its Early Access Programme after a successful closed beta programme during which chemists were invited to test…
Thermo Fisher Scientific Establishes 2030 Renewable Electricity Goal and Solar Power Purchase Agreement
Thermo Fisher Scientific Inc. the world leader in serving science, today announced a 15-year virtual power purchasing agreement (VPPA) with international solar developer ib vogt. Thermo Fisher’s 91-megawatt portion of the Serbal solar project will deliver approximately 192,000 megawatt hours of renewable electricity…
Evonetix Announce Agreement for Gene Synthesis Platform with Analog Devices
Evonetix have announced the signing of a joint development agreement and commercial supply agreement with Analog Devices, Inc. (ADI), a global semiconductor leader. This agreement signals the continuation of the long-standing combined work of both companies, bringing efforts to the next stage…
Körber and LabWare Pave Way MES-LIMS Integration
Körber and LabWare have announced a significant advancement in their partnership, achieving the “Ready” level required for LabWare to join Körber’s Ecosystem of partner companies. This collaboration reinforces the seamless integration capabilities between LabWare’s Laboratory Information Management System (LIMS) and Körber’s Manufacturing Execution…
Innovent Biologics and Synaffix Expand ADC Collaboration
Synaffix, a Lonza company, announces the expansion of its licensing agreement with Innovent Biologics, a biopharmaceutical company that develops, manufactures and commercialises high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases. Building on the core value proposition of Synaffix…
Vesper Bio Doses First Volunteer in Phase I Study for Frontotemporal Dementia
Vesper Bio ApS announces that the first volunteer has been dosed with its lead compound VES001, a patient friendly, first-in-class, brain penetrant, oral treatment, that could bring a meaningful disease-modifying benefit to patients suffering from Frontotemporal Dementia harbouring loss of function…
Aptar Pharma Opens New Mumbai Site
Aptar Pharma have announced the opening of its new Aptar Mumbai site, which will increase manufacturing capabilities in South East Asia. An inauguration ceremony held on December 1, 2023, marked the official opening of the new Aptar Mumbai production facility in…
AbbVie to Acquire Cerevel Therapeutics for $8.7 Billion
AbbVie Inc and Cerevel Therapeutics have announced a definitive agreement under which AbbVie will acquire Cerevel Therapeutics and its robust neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease (PD), and mood disorders….
Gyros Protein Technologies and Biotage Partner to Advance Peptide Purification Efficiency
Gyros Protein Technologies AB and Biotage have announced a partnership to offer Biotage PeptiPEC, based on Gyros’ PurePep EasyClean (PEC) catch and release technology, on Biotage Extrahera automated sample preparation system. The development of an automated plate-based peptide purification workflow provides a fast and environmentally…
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The Complexities of Manufacturing Orphan Drugs in Product Development
Cornell Stamoran, Vice President, Strategy and Government Affairs and Matt Mollan, Vice President Operations at Catalent for our latest EPM Magazine issue. There are approximately 1,500 active pipeline compounds within orphan designation today, and, like the overall pharmaceutical pipeline, small molecules…
Early Cryopreservation as a Stepping Stone to Sustainable Cell and Gene Therapy Manufacturing
Priya Baraniak, Ph.D, Chief Business Officer and Dominic Mancini, VP Operations at OrganaBio explored early cryopreservation as a stepping stone to sustainable cell and gene therapy manufacturing in our latest EPM Magazine issue. Scalability and sustainability have become choke points for…
Vetter Joins Science Based Targets Initiative
Vetter, a leading globally operating Contract Development and Manufacturing Organization (CDMO), has joined the Science Based Targets Initiative (SBTi) membership group as of November 2023. The goal of the companies in the SBTi is to achieve climate neutrality by 2050, thus representing…
Eli LIlly Obesity Drug Zepbound Available In US Pharmacies
Eli Lilly and Company have announced that the Zepbound (tirzepatide) injection is now available. Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those who are overweight (with a BMI of 27 kg/m2 or greater) and also…
Introducing New Equipment into GMP Facilities: A Vendor’s Perspective
Richard Hammond, Chief Technical Officer, Sphere Fluidics. Introducing new equipment in life sciences typically follows a well-worn path. At first, as a vendor, your new device is picked up by the research community as it enables new experimental approaches or…
FDA Clears Beckman Coulter Life Sciences AQUIOS STEM System
Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, has received 510(k) clearance from the Food and Drug Administration (FDA) to distribute its popular AQUIOS STEM System in the United States. This innovation provides labs with an…
PlaqueTec Recruits First Ten Patients in BIOPATTERN Trial
PlaqueTec have announced that it has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval to continue its BIOPATTERN trial following recruitment of the first ten patients with CAD. The trial has been designed to improve understanding of the…
Supply Chain Resiliency: A Lifeline in the Face of Drug Shortages
Bindiya Vakil is the CEO and founder of Resilinc and is an award-winning expert in supply chain risk management. In the first half of 2023, we witnessed a levelling off in the number of supply chain disruptions, yet drug shortages…
Hovione Expands Nasal Drug Delivery in Collaboration with IDC
Hovione has announced an expansion of its nasal drug delivery capabilities with the addition of a family of innovative nasal powder delivery devices developed in partnership with IDC. Intranasal drug delivery is a good alternative to conventional delivery routes for both local…
Pacesetting Pharma Firms Drive Innovation with Systemic HR Practices and Talent Intelligence
Many pharma and biotech companies lack the process and product innovation capabilities required to keep pace with industry disruption. Jordan Schmitting of The Josh Bersin Company offers practical tips on how pharma firms can address this challenge by rethinking their…
Simplifying CGT: A Necessary Precursor to Integrating AI and Automation
Josh Ludwig, Global Commercial Director, ScaleReady Over the past decade, the landscape of cell and gene therapy (CGT) has experienced transformative growth. Artificial intelligence (AI) and automation will be necessary next steps for CGT manufacturing to reach its full potential….
Innovation, Alliances, and the Environment: 2024 Priorities for Drug Manufacturers
Adaptability, global collaboration, supply chain innovation and mRNA technologies were just some of the key trends in 2023. Rephine’s Dr. Eduard Cayón expects these themes to continue to develop and accelerate in 2024, alongside growing pressure to innovate, and increasing…
CPHI Roundtable: Tjoapack – European Pharmaceutical Manufacturer
In our final EPM issue of the year, we reflected on the success of this year’s CPHI Barcelona show. As part of our look back at the year as a whole, we at EPM HQ wanted to platform some of the…
Bormioli and Desall Digitise Package Leaflets Using Augmented Reality
Bormioli Pharma has announced that it has chosen the winner of the open innovation competition launched on the Desall.com platform for the creation of innovative pharmaceutical packaging prototypes. AR Rotating Menu by the German design team Nothelfer was the winning concept. Based on augmented reality, in…
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Orphelia Pharma Secures US Patent
Orphelia Pharma have announced that the US Patent and Trademark Office (USPTO) has issued patent US11/730,732 for KIZFIZO, the first pediatric and ready-to-use drinkable formulation of temozolomide. KIZFIZO (temozolomide oral suspension, 40 mg/ml), known as Ped-TMZ or KIMOZO during its clinical development…
CPHI Roundtable: Purolite – European Pharmaceutical Manufacturer
In our final EPM issue of the year, we reflected on the success of this year’s CPHI Barcelona show. As part of our look back at the year as a whole, we at EPM HQ wanted to platform some of…
Samsung Biologics Engages Suppliers to Advance Global Decarbonisation Targets
Samsung Biologics, a global contract and development and manufacturing organisation (CDMO), hosted its inaugural Suppliers ESG Day, both at its Songdo headquarters and online, to share environmental, social, and governance (ESG) strategies and drive collective action to decarbonise. The company…
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WHO Authorise Emergency Use of Novavax Protein-based COVID-19 Vaccine
Novavax Inc have announced that Nuvaxovid XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunisation to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in…
AbbVie Receive EMA and FDA Updates on Lymphoma Treatment
AbbVie have provided updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL). The FDA has granted Breakthrough…
1nhaler Raises £2 Million to Develop Single-Use Sustainable Inhaler
1nhaler, a Scotland-based drug delivery device developer, has raised £2 million to develop its unique single-use dry powder inhaler (DPI). Inhalable medicines are already widely used to treat conditions such as asthma, epilepsy, allergies and Parkinson’s but, to date, delivery…
AstraZeneca Launches Evinova – European Pharmaceutical Manufacturer
AstraZeneca has launched Evinova, set to be a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients. With long-term backing from AstraZeneca and strategic collaborations with Parexel and Fortrea, Evinova offers globally-scaled digital…
Leveraging MES for Smart Manufacturing Practices
In the fast-evolving life sciences industry, there is an increasing demand for cost-effectively launching drug products at speed, using sustainable manufacturing methods. Successfully navigating manufacturing practices to reach these objectives is a difficult task, and so companies across life sciences…
The MedTalk Podcast: Recycling Plastics in the Medical and Pharma Packaging Industry
Olivia Friett is joined by Michiel van den Berg, Director of Global Pharmaceutical Packaging Development at TekniPlex to discuss methods of recycling, legislation on the subject and what companies can do to improve their recycling rates.
Medical-Spec Package Arrives in Ireland
As part of Sumitomo (SHI) Demag’s expanding presence in Ireland, the company’s newly-kitted out showroom, testing and tool trial facility in Limerick recently took delivery of a high-speed IntElect S 100 medical-specification production cell. Responding to one of the greatest…
Pioneer Life Sciences Fund Invests in At-Home Fertility Care Company Béa Fertility
Pioneer Group have announced an investment in Béa Fertility to further expand the company’s first of its kind at-home fertility treatment program. The terms of the deal are undisclosed. Proceeds will be used to fuel growth in the UK market and achieve…
Berry Global Healthcare Launches the PneumoHaler
Berry Global Healthcare has launched the PneumoHaler, a new lightweight, breath-actuated, multi-dose inhaler with a dose indicator for the effective management of asthma and chronic obstructive pulmonary disease (COPD). Designed to provide a ready-to-use solution for new inhalation treatments, the…
Staving off CTCL: How a Potential New Maintenance Therapy Could Benefit Patients
Cutaneous T-cell lymphoma (CTCL) is a rare type of cancer where the T-cells that normally help stave off infections become abnormal and begin to affect the skin. Richard Staines reports on new trial findings that could improve quality of life…
The Current Trends and Challenges Influencing the Oral Solid Dose Market
Dr. Uwe Hanenberg, Head of Product Development, Oral Solid Dose and Dr. Maria Lundin-Johnson, Head of Formulation Development, at Recipharm, explore the current trends influencing the oral solid dose (OSD) market and the significant challenges they present to the advancement…