• Messe Frankfurt to focus on highlighting strong anti-counterfeiting measures in wake of Covid-19

    As demand for medical supplies soars worldwide in the fight against Covid-19, there is a parallel risk of substandard and counterfeit medicines in the global market. With India being one of the world's largest producers of medical supplies, there is an urgent need to bring in strong anti-counterfeiting measures which will be addressed at Messe Frankfurt’s upcoming conference - Pharmasafe India 2020.

  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020


    The Committee recommended granting a marketing authorisation for a new vaccine that provides active immunisation to prevent Ebola virus disease in individuals aged one year and older. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need. For more information, see the press release in the grid below. The CHMP recommended granting a marketing authorisation for Hepcludex* (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D, Hepcludex benefited from the support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. Piqray (alpelisib) received a positive opinion from the CHMP for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation. The CHMP recommended granting a conditional marketing authorisation for Rozlytrek (entrectinib), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer. Xenleta (lefamulin) received a positive opinion for the treatment of community-acquired pneumonia in adults. The biosimilar medicine Zercepac (trastuzumab) received a positive opinion for the treatment of breast and gastric cancer. The generic medicine Apixaban Accord (apixaban) received a positive opinion for the treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Five recommendations on extensions of therapeutic indication The Committee recommended extensions of indication for Invokana, Lynparza, Ofev, Sivextro and Taltz. Update on remdesivir The CHMP discussed the status of the review of remdesivir for treating patients with COVID-19. On 30 April 2020, the CHMP started a rolling review of data and the first cycle of this rolling review was concluded on 15 May; the CHMP requested some further data and agreed that the next step would be for the company to submit this data together with an application for a conditional marketing authorisation. The company has not yet submitted an application but it is expected to do so shortly. Once an application has been submitted, the Committee will assess it under a timeline which will be reduced to the absolute minimum to still allow for a thorough evaluation of benefits and risks, meaning an opinion could come soon depending on the robustness of the data submitted. Withdrawals of applications Applications for initial marketing authorisations for Erlotinib Accord (erlotinib) and Fingolimod Mylan (fingolimod) have been withdrawn. Erlotinib Accord was intended for the treatment of non-small-cell lung cancer and pancreatic cancer. Fingolimod Mylan was intended for the treatment of multiple sclerosis. Question-and-answer documents on these withdrawals are available in the grid below. Agenda and minutes The agenda of the May meeting is published on EMA's website. Minutes of the April 2020 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the May 2020 CHMP meeting are represented in the graphic below. * This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine's orphan status and granting the medicine ten years of market exclusivity.

  • New vaccine for prevention of Ebola virus disease recommended for approval in the European Union

    EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine that provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged 1 year and older.
  • Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19


    At a virtual meeting with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party on Tuesday, 2 June 2020, the Agency presented an overview of its contribution to the pandemic response and provided updates on COVID-19 treatments and vaccines under development. In addition, the patients’ and healthcare professionals’ organisations heard about the work carried out by EMA and Member States on availability of authorised medicines. The PDF iconagenda of the virtual meeting is available. Recordings of each session of the meeting have also been made public:

  • COVID-19: reminder of the risks of chloroquine and hydroxychloroquine

    EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Both chloroquine and hydroxychloroquine, which are authorised for malaria and certain autoimmune diseases, have been used to treat patients with COVID-19 but their beneficial effects in this patient population are not established.
  • Milliken boosts plastic industry’s ability to supply materials for personal protective equipment

    Spartanburg, S.C. – Global materials science expert Milliken & Company is once again leveraging its unique capabilities to help produce needed medical personal protective equipment (PPE) amid the COVID-19 pandemic. The current shortage in plastic materials used for protective face shields is leading manufacturers to offer the readily available polypropylene plastic.
  • Mondi safely packages QIAGEN’s SARS-CoV-2 test cartridge

    Mondi's plant in Korneuburg, Austria ramps up production to supply packaging for the new to market SARS-CoV-2 test cartridge by QIAGEN Mondi will produce a high-barrier triplex laminate which will provide protection for the test kits which require limited exposure to light and oxygen to remain effective 02 June 2020 – Mondi, a leading global packaging and paper group, is committed to playing its part in the supply of essential products during the COVID-19 outbreak and has recently developed packaging for QIAGEN's SARS-CoV-2 coronavirus test kit.
  • How This Current Pandemic Changed Product Packaging Testing For Pharmaceutical Companies

    What started as an unknown virus is now holding the whole world hostage. Medical scientists are working round-the-clock to crack the puzzle brought by this novel coronavirus. Every industry has been a victim of this predicament, ranging from small to established companies. The only institutions thought to be holding the key out of the current pandemic are the pharmaceutical companies. 

  • Janssen/Catalent select Dividella NeoTOP 1604 for CV-19 vaccine packaging


    Rapid scale-up The project Includes joint investment and tech transfer to prepare segregated and dedicated manufacturing capacity at Catalent’s Bloomington facility in Indiana to prepare for rapid scale-up and cGMP commercial manufacturing of the investigational vaccine candidate. Catalent plans to hire approximately 300 additional employees at the site for this program starting in July to meet operational readiness for 24×7 manufacturing by January 2021. The 875,000 sq.-ft. facility provides sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging. Scale-up in production will include the use of two new high-speed machines, including a Dividella NeoTOP 1604 top-load cartoner for packaging vials. Unprecedented timeline In a joint news release (see Resources), Catalent CEO John Chiminski commented: “We are proud to collaborate with Johnson & Johnson in its efforts to combat the coronavirus pandemic and save lives.” “Both our organizations have committed to ambitious goals and are executing innovative strategies to meet the forecasted demand on an unprecedented timeline,” said Mr. Chiminski. “We will apply our extensive experience in quickly scaling up manufacturing operations for late-stage and commercial products,” he added. Monomaterial advantage Dividella Sales Director and member of the extended Board, Peter Grassl, said the advantages of choosing the modular 1604 went beyond the machine’s very high speed of up to 160 packages per minute, resulting in 1600 vials per minute. “Remember that vaccines also have to be transported, usually in cold chain, which is expensive. Therefore, it is very important to our customers to have the smallest possible package in order to save money on transport and storage, but at the same time the vials in the package must be securely packed in order to avoid breakages during transport. The bottom line is that those packs have to be as compact and lightweight as possible while still delivering protection. The NeoTOP 1604 is designed to embrace the monomaterial topload solutions that are so important in meeting these challenges,” said Mr. Grassl. “A further bonus is that they give easier access to vials – for hard-pressed healthcare workers under pressure and wearing full Personal Protective Equipment (PPE),” he pointed out. “This is why top load monomaterial packages are preferred by the doctors, because accessibility to the product is better, with no need to struggle in opening blisters or sideload packages while wearing gloves,” Mr. Grassl said. Maximizing OEE The NeoTOP’s ability to run at very high speeds, processing up to 160 multi-vial packs per minute, would be crucial in achieving the Overall Equipment Effectiveness (OEE) and uptime that would be vital in producing a CV-19 vaccine at sufficient scale. “Catalent already uses one of our NeoTOP machines and therefore knows about its great performance, needed for such critical production. Their trust in Dividella also convinced them we could meet their very aggressive timeline,” Peter Grassl explained. Catalent recently completed qualification of its 1,400 m2 secondary packaging expansion at Bloomington to add five new integrated packaging suites featuring new high-speed, automated secondary packaging capabilities with no glass-to-glass contact. This project involved collaborating with packaging industry leaders, OPTIMA, Mikron and Dividella Modular concept The NeoTOP modular concept, allowing easy reconfiguration, was an important consideration in both projects, and especially in CV-19 vaccine production. “Modularity is key for such a COVID machine, because the estimated run time of the CV-19 vaccine is only a couple of years. After that Pandemic is under control, those machines will –most likely- be used to pack different products and pack configuration in the future,” Mr. Grassl explained “Therefore, Dividella’s modularity and flexibility are key in order to re-utilize the machine. For example, the machine could be easily retrofitted to pack syringes instead of vials in the future thus making the machine a great long-term investment and reduce total cost of ownership, or TCO,” he concluded.

  • Gerresheimer supplies PET bottles for urgently needed hand sanitizer

    “A major customer has ordered hundreds of thousands of bottles from us to fill with hand sanitizer, and we're doing everything we can to supply them as quickly as possible,” says Christian Haas, Sales Manager at Gerresheimer. The bottles are being manufactured in a variety of sizes at Gerresheimer’s plant in Zaragoza and sent straight to Berlin in Germany for nationwide use to meet what is currently a very high level of demand. Production at full capacity The plant producing the PET bottles in Zaragoza is currently at full capacity: “We're facing an unprecedented challenge in our day-to-day work in these times that all of us are going through at present. The safety of all our employees is our top priority and we're taking all the necessary precautions to keep them healthy. We're extremely proud to be able to play our part in the battle against COVID-19 by supplying our customers with the containers they have requested to help fight against this terrible pandemic that has swept across the world,” says Jose Luis Reche, Operations Manager at Gerresheimer’s Zaragoza plant in Spain. Versatile PET bottles PET bottles are very versatile and are also made from recycled PET. You will meet them everywhere, be it in the drugstore, in the doctor's office, at home or at the hairdresser. In addition to the currently very popular disinfectants for hands, PET bottles are also suitable for care products, like skin care or hair care, disinfectants, shower gel, soap and body lotion.
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