EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Such a short timeframe will only be possible because some data have already been assessed during the first cycle of the rolling review, which started on 30 April and was concluded on 15 May. During this first phase, EMA scientific committees and working parties operated in synergy to complete their assessment of the dossier significantly earlier compared with a regular evaluation procedure, while still ensuring a robust evaluation of the available data. During the rolling review, EMA’s human medicines committee (CHMP) assessed data on quality and manufacturing, preliminary data from several clinical studies and supporting data from compassionate use programmes. At the conclusion of the first cycle of the rolling review, the CHMP invited the company to submit further data together with an application for a conditional marketing authorisation. In parallel, EMA’s safety committee (PRAC) completed the initial assessment of the preliminary risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine’s risks. The PRAC will continue to evaluate the safety data for remdesivir in an expedited manner to promptly identify and address potential safety concerns with the medicine. Furthermore, EMA’s committee for medicines for children (PDCO) rapidly issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children, in accordance with the accelerated timelines for COVID-19 products, and an EMA decision was adopted. Should the additional data now submitted with the CMA application be sufficient to allow CHMP to conclude that the benefits of remdesivir outweigh its risks in the treatment of COVID‑19, EMA will liaise closely with the European Commission to support fast-tracking of the decision-making process and granting of a marketing authorisation by the European Commission valid in all EU1and EEA Member States. More about the medicine Remdesivir is an antiviral medicine which is being investigated for the treatment of COVID-19. Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying). It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease. Although remdesivir is not yet authorised for marketing in the European Union, it is available to patients through clinical trials and compassionate use programmes, through which patients can get access to unauthorised medicines. Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein. More about the procedure Further information on how EMA fast-tracks its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible is available. 1As of 1 February 2020, the United Kingdom is no longer an EU Member State. However, EU law still applies to the UK during the transition period. Contact point EMA press office Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu Follow us on Twitter @EMA_News

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 3 June 2020. Regular participation in the meeting of the steering group was extended to all the heads of the national competent authorities (NCAs) of the EU Member States to discuss the measures taken by EU authorities to ensure the continued availability of medicines in Europe during the ongoing COVID-19 pandemic. In order to prepare for a potential second wave of coronavirus infections and to ensure that patients in Europe will have access to crucial medicines, the extended steering group continued to discuss how to improve the forecasting of future demand of medicines used in intensive care units (ICUs) and of other medicines and how to better match the estimated demand with the available supply. The steering group agreed to further improve the collection of demand data, taking into account best practices at national level, and to subsequently share these data within the European Medicines Regulatory Network. For this purpose, it was decided that EMA will establish an ad hoc working group that will be tasked with the development of a common framework for collecting and sharing demand data in the EU/EEA, in view of a possible next wave of the current COVID-19 pandemic in the autumn. The ad hoc group on forecasting demand data in the EU/EEA will also determine which medicines will be included in this exercise, which might go beyond ICU medicines, and will define adequate metrics for data collection at EU level. The new group will comprise experts nominated by the NCAs and have a limited time duration. The extended steering group will decide on the final composition of the ad hoc working group at its next meeting. The new working group is expected to develop a reflection paper summarising best practices from national forecasting models and providing practical recommendations for a harmonised approach. Note The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is chaired by the European Commission. Its membership is made up of representatives from the European Commission, the Heads of Medicines Agencies (HMA), EMA, the chairs of the Coordination groups for Mutual-recognition and Decentralised Procedures for both human and veterinary medicines (CMDh and CMDv), as well as risk communication specialists. Contact point EMA press office Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu Follow us on Twitter @EMA_News

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Flexible shaft manufacturer provides custom design expertise St. Petersburg, FL – S.S. White Technologies, the worldwide leader in the design and manufacture of flexible shafts, highlights their bespoke flexible shaft solutions for food industry applications. Flexible shafts transmit rotary motion much like a solid shaft, but can be curved over, under, and around areas in ways a solid shaft cannot. Flexible shafts are used in a variety of food applications, such as in rotary knives, mixers, commercial kitchen equipment controls, and in industrial food packaging. S.S. White provides customers with custom flexible shaft solutions designed for individual applications, all backed by S.S. White’s wealth of experience and expertise. Food industry applications suitable for using S.S. White Flexible Shafts include: Rotary knives for the beef, pork, and poultry industry Rotary knives and de-boners for the fish industry Rotary knives to trim meet in taco- and kebab-style restaurants Industrial fryers Mixers Various remote controls for kitchen equipment Coffee machines, for grind adjustments Glass bottle fabrication Printing machines for food packaging Packaging machines for pre-packed food S.S. White FDA-compliant flexible shafts are resistant to the extreme temperatures found in food industry applications, such as in freezers and ovens. They are resistant to humidity, water, grease, oils, making them easy to clean through either washing or autoclaving. S.S. White’s flexible shaft casings and fittings are all food grade material, and food grade lubricants are available. Flexible shafts can easily be replaced should they fail and are far more affordable than other comparable solutions. S.S. White provides flexible shaft assemblies as part of a custom solution. Every application in which a flexible shaft is used is different, and S.S. White not only manufactures the flexible shafts, but also provides the technical expertise to create bespoke solutions. The food industry requires precise, highly engineered products for a highly regulated environment, which S.S. White delivers consistently. ### About S.S. White Technologies S.S. White Technologies is a world leader in the design, engineering, manufacturing and testing of a variety of flexible shaft products for aerospace, medical, industrial and automotive markets. The majority of commercial and military aircraft platforms in the air today contain at least one S.S. White Technologies flexible rotary shaft, and more than one-half of US manufactured cars and second tier global automotive suppliers rely on S.S. White flexible rotary shafts. The company currently has design, engineering and manufacturing facilities in the United States and the United Kingdom, and manufacturing facilities in India. For more information, visit www.sswhite.net/ Contact: Kristin Nugent McNeil, Gray & Rice, Inc. 617-367-0100 ext. 148 kristin.nugent@mgr1.com

For more variability - the TURBOVAC i/iX family grows Cologne, June 2020 – In June 2020 the vacuum specialist Leybold has expanded its TURBOVAC i/iX series - 90, 250, 350 and 450 - by the sizes 850 i/iX and 950 i/iX to six models. The two new turbomolecular pump variants are characterized by extended, trouble-free operation, longer system life and lower operating costs. They are used in many applications from research and development and analytics to industrial. In other words, especially where a clean and stable high- and ultra- high vacuum is required – such as in coating, heat treatment, analysis, thin-film research and helium recovery. Significantly higher productivity Basically, the new members of the TURBOVAC i/iX family provide significantly improved vacuum performance in a wide range of applications. Especially due to the expansion of the family in the direction of higher pumping speeds and compression values, lower service costs and simple, intuitive operation. In some applications, the integration of the new 850 i/iX and 950 i/iX models will even lead to a significant reduction in the number of pumps and thus in the total life cycle costs. Mountable in any orientation These options are also useful for another reason: Each vacuum application has different installation conditions. This requires flexible installation directions, for example when there is little space for vacuum pumps, as is the case when integrating them into compact, industrial pumping system solutions. Here too, the TURBOVAC i/iX series, with its various models and variants in terms of pumping speeds or compression ratios, is one of the most flexible systems on the market for high-vacuum products and can be mounted in any orientation. Flexible integrated drive electronics Especially in order to promote sales in the industrial and coating market, EthernetIP, EtherCAT and Profinet Anybus options are now added to the existing Profibus, RS232 and RS485 communication modules. They are all available as IP54 versions. The EthernetIP, EtherCAT and Profinet modules have an integrated web server. TURBO.CONTROL i The entire TURBOVAC i/iX series can be controlled and monitored via the TURBO.CONTROL i. The advantage of the controller is that it is equally suitable for integration in high-vacuum applications and compact system solutions. Its application is uncomplicated: It can be operated intuitively via the display and front keys or via a web server interface. The web server allows all pump parameters to be easily monitored and set via PC or mobile device. Cost effective maintenance with very long intervals Last but not least, the maintenance-free and oil-free hybrid bearing concept ensures greater reliability and a longer service life: On the high-vacuum side, the rotor of the turbomolecular pump is guided in a wear-free magnetic bearing, while a ceramic ball bearing lubricated for life is integrated on the backing side, which users can replace themselves on site if necessary. For further information, please contact: Séverine Grimberg Global Communications Coordinator Scientific Vacuum Division Atlas Copco Vacuum Technique Bonner Strasse 498 50968 Cologne Phone: +49 221 347 1211 – Mobile: +49 160 91556457 E-mail: severine.grimberg@vt.atlascopco.com About Leybold Leybold is a part of the Atlas Copco’s Vacuum Technique business area and offers a broad range of advanced vacuum solutions for use in manufacturing and analytical processes, as well as for research purposes. The core capabilities centre on the development of application- and customer-specific systems for the creation of vacuums and extraction of processing gases. Fields of application are secondary metallurgy, heat treatment, automotive industry, coating technologies, solar and thin films such as displays, research & development, analytical instruments, food & packaging, as well as a multitude of other classic industrial processes. About Atlas Copco Great ideas accelerate innovation. At Atlas Copco, we have been turning industrial ideas into business- critical benefits since 1873. By listening to our customers and knowing their needs, we deliver value and innovate with the future in mind. Atlas Copco is based in Stockholm, Sweden with customers in more than 180 countries and about 37 000 employees. Revenues of BSEK 95/ 9 BEUR in 2018. For more information: www.atlascopcogroup.com

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. Ebola virus disease is a rare but severe and often fatal illness. Between 25% to 90% of the patients who contracted the disease died in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. Currently, the Democratic Republic of Congo (DRC) is fighting an Ebola epidemic. It was declared a public health emergency of international concern by the World Health Organization (WHO) in July 2019. So far, more than 3,400 people in DRC have been infected with the Ebola virus during the ongoing outbreak, and approximately 67% of those infected have died. The recommendation to grant a marketing authorisation for the new vaccine follows the approval of the first Ebola vaccine in November 2019. 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. This prophylactic 2-dose regimen is therefore not suitable for an outbreak response where immediate protection is necessary. As a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to Ebola virus, for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak, who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen more than four months ago. The ability to make the immune system respond to the virus after vaccination with Zabdeno and Mvabea was studied in a total of 3,367 adults, adolescents and children who participated in five clinical studies conducted in Europe, Africa and the USA. These studies demonstrated that the vaccine regimen is safe and could induce an immune response against Ebola virus. Efficacy data in humans has been extrapolated from animal studies. The exact level of protection provided by the vaccine regimen is however unknown. The most common side effects found in participants in the clinical trials were injection-site reactions (pain, warmth and swelling), fatigue, headache, myalgia, arthralgia and chills. Effectiveness data are being collected through an ongoing observational study in DRC. The results of this and other studies must be included in post-marketing safety reports which are continuously reviewed by EMA. As protection against Ebola virus disease is considered to be of major public health interest, 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. Currently, there are no therapies approved for Ebola. EMA is working together with regulatory authorities around the world to support WHO and to advise on possible pathways for the development, evaluation and approval of medicines and vaccines to fight Ebola. Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation. This was considered acceptable in light of the ongoing Ebola outbreak and high mortality rates in DRC. The opinion adopted by the CHMP is an intermediary step on Zabdeno and Mvabea’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State taking into account the potential role/use of the new Ebola vaccine in the context of the national health system of that country. Notes The applicant for both Zabdeno and Mvabea is Janssen-Cilag International N.V. A dose of Zabdeno vaccine should be administered as the first vaccination. A dose of Mvabea vaccine should be administered as the second vaccination approximately eight weeks after the first vaccination with Zabdeno. Contact point EMA press office Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu Follow us on Twitter @EMA_News

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. Several observational studies in COVID-19 have reported that chloroquine and hydroxychloroquine are associated with an increased risk of heart problems, a well-known side effect of such treatments, including cardiac arrhythmias and cardiac arrest. When prescribing these medicines, healthcare professionals should take into account pre-existing heart conditions, uncorrected potassium or magnesium imbalance, and concomitant use with medicines that prolong the QT interval as these factors may make patients more prone to heart rhythm disorders. Healthcare professionals should also note that heart rhythm disorders may be more likely or be more severe if chloroquine or hydroxychloroquine are used at higher doses than those recommended for their authorised indications or if they are combined with certain antibiotics such as azithromycin. EMA has previously communicated on these risks. In addition to their effects on the heart, these medicines may cause neuropsychiatric disorders, including agitation, insomnia, confusion, psychosis and suicidal ideation. These medicines are also known to affect the liver, cause neuronal damage that can lead to seizures (fits), and lower blood sugar. In view of the emerging data, some EU countries have suspended or stopped clinical trials investigating chloroquine and hydroxychloroquine in COVID-19 patients. For some trials, including WHO’s large multinational Solidarity trial, enrolment of patients to trial arms with these medicines has been suspended. A preliminary review of the Recovery trial, a large ongoing study on COVID-19 patients, did not identify reasons to suspend or stop the trial. EMA reiterates that while further analyses of available data are being carried out, chloroquine and hydroxychloroquine should only be used in clinical trials for treatment or prophylaxis of COVID-19 or in national emergency use programmes in hospitalised patients under close supervision. It is important that properly designed, randomised clinical trials can be completed, with adjustments as needed, to generate the necessary evidence on benefits and risks of these medicines in COVID-19. Patients who have been prescribed chloroquine or hydroxychloroquine for authorised indications (malaria and certain autoimmune diseases such as rheumatoid arthritis and lupus) should continue to take their medicines as advised by their doctor. Patients who have any questions about their treatment should talk to their doctor or pharmacist. EMA and the national competent authorities are closely monitoring medicines used in the treatment of COVID-19 and will continue communicating and take action as new information emerges. In addition, EMA continues to collaborate and share information with the WHO and international regulators. Patients and healthcare professionals are reminded to report any suspected side effects to their national regulatory authorities. This EMA public health statement has been issued by the COVID-19 EMA pandemic Task Force (COVID-ETF). EMA Press office Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu Follow us on Twitter @EMA_News

EVANSVILLE, Ind. – June 3, 2020 – Berry Global Group, Inc. (NYSE: BERY) announced today its collaboration with longtime customer, Mondelēz International to supply packaging containing recycled plastic for Philadelphia, the world’s most popular cream cheese. The package contains plastic material recovered using advanced recycling technology from Berry’s partnership with SABIC, announced earlier this year. Berry prides itself on its ability to provide sustainable, value-added packaging for leading brands around the world and is proud to collaborate with Mondelēz International to improve the sustainability of their packaging. “We are pleased to partner with Mondelēz International in providing packaging made from this advanced recycling technology. By recovering and diverting plastic that would have otherwise been sent to landfill or incineration, we are working towards our common goal of promoting a circular economy,” said Jean-Marc Galvez, President of Berry’s Consumer Packaging International Division. Today’s announcement adds to Berry’s list of initiatives to advance towards a more sustainable future. These initiatives include investment in both mechanical and chemical recycling, the innovative use of recycled material in products, and global commitments to address plastic waste in the environment. Last year, Berry committed that 100 percent of its fast-moving consumer goods packaging would be reusable, recyclable, or compostable by the year 2025. “This is an exciting project which demonstrates our ability to supply a leading worldwide brand with a solution to not only aid in their sustainability commitments, but which also aligns with Berry’s,” said Galvez. About Berry Berry Global Group, Inc. (NYSE: BERY), headquartered in Evansville, Indiana, is committed to its mission of ‘Always Advancing to Protect What’s Important,’ and proudly partners with its customers to provide them with value-added protective solutions that are increasingly light-weighted and easier to recycle or reuse. The Company is a leading global supplier of a broad range of innovative rigid, flexible, and nonwoven products used every day within consumer and industrial end markets. Berry, a Fortune 500 company, has over 48,000 employees and generated $12.6 billion of pro forma net sales in fiscal year 2019, from operations that span over 290 locations on six continents. For additional information, visit Berry’s website at berryglobal.com. Media Contact: Nielsen McAllister Public Relations Limited +44 (0) 1322 293939 info@nmpr.co.uk