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Opicapone approved in Japan
BIAL announced today that Opicapone tablets 25 mg received a manufacturing and marketing approval in Japan for the improvement of the end-of-dose motor fluctuations (wearing-off phenomenon) in Parkinson's disease in combination with levodopa-carbidopa or levodopa–benserazide hydrochloride.
FDA approves Opicapone
BIAL announced today that the U.S Food and Drug Administration (FDA) has approved Opicapone as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. “We are very pleased to achieve this major regulatory milestone for Opicapone, which offers patients living with Parkinson´s disease an effective, once-daily adjunctive treatment option to the gold standard levodopa/dopa-decarboxylase inhibitors preparations. This approval is a landmark in BIAL’s ongoing commitment to the quality of life of Parkinson’s patients and their caregivers. We look forward to working with our partner in the U.S., Neurocrine Biosciences, to make this therapy available to patients.” said António Portela, CEO of BIAL. In February 2017, BIAL and Neurocrine Biosciences entered into an exclusive licensing agreement for the development and commercialization of Opicapone in the U.S. and Canada. The commercial launch of Opicapone in the U.S.is expected to occur later in 2020. The FDA approval of Opicapone is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2). In BIPARK-1, a randomized, double-blind placebo- and active-controlled study, approximately 600 patients with Parkinson’s disease and end-of-dose motor fluctuations received once-daily doses of Opicapone (5 mg, 25 mg, or 50 mg), placebo or 200 mg of the COMT (catechol-O-methyltransferase) inhibitor entacapone for 14 to 15 weeks as adjunct to levodopa therapy. In BIPARK-2, which followed a similar study design, approximately 400 patients received once-daily doses of Opicapone (25 mg or 50 mg) or placebo
BIAL launches new campaign ‘Don’t let Parkinson’s stop you. Keep on moving’
Awareness raising film shows disease doesn’t define or confine people with Parkinson’s PORTO, Portugal, 6 April 2020 - BIAL Pharmaceuticals has created a new film for World Parkinson’s Day 2020 to dispel the stigma around Parkinson’s and show the amazing achievements, breadth and diversity of people living with the condition. The film, “Keep on moving”, is the latest part of a worldwide campaign, launched by BIAL four years ago. The campaign aims to increase awareness and knowledge of Parkinson's Disease and to inspire and empower millions of people living with Parkinson’s around the world.
Bial creates COVID-19 fund to help community
BIAL has just announced the creation of a fund, with an allocation of 500 thousand Euros, to support several community initiatives in the fight against the coronavirus. "BIAL, as a pharmaceutical company, in addition to ensuring the total maintenance of its activity, which is critical for millions of patients, also intended to make its contribution to the community by creating a fund that we endowed with half a million euros.", said António Portela, CEO of the company. “Unfortunately, we are experiencing a crisis of Public Health worldwide, where the collaboration between all stakeholders - States, governments, universities, companies and society in general - is crucial. With this action, BIAL aims to respond to different needs, some of which have already reached us, from health professionals and institutions, from welfare institutions or within the scope of programs and projects addressed to provide better provision care.”, adds António Portela. Ensuring the supply of medicines in the markets where the company operates is critical for BIAL, which currently does not anticipate constraints in terms of the continuous supply of its medicines. With most employees on home office, people from the Industrial, Quality and Logistics areas continue to work at the company's headquarters, that have extended the production period to reinforce the stocks of their medicines. Having health and safety of its employees and the continuity of the company's operations as priorities, BIAL has defined and has been updating, since the beginning of March, a Contingency Plan focused on the prevention and control of the new coronavirus. Among the measures adopted, BIAL proactively suspended all direct interactions of its employees with Pharmacies, Doctors and other Health Professionals. All visits to the company's headquarters were also cancelled, except for the ones related with the supply of products and materials essential to the maintenance of its activity, as well as the dispatch of medicines. At the same time, a series of measures were reinforced to ensure the safety of employees who remain working, namely in terms of hygiene and social distance. BIAL is constantly monitoring the authorities' guidelines to act accordingly, to update - if necessary - the Contingency Plan that is underway and to ensure that its medicines continue to reach all patients in need.
COVID-19
Aligned with BIAL's position of responsibility, having as a priority the Health of our employees and the continuity of the company's operations in order to ensure the availability of our medicines to all patients, BIAL has been implementing a wide set of measures to prevent and control the spread of the new Coronavirus (COVID-19). BIAL has developed and is implementing a strict Contingency Plan, in accordance with the recommendations of the World Health Organization. We believe that each of us has a role to play in controlling this epidemic. BIAL assumes and will continue to assume a socially responsible position, hoping to actively contribute to the prevention and control of the COVID-19 epidemic and ensure that our medicines remain available to all patients.
BIAL obtain the renewal of the Certificates of its Management Systems of Quality, Environment and Occupational Health and Safety
Certificates of Management Systems of Quality, Environment and Occupational Health and Safety, implemented in accordance with ISO 9001 / ISO 14001 / OSHAS 18001 standards, respectively These renovations reflect the consistency of BIAL’s Management Systems and the importance that each of these areas assume: Quality, as a strategic pillar of the company, the promotion of a healthy and safe work environment for all employees and environmental protection, translated into the recent signing of the “Business Ambition for 1.5ºC” agreement, an initiative of the United Nations Global Compact, to which BIAL has been a signatory since 2004.
BIAL Italy granted ISO 9001 certification, an entitlement on Quality Management Systems
BIAL Italy S.R.L has just been successfully granted the ISO 9001:2015 certification, by Certiquality/ IQNET. ISO 9001 takes over a process-based approach, which incorporates the PDCA (Plan-Do-Check-Act) cycle of continuous improvement, and integrates risk-based thinking. With this achievement BIAL Italy demonstrates its trustfulness and quality, with the ability to consistently provide products and services that meet customer, partners and regulatory requirements, using a global recognized standard. In Portugal, BIAL is certified by APCER/ IQNET since 1998. Certificato IQnet BIAL Italia S.R.L.: 9001 - 2015
The American Heart Association distinguished the work of BIAL’s R&D team
Four researchers from BIAL’s Research and Development (R&D) area were recognized as a "2019 Paul Dudley White International Scholar" by the American Heart Association. At the American Heart Association Scientific Sessions 2019, an event held in Philadelphia. The award aims to recognize authors that contributed to the highest ranked accepted abstract from each country.
BIAL responds to the call and signs “Business Ambition for 1.5ºC” agreement
Signed by several business leaders, this initiative empowers companies worldwide, and BIAL has made the commitment. The initiative of the United Nations Global Compact, to which BIAL has been a signatory since 2004, establishes specific targets and emission reduction goals, in order to reach the net-zero emissions by 2050 and restrict the global warming in 1.5ºC by 2030. “The document encourages organizations to truly commit themselves to the preservation of the planet by requiring them to commit to concrete measures to reduce greenhouse gas emissions, critical to stop global warming. Achieving the transition to a low carbon economy and avoiding the atmosphere’s overheating are its main goals”, according to the Global Compact Network Portugal’s statement. Find out more at https://unglobalcompact.org/take-action/events/climate-action-summit-2019/business-ambition.