Industry news
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New Pharmaceutical Plant of Russian Company Will Be Opened in Baku Soon
11 June 2019
Russia sees a significant unrealized potential for the development of economic relations with Azerbaijan, said the participants of the business breakfast, which was held within the 23rd St. Petersburg International Economic Forum (SPIEF) in Russia, Trend reports with reference to the video materials of the forum.
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Two More Countries Entered EU-FDA Mutual Recognition Agreement
11 June 2019
On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different territories and this means that the FDA will now rely on a total of 26 Member States whose inspection results can replace their own inspections.
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EMA Strengthens Cooperation with General Practitioners
10 June 2019
EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – the European Union of General Practitioners (UEMO) and the European section of the World Organization of Family Doctors (WONCA) – and the major organisation representing primary care professionals in Europe, the European Forum for Primary Care (EFPC), have signed a joint statement committing to strengthening interaction between EMA and this important group of healthcare professionals.
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The Architecture of Public Health: International Experience and National Priorities
10 June 2019
“Forty-one per cent of deaths in Russia are potentially avertable. Of this figure, just under half are avertible through a comprehensive set of reasons stemming from economic, social, and other factors. We call this public health. This is about promoting health in general and encouraging people to lead healthy lifestyles,” - Veronika Skvortsova, Minister of Health of the Russian Federation.
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New Russian Gastric Cancer Treatment Passed Pre-Clinical Trials
07 June 2019
Our colleagues have brilliantly finished pre-clinical trials, although this process was not easy. The company has scored significant results, won high marks from experts and secured sufficient funding. Clinical trials are to begin soon. Patients are eager to get the new treatment, Kirill Kaem, Skolkovo Foundation’s senior vice president for innovations, said at a press conference.
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FDA Requirements for Cleaning Validation
06 June 2019
Official GMP inspection reports deliver helpful answers to the question what do authorities require regarding cleaning validation. Through the Freedom of Information Act, the FDA is required to publish inspection results. This is particularly the case with Warning Letters. Here, even details of deficiencies regarding cleaning validation are included in the Warning Letter.
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06 June 2019
The $1.18tr forecast for the 2024 global prescription drug market reflects the role new technologies will play in addressing unmet medical needs, as strong expectations for immuno-oncology products and emerging cell and gene therapies drive growth. In 2018, new molecule approvals from the FDA reached their highest level in over a decade, and the projected CAGR of 6.9% from 2019-2024 significantly outpaces the 2.3% CAGR seen from 2010-2018.
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Top 15 Largest Pharma Companies Funneled more than $100b into R&D in 2018
05 June 2019
Big Pharma companies are still, naturally, the big spenders in drug R&D, and the numbers are impressive: last year, and for the first time, the top 15 largest companies (by sales) funneled more than $100 billion into research, and we also saw the FDA approve more drugs than ever before.
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FDA Announce New Pilot Program for Oncology Health Care Professionals
04 June 2019
The U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. A new call center called Project Facilitate will be a single point of contact where FDA oncology staff will help physicians treating patients with cancer through the process to submit an Expanded Access request for an individual patient, including follow-up of patient outcomes.
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China's driving sales growth ahead of the U.S. for Big Pharma. But can it last?
04 June 2019
If you follow Big Pharma companies’ investor updates, you’ll notice China popping up frequently these days. The world’s second-largest pharmaceutical market has been turning up sales increases that continuously surpass those in the U.S. and other developed regions.
