Industry news
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Global Guidance on Medicines and Diagnostic Tests Updated by WHO
12 July 2019
WHO’s Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable throughout health systems.
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Score! 'Good Pharma' ranking finds uptick in new drug data sharing and clinical trial transparency
12 July 2019
Pharma companies are learning to share. That is, when it comes to clinical research data, according to findings from the Good Pharma Scorecard biennial ranking. Now in its third edition, the research found Big Pharma data sharing around clinical research on the upswing, with 95% of patient trials now providing public results within six months of FDA approval. If the time period is extended to 12 months, that improves to 100% for the new drugs reviewed after approval in 2015.
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FDA promises ‘elevated’ new drug approvals, but warns of potential pitfalls: report
11 July 2019
The FDA has approved 14 new drugs so far this year, lagging behind the 20 approvals it had charted by this time last year. Is it a sign that the FDA is becoming more cautious in the wake of Scott Gottlieb’s departure? After all, it was under his tutelage that the agency churned out a record 56 green lights in 2018. Don’t worry, biopharma industry: The FDA's still committed to accelerated drug development and approvals. That was the message from the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, M.D., who appeared Tuesday at the SVB Leerink Therapeutics Day in Boston.
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Chinese Pharmaceutical Packaging Industry Grows Up
11 July 2019
A new study has found that the Chinese pharmaceutical packaging industry has grown at rates of around 10 percent in recent years. The report also says that the market was worth RMB100 billion in 2018 but is now worth RMB107.4 billion.
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WHO Updated Lists of Essential Medicines and Diagnostics
10 July 2019
WHO’s Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable throughout health systems.
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India’s Pharma Industry to Grow by 11-13% in 2020
10 July 2019
Indian pharmaceutical industry is likely to grow by 11-13% in the current fiscal, rating agency Icra said. “The growth trajectory for the Indian pharmaceutical industry is likely to remain at 11-13% in FY2020, on the back of healthy demand from the domestic market, given increasing spend on healthcare along with improving access,” - Icra said in a release.
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EU Network Takes Steps to Resolve Medicines Shortages
09 July 2019
The European Union task force set up to address problems with medicines supply has published two documents today guidance for marketing authorisation holders on reporting of shortages in the EU and good practice guidance for communication to the public on medicines’ availability issues.
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Joint GMP Inspection of the Eurasian Economic Union Inspectorates
08 July 2019
On 18-20 June a joint pharmaceutical inspection of the Eurasian Economic Union inspectorates, organized within the Working Group on formulating common approaches in regulation of drugs circulation within the Eurasian Economic Union and the Working group, which is currently being established, on issues related to pharmaceutical inspections’ conformity with the rules of Good Practices in the field of drugs circulation within the Eurasian Economic Union under the Board of the Eurasian Economic Commission for pharmaceutical inspectorates cooperation and mutual exchange of experience for the purpose of consolidating single approaches to pharmaceutical inspection of drug manufacturing for compliance with the Rule requirements of the Eurasian Economic Union’s Good Manufacturing Practice.
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Partnership for New Parkinson’s Disease Treatment
08 July 2019
The University of Dundee‘s Drug Discovery Unit (DDU) has announced a multi-million-pound partnership with Korean-based Bukwang Pharmaceutical Company in a bid to develop a new drug treatment for Parkinson’s disease. This announcement builds upon existing drug discovery partnerships the DDU has with Takeda and GSK.
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Seizing the Opportunity in Europe
05 July 2019
Bruno Wohlschlegel is a recognized leader with a wealth of strategic and operational achievements. His track record includes launch experience, marketing, business transformation from primary care to oncology, leadership of local and regional operations, as well as global responsibilities in executive leadership teams.
