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EMA CHMP recommends seven medicines for approval
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
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Partnership between the BP and USP to be formalised
The British Pharmacopoeia and United States Pharmacopeia partnership is to be formalised to strengthen the quality of medicines and public health.
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Treatment for dialysis patients with CKD anaemia approved in Japan
A treatment for anaemia associated with chronic kidney disease in dialysis patients has been approved in Japan.
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New cancer drugs approvals underpinned by flawed evidence
A new report has shown that trial evidence alone is not enough when approving new cancer drugs and that an assessment of that evidence is also needed.
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Demand for containment facilities and manufacturing to grow
The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.
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Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
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Germany imports largest ever shipment of EU medicinal cannabis
An import of medicinal cannabis from Portugal to Germany signifies the largest quantity ever moved within the EU, highlighting a surge in the medicinal cannabis products market.
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Operation Yellowhammer file confirms drug shortages after no-deal Brexit
The Operation Yellowhammer document has been published, which states that the UK will experience severe delays to the medical supply chain following a no-deal Brexit.
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FDA grants Orphan Drug Designation to sotatercept
Orphan Drug Designation has been given to sotatercept for the treatment of patients with pulmonary arterial hypertension.
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Innovative Medicines Canada files against federal plans
The lobbying group Innovative Medicines Canada has announced its lawsuit against plans to lower drug prices in the country.
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Scottish Medicines Consortium approves Kymriah® CAR-T therapy
The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
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CEO of Novartis pledges to speed data integrity disclosures
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
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Fosaprepitant and Decitabine generics receive FDA approval
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
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EC approves expanded use of ustekinumab for ulcerative colitis
The biologic treatment ustekinumab has been granted an expanded use for ulcerative colitis within the EU.
