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Licence extension submission accepted for kidney disease treatment by EMA
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
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Drug Markets
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Significant number of drugs on the market not yet fully approved
A large number of drug manufacturers are failing to complete the FDA's Accelerated Approval Program, meaning not all available drugs are fully approved, finds a study.
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Drug makers file complaint for regulations to lower Canadian drug prices
Five pharma companies have filed a complaint in Canadian court over new rules intended to lower the price of drugs in the country.
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Cannabinoids in pharma series: the future prospects of cannabinoids
This series investigates cannabinoids and pharmaceutical interest with industry experts explaining the position of the ingredient. In this third piece, we discuss the future of the cannabinoid industry and how it will grow within the realm of pharmaceuticals.
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Cervical cancer vaccine market set to increase at 12.1 percent CAGR
A recent report has predicted that the cervical cancer vaccine market will increase to $6bn by the end of the forecast period.
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OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
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Brand-name drug prices found to be rising at a slower pace in lower amounts
Drug companies are still raising prices for brand-name prescription medicines but not as often or by as much as they used to.
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RINVOQ™ arthritis treatment granted approval by FDA
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.
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US appeals court overturns patent case for Jevtana
Sanofi has won the latest appeal for the patent of its top oncology product, Jevtana (cabazitaxel).
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Global cephalosporin drugs market projected to rise 3.34 percent
The worldwide trade of the cephalosporin class of antibiotics will increase to $14.1 billion by the end of 2025.
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Complete response letter sent for two generic products
A complete response letter (CRL) has been sent to Dr Reddy’s for two generic products.
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Drug supplier Aspen to pay NHS £8m after competition probe
The CMA alleges that Aspen broke competition law, prompting the drug supplier to offer a payment and other compensations to the NHS.
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FDA to deactivate out-of-date drug listings in its database
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
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Ebola clinical trial stopped early due to positive results
An Ebola clinical trial has been stopped early as Regeneron's REGN-EB3 therapy shows superiority to ZMapp in preventing Ebola deaths.
