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MHRA consultation on application of AQbD principles enters last month
An MHRA consultation is due to end on 31 August, with public comments on AQbD principles closing soon.
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FDA grants Rozlytrek cancer treatment approval
The cancer therapeutic, Rozlytrek, has gained FDA approval as well as Priority Review, Breakthrough Therapy and Orphan Drug Designations.
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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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Pharma bodies confirm signing NDAs for no-deal Brexit plans
The DHSC has confirmed that several pharmaceutical industry bodies have agreed to NDAs regarding plans for a no-deal Brexit.
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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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New drug for treatment-resistant forms of tuberculosis approved
Pretomanid in combination with bedaquiline and linezolid has been approved by the FDA for treatment-resistant tuberculosis of the lungs.
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Cannabinoids in pharma series: cannabinoids on the market today
This series investigates the growing interest from the pharmaceutical industry in cannabinoids. In this first piece, we hear from industry experts about the current situation of the ingredient on the pharmaceutical market.
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Imbruvica® granted expanded use from European Commission
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
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FDA to deactivate out-of-date drug listings in its database
In order keep up-to-date records and protect public health the FDA has announced it intends to deactivate out-of-date drug listings.
Whitepapers/App Notes/Posters
Application note: MiniCapt® – Mobile Microbial Air Sampler
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.
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Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
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Amgen wins court patent ruling over Sandoz biosimilar
The US District Court has decided in favour of Amgen’s Enbrel, ruling over Sandoz’s Erelzi in a patent conflict.
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US court rules in favour of Lilly in Alimta® patent lawsuit
The US District Court has ruled in favour of Eli Lilly in the Alimta patent lawsuit against Dr. Reddy's Laboratories and Hospira, Inc.
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NICE releases draft guidance for using cannabis-based medicinal products
The NICE and NHS have announced their draft recommendations for the prescribed use of cannabis-based treatments.
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FDA antibody biosimilar product approvals increase in 2019
2019 has seen a marked increase of antibody biosimilar product approvals in the first half of the year, according to a report.