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Drug Research

UK’s NICE recommends Novartis’ Afinitor to treat neuroendocrine tumours The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Afinitor (everolimus) to treat unresectable or metastatic neuroendocrine tumours (NETs) in patients with progressive disease. News

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Drug Delivery

AstraZeneca recalls physician sample bottles of BRILINTA heart drug
AstraZeneca said that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of BRILINTA (ticagrelor) 90mg tablets as a precautionary measure.
Drug Research > Drug Delivery > News
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News

Drug Discovery & Development

FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
Production & Manufacturing > Process & Production > News
Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
Production & Manufacturing > Process & Production > News