Since I now have a piqued interest in the application of artificial intelligence in pharmacovigilance, I was interested to read the findings from a study using machine learning to identify ICSRs in social media. Until now, my impression of ADRs reported in the social media was that identifying valid ICSRs was more than challenging due to their diversity, complexity, colloquialisms and anonymity. Also, it seems the regulatory authorities acknowledge these challenges as it is not yet a regulatory requirement to monitor social media as a source for ICSRs. But is this looking set to change if machine learning and automation become the norm? Continue reading “Using state-of-the-art technology to combat challenges unique to 21st century culture”
In February 2018, durvalumab (IMFENZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy. Continue reading “Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA”
In November 2017, benralizumab (Fasenra™), developed by Kyowa Hakka Kirin & AstraZeneca, received its first global approval in the USA as add-on maintenance therapy for patients with severe eosinophilic asthma who are at least 12 years old.  Continue reading “Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.”
The recent first global approval of netarsudil ophthalmic solution 0.02% has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In December 2017 netarsudil (Rhopressa®), developed by Aerie Pharmaceuticals, received its first global approval in the US for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Interestingly, this approval was made two months in advance of the official scheduled Prescription Drug User Fee Act (PDUFA) goal date of 28th February 2018. Continue reading “Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma”
According to the Kyoto Encyclopedia of Genes and Genomes (KEGG), inotozumab ozogamicin (Besponsa®), developed by Pfizer, was also approved in Japan in January 2018. Continue reading “Inotuzumab ozogamicin (Besponsa®): Follow up Approval in Japan”
Chikungunya virus is a mosquito-borne viral infection that presents with headache, rash, muscle pain, and joint swelling; the latter two symptoms can persist and be debilitating for up to 6 months after initial infection.
Known outbreaks have occurred in several countries located in Europe, Africa, Asia, the Pacific and Indian Oceans and also the Americas. As well as local transmission via mosquitoes, more wide-spread transmission by infected travellers is feared.
Currently, according to the Centers for Disease Control and Prevention (CDC), the only effective prophylaxis available for this viral infection is to not get bitten by mosquitoes! Continue reading “Tropical virus Chikungunya in the eye of a storm”
Automation, machine learning, artificial intelligence, robots – hearing such terms mentioned in the workplace can strike fear in the everyday employee, that soon the human workforce will be replaced entirely by a ‘digital workforce’. And of course many sci-fi movies only play on this hype. Whilst in certain industries or for specific job roles there may be more than an element of truth to this, in the pharmacovigilance world, using machines to supplement human input is not only a necessity but also a blessing. Or so I learnt at the International Society of Pharmacovigilance (ISOP) Seminar on Intelligent Automation in Pharmacovigilance, held in Boston in December 2017. Continue reading “Why rise of the machines will be beneficial in the pharmacovigilance world”
Ocrelizumab has now also been approved in the EU for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features. This European approval in January 2018, followed two previous approvals in 2017, granted to Genentech, the developers, initially in the US (March)  and later in Canada (August) for the same indication. Continue reading “Ocrelizumab (Ocrevus®): Now also approved in the EU”
In January 2018, plecanatide (Trulance®), developed by Synergy Pharmaceuticals, received approval for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). This is the second indication for the agent and comes a year after its first global approval in the US for the treatment of adults with chronic idiopathic constipation (CIC). Continue reading “Plecanatide (Trulance®): Follow up Approval for IBS-C, a second indication, in USA”
On December 5th 2017, semaglutide (Ozempic®), developed by Novo Nordisk, received its first global approval in the US. Nine days later the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in the EU. This was followed swiftly by Health Canada’s approval in January 2018.  In all cases, semaglutide was approved for use in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control. The drug is dispensed as prefilled pens for subcutaneous injection once weekly. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner. It is administered on the same day each week, at any time and without regard for food intake. Continue reading “Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?”