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Pharmafile 01/22/2020 05:15
Novartis has inaugurated its new legal entity in Vietnam, Novartis Vietnam Co Ltd, and has become one of the first multinational companies in the country to transform from a representative office to a foreign-invested enterprise importer. During the inauguration ceremony, Novartis announced the arrival of the first import shipment of its medicines in the port of Ho Chi Minh City.
Pharmafile 01/21/2020 07:45
NICE has published draft guidance which does not recommend Stelara (ustekinumab) for treating moderately to severely active ulcerative colitis in adults, due to concerns about cost-effectiveness. Stelara would have been given when conventional therapy or a biological agent could nnot be tolerated or the disease responded inadequately or lost response to treatment.
Pharmafile 01/21/2020 07:31
Jazz Pharmaceuticals has secured approval from the European Commission for Sunosi (solriamfetol), it has emerged, as a therapy to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) or narcolepsy with or without cataplexy. The indication relates to patients whose EDS has not been effectively tackled by primary OSA therapy.
Pharmafile 01/21/2020 05:16
The European Medicines Agency (EMA) has granted a licence for the use of Mayzent (siponimod) in the treatment of certain adults with secondary progressive multiple sclerosis (SPMS). Mayzent is a tablet that is taken daily, and is the first oral disease-modifying treatment for patients with an active disease. The EMA granted the license based on Phase 3 data from the EXPAND trial.
Pharmafile 01/20/2020 07:24
Following the recommendation of the tablet formulation of the drug for use on the NHS in England and Wales, news has broken that AstraZeneca and MSD’s Lynparza (olaparib) has been accepted by the FDA in the US under Priority Review. The therapy is indicated in metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations in patients who have progressed following prior treatment with a new hormonal agent.
Pharmafile 01/20/2020 05:17
UK drug watchdog NICE has turned down Bayer’s Vitrakvi (larotrectinib) as a tumour-agnostic treatment solution on the NHS after it could not consider it a cost-effective use of the health service’s limited resources due to a lack of evidence. The therapy was being considered in the treatment of advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children who have no satisfactory treatment options.
Pharmafile 01/20/2020 04:39
The viral pneumonia outbreak that began in Wuhan China can spread between person to person, according to health experts at the World Health Organisation (WHO). Dr Takeshi Kasai, the WHO's Regional Director for the western pacific, said: "It is clear that there is at least some human-to-human transmission from the evidence we have, but we don't have clear evidence that shows the virus has acquired the capacity to transmit among humans easily."
Pharmafile 01/17/2020 06:48
Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA has move to authorise Blueprint Medicines’ kinase inhibitor Ayvakit (avapritinib) for the treatment of unresectable or metastatic gastrointestinal stromal tumours. In Europe, Sanofi has revealed that the European Commission has expanded the existing label for Toujeo to include the treatment of children and adolescent patients with diabetes.
Pharmafile 01/17/2020 06:31
Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded marketing approval to ViiV Healthcare, a subsidiary of GSK, for its once-daily pill Dovato (dolutegravir 50 mg/lamivudine 300 mg) for the treatment-naïve HIV-1 infection in patients of at least 12 years old who weigh at least 40kg. Data drawn from over 1,400 HIV-1 patients and submitted to the MHLW showed that Dovato proved non-inferior compared to the combination of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine, in plasinma HIV-1 RNA <50 copies per millilitre (c/mL) at 48 weeks of treatm.
Pharmafile 01/17/2020 06:10
A UK wide trial called MND-SMART has invited hundreds of people with motor neurone disease (MND) to participate. It will analyse treatments that can slow, stop or reverse disease progression. The trial has been developed by people with MND and clinical trial experts from across the UK. This includes specialists from the Euan MacDonald Centre for MND Research at the University of Edinburgh, University College London and the University of Warwick.
Pharmafile 01/17/2020 04:30
Novo Nordisk has seen label expansions approved from the FDA for both its glucagon-like peptide-1 (GLP-1) analogue injection Ozempic (once-weekly semaglutide) and its GLP-1 oral tablet Rybelsus (oral semaglutide). The expansions are indicated for the reduction of the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adult type 2 diabetes patients with established cardiovascular disease (CVD).
Pharmafile 01/16/2020 06:52
It has been announced that tablet form of Lynparza (olaparib), the PARP inhibitor developed by AstraZeneca and MSD, has secured recommendation from NICE for the treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in adult patients with a BRCA1 or BRCA2 mutation. Data supplied in support of the case for the drug’s recommendation demonstrated that Lynparza presented a progression-free survival benefit of 19.1 months, compared to 5.5 months for placebo.
Pharmafile 01/16/2020 06:22
The US and China signed the first part of a broader trade pact that included setting up a system to resolve conflicts over drug patents between the two countries. In a statement the Trump administration said: "Robust protection of intellectual property is critical to incentivizing the development of new and innovative treatments and cures."


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