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Pharmafile 11/14/2019 08:15
A new report released on World Diabetes Day has shone a light on a startling lack of knowledge surrounding type 2 diabetes, a condition that accounts for around 90% of the over 450 million cases of diabetes worldwide, according to the World Health Organization. The report, released by Merck KGaA and conducted by YouGov, collated the responses of 9,350 adult participants across nine countries: Brazil, Mexico, Russia, United Arab Emirates, Malaysia, Vietnam, China, Saudi Arabia and Chile.
Pharmafile 11/14/2019 07:55
Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), after the independent panel voted against the use of the pair’s SGLT2 inhibitor empagliflozin (branded as Jardiance) as an add-on insulin therapy in the treatment of type 1 diabetes. The drug is already approved, with the FDA passing approval in 2014 for the reduction of blood sugar levels in type 2 diabetes patients.
Pharmafile 11/14/2019 07:30
UK non-profit organisation Myeloma UK has selected Sarah McDonald as its new Director of Research, who in her new role will galvanise research and patient advocacy efforts within the company in the spirit of "advancing the organisation’s impact within the blood cancer research community". McDonald joins the organisation from fellow non-profit Sarcoma UK where she served as Director of Research and Policy.
Pharmafile 11/14/2019 07:09
NICE has chosen to recommend Consilient Health’s Elmiron (pentosan polysulfate sodium) for the treatment of bladder pain syndrome (BPS), it has emerged, for patients whose condition has not responded to oral treatments and are not offered the drug in combination with bladder instillations. The decision was reached as the two parties agreed to a patient access scheme to make the drug available to NHS patients.
Pharmafile 11/14/2019 06:52
MSD has announced its plans to put its Centre de Mirabel production facility in Riom, France up for sale – a move that will see the company axe more than 200 staff as part of its $1.2 billion reorganisation of its manufacturing operations to "further optimise the company’s manufacturing and supply network, as well as reduce its global real estate footprint". The sale will terminate 101 positions in production and 106 in R&D, a considerable portion of the 584 total active roles at the facility, which predominantly deals with the production and packaging of sterile antibiotic inj.
Pharmafile 11/13/2019 08:38
After more than two decades at the head of the company, it has emerged that Miles D White (pictured, right) will be stepping down from his role as Chief Executive Officer of Abbott. White had served in the position for 21 years since 1998, making him the second-longest serving non-founding CEO in the S&P100.
Pharmafile 11/13/2019 07:53
After drawn out negotiations and much discontent among cystic fibrosis (CF) patients and their advocates, Vertex has announced that a deal has finally been reached that will make its crucial CF medications available to patients across Wales and Northern Ireland. On 12 November, it emerged that the Regional Pharmaceutical Procurement Service in Northern Ireland reached an agreement with the manufacturer to make available all of its currently licensed CF therapies to patients in the region.
Pharmafile 11/13/2019 06:41
GlaxoSmithKline has unveiled new Phase 3 data for its IL-5 inhibitor Nucala (mepolizumab), revealing that the therapy met its primary endpoint in the treatment of the rare disease hypereosinophilic syndrome (HES). In the trial, 50% fewer participants were shown to experience a flare-up of HES-related symptoms when treated with Nucala alongside standard of care as opposed to placebo plus standard of care over 32 weeks of treatment.
Pharmafile 11/12/2019 08:01
Pfizer has lifted the lid on new Phase 3 data exploring the efficacy of tofacitinib in the treatment of juvenile idiopathic arthritis (JIA) in paediatric and adolescent patients younger than 18 but older than two years old, confirming that the drug met its primary endpoint. In a withdrawal study encompassing 225 patients with polyarticular course JIA, psoriatic arthritis or enthesitis-related arthritis, the drug successfully reduced the occurrence of disease flare compared to placebo after 44 weeks of treatment, meeting the study’s main goal.
Pharmafile 11/12/2019 07:35
Eisai’s Kisplyx (lenvatinib) has secured recommendation from the Scottish Medicines Consortium, it has been revealed, meaning that patients on the NHS in Scotland will soon be able to access the drug for the treatment of advanced kidney cancer. Specifically, the drug is authorised in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC) in adult patients who have received one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Pharmafile 11/12/2019 06:09
NHS patients in Scotland will soon be able to access Novartis’ CDK4/6 inhibitor Kisqali (ribociclib) after the Scottish Medicines Consortium (SMC) moved to authorise the drug in combination with fulvestrant for routine use on the health service in the treatment of metastatic HR+/HER2- breast cancer – the most common advanced form of the disease. The ruling follows another affirmative authorisation from NICE in July this year in the same indication.
Pharmafile 11/12/2019 05:33
It has been announced that Marc Funk, Chief Executive Officer at Lonza, is set to step down from the role early next year. The company said that Funk’s decision was based on personal reasons, and that he will leave the firm in January 2020. It was also revealed by the Board of Directors that the vacated role will be covered by Chairman Albert Baehny on an interim basis until a permanent successor is found and installed. Furthermore, Board Member Christoph Maeder was appointed by the Board to serve as Lead Independent Director, “for reasons of good governance”.
Pharmafile 11/11/2019 08:03
You studied biology at Liverpool John Moores University before heading straight to GSK in 1990 as a Sales Representative; was a career in pharma always the plan? No it wasn’t. I studied biology at John Moores, specialising in plant Pathology, so I was initially interested in horticulture. I’d grown up in a farming community, so I quickly worked out, after a placement year working for the Ministry of Agriculture, that the part I really loved was going out and engaging with the farmers, setting up trials in their fields, and working with the community.
Pharmafile 11/11/2019 07:55
The NHS is authorised to use its first two cannabis-based medicines for routine use after NICE saw fit to recommend both Epidyolex (cannabidiol) oral solution and Sativex (nabiximols) from the UK’s own GW Pharmaceuticals. As part of the ruling, Epidyolex, when combined with clobazam, is authorised in the adjunctive treatment of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years old.
Pharmafile 11/11/2019 07:15
Roche has lifted the curtain on new data which shows that its investigational survival motor neuron-2 (SMN2) splicing modifier risdiplam met its primary endpoint in the treatment of type 2 or 3 spinal muscular atrophy (SMA) in patients between the age of 2 and 25. The new findings confirmed that the therapy generated a significant change from baseline on the Motor Function Measure 32 (MFM-32) scale after 12 months of treatment compared to placebo, smashing the main goal of the study.
Pharmafile 11/11/2019 06:37
The latest findings have been revealed from the final stage of Novartis’ Phase 2b evaluation of its non-bile acid FXR agonist tropifexor in the treatment of biopsy-confirmed stage 2-3 fibrotic non-alcoholic steatohepatitis (NASH). Data from an interim analysis of the study revealed that the upper doses of the drug – 140 Mu g and 200 Mu g specifically – were proven to "significantly improve" a raft of biomarkers for the condition, including body weight, hepatic fat fraction, and alanine aminotransferase.
Pharmafile 11/11/2019 06:03
AnaptysBio has announced disappointing new Phase 2b data for its candidate etokimab in the treatment of moderate-to-severe atopic dermatitis. The company revealed that, in a study of 300 adult participants, the drug had failed to show superior benefit in the treatment of the condition according to the Eczema Area and Severity Index (EASI) after 16 weeks of treatment compared to placebo, falling short of the trial’s primary endpoint.
Pharmafile 11/11/2019 05:36
The FDA has moved to authorise Celgene and Acceleron Pharma’s Reblozyl (luspatercept-aamt) in the treatment of anaemia associated with the rare hereditary blood disorder beta thalassaemia, it has emerged. The decision relates specifically to adult patients who require regular red blood cell (RBC) transfusions and makes Reblozyl the first and only erythroid maturation agent approved by the US regulator to treat the condition.

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