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Pharmafile 10/18/2019 06:06
This article follows parts and of our trio of in-depth pieces focusing on the growing medical cannabis phenomenon. In June 2019, Pharmafocus visited the headquarters of cannabis company Canopy Growth in the Canadian town of Smiths Falls. Louis Goss investigates how the industry is taking off in Canada and how this might inform the evolution of medicinal cannabis legislation in the UK.
Pharmafile 10/18/2019 06:00
It’s time for a rundown of the top 10 articles on PharmaFile this past week. The past seven days saw the first and only transdermal patch for schizophrenia being approved and additionally a new UK medicines bill which could see faster access to key conditions such as dementia and Alzheimer’s. Furthermore there were three FDA approvals for a variety of different conditions. 10.
Pharmafile 10/18/2019 05:23
Fiscal year 2019 was a record-breaking one, according to the FDA. The US regulator smashed its previous total for annual generic drug approvals with 1,171 positive reviews completed that year, comprising 935 approvals and 236 tentative approvals. Furthermore, of this total, 125 approvals were the first generic versions of their respective reference products, meaning there was no previous generic competition prior to the FDA’s ruling.
Pharmafile 10/18/2019 05:13
The US FDA has recommended approval for cefiderocol, a novel antibiotic for complicated urinary tract infections, including pyelonephritis, in patients with limited or no other treatment options. While members of the FDA’s Antimicrobial Drugs Advisory Committee were mostly impressed by the data submitted for the drug, voting 14-2 for recommendation, some raised concern about a mortality imbalance disfavouring cefiderocol in the CREDIBLE-CR study which compared the drug to current best available in therapy in patients with numerous carbapenem-resistant infections.
Pharmafile 10/18/2019 04:15
MSD have announced it plans to eliminate approximately 500 jobs in multiple US states according to a filing with the Pennsylvania Department of Labour and Industry. The drug manufacturer’s layoff notice states that the cuts will primarily affect impact-field and office-based sales staff alongside a small number of marketing employees.
Pharmafile 10/17/2019 06:47
Five drug makers and distributors are now offering $22 billion in cash, as well as drugs and services, valued at $28 billion; to resolve ongoing lawsuits against the industry on claims it fuelled the opioid crisis in the US. The industry currently faces roughly 2,600 lawsuits brought by state and local governments, hospitals and other bodies seeking to hold the drug manufacturers culpable and responsible for the toll of the opioid abuse.
Pharmafile 10/17/2019 06:35
UCB Pharma has announced new data from the first of three Phase 3 studies investigating the efficacy of its IL-17A and IL-17F inhibitor bimekizumab in the treatment of moderate-to-severe chronic plaque psoriasis in adult patients. The findings showed that the therapy met both its co-primary endpoints of generating in patients an improvement of at least 90% on the Psoriasis Area and Severity Index and a score of clear or almost clear according to the Investigator Global Assessment (IGA) after 16 weeks.
Pharmafile 10/17/2019 05:44
Ipsen has announced that through its subsidiary Clementia Pharmaceuticals, it has entered into an exclusive, worldwide license agreement for the development and commercialisation of BLU-782. BLU-782 is an oral, highly selective investigation ALK2 inhibitor being developed for the treatment of fibrodysplasia ossificans progressive (FOP). The agreement ultimately enhances Ipsen’s rare disease portfolio and advances Blueprint Medicines’ goal of rapidly and efficiently developing BLU-782 as a potential treatment for FOP.
Pharmafile 10/17/2019 05:12
In disappointing news, Eli Lilly has revealed that pegilodecakin, in combination with the chemotherapy regimen FOLFOX (Folinic acid, Fluorouracil and Oxaliplatin), proved inferior to FOLFOX alone in the treatment of metastatic pancreatic cancer in patients who saw disease progression during or following a first-line gemcitabine-containing regimen, failing to meet its primary endpoint in a Phase 3 study. The findings showed that the pegilodecakin-plus-FOLFOX regimen was associated with a 5% higher rate of Grade 3/4 adverse events, including neutropenia, thrombocytopenia, fatigue and.
Pharmafile 10/17/2019 04:33
AstraZeneca have announced that the US FDA has granted Priority Review for its experimental breast cancer treatment trastuzumab. The Prescription Drug User Fee Fact (PDUFA) date for trastuzumab deruxtecan, an HER-2 targeting antibody drug conjugate and potential new medicines for the treatment of HER2-positive metastic breast cancer is set for the second quarter of 2020.
Pharmafile 10/16/2019 07:46
Gilead Sciences have announced that Andrew Dickinson has been appointed as Chief Financial Officer (CFO) effective 1 November. Dickinson currently serves as the company’s Executive Vice President of Corporate Development and Strategy and in his new role will become part of a senior leadership team reporting directly to Chairman and Chief Executive Officer Daniel O’Day.
Pharmafile 10/16/2019 07:23
Israel-based Kanabo Research is one of many emerging firms leading the international surge of research and development into the potential of cannabis-based therapies. Founder & CEO Avihu Tamir discusses the company’s work within the context of the growing cultural shift in attitudes towards the substance around the world. Where is Kanabo focusing its efforts when it comes to the treatment of patients?
Pharmafile 10/16/2019 06:46
Tokyo-headquartered firm Eisai has announced that its antiepileptic drug (AED) Fycompa (perampanel) has received approval from China’s National Medical Products Administration (NMPA) for the adjunctive treatment of partial onset epileptic seizures(with or without secondarily generalised seizures) in patients over the age of 12. The decision, awarded under the Administration’s Priority Review pathway in just over 12 months, was based on data from a number of Phase 3 studies which indicated that Fycompa reduced seizure frequency by 17.3%, 29% and 38.9% in its 4, 8 and 12mg formulatio.
Pharmafile 10/15/2019 12:06
A large controlled clinical trial has linked the early use of tranexamic acid to a small fall in the risk of death in patients who have suffered traumatic brain injury. Tranexamic acid is an off-patent drug used in managing bleeding trauma patients. Previous studies have shown the benefits of the drug in that population but there is a lack of evidence on its use in traumatic brain injury (TBI) patients.
Pharmafile 10/15/2019 11:44
Takeda has sold selected prescription and over the counter products to Acino in the Near East, Middle East and Africa as it looks to trim down its debt and portfolio following its $62 billion acquisition of Shire. The products in question are currently grouped within Takeda’s ‘Growth and Emerging Markets’ business unit with the company noting that these are primarily outside of its core business areas.
Pharmafile 10/15/2019 05:56
The Government has announced new legislation aimed at providing faster access to medicines, including those treating dementia and Alzheimer's. The Medicines and Medical Devices Bill, announced in the Queen’s Speech on 14 October, would see measures designed to improve treatments and give patients access to innovative new medicines. The Government has stated it will also build on September’s Health Infrastructure Plan to build 40 new hospitals, with a £33.9 billion a year increase in NHS spending by 2023-2024.
Pharmafile 10/15/2019 05:54
Eli Lilly has announced that the FDA has given the green light to Reyvow (lasmiditan) in the acute treatment of migraine, with or without aura, in adult patients. According to the regulator, this marks the first and only FDA approval of a serotonin (5-HT)1F receptor agonists in this treatment area. Supporting the approval were data from two Phase 3 studies, both of which met their primary endpoints of pain freedom and freedom from most bothersome symptoms – including nausea, light sensitivity and sound sensitivity – two hours following administration, compared to placebo.
Pharmafile 10/15/2019 04:50
A new clinical trial at King’s College London will investigate the use of cannabidiol (CBD) – a compound found in the cannabis plant – to treat hallucinations and delusions in people living with Parkinson’s. The phase 2 trial is funded with a £1.2 million grant direct from Parkinson’s UK. There are currently over 145,000 people living with Parkinson’s in the UK and between 50 and 60% of them will be affected by psychosis at some point in their life.
Pharmafile 10/15/2019 04:44
Janssen’s Xarelto (rivaroxaban) has secured FDA approval for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalised acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding, it has emerged. In a Phase 3 study examining 20,000 participants with acute mental illness, Xarelto proved itself non-inferior to enoxaparin in sort-term use (ranging from around six to 14 days) and superior in long-term use (ranging from around 31 to 39 days) to short-term use of enoxaparin plus placebo, meeting the trial’s co-pri.

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