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Roche recently announced that its product, Evrysdi (risdiplam), which was approved by the US Food and Drug Administration (FDA) in August 2020, was recommended for approval for the treatment of spinal muscular atrophy (SMA) in patients two month of age and older by the European Medicines Agency (EMA). GlobalData, a leading data and analytics company, […]
Spain’s 12-month total prevalent MDD cases to increase at AGR of 1.23% between 2019-29, says GlobalData
The 12-month prevalent cases of major depressive disorder (MDD) is expected to increase from 53.37 million cases in 2019 to 55.36 million cases in 2029, at an annual growth rate (AGR) of 0.37% across the eight major markets *8MM. Out of the 8MM, Spain is expected to grow at an annual growth rate (AGR) of […]
Europe needs to emulate UK to avert further resurgence of COVID-19 cases, says GlobalData
The COVID-19 vaccination rate in the UK exceeds that of any other country in Europe and is on track to be the first country in the continent to control the pandemic through vaccination. Incidentally, Europe remains one of the worst affected regions in the world and must use the UK as a gold standard to […]
Over 25% of rare disease trials are terminated due to low patient accrual rates, says GlobalData
Over a quarter of rare diseases trials were terminated between 2016 and 2020* due to low accrual rates, according to research by GlobalData, a leading data and analytics company. Difficulties with patient recruitment for rare disease clinical trials could be mitigated by the use of virtual trials. Low accrual rate was the most common reason […]
Recent trial failures highlight challenges in clinical development for head and neck cancer, says GlobalData
AstraZeneca/Medimmune Therapeutics’ Imfinzi (durvalumab), an immunotherapy targeting programmed death-ligand 1 (PD-L1), recently failed to demonstrate increased overall survival (OS) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in its Phase III KESTREL clinical trial (NCT02551159). This recent failure highlights the challenges in trial completions and development of novel entities in […]
AbbVie pips Gilead to dominate Japan’s hepatitis C virus digital marketing space, says GlobalData
The hepatitis C virus (HCV) therapeutics market in Japan is highly competitive with stiff competition between Gilead and AbbVie. However, AbbVie has taken an edge over Gilead in terms of HCV-related digital initiatives, finds GlobalData, a leading data and analytics company. According to GlobalData’s ‘Pharmaceutical Intelligence Center’, the number of diagnosed prevalent cases of HCV […]
COVID-19 booster shots becoming more likely as variants could reduce effectiveness of vaccines
If new SARS-CoV-2 variants continue to develop, they could affect not only the effectiveness of COVID-19 vaccines, but also the natural immunity that COVID-19 survivors have developed – making annual booster shots required for COVID-19 immunity, says GlobalData, a leading data and analytics company. Johanna Swanson, Product Manager at GlobalData, comments: “Of the several natural variants […]
FDA retaining oversight of genetically modified animals for therapeutics will reassure the public
The Trump administration’s decision to relax oversight of genetically modified (GM) animals for food prioritizes big businesses and the livestock industry, while overriding FDA scientists in decisions around GM animal use, says GlobalData, a leading data and analytics company. As oversight of GM animals for food will move from the FDA to the USDA due […]
MANTA and MANTA-RAy safety readouts boost Jyseleca’s prospects in the US
Following Galapagos’ announcement of pooled interim results from its ongoing MANTA and MANTA-RAy safety studies for Jyseleca (filgotinib); Rose Joachim, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “Interim data from MANTA and MANTA-RAy should ease fears that Jyseleca may negatively impact sperm health in men with inflammatory bowel disease […]
Immunotherapy for microsatellite stable colorectal cancer holds promise
During Colorectal Cancer Awareness month, it is important to highlight that precision medicine approaches are gaining traction in this indication. Positive results from any of the ongoing late-stage trials in microsatellite stable (MSS) colorectal cancer patients could see immunotherapy gaining a foothold in this indication, says GlobalData, a leading data and analytics company. Jessica McCormack, […]
Impressive semaglutide results likely to reinforce Novo Nordisk’s position as leading player in obesity market
In February 2021, Novo Nordisk released impressive data from its Phase IIIa STEP1 trial for semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in a bid to strengthen its position as the market leader in obesity. There is a clear unmet need in the market for more efficacious and convenient therapies, says GlobalData, a leading data […]
Covaxin interim efficacy data will further boost market penetration, says GlobalData
Following the news that Bharat Biotech’s COVID-19 vaccine Covaxin showed 81% interim efficacy; Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “In January 2021, Covaxin was granted emergency use approval in India in the absence of late-stage efficacy data, raising questions on its effectiveness. This was reflected in […]
US promises to vaccinate everybody by June, but vaccine hesitancy might prevent reaching herd immunity soon
Following the news of President Biden’s announcement that the US will have enough COVID-19 vaccine supply for all US-Americans by the end of May; Philipp Rosenbaum, PhD, Senior Healthcare Analyst at GlobalData, a leading data and analytics company, offers his view: “Getting every US-American adult vaccinated by the May will require a big effort from […]
COVID-19 has accelerated digital transformation timeline for pharmaceutical industry
Even though the pharmaceutical sector used to display a more conservative stance toward the adoption of new technologies, the COVID-19 pandemic acted as a trigger that forced the pharmaceutical sector to accelerate the digital transformation timeline, says GlobalData, a leading data and analytics company. According to a GlobalData survey, 35% of pharmaceutical industry professionals believe […]
COVID-19 pandemic continues to significantly impact clinical research
With the COVID-19 pandemic recently passing one year in duration, clinical research continues to be significantly affected. Sponsors have had to modify trial designs to prevent the suspension, termination, or withdrawal of planned and ongoing clinical trials. The adaptation and usage of decentralized trials and virtual technologies have been strongly accelerated in order to mitigate […]
Launch of generic brands for expensive oncology drugs improves treatment affordability and access in India, says GlobalData
The Central Drugs Standard Control Organization (CDSCO) has recently approved several generic versions of sunitinib to treat kidney cancer. Against this backdrop, the approval of generic brands of expensive oncology drugs will not only help in reducing the cost of these life-saving drugs but also improve access and adherence to treatment in the future, says […]
New standard of care in hepatocellular carcinoma shifts the treatment paradigm to a grey area, says GlobalData
The approval of Roche’s Avastin (bevacizumab) plus Tecentriq (atezolizumab), in addition to the long list of pipeline products, opens up gaps in the treatment paradigm regarding the sequence of treatments, says GlobalData, a leading data and analytics company. Mandana Emamzadeh, PhD, Pharma Analyst at GlobalData, comments, “The hepatocellular carcinoma (HCC) market is evolving swiftly after […]
The COVID-19 pandemic is driving an increase in novel FDA approvals and outsourcing of manufacturing
Innovative drug approvals increased in the US between 2019 and 2020. This increase happened despite the FDA’s stretched resources, as it had to reassign staff to cope with COVID-19-related activities. The agency approved 121 novel drugs in 2020, compared with 119 in in 2019, says GlobalData, a leading data and analytics company. Adam Bradbury, PharmSource Analyst at GlobalData comments: “There was a large increase in approvals of new molecular entities (NMEs), the most innovative drug type with 21% more NME approvals than in 2019. There were also more small cap pharma–sponsored drug approvals and overall approvals compared […]
COVID-19 disruption of clinical trials varies by therapy area
The number of clinical trials disrupted by the COVID-19 pandemic continues to increase into 2021, although the degree of disruption varies depending on the therapy area, says GlobalData, a leading data and analytics company. Scotty Chung-Siu, MPH, Senior Analyst at GlobalData, comments: “Companies and organizations continue to report trial disruptions due to the COVID-19 pandemic, including delayed initiation, delayed enrollment, and slow enrollment, although not all therapy areas have been equally affected.” Comparing April 2020 […]
Healthcare policy and legislation shows promise of changes under Biden’s administration
While the US has excelled in vaccine development, its distribution and administration efforts did not go according to plan due to the dependence on states. The Biden administration has enacted a COVID-19 plan that includes an investment of $25bn in vaccine manufacturing and distribution. It is uncertain what the future holds for the US healthcare […]