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One of the most important topics for the upcoming presidential election in the US will be the next government’s response to the COVID-19 pandemic. COVID-19 testing started late and left the US unprepared for the initial wave. With an ongoing, even larger second wave oncoming, the US is seeing no sign of relief in sight at the beginning […]
Strong 52-week Mirikizumab Phase II data holds promise for Eli Lilly in Crohn’s disease
New data unveiled at the United European Gastroenterology Week (UEGW) virtual conference showed that Eli Lilly’s Crohn’s disease (CD) hopeful, mirikizumab, can deliver durable endoscopic and symptomatic efficacy after 52 weeks in moderate-to-severe patients who had failed or were intolerant to conventional therapy and had failed at least one other biologic agent. mirikizumab’s prospects are favorable in the […]
COVID-19 may prompt agreement on post-Brexit trade deal
With the world still grappling with the COVID-19-induced economic recession, the UK and the EU have another challenge to face – Brexit. Both sides will lose out economically in the event of no-deal, and the harder Brexit is the greater losses will be, says GlobalData a leading data and analytics company. Urte Jakimaviciute MSc, Senior Director of Market Research, comments: “The Brexit trade […]
Vaccine research shows promise as need grows with second waves of COVID-19
Second waves of COVID-19 worldwide will coincide with the start of the winter months in the northern hemisphere and with the flu season, making the development of a viable vaccine even more imperative to prevent a worsening of the impact of COVID-19, says GlobalData, a leading data and analytics company. Mohamed Abukar, Pharma Analyst at GlobalData, comments: […]
Alkermes is expected to expand its presence in the schizophrenia market with its candidate ALKS-3831
Following the announcement of positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the FDA in support of Alkermes’ ALKS-3831 for the treatment of Schizophrenia and Bipolar I Disorder; Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and […]
Breast Cancer Screening Needs to Continue Despite COVID-19
October is Breast Cancer Awareness Month, a worldwide annual campaign that highlights the importance of breast cancer awareness, education and research. One of the consequences of COVID-19 is delays in health checks and preventative screening for cancer, which could result in a huge number of additional cancer casualties, if not managed correctly, says GlobalData, a leading data […]
COVID-19 clinical trial disruption declines but trials continue to suffer from slow recruitment
The total number of trials disrupted by COVID-19 since June has been falling slowly, while trials impacted by slow enrollment continue to increase. For trials currently affected by slow enrollment, one-tenth of these are specifically due to the unavailability of sites and investigators, says GlobalData, a leading data and analytics company. Brooke Wilson, Trials Intelligence […]
COVID-19 pandemic impacting capsule endoscopes market with 12.9% lost revenue expected in 2020
Nearly 13% of revenue from capsule endoscopes will be lost in 2020 due to COVID-19, as many elective surgical procedures have been postponed, says GlobalData, a leading data and analytics company. Eric Chapman, Medical Devices Analyst at GlobalData, says: “GlobalData estimates an overall reduction of 12.9% of revenue for capsule endoscopes by the end of […]
Eli Lilly’s and Regeneron’s EUA applications for their COVID-19 mAb therapies short of clinically relevant data; clinical study participations hampered if process politicized
As US President Donald J. Trump puts his weight behind Eli Lilly and Regeneron Pharmaceuticals’ bid for an FDA Emergency Use Authorization (EUA) for their respective COVID-19 monoclonal antibody (mAb) therapies; Manasi Vaidya and Reynald Castañeda, Pharma Writers for the Investigative News team at GlobalData, offer their view: “Experts we interviewed emphasized the need for […]
Invokana may experience moderate rebound from decreasing US sales trend following FDA backtracking on boxed warning
The FDA has removed a boxed warning concerning the risk of leg and foot amputations for Janssen’s sodium glucose co-transporter (SGLT) inhibitor, Invokana (canagliflozin) – including its combination varieties Invokamet (canagliflozin + metformin) and Invokamet XR (canagliflozin + metformin extended-release). With the removal of the boxed warning, it is expected that Invokana will experience a […]
FDA and EMA designations for Acceleron’s Sotatercept highlight potential to differentiate in PAH space
Acceleron Pharma’s sotatercept, was granted priority designation by the European Medicines Agency for pulmonary arterial hypertension (PAH) in May 2020. This further signifies the drug’s major advantages over existing treatments, and will provide enhanced support for its development for targeting underlying disease progression in PAH, according to GlobalData, a leading data and analytics company. The […]
Price cap extension on knee implants will drive growth in India
To provide relief to patients undergoing orthopedic surgery requiring knee implants, the National Pharmaceutical Pricing Authority (NPPA) extended the timeline of price cap on these devices by one more year. The move is likely to drive the sale of knee implants in India, says GlobalData, a leading data and analytics company. GlobalData’s report Knee Reconstruction (Orthopedic Devices) – Global […]
Biopharma more optimistic about 2020 revenue, although employee safety concerns remain
Senior management of biopharma companies across North America, Europe and the Asia Pacific (APAC) region were more optimistic about the COVID-19 pandemic’s impact on annual revenue in Q3 2020 compared to Q1, according to a recent survey by GlobalData, a leading data and analytics company. Fiona Barry, Pharma Analyst at GlobalData, comments: “Biopharma executives and other […]
COVID-19 pandemic impacting urinary tract stents market with 11.4% lost revenue expected in 2020
Many surgical procedures have been postponed during 2020 due to COVID-19. This will lead to over 11% loss of revenue from urinary tract stents in the US, according to GlobalData, a leading data and analytics company, GlobalData includes ureteral, prostate and urethral stents within this market for indications such as urolithiasis, urethral strictures, pyeloplasty, benign […]
Smith & Nephew strengthens presence in global orthopedic market with acquisition of Integra’s Extremity Orthopaedics business
Following the announcement that Smith & Nephew has acquired the Extremity Orthopaedics business of Integra LifeSciences for $240m; Kamilla Kan, Medical Devices Analyst at GlobalData, a leading data and analytics company, offers her view on this deal: “According to GlobalData, over 71% of Integra LifeSciences’ net sales are across business segments from North America. By […]
European dose manufacturing site purchases driven by solid dose’s low profitability
Three-fourths of dose manufacturing facilities acquired by dedicated CMOs in 2019 were located in Europe, according to an analysis of sites supplying the US, Canada, Europe, or Japan, says GlobalData, a leading data and analytics company. Adam Bradbury, Pharma Analyst at GlobalData, comments: “While European commercial dose facilities have been popular acquisitions for some time, […]
The growth of global insulin pen market decelerates to 2.3% in 2020 due to COVID-19
The insulin delivery market has been negatively affected by the major upheavals experienced in diabetic care due to COVID-19. The insulin pen market, which was seeing a compound annual growth rate (CAGR) of 5.1% prior to COVID-19, according to leading data and analytics company GlobalData, has now decreased to show 2.3% growth in 2020 due to new patient start delays from physician […]
Oral GnRH antagonists could have market potential in female health space beyond endometriosis-related pain and uterine fibroid indications
Oral GnRH antagonists have off-label potential in the female infertility space, beyond the indications of endometriosis-associated pain and uterine fibroids, which constitute the main development focus for companies competing in the space, says GlobalData, a leading data and analytics company. Due to their novel oral formulation, the company notes that GnRH antagonists could replace subcutaneous […]
Demand for US LNG is likely to remain depressed in the near future
Global economic slowdown has led to reduced demand for LNG produced in the US. As a result, LNG exports from the country are likely to remain low in the near future, says GlobalData, a leading data and analytics company. Haseeb Ahmed, Oil and Gas Analyst at GlobalData, comments: “Significantly low prices of gas along with an LNG supply glut has pushed companies to revisit their capex spends on upcoming multi-billion-dollar gas projects. In March 2020, Royal Dutch Shell exited the proposed Lake Charles LNG export project in Louisiana. […]
Same day EC and Japanese MHLW wins for Gilead and Galapagos’ Jyseleca, but lost US revenues won’t be recovered
Gaining approval by the EC and Japanese Ministry of Health, Labour and Welfare (MHLW) on the same day for adults with moderate-to-severe active rheumatoid arthritis (RA) is a clear win for the developers of Jyseleca (filgotinib), however, this was at the heels of an FDA complete response letter (CRL). Given the importance of this market, […]