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The Food and Drug Administration’s (FDA) accelerated approval program has recently come under fire due to high-profile withdrawals of immune checkpoint inhibitors (ICIs) from the oncology market. Conservative withdrawal of drugs marketed under accelerated approval has more upside for cancer patients with few available options compared to liberal withdrawal, says GlobalData, a leading data and […]
Changes in rheumatologists’ biosimilar prescription rates between 2018 and 2020 differ based on geography, says GlobalData
In 2020, 92% of 5EU physicians stated that they used biosimilars in at least 25% of their RA patients, compared to 70% of physicians in 2018. Between 2018 and 2020, the percentage of Japanese physicians using biosimilars in at least 25% of their RA patients jumped from 23% to 78%. Biosimilar usage in the US […]
UK COVID-19 vaccine approvals would have taken longer if UK remained in EU, say European healthcare professionals in a GlobalData survey
More than 50% of surveyed healthcare industry professionals from Europe believe that Brexit allowed the UK to accelerate its COVID-19 vaccines approval process 31% of respondents from the UK highlighted that the UK’s departure from the bloc did not influence the fast-tracked authorization of COVID-19 vaccines While the Pfizer/BioNTech vaccine approval was commenced in accordance with […]
Roche’s antibody cocktail for COVID-19 may face affordability issues in India, says GlobalData
Following the news that Roche has received emergency use authorization (EUA) for a COVID-19 antibody cocktail casirivimab and imdevimab; Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view: “Roche’s antibody cocktail casirivimab and imdevimab are among the only two drugs to be exclusively developed and approved for COVID-19 treatment. […]
Most Prominent CMO, Thermo Fisher, to acquire third most prominent CRO, PPD, for $17bn, says GlobalData
Thermo Fisher Scientific, a diversified life science company, has announced its intent to purchase PPD, a Clinical Research Organization (CRO), for $17B. PPD is a publicly traded CRO and is the third largest CRO in terms of ongoing trials. PPD will be part of Thermo Fisher’s Laboratory Products and Services Segment, says GlobalData, a leading […]
Merck & Co and BMS set to retain their positions as current and future key players in head and neck cancer, says GlobalData
Merck & Co. and Bristol-Myers Squibb (BMS) have transformed the treatment paradigm in advanced and metastatic head and neck squamous cell carcinoma (HNSCC) settings by improving real-world patient outcomes in the first and second-line metastatic setting. These two companies are expected to retain their position as market leaders in HNSCC, primarily based on proven product […]
Diagnosed prevalent cases of CKD in the US projected to increase by 15.90% by 2030, says GlobalData
Diagnosed prevalent cases of chronic kidney disease (CKD) in the seven major markets (7MM*) combined is expected to increase from 8.57 million cases in 2020 to 9.44 million in 2030, at an annual growth rate (AGR) of 1.02%, according to GlobalData, a leading data and analytics company. Of the 7MM, the diagnosed prevalent cases of […]
Hepatocellular carcinoma market to reach $5.3bn by 2029, says GlobalData
The hepatocellular carcinoma (HCC) market is expected to grow from $1bn in 2019 to $5.3bn in 2029 in the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 17.8%, says GlobalData, a leading data and analytics company. The company’s latest report, ‘Hepatocellular Carcinoma: Global Drug Forecast and Market Analysis to 2029’, reveals […]
Results from post hoc study may bolster current use of Veltassa among older patients with CKD-HK, says GlobalData
A post hoc analysis of the multicenter AMETHYST-DN study found that the use of Vifor Pharma’s Veltassa (patiromer) significantly reduced serum potassium in patients ages 75 years and older with chronic kidney disease (CKD)-related hyperkalemia (HK). This study could be of high clinical value to physicians with elderly patients looking to find an optimal treatment […]
Clinical trials continue to resume but are still impacted by slow enrollment, says GlobalData
The surge in new variants for COVID-19 and an increase in subsequent cases is continuing to have an impact on clinical trials, while still allowing them to resume. The total number of disrupted trials has levelled off, but the number of clinical trials that have resumed continues to rise, although somewhat slower than the initial […]
Unmet needs in T1D highlight significant market gaps despite robust pipeline, according to GlobalData
It is expected that 15 therapeutics will launch in the Type 1 Diabetes (T1D) market in the eight major markets (8MM*) before 2030. They include Adocia’s BioChaperone Insulin lispro, an ultra-fast prandial insulin; Zealand Pharma’s dasiglucagon, a liquid-stable glucagon to manage hypoglycemia for use in a bihormonal pump; and Provention Bio’s teplizumab, the first preventative […]
Chronic hepatitis B market set to reach $5.16bn by 2029, says GlobalData
The market landscape in the nine major markets (9MM*) for chronic hepatitis B (CHB) is expected to see significant change between 2019 and 2029. Projected by GlobalData to grow from $3.8bn in 2019 to $5.16bn in 2029, at a compound annual growth rate (CAGR) of 3.1%, the market will see growth due to the development […]
NIH grant-funded drugs are being repurposed for COVID-19, says GlobalData
Drugs being developed for COVID-19 were awarded the highest number of SBIR/STTR funding grants, at 187 grants. Most grants awarded to drugs that are currently indicated for COVID-19 were awarded pre-2020, before the pandemic began, says GlobalData, a leading data and analytics company. Madeleine Roche MSc, Analyst at GlobalData comments: “It is likely that many […]
China’s fast-track regulatory reforms face difficulties in attracting non-Chinese companies, says GlobalData
China has reformed its regulatory system in recent years to include various fast-track programs similar to the US, EU, and Japan to incentivize the development of drugs for unmet medical needs and serious conditions. However, only a few companies based outside of China have been granted priority review status by the National Medical Products Administration […]
Freeline Therapeutics edges ahead of gene therapy competitors by progressing dose escalation for FLT190 Phase I/II study, says GlobalData
Freeline Therapeutics recently announced plans to progress dose escalation for its Phase I/II trial for FLT190, an adeno-associated variant (AAV) based gene therapy for Fabry disease. The current position that Freeline has achieved with FLT190 places the company ahead of its direct competitors and into a strategic position to dominate the Fabry gene therapy landscape, […]
China focuses on next-generation intranasal COVID-19 vaccines amid rising mutant strains, says GlobalData
COVID-19 infections continue to rise with several countries facing second-and third-wave infections with the newly evolved mutant strains, thereby increasing the demand for effective vaccines. Several pharmaceutical companies across the world have started working on the inhaled vaccine formulations and China is also developing next generation intranasal COVID-19 vaccines, says GlobalData, a leading data and […]
First cell therapy for solid tumors could be approved by 2022, says GlobalData
Although cell therapies such as CAR-T have been approved and used successfully to treat hematological cancers, there are currently no cell therapies approved for the treatment of solid tumors. However, positive data recently presented by Iovance Biotherapeutics from its lead candidate, tumor infiltrating lymphocyte (TIL) therapy lifileucel, in heavily pre-treated melanoma patients suggests an approval […]
Melanoma market to reach $7.4bn by 2029 in the 8MM driven by launch of 12 pipeline agents, says GlobalData
The melanoma market has experienced moderate growth since 2016, and is expected to increase further, from $5.59bn in 2019 to $7.42bn in 2029 across the eight major markets (8MM*) at a compound annual growth rate of 2.9%, according to GlobalData, a leading data and analytics company. Growth will be driven by the anticipated launch of […]
CMOs reap the benefits of COVID-19 manufacturing and timescale demands, says GlobalData
The COVID-19 pandemic brought not just a more difficult business environment to operate in, but also opportunities for contract manufacturing organizations (CMOs), as even the largest biopharma companies require extra capacity to supply billions of doses. Due to compressed timelines and manufacturing scale challenges for COVID-19 vaccines and medicines, CMOs signed contract manufacturing service agreements […]
CureVac’s unique vaccine properties are key for mRNA vaccine delivery to developing nations, says GlobalData
As COVID-19 cases continue to soar in some countries, demand for Pfizer and Moderna’s vaccines is fast exceeding production capabilities, while restrictions placed on AstraZeneca and Johnson & Johnson’s adenovirus-based vaccines have placed additional pressures on global vaccine rollouts, particularly in Europe. CureVac’s expected entry into the COVID-19 vaccine market may provide a viable alternative […]