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Since COVID-19 was officially declared a pandemic by the World Health Organization (WHO), the peak in total number of clinical trials for the virus was seen in the month of April 2020. However, there has since been a steady decrease in new clinical trial investigations, except for the months of December 2020 and March 2021. […]
RMAT designations predict future directions of cell and gene therapy in oncology
26% of all cell and gene therapies in late-stage development in the US are being developed for oncology. The FDA has backed the use of CAR-T cell therapies for cancer indications. Novel therapeutic approaches indicate a focus on expanding cell and gene therapy for use in solid tumors. Regenerative medicine advanced therapy (RMAT) designations are […]
A new day for Alzheimer’s Disease treatment after FDA approval of Biogen’s Aduhelm, says GlobalData
Following FDA’s approval of Aduhelm (aducanumab) for the treatment of Alzheimer’s Disease (AD), after no new drug for this indication has been approved in the past 18 years despite more than 400 clinical trials and billions of dollars being spent; Alessio Brunello, Managing Analyst at GlobalData, a leading data and analytics company, offers his view: […]
Tremfya positive post-marketing data in COSMOS trial puts drug on path to see net sales of $577m globally for PsA by 2028, says GlobalData
The post-marketing data in the treatment refractory population of the COSMOS Phase IIIb study could allow J&J the opportunity to position interleukin (IL)-23 inhibitor Tremfya early in the PsA treatment algorithm, ahead of the older IL-17 drug class, according to GlobalData. If this happens, and J&J is able to contract aggressively with payers, the leading […]
Dental devices market to rebound in 2021 as acquisitions rise
The COVID-19 pandemic saw certain markets such as anesthesia and respirator devices grow in 2020, while many others such as dental devices stagnated or saw a huge decline. However, dental devices are projected to make a strong recovery in 2021. The global market value for dental devices in 2021 is estimated to be $20.5bn, up […]
Interim data from UK study ‘Com-COV’ suggest higher reactogenicity
Preliminary safety results from the Oxford led Phase II Com-COV trial investigating immune responses in patients given heterologous prime-boost vaccine schedules indicate that mixing vaccines leads to higher reactogenicity and more frequent side effects, observes GlobaData, a leading data and analytics company. Nancy Jaser, PharmD/MBA, Pharma Analyst at GlobalData, comments: “The preliminary safety results may […]
Eli Lilly’s tirzepatide continues to outperform popular diabetes drugs in head-to-head clinical trials, says GlobalData
Eli Lilly’s highly anticipated tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 receptor agonist (GLP-1RA), recently demonstrated that it was able to not only reduce HbA1c levels in type 2 diabetes (T2D) patients, but also confer weight loss when compared to insulin glargine in the SURPASS-4 trial. Tirzepatide has the potential […]
Diagnosed prevalent cases of systemic sclerosis to reach 187,000 by 2030 in the 7MM, says GlobalData
The diagnosed prevalent cases of systemic sclerosis (SSc) in the seven major markets (*7MM) are projected to increase from 171,000 cases in 2020 to 187,000 in 2030, equating to an annual growth rate (AGR) of 0.97%, according to GlobalData, a leading data and analytics company. GlobalData’s latest report, ‘Systemic Sclerosis (Scleroderma) – Epidemiology Forecast to […]
COVID-19 puts Cadila Healthcare at the forefront of innovation in India, says GlobalData
Cadila Healthcare Ltd. is among the leading players in India which focuses on bringing in-house developed innovative therapies for patients. Cadila Healthcare has developed a diversified COVID-19 portfolio among the Indian players through in-house development and licensing opportunities. In line with this, the COVID-19 pandemic has put Cadila Healthcare at the forefront of innovation in […]
Bristol-Myers Squibb’s Mavacamten demonstrates significant improvement of health status for symptomatic oHCM patients in the EXPLORER-HCM trial, says GlobalData
At the 70th annual American College of Cardiology (ACC) 2021 meeting, positive data from the EXPLORE-HCM trial was presented for Bristol-Myers Squibb’s mavacamten, a targeted inhibitor of cardiac-myosin that is currently at the pre-registration stage of development in the US for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). According to GlobalData, a leading data […]
Medtronic investors must be cautious about changing competitive dynamics in China and APAC
Following the news of Medtronic’s latest financial report for Q3 FY2021 that medical device revenues have fully recovered through the anniversary of the COVID-19 pandemic, but a major threat is looming for medical device manufacturers with international presences in China; Richard Hyde, Medical Analyst at GlobalData, a leading data and analytics company, offers his view: […]
High unmet needs in HNSCC may be partially addressed by clinical development over next decade, says GlobalData
Improved efficacy for HNSCC therapeutics able to demonstrate an overall survival benefit remains a key unmet need in the indication. The next decade may see the introduction of personalized therapy options in locally advanced HNSCC settings along with identification of new druggable targets. Research is being conducted to test therapeutic de-intensification in oropharyngeal carcinoma patients. […]
Boehringer’s BI 425809 has potential to address cognitive impairment in schizophrenia market, says GlobalData
Boehringer Ingelheim recently announced that its product, BI 425809, has received Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for Cognitive Impairment Associated with Schizophrenia (CIAS). There are currently no approved pharmacological treatments for CIAS and if BI 425809 is successful, it could address this unmet need in the schizophrenia market. […]
Long-acting growth hormones to account for over 90% of growth hormone deficiency market share across US, Germany, and Japan by 2030, says GlobalData
Rapid uptake of long-acting growth hormones (GH) is set to shake up the growth hormone deficiency (GHD) space in the three major markets (3MM): the US, Germany and Japan. These therapies are projected to capture over 90% of market share in this region by 2030 due to their potential to improve patient convenience and compliance, […]
Opioid use disorder cases could total 1.9 million in the US in 2021 following 13% substance use increase in 2020, says GlobalData
Substance use rose by 13% in the US during 2020, which could result in an additional 252,000 cases in the number of Americans who abuse substances as the number of overdoses also increased. Prevalent cases of opioid use disorder (OUD) could roughly total 1.9 million in 2021 and such an increase will cost the US […]
UK regulatory review of Alexion acquisition by AstraZeneca threatens GSK, says GlobalData
The UK regulatory review of Alexion Pharmaceuticals acquisition by AstraZeneca limits the ability of GlaxoSmithKline (GSK) to buy its way out of a proxy brawl with activist investor Elliott, says GlobalData, a leading data and analytics company. Despite the acquisition passing the regulatory review from the US Federal Trade Commission (FTC), the UK Competition and […]
Neuropathic pain market most valuable segment within the pain indications and is forecast to reach $25.2bn by 2027, says GlobalData
The neuropathic pain market is the most valuable segment within the pain indications and was valued at $10.8bn in 2020 globally. It is forecast to reach $25.2bn by 2027 at a compound annual growth rate (CAGR) of 12.9%. The launch of different late-stage pipeline products throughout the forecast period will contribute heavily to the growth […]
Potential for novel narcolepsy treatment if it can overcome safety concerns, says GlobalData
NLS Pharmaceutics has recently announced new data confirming that its narcolepsy product, a controlled release (CR) formulation of mazindol, has agonist activity at orexin-2 receptors (OX2R). While mazindol is a monoamine reuptake inhibitor like the many other stimulants used to treat narcolepsy, the additional OX2R agonist activity could give it a competitive edge in the […]
ANVS401’s trial hints at promising new approach for early Parkinson’s treatment, says GlobalData
Annovis Bio recently announced positive results from a Phase IIa trial of its pipeline asset ANVS401 (posiphen) in patients with early Parkinson’s disease (PD). The data presented further strengthens the previous interim trial findings, where ANVS401 showed an improvement in the overall motor skill functions of PD patients with no serious adverse events, says GlobalData, […]
World MS Day: Opportunities remain for products that fulfil significant unmet needs in the MS market, says GlobalData
The multiple sclerosis (MS) therapeutics market is becoming increasingly crowded, but the overall fulfillment of unmet needs is medium. There are no curative therapies for MS, and most existing disease modifying therapies (DMTs) are only partially effective in preventing relapses, with limited impact on the accrual of disability. This means that most patients still experience […]