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AbbVie has recently announced that Qulipta (atogepant) has received FDA approval for the preventive treatment of episodic migraine in adults. Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. The market for oral prophylactic treatments to reduce the number of migraine days […]
Pharma industry needs to outsource manufacturing for COVID-19 vaccine boosters and children’s doses, says GlobalData
The pharmaceutical industry will need to outsource even more pharmaceutical manufacturing to keep up the pace with the expected developments of the COVID-19 vaccines and drugs, says GlobalData, a leading data and analytics company. GlobalData’s report, ‘COVID-19: Contract Pharmaceutical Development and Manufacturing Relationships’, reveals that the coming changes, like the approval of COVID-19 vaccines in […]
Boxed warnings and restrictive labelling for Incyte’s atopic dermatitis topical Opzelura sets precedent for pipeline topical JAK inhibitors, says GlobalData
While GlobalData expects the approval of Opzelura (ruxolitinib) to be the first of many JAK inhibitors to enter the US market for the treatment of atopic dermatitis (AD), the leading data and analytics company notes that developers of these drugs need to find ways to overcome the FDA’s restrictive labelling. Ramla Salad, Pharma Analyst at […]
Innovative efforts by both academia and industry offer renewed hope for the treatment of a rare pediatric brain tumor, says GlobalData
Diffuse intrinsic pontine glioma (DIPG) is an extremely rare pediatric brain tumor with a dismal prognosis. On average, less than 50% of patients are expected to be alive a year after diagnosis. GlobalData notes that the attrition rate of drugs for gliomas, which include DIPG, is high compared to other cancers, and there is only […]
Amgen’s Otezla wins patent battle, but a marketing war may await, says GlobalData
The recent ruling in favor of upholding Amgen’s patents for its phosphodiesterase inhibitor Otezla (apremilast) until its patent expiry in 2028 is an important safeguard for Amgen, according to GlobalData, and will allow the company to protect the last seven years of Otezla’s sales. The leading data and analytics company notes that, despite Otezla’s assured […]
Reduced risk of CV morbidity and mortality demonstrated in FIGARO-DKD study
At this year’s European Society of Cardiology (ESC) Congress, positive results were presented from Bayer’s FIGARO-DKD Phase III trial of Kerendia (finerenone), providing insight into the drug’s ability to reduce risk of morbidity and mortality in diabetic kidney disease patients. The positive data from the FIGARO-DKD study will help support the use of finerenone to […]
Combination therapy approaches may be the most promising method for glioblastoma multiforme patients, says GlobalData
With Bristol Myers Squibb’s (BMS) Phase III CheckMate-498 and CheckMate-143 Opdivo (nivolumab) studies both failing to meet primary or secondary endpoints, the use of single-agent PD-1 blockade for glioblastoma multiforme (GBM) remains unsatisfactory, says GlobalData. The leading data and analytics company notes; considering that multiple immunosuppressive mechanisms and low immunogenic responses are observed in GBM, […]
High Delta variant prevalence in children places millions of adults in nursing homes at risk
The Delta variant continues to infect a substantial number of school-aged children as school begins throughout the US. This may exacerbate transmission to the general population and subsequently place millions of adults at risk for severe COVID-19, such as those living in nursing homes at an additional risk for contracting COVID-19, says GlobalData, a leading […]
Amylyx’s ALS drug AMX0035 likely available much sooner than expected, says GlobalData
Following the recent shift in the FDA’s stance on Amylyx Pharmaceuticals’ AMX0035* new drug application (NDA), leading data and analytics company, GlobalData, expects that this drug could be available for amyotrophic lateral sclerosis (ALS) patients much sooner than anticipated. Sarah Elsayed, Neurology Analyst at GlobalData, comments: “As AMX0035 targets a serious neurological condition with huge […]
Faster approvals likely to make CAR-T landscape competitive in China, says GlobalData
China’s National Medical Products Administration (NMPA) has approved its second chimeric antigen receptor T (CAR-T) cell immunotherapy product JW Therapeutics’ relmacabtagene autoleucel injection (relma-cel) shortly after the approval of its first CAR-T therapy, Gilead & FosunKite’s Yescarta, in June 2021. With several CAR-T therapies in Phase II pipeline in China, particularly dominated by domestic companies, […]
Vertex to replace Trikafta as gold standard treatment for cystic fibrosis but other CTFR therapies welcome, says GlobalData
Of the five late-stage pipeline products expected to be licensed in the 7MM* for cystic fibrosis (CF) between 2020 and 2030, four will be CF transmembrane conductance regulator (CFTR) modulators, according to GlobalData. The leading data and analytics company notes that Vertex’s next-generation triple combination, VX-121 + tezacaftor + VX-561 (deutivacaftor), is expected to replace […]
Low level of innovation and generic competition to result in the neuroendocrine tumor market growing only 0.9% by 2030, says GlobalData
The market for neuroendocrine tumors (NETs) – a rare type of tumor where cancerous growth can begin in any cell within the hormone or nervous system – is expected to see a very slow 0.9% compound annual growth rate (CAGR) over the next decade in the world’s eight major markets (8MM*) due to substantial generic […]
Delays in availability will impact overall market potential of recently approved COVID-19 vaccines in India, says GlobalData
India currently has six approved COVID-19 vaccines. However, Zydus Cadila’s, Johnson & Johnson’s, and Moderna’s vaccines are not yet available in India. Considering the gigantic vaccination drive in India, any delay in their availability will impact the overall market potential of the recently approved COVID-19 vaccines, says GlobalData, a leading data and analytics company. On […]
Loss of touch, inconsistent video call technology are key drivers for doctors to opt for face-to-face consultations, says GlobalData
Returning to face-to-face GP appointments is drawing interest from all sectors, as it could be used as another indicator of routine life reverting to prepandemic levels. Indeed, there are diseases that require the sense of touch for proper diagnosis and patient monitoring, which cannot be done via video calls, according to reporting by Reynald Castañeda, […]
India needs more digital public initiatives on diabetes, obesity, and mental health amid COVID-19 era, says GlobalData
In collaboration with the LaparoObeso center, the Indian state of Maharashtra has recently launched a digital campaign to raise awareness of diabetes and obesity. In addition, the Indian state of Delhi’s premier medical institute, All India Institute of Medical Sciences, Delhi (AIIMS Delhi), has developed mobile apps for patients with chronic mental illness and their […]
Too many adults in the US remain unvaccinated to focus on vaccinating children, says GlobalData
Following the news that Pfizer/BioNTech will apply for authorization of their COVID-19 vaccine Comirnaty for children ages 5–11 after showing positive initial data from a trial at a lower dose in this age group; Philipp Rosenbaum, PhD, Senior Healthcare Analyst at GlobalData, a leading data and analytics company, offers his view: “It will be a […]
COVID-19 shapes Indian pharma deals landscape, says GlobalData
India has a rapidly growing pharmaceutical market that, being the third largest pharmaceutical industry in the world by volume, holds a prominent place in global health. Over the last decade, the Indian pharmaceutical market has seen increasing domestic and foreign investment. While the overall number of deals fluctuated only slightly between 2011 and 2019, a […]
Despite bumetanide failure, promise remains in autism market, says GlobalData
Servier and Neurochlore have recently announced that, following a lack of efficacy in two Phase III trials of bumetanide for autism spectrum disorder (ASD) in adolescents, they would be terminating these trials early. These results are particularly disappointing given the promise bumetanide had shown in an earlier Phase IIb trial, and because there is a […]
HER2+/HR+ breast cancer diagnosed incident cases set to reach 114,000 in 2030, says GlobalData
The burden of diagnosed HER2+/HR+ breast cancer is expected to increase at an annual growth rate (AGR) of 1.70% from around 100,000 cases in 2020 to 114,000 cases in 2030 in the eight major markets (8MM*), according to GlobalData, a leading data and analytics company. GlobalData’s latest report, ‘HER2-Positive Breast Cancer: Epidemiology Forecast to 2030’, […]
‘EU biosimilar wave’ can be used to predict future biosimilar activity in the EU, says GlobalData
Leading data and analytics company GlobalData has predicted that the arrival of biosimilar therapies in the EU will continue to fall in the coming years following a wave pattern that has been occurring since 2006. GlobalData’s senior drugs database analyst Quentin Horgan notes that we are currently in the downward trajectory of a wave that […]