Inaugural ’Accelerate’ program designed and delivered by Harvard Medical School Executive Education with the goal of accelerating clinical development and medical affairs Leia Mais »
Arcutis may face challenges when marketing roflumilast despite commercial advantage, says GlobalData
Arcutis Biotherapeutics recently announced the submission of a New Drug Application (NDA) for its topical phosophodiesterase 4 (PDE4) inhibitor, roflumilast, in the treatment of mild-to-severe plaque psoriasis (PsO). Despite having a potential commercial advantage as the first branded topical therapy for an underserved PsO patient subgroup, GlobalData, a leading data and analytics company, notes that Arcutis may still face several challenges when marketing roflumilast. Leia Mais »
SGS is proud to announce that the expansion of its bioanalytical laboratory in Poitiers, France is complete, with the addition of a new 800-m2 building to meet growing global demand for bioanalytical testing services to support drug development. Leia Mais »
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 considerable increase was confirmed for deals struck in 2020. Between 2019 and 2020, the deal number increased by 22%, likely triggered by the COVID-19 pandemic, reveals GlobalData, a leading data and analytics company.
Chris Pilis, Immunology Analyst at GlobalData comments: “Contract service agreements (CSAs), the most popular among the deal types in India, saw a strong increase in number—from 130 agreements in 2018 to 183 in 2019—and retained their elevated level through the next year. Spiking COVID-19 cases in 2020 drove large pharmaceutical companies to strike deals to outsource clinical research and manufacturing of anti-viral therapeutics and vaccines.
“Being the world’s largest vaccine producer, India was an optimal market to pursue these agreements. However, CSAs were not the only type of deal that saw an upward trend because of the pandemic; strategic alliances, including licensing agreements and partnerships, increased by 40% from 2019 to 2020. Most of these deals (30%) focused on COVID-19.”
Other deal types were less popular. Mergers & acquisitions (M&As), even though common in the pharma industry, have remained low in number in India, averaging only 54 deals per year from 2011 and 2015 and dropping further between 2016 and 2020 to about 30 deals per year.
Mr Pilis continues: “The uncertainty brought about by the COVID-19 pandemic may have caused companies to continue to postpone more permanent relationships such as M&As, opting instead for more short-term or easily terminated CSAs and strategic alliances. Similarly, capital raising deals have remained low and static over the past five years. The minimal number of innovative drugs such as biologics (3% of the market) have probably prevented deals such as venture capital financing from taking place in India.”
Over the last decade, an increase in pharma deals has been observed in India because of its market expansion as well as the demand for novel therapeutics during the COVID-19 pandemic.
Mr Pilis concludes: “India’s leading role as the world’s top vaccine manufacturer has attracted many CSAs and strategic alliances in 2020. However, deals such as M&As and capital raises did not show similar COVID-19 pandemic-associated growth, possibly due to uncertainty and the limited innovation in fields such as biologics. The deals landscape highlights the current state of the India’s pharma market and will likely change substantially if the country shifts its focus more to innovation from its generic products industry.”
UK Government must use other methods to encourage vaccine uptake after scrapping vaccine passports, says GlobalData
Following the news that Health Secretary Sajid Javid has confirmed that plans for vaccine passports in England have been scrapped; Leia Mais »
New study reveals AB-Biotics nature-backed probiotic blend for infants significantly improves symptoms of colic
September 2021 – New scientific research highlights the beneficial effect of AB-Biotics’ AB-KOLICARE® – which contains a 100% natural blend of science-backed probiotics – in infants with colic. Adding to an existing bank of science exploring the role of probiotics in infantile colic, the findings revealed that daily oral supplementation of AB-KOLICARE® significantly improves symptoms of the condition, including crying time – creating opportunities for innovation in the infant nutrition space. Leia Mais »
South Korea’s preferential drug pricing system can boost innovation in pharma research, says GlobalData
South Korea has recently decided to provide practical support to innovative pharmaceutical companies by revising the existing health insurance benefits system. The new system of preferential drug pricing, if designed effectively, can boost innovation in the country’s pharmaceutical research, says GlobalData, a leading data and analytics company. Leia Mais »
The burden of diagnosed incident cases of severe sepsis is expected to increase at an annual growth rate (AGR) of 2%, from around 2.3 million cases in 2020 to 2.8 million in 2030 in the seven major markets (7MM*), according to GlobalData, a leading data and analytics company. Leia Mais »
Endometriosis is an indication that needs new therapy options. The variety of symptoms across cases, non-specificity of symptoms, and overlap of symptomology with other conditions make it difficult to manage, with cases often being misdiagnosed. According to GlobalData’s Pharma Intelligence Center database, there are 46 pipeline drugs currently being developed for endometriosis worldwide*. The leading data and analytics company notes that ObsEva’s Yselty, a gonadotropin-releasing hormone (GnRH) receptor antagonist, represents one of those 46 therapies and provides promise in the endometriosis drug market.
ObsEva announced in August 2021 that the company expects an EDELWEISS 3 data readout during Q4 2021.
Sarah Bundra, Pharmaceutical Analyst at GlobalData comments: “Phase III data from ObsEva’s EDELWEISS 3 study will be very important in determining the potential success of Yselty in the endometriosis market. The therapy faces competition from two other GnRH antagonists, Myovant/Pfizer’s relguolix and AbbVie’s Orilissa (elagolix sodium), making Yselty a third-to-market entrant in its class. This would put ObsEva at a significant disadvantage; however, uptake of Orilissa has been poor, signalling the need for more effective endometriosis GnRH antagonists.
“Orilissa is available at 150mg and 200mg dose options, with the higher dosage option contributing to considerable bone mineral density (BMD) loss. BMD loss has been a historically problematic side effect of many endometriosis medications, so if EDELWEISS 3 indicates success in that area, then ObsEva would have an edge over its competitors.”
Yselty provides promise in the endometriosis drug market because of its ability to alleviate pain, minimize adverse effects such as BMD loss, and the flexible dosage options provided. Since Orilissa has already been on the market for three years and Phase III data has been published for relugolix, ObsEva risks receiving a smaller market share upon Yselty’s release.
Bundra continues: “Factors that could bolster Yselty’s success include minimal side effects (BMD loss and hormonal flares), multiple dosage options, and longevity of potential use. Orilissa (200mg), on the other hand, can only be taken for up to six months, which can be problematic for a chronic condition like endometriosis.
“AbbVie currently enjoys a market free from GnRH antagonist competition, although that will likely change once relugolix finishes development. Yselty’s capacity to compete will be largely dictated by the EDELWEISS 3 Q4 2021 data readout.”
*Includes endometriosis therapies in development by pharma companies, government bodies and institutions from the Pre-clinical stage to Phase III development.
AIM ImmunoTech Submits Pre-IND Application to FDA for Potential Infusion Therapy Drug to Treat Post-COVID Symptoms
OCALA, Fla., Sep., 2021 — AIM ImmunoTech Inc. (NYSE American: AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).This will be a Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, is managing the FDA submission and will manage the clinical trial. Leia Mais »