International News

Following the news that Health Secretary Sajid Javid has confirmed that plans for vaccine passports in England have been scrapped; Leia Mais »

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 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.

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 »

The UK e-commerce market is the 4^th largest in the world with an estimated revenue of £77 billion in 2020, placing the country ahead of Germany but behind Japan. Unprecedented growth in online business in general is placed squarely on the shoulders of the COVID-19 pandemic, and in pharmaceuticals, the frequency of product shipping and timed deliveries is skyrocketing. Leia Mais »

26 August 2021

A study led by University of Birmingham experts has been awarded the Guinness World Records title for the world’s largest scientific collaboration – involving over 140,000 patients in 116 countries.

The record for ‘Most authors on a single peer-reviewed academic paper’ is now held by the Universities of Birmingham and Edinburgh after 15,025 scientists around the globe contributed to major research into the impact of COVID-19 on surgical patients.

Funded by the NIHR, the researchers concluded that patients waiting for elective surgery should be treated as a vulnerable group and access COVID-19 vaccines ahead of the general population – potentially helping to avoid thousands of post-operative deaths linked to the virus.

This could be particularly important for Low- and Middle-income Countries (LMICs) where access to vaccination remains limited and mitigation measures such as nasal swab screening and COVID-free surgical pathways to reduce the risk of virus-related complications are not available for many patients.

Overall, the scientists estimated that global prioritisation of pre-operative vaccination for elective patients could prevent an additional 58,687 COVID-19-related deaths in one year.

The COVIDSurg Collaborative international team of researchers published its findings in BJS, Europe’s leading surgical journal, after studying data from 1,667 hospitals in countries including Australia, Brazil, China, India, UAE, UK and USA.

Study co-lead author Mr Aneel Bhangu, a surgeon from the University of Birmingham, commented: “Being awarded the Guinness World Records title for the world’s largest scientific collaboration highlights the scale of our global partnership, which aims to contribute to our understanding of COVID-19 and help to save as many lives as possible around the world.

“It marks the commitment and hard work of thousands of medical colleagues around the world to understand the changes that are needed in how surgery must be delivered if we are to beat the virus and reduce its impact on surgical patients.”

Before the COVID-19 pandemic, five billion people lacked access to surgical care and 143 million more operations per year were required globally. There was already a major global inequity in access to safe and affordable surgery across low and middle-income countries, with an urgent need to expand capacity.  The pandemic has acutely worsened that situation.

Launched in March 2020, the COVIDSurg Collaborative has provided data needed to support changes to surgical delivery in the fastest time frame ever seen by a surgical research group. Research from this huge study group has also explored the timing of surgery after COVID infection, preoperative isolation, and risks of blood clots, all published in the field-leading journal Anaesthesia.

Co-author Mr James Glasbey, also a surgical trainee from the University of Birmingham, commented: “Over 15,000 surgeons and anaesthetists from across 116 countries came together to contribute to this study making it the largest ever scientific collaboration, surpassing even ground-breaking research from the Large Hadron Collider at CERN in Switzerland. Every day we hear in the news that waiting lists are growing, and patients are unable to access the surgery that they need. This situation sadly is deteriorating in countries all over the world. Policy makers can use the data from this scientific collaboration to safely restart elective surgery.”

During the first wave of the pandemic, up to 70% of elective surgeries were postponed, resulting in an estimated 28 million procedures being delayed or cancelled. Whilst surgery volumes have started to recover in many countries, ongoing disruption is likely to continue throughout 2021, particularly in the event of countries experiencing further waves of COVID-19. Vaccination is also likely to decrease post-operative pulmonary complications – reducing intensive care use and overall healthcare costs.

Gene therapies could revolutionize cardiovascular disease management offering a one-time treatment for conditions such as heart failure, says GlobalData Leia Mais »

Top biopharma companies could be affected by Brazilian drug patent suspension, says GlobalData

While the suspension of patent extensions in Brazil could lead to lower drug prices and cheaper generic drugs, this move may deter large biopharma companies from marketing innovative drugs in Brazil in the future, says GlobalData, a leading data and analytics company. Leia Mais »