13 of Merck’s Islatravir studies placed on clinical hold by FDA
Decreased total lymphocyte and CD4+T cell counts related to islatravir result in FDA clinical hold. Merck has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) applications involving the HIV investigational drug islatravir. The hold applies to islatravir (MK-8591) oral and implant formulations for HIV-1 pre-exposure prophylaxis (PrEP), the HIV-1 injectable formulation for prophylaxis and treatment as well as the HIV-1 once daily oral doravirine/islatravir (DOR/ISL) treatment. The FDA directive comes after a decrease in total lymphocyte and CD4+T cell count was observed in studies where participants were receiving islatravir. As part of the hold, new islatravir studies are not permitted and participants receiving islatravir on PrEP studies will no longer receive treatment. Nevertheless, participants will be offered an approved oral PrEP treatment and their lymphocyte and CD4+T cell counts will continue to be monitored. Participants who initiated treatment on DOR/ISL studies will continue treatment on partial clinical hold. All screening and randomisation has been halted for the DOR/ISL treatment arm. Merck Research Laboratories Global Clinical Development infectious diseases vice-president Dr Joan Butterton stated, “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.” A total of six studies have been placed on full clinical hold while seven are placed on partial clinical hold. Additionally, Gilead and Merck’s Phase 2 study where both islatravir and lenacapavir were administered to virologically supressed HIV participants has discontinued treatment. Both companies are committed to their collaboration to ensure that the needs of people living with HIV are met.
2020's Top 10 medical device companies in the world
Ranked by revenues of the medical device segments, 10 companies account for nearly half of the US$450 earned by the market participants. The medical device industry was estimated to be worth over USD450 billion in 2019. With growth continuing to be fueled by long-term trends such as an increases in the number of healthcare facilities, healthcare expenditures, technological advancements as well as an aging population across much of the developed world, the industry is expected to keep growing at impressive rates for many years to come. With emerging economies lagging behind their mature markets, these are also expected to see impressive growth rates due to some of the similar trends. Above is a graphic representation of the leading companies operating in the space. Jointly, these account for nearly USD210 of the revenue, or just below half of it. Led by the medical device giant Medtronic, the list features well-known names such as J&J, Thermo-Fisher, Abbott and GE Healthcare, making up the top half.
2020-10-12 Covid-19 Vaccine Race: Weekly Round-up
China emerging as key player in race to find Covid-19 vaccine candidate, with half of candidates in Phase III studies produced by the Asian superpower. The numbers As of October the 11th, 37,219,209 people had been infected by the virus worldwide and a total of 1,073,079 Covid-19 related deaths had been reported since late January. The outbreak which started in the Chinese city of Wuhan had spread to more than 180 countries and territories, affecting every continent with the exception of Antarctica. Impact and response In response to the rapid spread, countries imposed varying degrees of national lockdowns and imposed restrictions on international travel as they battled to flatten their respective curves to contain the loss of lives and minimize the economic calamity. The economic fallout resulting from the pandemic has culminated in mass layouts, a growing list of bankruptcy fillings as well as battered financial markets. Since January, the pandemic’s epicenter has shifted from China, then Europe, and now seems to be headed towards emerging markets such as Brazil and India. Vaccine race At present, more than 170 candidates are currently being tracked by the WHO as researchers across the globe race to develop a vaccine quicker than usual. While more than 80 percent of the candidates are still in the pre-clinical stage, 10 of these have entered Phase III studies, bringing them closer to approval before being made available for large-scale use. Notably, half of the candidates currently conducting Phase III trials are by Chinese companies, highlighting the superpower’s push to lead the race as U.S. companies continue to grapple with strict safety protocols. The Chinese candidates are being developed by units of Sinopharm, Fosun Pharma, Sinovac Biotech and CanSino Biologics. Other players leading the race include the University of Oxford/AstraZeneca, Novavax, Moderna, J&J and the Gamaleya Research Institute.Use this space to connect with your readers and potential customers in a way that’s current and interesting. Think of it as an ongoing conversation where you can share updates about business, trends, news, and more.
2020-10-19 Covid-19 Vaccine Race: Weekly Round-up
With the global count of Covid-19 cases fast approaching 40 million, the past seven days have certainly not been lacking in terms of activity on the Covid-19 vaccine race front. With two leading vaccine studies being put on hold, the WHO’s Solidarity casting worrying doubts over remdesevir, it seems the race is now left open for two US pharma giants. Monday, 12 Oct The week started off with an announcement that J&J had paused its own Covid-19 trial to investigate an unexpected illness affecting one of the trial participants. The J&J pause is in addition to a halt imposed by regulators more than a month ago on the AstraZeneca/University of Oxford trial after neurological symptoms were reported in two volunteers. With the two paused and questions arising about the effectiveness and safety of adenoviral vectors, this seems to be paving the way for Moderna and Pfizer-BioNTech as they emerge as frontrunners in the race. Tuesday, 13 Oct On Tuesday, the focus shifted to Eli Lilly, after it reported that its own closely watched monoclonal antibody trial had also been paused over safety concerns. On the same day, the National Institutes of Health said it had paused the study after the trial’s independent data and safety monitoring board reported the study had reached a “predefined boundary for safety” after five days of treatment. However, no indication was provided regarding whether it was the treatment group or the placebo group that may have crossed a safety threshold. It is likely to take two weeks before more is disclosed regarding the fate of the trial. Thursday, 15 Oct As if the week was not eventful enough, a startling reveal by the WHO on Thursday that results from its much-anticipated 11,266 patient Solidarity trial showed remdesevir provided little or no effect on chances of survival or on the length of hospital stays among patients with the respiratory disease sent shockwaves across the world. With Gilead Sciences, the company that developed the drug questioning the scientific rigor behind the study, the WHO refused to back down and stood by its findings which are contrary to those from Gilead’s 1,062-patient trial which purported the drug cut recovery time by five days and helped reduce the risk of death in some patients who received oxygen. To complicate matters, remdesivir had already received emergency use authorisation from the US FDA on May 1. In addition, the EU also authorized its emergency use and agreed to a €1bn remdesivir-supply deal on Tuesday, weeks after Gilead was reportedly informed by the WHO about its findings. Furthermore, the WHO’s trial also found that other medicines such as malaria drug hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon which have been repurposed since the pandemic began offered little or no benefit to Covid-19 patients. The hydroxychloroquine and anti-HIV studies were abandoned earlier in the year, and interferon was dropped on Thursday. Friday, 16 Oct More encouraging news came from Pfizer on Friday. The company reported that it could seek emergency-use authorization for its Covid-19 vaccine by late November if shown to be effective in its large late-stage trial. In an open letter published on the company’s website, the company’s Chief Executive Officer Albert Bourla mentioned the pharma giant should be able to meet the milestone to have at least half the study patients be watched for side effects for two months as required by the FDA in the third week of November. So who's leading the race? With questions being cast over adenoviral-based treatments, messenger RNA vaccine candidates developed by Moderna and the Pfizer-BioNTech partnership are seen to be leading the race. With the J&J and AstraZeneca/Oxford vaccine studies on hold for safety checks, this puts them significantly behind the two mRNA vaccines. Though Moderna is slightly behind Pfizer in the race, it is expecting to have preliminary efficacy data by the end of November – just a few days behind Pfizer’s. While both Pfizer and Moderna began their respective late-stage trials at the end of July, Pfizer is lightly ahead due to the speed at which it enrolled participants in its trial as well as its dosing regimen.
Abbvie seeks to add new indication, psoriatic arthritis to Skyrizi
With first-line treatments proving unsuccessful against psoriatic arthritis, Skyrizi intends to be an addition treatment option. Abbvie has recently received a recommendation from the Committee for Medical Products for Human Use (CHMP), for the approval of Skyrizi in psoriatic arthritis (PsA). The immunologic drug was previously approved for use in psoriasis. However, Skyrizi has now been recommended to treat adults that have not been successful with at least one treatment option for PsA. The conventional first-line treatments are anti-rheumatic drugs like methotrexate. These drugs are generally effective; though, it was found that 71% of people with PsA have not responded positively to their first line treatment. Earlier this year Abbvie revealed that in the Keepsake-1 and Keepsake-2 clinical trials, Skyrizi had a higher efficacy than the placebo. The drug also achieved its secondary endpoints of skin clearance, reduced disease activity as well as physical function. As measured by the Psoriasis Area Severity Index (PASI900), Skyrizi demonstrated to have a skin clearance improvement of no less than 90% after 6 months in comparison to the placebo. In addition, patients receiving the drug experienced an improvement in joint pain more often than the patients on the placebo injections. A 20% decrease in combination symptoms was reported in 57% and 51% of patients on the Keepsake-1 and Keepsake-2 trails, respectively. Taking into account the positive strides the drug has made with both clinical trials and the recommendation from CHMP, Skyrizi could be approved and released to the European Union market in months. Gary Nachman, market analyst at the Bank of Montreal indicted that the current approval could broaden Abbvie’s market, with a projected $350 million sales in 2025.
Abdool Karim joins World Health Organization’s elite Science Council panel
The world-renowned scientist joins elite panel of leading figures to advise WHO on key health matters. Announced by the Centre for the AIDS Program of Research in South Africa (CAPRISA) in a statement on Monday, the world renowned South African infectious disease epidemiologist, Professor Salim Abdool Karim, has been appointed as a member of the World Health Organisation (WHO)’s Science Council. The nine-member council was established by the WHO’s director-general Dr Tedros Ghebreyesus, to directly advise the organisation about high-priority scientific issues. The Council’s membership comprises of the world’s leading health researchers and is chaired by Nobel Laureate Dr Harold Varmus. Abdool Karim, who is director of CAPRISA, recently stepped down as the co-chair of South Africa’s Covid-19 ministerial advisory committee to focus on HIV-related work. In his new role as member of the Science Council, he will be working alongside a distinguished panel of influential figures to provide counsel to WHO regarding how to respond to “…health problems such as global health threats, interpret the latest scientific and medical knowledge, and identify the latest advances in technology to improve health globally,” according to CAPRISA’s statement. “Pandemics such as AIDS and Covid-19 have highlighted the important role of science in global health. I am looking forward to participating in this Council providing scientific advice to WHO on future developments in health that the world needs to be better prepared for,” said Abdool Karim in the statement.
Adcock Ingram looking to fight codeine addiction among South African youth
Local pharma company partners in campaign to raise awareness about dangers of codeine addiction. The local pharmaceutical company Adcock Ingram has joined forces with the police to fight codeine addiction among the youth. Through the campaign called #LeanOnMe, the Midrand-based company along with its partners are looking to raise awareness about the dangers of using “lean”, which is a mixture of codeine and other ingredients such as fizzy drinks. An opioid, codeine is used to treat pain and is found mainly in pain pills and cough syrups. Opioids are narcotics with a known potential for dependence. Codeine itself is also known to have euphoriant effects, which can reinforce further use and lead to dependency. Back in 2018, it was estimated that 600,000 South Africans were addicted to this “purple drink” which could have detrimental effects when used excessively. In South Africa, codeine-containing cough syrups are regulated in terms of Schedule 2 and Schedule 3 of the Medicines and Related Substances Control Amendment Act. And unless prescribed by an authorised prescriber, codeine-containing products can only be sold by a registered pharmacist, or a post-basic pharmacist’s assistant under the personal supervision of a pharmacist, at a licenced pharmacy. However, illicit sales of the products have been on the rise and have fuelled youth addiction. The country’s regulator, SAHPRA, is also monitoring the rise in illicit codeine sales closely and has encouraged any complaints be reported via telephone on (012) 842 7609/10 or by email: firstname.lastname@example.org or to the National Adverse Drug Events Monitoring Centre on (021) 447 1618.
Adverse reactions to COVID-19 vaccines are being closely monitored in South Africa.
The country is prioritizing the safety of its citizens by closely tracking adverse reactions after vaccination. South Africa focused on vaccinating healthcare workers during phase one of its vaccine campaign. The country began its second phase on May 17th for people 60 years and older. To date, just over a million medical staff and public citizens have been vaccinated. Health workers received the Johnson & Johnson vaccine whilst the Pfizer vaccine was introduced to the public for phase two. Since all vaccines and medications have side effects, a key aspect of the vaccination campaign is to monitor adverse reactions after vaccination, especially to build trust and confidence. If the public knows that all adverse reactions are taken seriously and proper measures are taken, people will trust that the vaccine is safe. A National Committee of Experts on Immunization Safety was established to investigate and report on adverse reactions after vaccination. Each province and district have staff responsible for this investigation however, any person can report a reaction via the MedSafety App or by completing a Case Report Form. Once the provincial or district team receive the medical records of people who have had adverse reactions, they present them to the committee. The Committee uses an algorithm generated by the World Health Organization (WHO) to categorize the reaction. A finalized report then goes to the WHO for global monitoring. Monitoring adverse reactions on a national or global scale can detect rare events – of which a risk-benefit decision can be made to determine whether the vaccine should continue.
Africa celebrating one-year anniversary of being certified wild polio-free
The historic milestone follows closely coordinated efforts by global partners to rid Africa of the virus. On Wednesday, the WHO African Region celebrated a one-year anniversary of the continent being certified wild polio-free. This comes after the Africa Regional Certification Commission certified the region as being free of the virus on 25 August last year, after four years without observing a single case. Until now, two of three wild polio virus strains had been eradicated across globally. The latest milestone means the continent has now been declared free of the last remaining strain of wild poliovirus. Nigeria, which accounted for more than half of all global cases less than ten years ago was the last country on the continent to be declared wild polio-free. To date, there is no cure for the virus which usually affects children aged under five, sometimes causing irreversible paralysis. When the World Health Assembly launched the Global Polio Eradication Initiative (GPEI) back in 1988 with the goal of eradicating polio by the 2000, the disease was endemic in 125 countries and was paralyzing 350,000 children every year. Since then, about 400 million children have been vaccinated each year and global polio cases have dropped by 99%. The campaign to rid Africa of polio also inspired the late Nelson Mandela to join forces with Rotary, the GPEI and other African countries to launch the Kick Polio Out of Africa initiative back in 1996. Since the launch of the campaign, nine billion doses of the oral polio vaccine have been distributed across the continent, reversing the damaging effects of the virus that paralyzed thousands of African children 25 years ago.
Africa failing to invest in mental health problems in children and adolescents
Mental health problems are steadily increasing in Africa, greater investments are needed from local governments. The world celebrated World Mental Health Day on 10 October 2021, this day has shown a light on the efforts being made to provide mental health support to children and adolescents in Africa. UNICEF and the WHO have expressed that there is a demand for increased investments for mental health support, responsiveness, and prevention. According to the WHO, in sub-Saharan Africa one in every seven children deal with significant psychological adversity. Mohamed Fall, Regional Director for Eastern and Southern African noted that “Our systems are still failing them,” with 50% of mental health problems developing by the age of 14 and 75% in the mid-20s more needs to be done. Africa’s investment in its youth’s mental wellness is predominantly low, with government currently spending less than one US dollar per capita. The COVID-19 pandemic has placed more pressure on the already growing mental health decline, with the youth experiencing hardships that most adults would struggle to deal with. In a time where schools are closing, job opportunities are dwindling and decreased social interaction the youth is left vulnerable to mental health problems. “The lack of access to basic social, health and education services, combined with wide-reaching structural inequalities, are all known to be aggravating risks for mental ill-health,” said Mr Fall. A 10-year, Joint Programme on Mental Health and Psychosocial Well-being and Development of Children and Adolescents in Africa has been agreed upon by UNICEF and the WHO. The programme that was signed in 2020 aims to partner with local governments in efforts to improve psychosocial and mental health support systems.
Africa has entered the race to get Pfizer's COVID-19 pills
The antiviral pill developed by Pfizer was approximately 90% successful in reducing hospitalizations and fatalities. Africa's leading public health body said it was in talks with Pfizer about getting supply of its antiviral COVID-19 pills for the continent, making it the latest to jump into the race for a drug that might be a game changer in the fight against the virus. According to Pfizer, the Paxlovid medication was nearly 90% effective in preventing hospitalizations and deaths, and data suggests it is still effective against the Omicron variant. "We are in really close discussions with Pfizer to see what can be done to make the drugs available on the continent and accessible on the continent, that is, the Paxlovid drugs," said John Nkengasong, director of the Africa Centres for Disease Control and Prevention. Paxlovid is in high demand from governments around the world, while Merck's Molnupiravir has suffered obstacles following disappointing trial results. While vaccines have been governments' major weapon against COVID-19, there is hope that Merck and Pfizer's experimental pills, which may be administered at home rather than in hospitals or medical settings, would help reduce the number of people dying or are hospitalized. Obtaining supplies of COVID-19 drugs, together with ramping up vaccinations and testing, is one of three important measures for tackling the pandemic in Africa in 2022, according to Nkengasong. Since the start of the pandemic, Africa has officially recorded just over 10 million cases of COVID-19, while the true figure is likely far higher due to inconsistent testing.
Africa hits 6 million confirmed COVID-19 cases since pandemic started
The number of infections on the continent continue to rise as third wave escalates. As of yesterday, 13th July the African continent has exceeded the six million confirmed COVID-19 cases mark as per data retrieved from the Africa Centres for Disease Control and Prevention (Africa CDC). This situation comes merely days after the World Health Organization had warned that the third wave of COVID-19 infections in Africa could get worse as new and faster spreading variants were driving infections. The most common variant at present is believed to be the highly transmissible Delta variant which continues to rage across the continent spreading to more and more countries. It is said that a total of 23 countries on the continent have experienced a third wave of infections so far, with Senegal and Malawi being the latest two countries hit. Reported deaths from the 55 African countries have reached a total of 153,549 as of yesterday. According to Africa CDC data, the number of COVID-related deaths has increased by approximately 28% in the past month. South Africa has reported the most cases of the virus thus far, 2,219,316 with 65,142 related deaths, with the Gauteng province leading with infections. Other highly affected African countries include Morocco (545,016), Tunisia (510,396), Egypt (283,230), Ethiopia (277,212), Libya (209,409) and Kenya (189,703). Although over 37,004,431 vaccines have been administered across the continent, Africa has significantly lagged behind the rest of the world in COVID-19 vaccines, with less than 2% of the continent having been fully vaccinated at this time.