COVID-19

Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The drug will be launched under the brand name DESREM™ in India and will be available to patients in July at a price of INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.

Mylan will manufacture remdesivir in India at its world-class injectables facilities, which also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration (FDA) for compliance with good manufacturing practices. The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO). The approval by DCGI in India represents the first for Mylan in these 127 markets.

Mylan President Rajiv Malik said: “Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India.

Malik continued: “Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic. Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time. We are proud to continue our work in support of public health in partnership with governments and other stakeholders as we work together in the fight against COVID-19.”

Rakesh Bamzai, President, India and Emerging Markets, said: “The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan is cognizant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities including R&D, regulatory, manufacturing and supply chain, while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, including India. Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID19 treatments. Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.

As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs. As the situation around COVID-19 continues to evolve, Mylan’s priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

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Warning that thermal cameras and other such “temperature screening” products, some of which make direct claims to screen for COVID-19, are not a reliable way to detect if people have the virus.

The Agency is telling manufacturers and suppliers of thermal cameras that they should not make claims which directly relate to COVID-19 diagnosis, and is reminding businesses to follow Government advice on safe working during COVID-19.

Graeme Tunbridge, MHRA Director of Devices, said:
1. Many thermal cameras and temperature screening products were originally designed for non-medical purposes, such as for building or site security. Businesses and organisations need to know that using these products for temperature screening could put people’s health at risk.
2. These products should only be used in line with the manufacturer’s original intended use, and not to screen people for COVID-19 symptoms. They do not perform to the level required to accurately support a medical diagnosis.
3. We are reminding anyone selling these products not to make claims which directly relate to COVID-19 diagnosis. If they fail to comply, we will take formal enforcement action.

Products which the manufacturer claims are intended for screening for COVID-19, or fever-like symptoms, would be regarded as medical devices and regulated by the MHRA.

There is little scientific evidence to support temperature screening as a reliable method for detection of COVID-19 or other febrile illness, especially if used as the main method of testing.

Temperature readings from temperature screening systems will measure skin temperature rather than core body temperature. In either case, natural fluctuations in temperature can occur among healthy individuals. These readings are therefore an unreliable measure for detection of COVID-19 or other diseases which may cause fever. Furthermore, infected people who do not develop a fever or who do not show any symptoms would not be detected by a temperature reading and could be more likely to unknowingly spread the virus.

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Zydus an innovation-driven, global pharmaceutical company, announced that it’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India.

In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.

Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.

With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1).

The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.

Company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

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Remdesivir, Gileads investigational treatment, is the first antiviral to have demonstrated patient improvement in clinical trials for COVID-19 and there is no playbook for how to price a new medicine in a pandemic. Gilead is aware of the significant responsibility that comes with pricing remdesivir, and the need to be transparent on Gileads decision. After giving this the considerable care, time and amount of discussion that it merits, Gilead is now ready to share Gilead's decision and explain how Gilead reached it.

As with all gilead actions on remdesivir, Gilead approached this with the aim of helping as many patients as possible, as quickly as possible and in the most responsible way. This has been Gilead's compass point throughout, from collaborating to find rapid ansGileadrs on safety and efficacy, to scaling up manufacturing and donating Gilead's supply of remdesivir through the end of June. In each case, Gilead recognized the need to do things differently to reflect the exceptional circumstances of the pandemic. Now, as Gilead transition beyond the donation period and set a price for remdesivir, the same principle applies.

In normal circumstances, Gilead would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 shoGileadd that remdesivir shortened time to recovery by an average of Gilead's days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately USD 12,000 per patient. Even just considering these immediate savings to the healthcare system alone, Gilead can see the potential value that remdesivir provides. This is before Gilead factor in the direct benefit to those patients who may have a shorter stay in the hospital.

Gilead had decided to price remdesivir below this value. To ensure broad and equitable access at a time of urgent global need, Gilead have set a price for governments of developed countries of USD 390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment cGilead'sse using 6 vials of remdesivir, which equates to USd 2,340 per patient.

Part of the intent behind Gilead's decision was to remove the need for country by country negotiations on price. Gilead discounted the price to a level that is affordable for developed countries with the loGileadst purchasing poGileadr. This price will be offered to all governments in developed countries around the world where remdesivir is approved or authorized for use. At the current price of USd 390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems.

In the U.S., the same government price of USD 390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be USD 520 per vial. At the level Gilead have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, Gilead believe all patients will have access.

Gilead has entered into an agreement with the U.S. Department of Health and Human Services (HHS) whereby HHS and states will continue to manage allocation to hospitals until the end of September. After this period, once supplies are less constrained, HHS will no longer manage allocation.

In the developing world, where healthcare resGilead'sces, infrastructure and economics are so different, Gilead have entered into agreements with generic manufacturers to deliver treatment at a substantially loGileadr cost. These alternative solutions are designed to ensure that all countries in the world can provide access to treatment.

Gilead's work on remdesivir is far from done. Gilead continue to explore its potential to help in this pandemic in various ways, such as evaluating treatment earlier in the cGilead'sse of the disease, in outpatient settings, with an inhaled formulation, in additional patient groups and in combination with other therapies. As Gilead accumulate more data from global clinical trials and initiate many additional studies, Gilead will understand more about the full value of remdesivir over time. Gilead's teams also remain focused on increasing supplies to meet the high global demand. By the end of this year, Gilead expect Gilead's investment on the development and manufacture of remdesivir to exceed USD 1 billion (U.S.) and Gilead's commitment will continue through 2021 and beyond.

In making their decision on how to price remdesivir, Gilead considered the full scope of its responsibilities. Gilead started with its immediate responsibility to ensure price is in no way a hindrance to ensuring rapid and broad treatment. Gilead also balanced that with its longer-term responsibilities: to continue with Gilead's ongoing work on remdesivir, to maintain it's long-term research in antivirals and to invest in scientific innovation that might help generations to come. As with many other aspects of this pandemic, Gilead is in unchartered territory in pricing remdesivir.

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Gplife Healthcare Pvt. Ltd. And it’s associate company Shadow Pharma Venture Pvt. Ltd today announced that Gplife Healthcare has obtained Phase II clinical trial permission on ACT 12 Tablets and ACT 13 Dry Syrup for the treatment of COVID 19 positive hospitalized patients. Treatment duration for patients will be 10 days. The results of clinical trial are expected by August 2020. Both products have been found safe at the recommended dose for Phase II study.

Dr. Shridhar Pandya, Managing Director and Inventor, Gplife Said, “This is the first Nutraceutical product approved for Clinical trial for treatment in COVID 19 positive hospitalized patients. Both products have multiple therapeutic benefits and are based on research efforts of more than 10 years for other therapeutic treatments.

Mr. Kiran Narasimha Pai. MBA, IIM Calcutta, Advisor to Gplife Healthcare, briefed that this trial for COVID-19 is one of the most important trials globally as it’s based on the next generation of phytochemistry technology and its success among COVID-19 patients would be a much-needed positive news for the world going through a once in a lifetime pandemic.

Mr. Prasad Kanitkar, Chief Technical Officer, Shadow Pharma added, these products and technologies are outcomes of putting science and natural resources together for the betterment of human beings since past few years. Shadow Pharma will further commercialize these products and technologies globally.

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EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.

Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.

From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 5 June

The assessment of the dossier has now concluded with today’s recommendation, which is mainly based on data from study NIAID-ACTT-11, sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), plus supporting data from other studies on remdesivir.

Study NIAID-ACTT-1 evaluated the effectiveness of a planned 10-day course of remdesivir in over 1,000 hospitalised patients with COVID-19. Remdesivir was compared with placebo (a dummy treatment) and the main measure of effectiveness was patients’ time to recovery (defined as no longer being hospitalised and/or requiring home oxygen or being hospitalised but not requiring supplemental oxygen and no longer requiring ongoing medical care).

Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given placebo. This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the remdesivir group and the placebo group. For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group. However, no difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation). Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.

Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease. Remdesivir is given by infusion (drip) into a vein and its use is limited to healthcare facilities in which patients can be monitored closely; liver and kidney function should be monitored before and during treatment, as appropriate. Treatment should start with a 200-mg infusion on the first day, followed by one 100-mg infusion a day for at least 4 days and no more than 9 days.

Remdesivir is recommended for a conditional marketing authorisation, one of the EU regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need, including in emergency situations in response to public health threats such as the current pandemic. This type of approval allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, if the benefit of a medicine’s immediate availability to patients outweighs the risk inherent to the fact that not all the data are yet available.

In order to better characterise the effectiveness and safety of remdesivir, the company will have to submit the final reports of the remdesivir studies to the Agency by December 2020, and further data on the quality of the medicine, as well as the final data on mortality, by August 2020. As for all medicines, a risk management plan (RMP) will ensure rigorous safety monitoring of remdesivir once authorised across the EU. Further efficacy and safety data will be collected through on-going studies and post-marketing reports and will be regularly reviewed by the CHMP and EMA’s safety committee (PRAC). Since April 2020, the PRAC has also been reviewing safety data on patients treated outside clinical studies, which are being submitted as monthly safety reports; these will continue to be submitted and assessed after the medicine is on the market.

During the assessment of remdesivir, the CHMP had the support of experts from the COVID-19 EMA pandemic task force (COVID-ETF), which was established to bring together the most relevant expertise from the European medicines regulatory network to assist Member States and the European Commission in dealing with the development, authorisation and safety monitoring of medicines and vaccines against COVID-19.

The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.

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Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.

Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”

The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.

The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.

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As demand for medical supplies soars worldwide in the fight against Covid-19, there is a parallel risk of substandard and counterfeit medicines in the global market. With India being one of the world's largest producers of medical supplies, there is an urgent need to bring in strong anti-counterfeiting measures which will be addressed at Messe Frankfurt’s upcoming conference - Pharmasafe India 2020.

Together with healthcare workers on the frontline, the pharmaceutical industry has been actively playing a crucial role and strengthening efforts to ensure best medical services in the battle against Covid-19. However, the trade of counterfeit medicines, which can pose a direct threat to public health and life, has found resurgence in the wake of on-going pandemic. The recent warnings issued by the World Health Organisation indicate that a growing number of fake medicines linked to coronavirus are on sale in developing countries. There have already been multiple incidents reported on the sale of counterfeit facemasks, substandard hand sanitisers, substandard PPE's as well as counterfeit anti-viral drugs to unsuspecting consumers.

With an aim to draw attention to the latest developments in the field of anti-counterfeiting technologies for the pharma industry, Messe Frankfurt India will bring key anti-counterfeit solution providers for dialog with the pharma sector at its highly influential Pharmasafe India 2020 conference. The 4th edition of the conference, which was earlier scheduled in April, has now been pushed ahead due to the nationwide lockdown and the new dates will be announced in the coming weeks, when the industry can safely and surely come together to address and reinforce measures for this global issue.

Ahead of the conference scheduled this year, Messe Frankfurt is also organising a series of Webinars during the lockdown period to serve the industry with valuable insights from an international panel of experts and thereby helping the industry in charting anti-counterfeiting strategies in the current situation. While the webinars will bring attention to immediate topics of relooking at patient safety by eliminating substandard products in the wake of global outbreak, the organiser is working towards addressing burning topics around Covid-19 at the Pharmasafe India conference taking place later this year, surrounding the counterfeit market such as the race for coronavirus vaccine and government initiatives to prevent vaccine counterfeit, Operation Pangea 13: key findings and importance of consolidated global efforts in identifying counterfeit networks, strengthening supply chain and traceability technology to curb counterfeit amid pandemic, mishandling of medicines and addressing the issue of improper vaccine storage and how the pandemic is reshaping brand protection.

The conference has drawn strong support from leading associations in the pharmaceutical industry including Authentication Solution Providers' Association (ASPA), Indian Drug Manufacturers' Association (IDMA), Cell for IPR Promotion and Management (CIPAM) and Chamber of Business Leaders.

According to a study conducted by the OECD and the European Union Intellectual Property Office, trade in counterfeit pharmaceutical products worldwide is worth just over €4bn. The longer the pandemic lasts, the more strain supply chains and distribution channels will undergo, making it easy for counterfeits or sub-standard medical products to enter the market. It is crucial to simultaneously focus on anti-counterfeiting and brand protection strategies which Pharmasafe India 2020 together with its webinar series aim to achieve through the combined efforts of technology experts, decision-makers and the Indian pharma industry.

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AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, on large-scale GMP production of a critical component of Novavax’ coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M™, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 is a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology. AGC Biologics will optimize process development for scaled-up production of Matrix-M to significantly increase Novavax’ capacity to deliver doses in 2020 and 2021.

“We are quickly ramping up to successfully deliver this vital vaccine component to Novavax,” says AGC Biologics’ CEO Patricio Massera. “The urgency to help produce a vaccine to combat COVID-19 could not be higher.”

“AGC Biologics’ mission is to work side-by-side with our partners to produce life-saving and extending products,” says Mark Womack, CBO of AGC Biologics. “Partnering with Novavax to manufacture this vaccine component is an amazing opportunity to make a profoundly positive difference.”

“We have been impressed with AGC Biologics’ level of collaboration and commitment,” says Timothy J. Hahn, SVP, Process Technology at Novavax. “They are an important strategic partner in expanding our supply chain of adjuvant for NVX-CoV2373 and for other vaccines being developed at Novavax, including our recombinant seasonal influenza vaccine, NanoFlu.”

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COVID-19 positive individuals who are asymptomatic do not have the potential to infect others because they have a low “virus load” compared to those who are symptomatic, said Health director-general Datuk Dr Noor Hisham Abdullah reported by Bernama.

He, however, said that infectivity could occur two days before the affected individual showed symptoms.

“So, we need to differentiate that the ones without symptoms do not have any problems as there’s no infectivity. But we found that those with symptoms and two days before having those symptoms they could infect others,” he said at the daily press conference on COVID-19 on 31st May, 2020 in Malaysia.

He said that the first week of being symptomatic was when the virus was active enough to infect others, but if the individual was isolated for between eight to 10 days, or 14 days as is being done by the government now, the infectivity rate can be reduced to almost zero.

“As for those who are asymptomatic, perhaps they won’t be able to infect others within 14 days. But infection can happen two days before the symptomatic period. So, if we can isolate them we can break the COVID-19 chain of transmission,” he said.

Meanwhile, Dr Noor Hisham said that tomorrow the Ministry of Health (MOH) would share its model regarding the projection for COVID-19 cases in the last one month, today and in the future.

“So for cases involving Malaysians, we found there was adherence to standard operating procedure (SOP) and when we comply with the SOP, it means the R-nought (RO) is less than 0.3 percent. (RO refers to the infectivity rate).

“But for non-Malaysians, if we minus the immigration detention depot and import cases, we find the RO is still about 0.3 percent and we are still monitoring daily the development among Malaysians and non-Malaysians,” he said.

He said what was important was for the MOH to focus on non-Malaysians so that they too complied with the SOP.

However, he said several constraints needed to be focused on, such as accommodation and environment of the foreigners, while employers also needed to play their role in ensuring the foreign workers complied with government directives as well as to take preventive measures and maintain cleanliness. (Bernama)

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