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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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In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals got approval of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.

Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart diseasewith mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement.Of most importance, Favipiravir has shown clinical improvementof up to 88% in COVID-19 mild to moderate COVID 19 cases.

Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.

Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before,putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.”

He added, “FabiFlu® has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country.”

Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.

Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use.The drug will be available as a prescription-based medicationfor INR 103/tablet,with recommended dose being1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.

Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.

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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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Novartis announced updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar® (dabrafenib) and Mekinist® (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma1. Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years.

Among patients in the study’s placebo arm 36% (95% CI, 32%-41%) were alive and relapse-free at the time of this analysis, generally consistent with typical melanoma relapse-free survival rates seen among patients with resected stage III disease without treatment. Consistent RFS benefit was observed across all AJCC 7 stage III subgroups.
Median RFS, or the length of time when 50% of patients are still alive and relapse-free, was not yet reached at the 5-year data cut-off for patients on Tafinlar + Mekinist treatment, suggesting long-term benefit of targeted therapy in the adjuvant (post-surgical) setting (NR; 95% CI, 47.9 mo-NR). Median RFS was 16.6 months for patients taking a placebo (95% CI, 12.7-22.1 mo). Treatment with Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo (hazard ratio [HR] 0.51; 95% CI 0.42, 0.61)1.

“Our goal as clinicians is to give our stage III patients the best chance for relapse-free survival,” said Prof. Axel Hauschild, MD, Professor of Dermatology, University Hospital Schleswig-Holstein, Germany. “Results from COMBI-AD show that adjuvant treatment with Tafinlar + Mekinist after surgical resection gives melanoma patients the chance for long-term relapse-free survival. Five years is a clinically and emotionally significant milestone for patients. Recurrent BRAF+ melanoma, once spread to other organs, can be more dangerous and difficult to treat. The durable, long-term results seen among patients in the COMBI-AD trial clearly point to the important role targeted therapy plays in the adjuvant setting.”

The COMBI-AD study results are drawn from a prospective analysis of 870 patients with BRAF V600-mutated melanoma treated with Tafinlar + Mekinist after their surgery. This study represents the largest collection of data and longest follow-up to date in this patient population treated with targeted therapy2. The findings were presented at the ASCO20 Virtual Scientific Program (Abstract #10001).

“The five-year survival mark is an important and predictive milestone for people with melanoma and the doctors who care for them,” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis. “We see an almost 50% risk reduction in melanoma relapse or death in the COMBI-AD data announced today, and we believe patients will find this information helpful in choosing a treatment after surgery. We thank the patients and their families who participated in this long-term clinical trial. Their participation and commitment is helping the community learn how a BRAF-targeted therapy can reimagine outcomes for patients with resectable stage III melanoma.”

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PHD Chamber of Commerce & Industry, Health Committee organized an interactive video conference of series on "Digital Health: The Future: Telemedicine-Where do We Stand Today" on 29th May 2020.

During the discussions with experts from hospitals, MCI, Industry, academia and the radiology and health insurance experts thanked the Govt for guidelines on Telemedicine making it legal for the doctors in India while demanding the Regulatory framework for Telemedicine for International patients as well. They also opined that with AI under supervision of the Clinicians, Telemedicine can extend health support to the rural patients and we could see 20-25% of healthcare being provided through Telemedicine
The eminent panellists of the webinar were Dr. N. Subramanian, Chairman, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals, Mr. Aditya Berlia, Co-Founder & Pro Chancellor, Apeejay Satya University, Dr. Hans Raj Baweja, Chairman, Ethics Committee, Medical Council of India, Dr. Harsh Mahajan, Founder & Chief Radiologist, Mahajan Imaging, Dr. Puneet Girdhar, Sr. Director & Spine Surgeon, BLK Super speciality Hospital, Mr. S K Mehra, Managing Director & CEO, Health Insurance TPA of India.

Dr. N. Subramanian, Chairman, Health Committee, PHDCCI & Director, Medical Services, Indraprastha Apollo Hospitals welcomed all the panellist and said that telemedicine plays a very important role in our lives to reach out to everyone and it is expanding & getting better every year. The risk of NCDs are so high for the treating doctors that the awareness and prevention is the only way to avoid complications where telemedicine and AI play a major role to make the data available and stratifying the risks. It can also manage the algorithms in treating patients with high risk demographics where the Government has the access to real time data and the changing patterns of the disease. Dr. Subramanian advised young practitioners who are keen to adopt the telemedicine technology that it is very important to have certain amount of discipline and they should establish a relationship and trust with the patients esp. for incase of Telemedicine.

Dr Harsh Mahajan, Founder & Managing Director, Mahajan Imaging while briefing about the tele-radiology said that the computing and internet availability improves exponentially the effectiveness of Telemedicine as also reduces the cost drastically of healthcare delivery. He said we will be able to serve the underprivileged sections of the society and remote areas through Telemedicine. He further said that with the advent of Corona, telemedicine has become the necessity where technology helped us a lot to fight this crisis. He also told that telemedicine and AI make work easier and it will become indispensable in coming years but it has to be under supervision of a clinician. Answering to one of the questions from audience, Dr. Mahajan said that telemedicine is here to grow exponentially and serve the multiple purpose like diagnosis, training, education and serve the agenda of preventive measurement. He further added that apart from teleradiology, telemedicine can be used in digital pathology, dermatology, ophthalmology and many other segments.

Mr. Aditya Berlia, Co-Founder & Pro Chancellor, Apeejay Satya University said that the doctor to patient ration in urban area is around 1:10,000 and in rural area it is worst at 1:30,00,00 and this is a worldwide scenario. The Covid-19 has changed the patient & doctor psychology at large and 20-25% medical system will move to telemedicine in coming years. He also said that Covid 19 had given a massive boost to telemedicine and there is an urgent intervention needed from the regulatory part as there is a problem with the data collection part. He further added that in next one year there will be a tremendous use of telemedicine for quick follow-up consultations, consultations by patients who panic and 2nd opinion consultations for referral patients and if we are able to do this then it is a phenomenal achievement.

Dr. Hans Raj Baweja, Chairman, Ethics Committee, Medical Council of India said that there were lot of legal limitations we faced before Covid era as telemedicine is existing and practiced in other countries but never recognised in India. Its only due to this Corona pandemic on 25th March 2020 the telemedicine guidelines were finalised which says that every doctor in India can go on telemedicine platform in India. Explaining the key points of telemedicine guidelines, like mandatory patient consent, mandatory patient identity as it is difficult to identify the patient in audio consultations, taking of history & entering all the details in the prescription, Dr. Baweja said that it is mandatory for doctors also to introduce themselves at the time of consultation and only generic medicines should be prescribed.

Dr. Puneet Girdhar, Sr. Director & Spine Surgeon, BLK Super speciality Hospital said that in the past everyone knew about telemedicine but due to legal limitations, patient psychology and other complications very few were using it and now with the Corona Virus hitting changed even hospitals have come up with their individual telemedicine apps.

Mr. S.K. Mehra, Managing Director & CEO Health Insurance TPA of India said that there’s huge demand of Telemedicine among doctors in coming years. He said this is the right time to start and set some protocols & regulations, which will also help in the expansion of the Telemedicine. He said this concept will certainly help the senior citizens, where they require general consultation or normal follow up for the medicine. Mr. Mehra also explained about the existing insurance policies and the important aspects of telemedicine consultation coverage in the insurance.

While moderating the session Dr. Deep Goel, Senior Director, Dr. B L Kapur Memorial Hospital said that the mother earth is under repair and the social distancing will be the new normal in coming times.

Mr Vivek Seigell, Principal Director Health, PHD Chamber who moderated the session with Dr Deep Goel said that the recommendations and details of the discussions held will be sent to NITI AAYOG as policy inputs on various aspects of Telemedicine esp. for the consulting for International Patients.

Dr. Subramanian, Chairman, Health Committee, PHDCCI gave the Vote of Thanks and the webinar was attended by more than 100 delegates.

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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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The Centre for Cellular and Molecular Biology (CCMB) has established stable cultures of coronavirus (SARS-CoV-2) from patients’ samples. Virologists at CCMB have isolated infectious viruses from several isolates. The ability to culture the virus in lab enables CCMB to work towards vaccine development and testing of potential drugs to fight COVID-19.

Novel coronavirus enters human cell by binding with the ACE-2 receptor on the cell surface. Not all cells have ACE-2 receptors. Human epithelial cells in the respiratory tract copiously express ACE-2 receptors, causing respiratory disease in the infected patient. However, we cannot grow human epithelial cells in lab. “Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”, says Dr Krishnan H Harshan, Principal Scientist, CCMB. They use Vero cells (kidney epithelial cell lines from green African monkey), which express ACE-2 proteins and carry a cell division that allows them to proliferate indefinitely.

But why cultivate a dreadful germ? If we culture a large amount of the virus and inactivate them, then it can be used as inactivated virus vaccine. Once we inject the inactivated virus, the human immune system triggers the production of germ-specific antibodies. One can inactivate the virus by heat or chemical means. The inactivated virus can trigger antibody response, but does not infect and make us sick as they cannot reproduce.

“Currently, primary epithelial cells generated from human origins do not grow for many generations in labs, which is key to culturing viruses continuously. At the same time, the labs that are growing the virus need an ‘immortal’ cell line”

For the development of antibodies or antidots, virus cultures are important. Inactivated viruses can trigger antibody response in other mammalian hosts in addition to humans. Various such hosts are currently under test for their efficiency of antibody response. Such antibodies generated in these non-human hosts can be purified, processed and collected. The antibodies can be used as therapeutic intervention for patients suffering from the infection. Such antibodies can trigger antiviral response upon injection into humans and have the potential of limiting the infection. Administering antibodies does not provide immunity like a vaccine does, but can be considered as anti-dotes against the virus.

These cultures may also be helpful in the process of drug screening. Potential drugs can be tested against the virus in a test-tube for their efficacy.

“Using the Vero cell lines to grow the coronavirus, CCMB is now in a position to isolate and maintain viral strains from different regions. We are working towards producing viruses in huge quantities that can be inactivated, and used in vaccine development and antibody production for therapeutic purposes”, says CCMB Director, Dr Rakesh Mishra. CCMB has also started testing potential drugs with other partners such as the Defence Research Development Organisation (DRDO) using this viral culture.

“We hope that such systems are replicated at multiple research institutes and private companies to become a useful resource in the fight against this pandemic as well as for future preparedness”, said Dr Mishra.

- India Science Wire

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Roche announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS.’’

The approval is based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRRs) for a two-hour OCREVUS infusion time vs. the conventional 3.5-hour time in patients with relapsing-remitting MS (RRMS) (289 patients shorter infusion; 291 conventional infusion). The first dose was administered per the approved dosing schedule (two 300 mg intravenous (IV) infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time.

The primary endpoint of this study was the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The majority of IRRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRRs were life-threatening, serious or fatal. No patients discontinued the study due to an IRR and no new safety signals were detected.

As previously communicated, the U.S. Food and Drug Administration accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by 14 December 2020.

With rapidly growing real-world experience and more than 160,000 patients treated globally, OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and primary progressive MS (PPMS). OCREVUS is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

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