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  • Strides Pharma Science Limited (Strides) announced that its step down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA).

    The product is a generic version of Fioricet® with Codeine Capsules, 50 mg/325 mg/40 mg/30 mg, of Teva Branded Pharmaceutical Product R&D, Inc.

    According to IQVIA MAT May 2020 data, the US market for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg is approximately US$ 10 Mn. The product will be marketed by Strides Pharma Inc. in the US market.

    The company has 124 cumulative ANDA filings with USFDA of which 87 ANDAs have been approved and 37 are pending approval.


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  • 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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  • WHO accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms. The Solidarity Trial was established by WHO to find an effective COVID-19 treatment for hospitalized patients.

    The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the 1-2 July WHO Summit on COVID-19 research and innovation.

    These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect.


    For each of the drugs, the interim results do not provide solid evidence of increased mortality. There were, however, some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial. These will also be reported in the peer-reviewed publication.

    This decision applies only to the conduct of the Solidarity trial in hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19. The interim Solidarity results are now being readied for peer-reviewed publication.


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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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  • Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

    The approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9). This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population (HR 0.69; 95% CI: 0.56 to 0.86; 2-sided P=0.001).1 OS was measured from the time of randomization, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months. The JAVELIN Bladder 100 results were presented at the ASCO 2020 Virtual Scientific Meeting.

    “As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” said Petros Grivas, M.D., Ph.D., one of the principal investigators in the JAVELIN Bladder 100 trial. “With median overall survival of more than 21 months, measured from randomization, the longest overall survival in a Phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease.”

    Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,3,4 and only 5% of patients with metastatic disease at diagnosis will live longer than five years.


    “Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network. “We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope.”

    For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.


    The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval.

    “Today’s approval of BAVENCIO in the most common type of advanced bladder cancer underscores our commitment to advancing scientific innovation and transforming outcomes for people with genitourinary cancers,” said Andy Schmeltz, Global President, Pfizer Oncology.

    “With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice,” said Rehan Verjee, President of North America and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck.

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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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  • HUL announced  the next step in the evolution of its skin care portfolio, with the rebranding of its flagship brand Fair & Lovely. Taking forward the brand’s journey towards a more inclusive vision of beauty, the company will stop using the word ‘Fair’ in the brand name ‘Fair & Lovely’. The new name is awaiting regulatory approvals and we expect to change the name in the next few months.

    Over the last decade, Fair & Lovely’s advertising has evolved to communicate a message of women’s empowerment. The brand’s vision is to adopt a holistic approach to beauty that cares for people, that must be inclusive and diverse - for everyone, everywhere. The brand is committed to celebrating all skin tones.

    In early 2019, the brand’s communication moved away from the benefits of fairness, whitening and skin lightening, towards glow, even tone, skin clarity and radiance, which are holistic measures of healthy skin. HUL also removed from Fair & Lovely’s packaging, words such as ‘fair/fairness’, ‘white/whitening’, and ‘light/lightening’ that could indicate a fairness-led transformation. The cameo with two faces showing shade transformation, as well as the shade guides were removed from the packs. The Company will continue to evolve its advertising, to feature women of different skin tones, representative of the variety of beauty across India.


    Sanjiv Mehta, Chairman and Managing Director, HUL said, “We are making our skin care portfolio more inclusive and want to lead the celebration of a more diverse portrayal of beauty. In 2019, we removed the two faced cameo as well as the shade guides from the packaging of Fair & Lovely and the brand communication progressed from fairness to glow which is a more holistic and inclusive measure of healthy skin. These changes were very well received by our consumers. We now announce that we will remove the word ‘Fair’ from our brand name Fair & Lovely. The new name is awaiting regulatory approvals, and the pack with the revised name will be available in the market in the next few months.”

    Fair & Lovely is based on pioneering technology that has made multiple skin health benefits available to millions of consumers at an affordable price. The brand has been progressively changing its formulation, and includes other vitamins like B6, C & E, allantoin, known to improve skin health and protect the skin from external aggressors, UV rays and environmental pollution.


    The product is designed to improve skin barrier function, improve skin firmness and smoothen skin texture - all of which help enhance radiance and glow holistically. The brand has never been and is not a bleaching product. In addition to the changes to Fair & Lovely, the rest of our skin care portfolio will also reflect the new vision of positive beauty.

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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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