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“Ministry of AYUSH, Govt. of India suggested the use of homeopathic medicine Arsenicum album - 30 for its possible role in preventing COVID-19 infection”said Dr. Anil Khurana, Director General, Central Council for Research in Homoeopathy.

PHD Chamber with South Delhi Homoeopathic Association (SDHA) organized 28th Annual Homoeopathic Conference, Kent Memorial Lectures 2020, Inaugural Session held on 19th September 2020.

The eminent panellists present were Dr. Anil Khurana, Director General, Central Council for Research in Homoeopathy, Dr. R. K. Manchanda, Director AYUSH, Govt. of NCT. of Delhi, Mr. Arvind Varchaswi, Chairman, AYUSH Committee,      Mr. Vivek Seigell, Principal Director, PHDCCI, Dr. R.N. Wahi, Chairman, Organising Committee, SDHA, Dr. Satya Vir Sharma, Director (Finance), SDHA.

Dr. Anil Khurana, Director General, Central Council for Research in Homoeopathy talked about success story about homoeopathy treating and managing the symptoms for Chikungunya and Dengue in the past years. Dr. Khurana said that Homoeopathy have played a significant role in providing treatment in active conditions. He mentioned, that Ministry of AYUSH, Govt. of India have taken various steps and CCRH council is working on various scientific research and clinical trials are in progress during COVID-19 period. He also shared about the latest guidelines launched by the Ministry for Tele- Medicine for all homoeopathy physcians, while imparting tele consultation to the patients.

Dr. Khurana said that these guidelines contain information and advisories, which could play an important role in the management of COVID19 pandemic. He also talked about the AYUSH Sanjivani app to generate data on usage of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-rigpa and Homoeopathy) advocacies and measures among the population and its impact in prevention of Covid-19.He  mentioned that Ministry of AYUSH, Govt. of India have suggested the use of Arsenicum album - 30 for its possible role in preventing COVID-19 infection.

Dr. R. K. Manchanda, Director AYUSH, Govt. of NCT. of Delhi shared a brief presentation about the opportunities for Homoeopathic Associations. Dr. Manchanda mentioned about emerging of global scenario during COVID-19 period. He also shared about ongoing challenges faced by homoeopaths. He also mentioned about Increasing public demand and presence of homeopathy in various countries. He also talked about the efforts been made for prevention and treatment of COVID-19 patients by Homoeopathic physicians in all over India. He also urged all Associations should focus on high quality research oriented communications  and should also be part of global movements.

Mr. Arvind Varchaswi, Chairman, AYUSH Committee talked about how to focus on an individual immunity by maintaing a balance lifestyle and personal hygiene during ongoing pandemic. He also talked about the benefits of Yoga, Meditation and stretching exercises for maintaing a healthy lifestyle.

He also mentioned about Immunomodulators availability for boosting immunity during these challenging times. He said Homoeopathy is a system of medicine, which is also well recognized in Europe and USA and other parts of countries as well.

Mr. Vivek Seigell, Principal Director, PHDCCI talked about the Indian system of medicine and benefits of Homoepathy. He also urged homoepathic physician to come forward and promote the system of homoepathy. He also mentioned that associations should collaborate & work together for promoting the entire system and take PHD Chamber’s platform for promoting homoeopathy as a strong system of medicine.

Dr. R.N. Wahi, Chairman, Organising Committee in his opening remarks thanked all the panellist for joining 28th Annual Homoepathic conference. Dr. Wahi talked about the role and significane of homeopathy. He further added that there’s a utmost need for involvement of new technology and scientific research into the system.

Dr. Satya Vir Sharma, Director (Finance), SDHA thanked all the panellist and homoeopathy physicians for sparing their valuable time in joining today’s conference. He said the two days technical sessions with the experts will certainly uplift the system of homoeopathy medicine and morale of all physicians attending the conference.

The Inaugural session for 28th Annual Homoeopathic Conference, Kent Memorial Lectures 2020 was attended by over 120 homoeopathy physicians and medical practitioners.

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Takeda Pharmaceutical Company Limited or ‘Takeda’ declared that it had broadened its cell therapy manufacturing efficiencies by opening a brand new 24,000 square-foot R&D cell therapy manufacturing facility at its Boston-based Research and Development headquarters. The new manufacturing facility will enhance end-to-end research and development abilities and speed up the development of next-generation cell therapies. This will initially be concentrated on oncology and, in the future, extend into other therapeutic areas. Moreover, the manufacturing facility, which follows the current Good Manufacturing Practices (CGMP) to meet all the regulatory requirements in the U.S., E.U. and Japan, would also produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials.

The company is currently collaborating with the best scientists and innovators to develop a very diverse immuno-oncology pipeline evolving into new mechanisms with healing properties. According to Chris Arendt, Head of the Oncology Therapeutic Area Unit of Takeda, there are three oncology cell therapy programs in the clinic right now, and two more will join in the fiscal year 2021. Therefore, Takeda is working with urgency and purpose, and the new facility will help speed up and improve the manufacturing capabilities to carry out various diverse cell therapy programs simultaneously.

Due to its focus on redirected immunity, Takeda is currently involved in researching next-generation cell therapy. Takeda’s several immuno-oncology programs make use of innate immunity, including innovative cell therapies, innate immuno-modulation, immune engager platforms, novel-scaffold immune checkpoint platforms, as well as oncolytic viruses.

Takeda Pharmaceutical Company Limited is a biopharmaceutical company that has a presence in about 80 countries all over the world. Takeda specializes in pharmaceutical, oncology, therapeutics, vaccines, and gastroenterology. In its quarter 1 financial reports for the financial year 2020, its revenue from operations stood at JPY 801,850 million, which is 5.6% less than that of the previous year's corresponding period. However, the operating profit for Q1 stood at JPY 167,285 million, which is 270.4% more than that of Q1 FY2019.

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Dr. Reddy’s Laboratories Ltd announced the launch of over-the-counter (OTC) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1% are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. The Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is also indicated for the temporary relief of red eyes.

“This launch marks the entry of Dr. Reddy’s into the OTC eye care space, and is a testament to our deep capabilities in bringing store-brand equivalents of Rx-to-OTC switches to the U.S. market,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “We are very excited to extend our strategic collaboration with Gland Pharma to bring these products to the market. We thank the teams at Gland and Dr. Reddy’s whose hard work and efforts have enabled the execution of this launch in such a short timeframe.”

The Pataday® brand had U.S. sales of approximately $31 million since the launch in March 2020 according to IRi*.

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is available in a 2.5 mL bottle and Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is available in a 5 mL bottle size.

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The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on wellstudied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are very pleased to partner with Dr. Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”

Prof. Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 in Moscow, said, “The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”

On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com

On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020.

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Shadow Pharma Venture Private Limited, Mumbai and Gplife Healthcare Private Limited, Surat have announced that the next generation Phytochemistry technology-based Nutraceutical formulations ACT- 12 and ACT - 13 have successfully cleared Phase II clinical trials for the treatment of COVID 19 positive hospitalized patients.

The formulations were compared for its safety and clinical efficacy against standard of care in COVID 19 patients.

60.0% of cases from Test Group showed PCR negativity compared to 40.0% in standard Group at Day 4. No Patient continued to remain Covid positive after the 10th day in the Test group and 7 Patients remained Covid positive after 10 days in the standard group. The IgG and IgM immunoglobulin levels were noticed to be higher demonstrating improved antibody functionality and thereby the immunomodulatory activity offered.

Anti-inflammatory effect by Lowering LDH, CRP with improvement in SpO2 & Thrombocytopenia can reduces risk of lung fibrosis.

Kiran Narasimha Pai (MBA IIM Calcutta), Advisor to Gplife Healthcare, said that “These results are among the best results for any Nutraceutical or Phytochemistry based formulation in the world for the treatment of COVID-19. If the same results with No mortality and 40% faster recovery rates can be replicated in a much larger Phase III trial, then we could be looking at the end of, at least, the severity of the COVID-19 pandemic."

He further said, "Since these products have essentially very low side effects and are FSSAI approved, they can be started as an adjuvant treatment globally, almost immediately”.

Prasad Kanitkar, Chief Technical Officer (CTO), Shadow Pharma added “These products and technologies are the outcome of putting Science and Nature together for the betterment of human beings and hope of life in ongoing pandemic.” He congratulated Dr. Shridhar Pandya Scientist and Director Gplife on making this research a reality at the exact time when the whole world needed it. Shadow Pharma Venture Pvt. Ltd. Mumbai has tied up with Gplife Health Care Pvt. Ltd. to commercialize its COVID 19 ACT 12 & ACT 13 Treatment Therapy and remaining Nutraceutical portfolio.

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COVAXIN vaccine shows remarkable immunogenicity and protective efficacy against SARS-CoV-2 (new coronavirus). It’s research name is BBV152 which an inactivated SARS-CoV-2 vaccine.

Two doses vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques (divided into four groups equally). One group was administered with placebo, while three groups were immunized with 3 different vaccine candidates at 0 and 14 days. All the macaques were exposed to viral challenge 14 days after the 2nd dose. The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey.

No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group. Adverse events were not seen in animals immunized with a two-dose vaccination regimen.

Genomic RNA (gRNA) was detected from nasal swab (NS) specimens of all animals in the placebo group from 1 to 7 DPI (Days Post-Infection). Viral clearance was observed in NS specimens of all the animals from the vaccinated group on 7 DPI. Subgenomic RNA (sgRNA) was detected in two of five animals at 3 DPI and one of five animals at 7 DPI of the placebo group.  sgRNA was detected in the NS sample of only one animal of the vaccinated group IV on 5 DPI.

Neutralizing antibodies and IgG responses were observed from 3rd-week post-immunization in vaccinated groups. IgG titer rose in an increasing pattern with the highest response in group III. The presence of gRNA in NS was observed in the placebo group until 7 DPI. Vaccinated groups had no detectable gRNA in NS on 7 DPI indicating the ability of vaccine candidates to limit upper respiratory tract viral replication, which is a key factor determining the virus transmission.

gRNA and sgRNA were not detected in the Bronchoalveolar lavage fluid from 5 DPI suggesting that vaccination hindered virus replication and enabled faster clearance from lower airway protecting the animals. gRNA was detected in multiple organs at necropsy in the placebo group, whereas it was found to be cleared in the vaccinated groups.

Altogether this study demonstrates that a two-dose vaccination regimen using 3µg dose of the vaccine candidate with adjuvant induce a significant immune response and provide effective protection in animals challenged with SARS-CoV-2.

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate. 

"We are excited about the potential of helping patients with AL amyloidosis who currently have no FDA-approved therapies for the treatment of their disease," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "The results from the Phase 3 ANDROMEDA study also provide preliminary evidence of DARZALEX FASPRO's potential to modify the organ damage that is a hallmark of this serious disease with high unmet needs and we look forward to collaborating with the agency in the review of the application."

The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.

The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.

AL amyloidosis is a life-threatening disorder that occurs when plasma cells in the bone marrow produce abnormal light chains, that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, GI tract and nervous system. Diagnosis of AL amyloidosis is often delayed because patients present with non-specific symptoms that mimic other conditions, resulting in a poor prognosis. There are currently no FDA-approved therapies to treat this devastating disease. While AL amyloidosis is the most common type of amyloidosis, it remains a rare disease with an estimated 30,000 to 45,000 people living with the disease in the U.S. and Europe. Each year, an estimated 4,500 people develop AL amyloidosis in the U.S. alone.

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Doctors at the Krishna Institute of Medical Sciences (KIMS), one of India’s leading healthcare providers, have successfully performed India’s first-ever double lung transplant surgery on a Covid-19+ve patient, who was discharged from the hospital on Friday. The procedure was performed at the main branch of the hospital located at Hyderabad, and was led by Dr. Sandeep Attawar, who is considered a pioneer in heart and lung transplant surgeries in India.

The patient, a Rizwan (Monu) 32-year-old man from Chandigarh, Punjab, was suffering from sarcoidosis that affected his lungs significantly, leading to fibrosis of the lungs. Condition of the patient deteriorated rapidly. A double lung transplant was the only permanent option for cure. The situation worsened when the patient contracted coronavirus while awaiting for his double lung transplant. This worsened matters as it increased his oxygen requirement from 15 liters/minute to 50 liters/min for the past 8 weeks.

Commenting on the procedure, Dr. Sandeep Attawar, Thoracic Organ Transplantation Surgeon, KIMS Heart & Lung Transplant Institute, KIMS Hospitals said, “The patient was a severe case of lung sarcoidosis, and Covid-19 virus only complicated the precarious lung condition. Fortunately, a match to his lungs was found in a person declared braindead in Kolkata, and the harvested lungs were airlifted to Hyderabad to save the life of the patient. The procedure was complex and had little scope for errors; and only a timely transplant of lungs helped save the patient. What is more important is that good outcomes are difficult to achieve as these patients are extremely sick, under nourished and bed ridden before the transplant. Post discharge, he will need close monitoring, bio bubble environment & careful drug control for 6 weeks at least.

Dr. Sandeep Attawar, is the most experienced heart and lung transplant surgeons in the country. A veteran in the field of transplant surgeries with over 24-years’ experience, Dr. Attawar has to date performed over 12,000 heart surgeries, and has over 250 transplant surgeries for lungs, heart, and artificial heart implants (LVAD) to his credit.

The prevailing scenario around the world in general and India is compelling patients to stay indoors for a prolonged period. While people are ignoring/neglecting certain ailments and not seeking medical care at the right time, prolonged neglect could result into complex ailments. Hence, it is suggested that people stay aware of the symptoms of possible ailments they could contract and respond to it with medical care.

The world was already struggling with some highly infectious diseases like tuberculosis, influenza, when COVID-19 struck. It is a highly transmissible disease and spreads within fraction of a second. Infected patient’s respiratory secretions are highly contagious and there are very high chances of spread of disease through this.

In a development that could bring huge relief for healthcare professionals, Sree Chitra Institute of Medical Sciences in Thiruvananthapuram has developed canister bags, lined with super-absorbent material containing an effective disinfectant. The bag has been named AcryloSorb. The method is meant for safe handling and disposal of respiratory secretions of patients in Intensive Care Units as well as of those admitted in wards with copious respiratory secretions.

“Disposal of respiratory secretions of patients suffering from highly contagious diseases such as COVID-19, tuberculosis (TB) and influenza, poses a high risk of infection among healthcare workers. In the canister bags, secretions are sucked into bottles or canisters using vacuum line and discarded through the waste fluid disposal system after subjecting to decontamination process. There is a high risk of contamination during the handling that poses a high risk to health workers. The disposal needs well-equipped sluice rooms with disinfection facilities. The canister bags can absorb 500 ml of secretions and solidify them immediately. And the presence of the disinfectant makes the whole system decontaminated within no time,” says a press statement issued by the institute.

“ Disposal of respiratory secretions of patients suffering from highly contagious diseases such as COVID-19, tuberculosis (TB) and influenza, poses a high risk of infection among healthcare workers.

The product has been tested as per international standards and the linear structure has a patented design, the institute states. Field trials of the in-house designed suction canister liner bags are being conducted at the institute. It’s expected to bring the bag to the market at a cost of Rs 100 per bag.

Sree Chitra Institute claims the canister bag allows easy, spill-proof disposal of the biomedical waste. The press release reads, “Solidification and disinfection inside the bags eliminate the risk of secondary infections by avoiding spilling, and aerosol formation. Canister bags are enclosed in a customizable sealer bag which can pack it as spill-proof decontaminated biomedical waste disposable through incineration.”

The team that developed the technology include Dr Manju, S, Dr Manoj Komath, Dr Asha Kishore (who is also the Institute Director) and Dr Ajay Prasad Hrishi who are biomaterial scientists and clinicians - The institute has transferred the know-how of the bags to Romsons Scientific and Surgical Private Limited in Uttar Pradesh that produces medical devices.

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Strides Pharma Science Limited (Strides) stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.

As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc. 

Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years.

As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year.

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