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Zydus Cadila, a global innovation driven healthcare company, announced that it is launching Forglyn pMDI, India’s first pressurized Metered Dose Inhaler (pMDI) with a combination of Long Acting Muscarinic Antagonist (LAMA) and Long Acting Beta Agonist (LABA) for patients suffering from Chronic Obstructive Pulmonary Disease (COPD) in India. Forglyn pMDI is priced at Rs. 495 per pack and has been developed in-house using Zydus’ innovations in formulation technology. The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment.

COPD is a common respiratory disorder characterized by progressive airflow obstruction due to alveolar and bronchial abnormalities and inflammation caused by exposure to noxious substances. A highly debilitating disease, COPD impacts the normal daily activities and limits the quality of life. The disease is progressive in nature and can sometimes worsen due to sudden exacerbations, leading to significant disability and death. COPD is the third leading cause of death worldwide and in India an estimated 55.3 million patients suffer from COPD.

Speaking on the development, Managing Director, Cadila Healthcare Ltd., Dr. Sharvil Patel said, “Our focus has always been on helping people lead a better quality of life and making therapies accessible and affordable to people. Our innovations have brought in next-generation therapies in respiratory, women’s healthcare, cardio-metabolic disorders, gastrointestinal and pain management segments. With this new technology, we hope to bring much relief to patients suffering from COPD and help them improve their health and quality of life.”

The novel process for Forglyn pMDI developed at the group’s Pharmaceutical Technology Center, ensures that delivery of the two drugs administered simultaneously through the inhaler are consistent and uniform which is critical for inhalation products. The process technology employed for the manufacturing of this product is simple, affordable and scalable. The Company has also filed a patent application for the novel process of this product.

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Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production and rapidly expand the supply of our investigational antiviral drug Veklury® (remdesivir) by making significant investments to increase internal manufacturing capacity, expand our contract manufacturing network and implement process improvements. While working to increase our manufacturing capacity over these past months, the company also donated 1.5 million vials of Veklury and provided clinical drug supply at no cost for evaluation as an investigational agent in clinical trials around the world. As a result of the decision to make early investments to increase Veklury manufacturing efforts, Gilead is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19.

Starting on October 1, Gilead will be responsible for distributing Veklury in the United States upon conclusion of the previous distribution agreement with the U.S. Federal government. To ensure stable management of drug supply in the near term, AmerisourceBergen will continue to serve as the sole U.S. distributor of Veklury through the end of this year and will sell the product directly to hospitals. This distribution model closely reflects the traditional model hospitals use to procure medicines. Hospitals will control the quantity of Veklury that they order, enabling them to have ample, predictable supply of Veklury in advance of any anticipated increase in COVID-19 incidence.

Results from three randomized, controlled clinical trials have consistently demonstrated the clinical benefits of Veklury. These data support the use of Veklury as a standard of care in hospitalized COVID-19 patients.

The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster and, in turn, increase healthcare provider capacity and reduce healthcare system costs.

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The Council of Scientific & Industrial Research (CSIR), India’s premier research organization, and Mylan Laboratories Limited, the India-based subsidiary of leading global pharmaceutical company Mylan, today announced a partnership to address unmet patient needs amidst the evolving COVID-19 pandemic. Under the partnership, CSIR’s constituent laboratory Indian Institute of Chemical Technology (CSIR-IICT), and Mylan will collaborate to identify potential therapies for COVID-19.

A series of clinical trials will be conducted towards new and innovative solutions to manage COVID-19 pandemic in India as part of this collaboration. The first of the clinical trial to be rolled out is a multiple arm phase 3 study that will be conducted in adult patients with mild to moderate COVID -19 at risk of complications.

Director General of CSIR, Dr. Shehkar C Mande stated, “The current collaboration with Mylan is a significant milestone and during the current COVID-19 pandemic, CSIR has prioritized conducting clinical trials of well proven drugs in partnership with industry towards the development of multiple therapeutic options for COVID-19.” 

Director of CSIR-IICT, Dr Chandrasekhar said, “CSIR is delighted to associate with Mylan as knowledge and scientific partner, and looks forward to working with the company, especially given Mylan’s vast industry experience in clinical trials and commercialization.”  

Mylan Chief Operating Officer, Sanjeev Sethi stated, “Our collaboration with CSIR, India’s premier research organization, is a strategic step forward aimed at identifying effective treatments for patients with COVID-19. In addition to bringing forward new indications, this partnership will also help us identify multiple molecules that can potentially be leveraged in therapies for various other infectious diseases in the future. Mylan is cognizant of its responsibility in fighting this pandemic and continues to leverage its global resources and capabilities including R&D, clinical research, regulatory, manufacturing and supply chain, while engaging with key stakeholders to serve patients in need.”

The application for the clinical trials has been submitted to the Drugs Controller General of India (DCGI) for regulatory approval.

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Eisai Co., Ltd announced that it has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) on the license extension application submitted by its U.K. subsidiary Eisai Ltd. regarding the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa® (generic name: perampanel) in the treatment of pediatric patients. The CHMP's positive opinion is to extend the use of Fycompa as an adjunctive therapy for partial-onset seizures (POS) (with or without secondary generalization) by expanding the approved age range from 12 years and above to 4 years and above, and for primary generalized tonic-clonic seizures (PGTCS) from 12 years and above to 7 years and above.

The application, submitted to EMA in February 2019, was based on the results of Phase III (Study 311) and Phase II (Study 232) clinical studies conducted globally to evaluate Fycompa as an adjunctive therapy in pediatric patients with POS or PGTCS. Study 311 evaluated the safety, tolerability, and exposure-efficacy relationship of Fycompa when administered as an adjunctive therapy in pediatric patients aged 4 to less than 12 years with inadequately controlled POS or PGTCS. Study 232 evaluated the pharmacokinetics, efficacy, and long-term safety of Fycompa as an adjunctive therapy in pediatric patients with epilepsy (from 2 to less than 12 years of age).

Fycompa is a first-in-class AED) and a once-daily tablet discovered at Eisai's Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. In Japan, Fycompa is currently approved for monotherapy and adjunctive use in the treatment of POS (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older, as well as adjunctive treatment for PGTCS in patients with epilepsy 12 years of age and older. Furthermore, Fycompa is also indicated for monotherapy and adjunctive use in the treatment of POS (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older and for adjunctive therapy in the treatment of PGTCS in patients with epilepsy 12 years of age and older in the United States.

Eisai considers neurology, including epilepsy, a therapeutic area of focus. As we offer several treatment options in Europe, including Fycompa, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

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Roche announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

“While we have made great progress in the treatment of many forms of breast cancer, TNBC remains an aggressive and difficult-to-treat disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are proud of our work to address challenges and advance scientific understanding of cancer immunotherapy in the context of distinct chemotherapy regimens and in various TNBC treatment settings. Although the IMpassion131 study did not reach its endpoint, we are pleased to bring new treatment options for some TNBC patients, and remain committed to improving the lives of all women with early and advanced stages of this disease.”

Results from the Phase III IMpassion031 study, evaluating Tecentriq in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including nab-paclitaxel), demonstrated a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early TNBC, regardless of PD-L1 expression. pCR was observed in 57.6% (95% CI: 49.7–65.2) of patients treated with Tecentriq in combination with chemotherapy, an increase of 16.5% from 41.1% (95% CI: 33.6–48.9) in patients treated with placebo plus chemotherapy (one-sided p=0.0044, significance boundary = 0.0184) in the intention-to-treat (ITT) population. The safety profile was consistent with the established profile of the individual drugs and no new safety concerns were identified.

The IMpassion031 study is the second positive Phase III study from Roche demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the US and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1 (IC≥1%).

The final overall survival (OS) analysis of the Phase III IMpassion130 study, evaluating Tecentriq in combination with nab-paclitaxel, compared with placebo plus nab-paclitaxel, as a first-line treatment for patients with metastatic TNBC, was consistent with the first and second interim analyses. There was no significant difference in OS between the treatment groups in the ITT population. Clinically meaningful improvements in OS were seen with Tecentriq plus nab-paclitaxel in PD-L1-positive patients. The magnitude of OS improvements with Tecentriq in PD-L1-positive patients remained clinically meaningful, with an increase of 7.5 months in median OS with Tecentriq plus nab-paclitaxel, compared with placebo plus nab-paclitaxel (hazard ratio [HR]=0.67; 95% CI: 0.53–0.86). However, this result could not be formally tested due to the prespecified statistical testing hierarchy. The cumulative safety of the Tecentriq plus nab-paclitaxel combination remains consistent with the previously reported safety data for this study and the known risks of individual study drugs. No new safety concerns were identified with longer follow-up.

Finally, results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel, compared with placebo plus paclitaxel, as a first-line treatment for patients with metastatic TNBC, did not show significant improvement for progression-free survival in the PD-L1-positive population (HR=0.82; 95% CI: 0.60–1.12). The OS data showed a negative trend; however, the study was not powered for the secondary endpoint of OS, and OS data were immature at time of analysis (initial HR=1.55 [95% CI: 0.86-2.80] in the PD-L1 positive population, based on 21% of patients with an event; updated HR=1.12 [95% CI: 0.76-1.65]), updated analysis based on 41% of patients with an event). The safety profile of Tecentriq plus paclitaxel was consistent with the established safety profile of the individual study drugs and no new safety concerns were identified.

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

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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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