Telengana-Based Shashik Pharma Develops Curative Ayurvedic Products for 11 Major Diseases and Disorders
Shimla: Shashik Research Pharma Private Limited, a Telengana based Ayurvedic Pharmaceuticals Company, announced a breakthrough in the history of Ayurveda in the country. The company has developed curative Ayurvedic products for more than 11 major diseases and disorders. Launched in 2016, Shashik Pharma is a company founded by a renowned Dr. Shashikala Bandi, who has been doing research in discovering new medicines for over 10 years. She has now successfully discovered medicines to treat various diseases, disorders and deficiencies. She has treated hundreds of patients as part of her research and has a success rate in excess of 95%. She is now licensed to produce and sell these medicines by the Ayush department, Government of India. "We have received approval from Ayush Ministry of the Government of India for all its discoveries. We are now in the process of launching the sale of these medicines globally and is looking for channel partners to take its vision forward and to penetrate the market extensively, Said Dr. Shashikala Bandi, Founder of Shashik Pharma. She further elaborated; these medicines have huge market potential as it addresses the contemporary, emerging concerns like thyroid, gynaecology issues including PCOD, kidney stones and infertility problems. These discoveries pit the company against major MNCs whose drug only manage these diseases. Shashik Pharma is also planning to apply for getting regulatory approvals from the Western markets – hitherto inaccessible for Indian traditional pharma companies. Currently the clinical trials are on; exports will start on completion of the trials.


DGFT Defers Implementation of Track and Trace System for Pharma Exports to November 15
Mumbai: The date for implementation of track and trace system for export of drug formulations with respect to maintaining parent-child relationship in packaging levels and its uploading on Drug Authentication and Verification Application (DAVA) portal has been extended upto November 15, 2018 for both non-SSI manufactured drugs as well as SSI manufactured drugs. A notification issued by the Directorate General of Foreign Trade (DGFT) on May 9, 2018 stated that export of drugs manufactured by SSI and non-SSI units and having manufacturing date on or before November 15, 2018 are exempted from maintenance of data in the parent-child relationship for three levels of packaging and its uploading on the central portal. All drugs manufactured by SSI or non SSI units and having manufacturing date after November 15, 2018 can be exported only if both tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the central portal. For this, DGFT has amended Para 2.90A of Handbook of Procedure - 2015-20 (as notified vide Public Notice No.43/2015-20 dated 05.12.2017) read with Public Notice No. 52 / 2015-20 dated 05.01.2016, for laying down the procedure for implementation of the track and trace system for export consignments of drug formulations. The amended Para 2.90 A (vi) and (vii) which outlines the implementation date of track and trace system for export of drug formulations for non SSI as well as SSI units has been substituted and would read as above. The DGFT notification has brought relief to pharmaceutical exporters who have been in the soup since last month following a notification by DGFT directing customs authority at Jawaharlal Nehru Port Trust (JNPT) not to allow export consignments failing to adhere to barcoding norms and data upload on DAVA portal. A couple of weeks back, customs authority at Chhatrapati Shivaji International Airport, Mumbai also received the notification in this regard. It is learnt that 300-500 pharmaceutical containers were stuck at JNPT port following DGFT notification. Meanwhile, pharmaceutical exporters have welcomed the DGFT notification. Says Nipun Jain, CEO, SME Panel, Pharmexcil who was instrumental in ensuring exemption from bar-coding for exports, “The DGFT notification has brought cheers to exporters. We appreciate the DGFT's efforts in addressing exporters' concerns and extending implementation of barcoding by six months giving them time to comply with it.” Jain further said, “Glitches in functioning of DAVA portal has deterred exporters/manufacturers from uploading their products’ data on the portal for two level of packaging i.e. secondary and tertiary maintaining parent-child relationship. Now Union commerce ministry has directed National Informatics Centre (NIC) which developed the portal to upgrade it in six months to ensure its hassle free operation.” The ministry also instructed DGFT to defer the implementation of bar-coding on pharmaceutical consignment for export to six months and start its execution in November when NIC resolves glitches of the central portal. It asked DGFT to issue a notification in this regard. Echoing Jain's view Bhavin Mehta, director, Kilitch Drugs said, “The DGFT circular postponing implementation of barcoding by six months is a positive step in addressing problems faced by pharma exporters while adhering to track and trace norms. Now they have six months' time to get ready for the barcoding.” We hope functioning of DAVA portal would get improved by then and exporters/manufacturers would be able to upload data on the portal smoothly, he added.


Pharma Cos Marketing Medicines Made by Third Parties to Soon be Liable for Quality Lapses Flagged by CDSCO
New Delhi: Companies marketing medicines in India will soon be as liable as the manufacturers for any violations of drug regulations that could lead to spurious or substandard medicines. The move is expected to check lapses in quality of medicines consumed by patients in the country, according to persons aware of the development. The Drugs Technical Advisory Board (DTAB) last week approved a proposal to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms liable for any contraventions of the regulations, a senior government official told ET on condition of anonymity. This would allow the country’s drug regulator to penalise firms marketing medicines in cases where the medicines are found to have violated the regulations, the official said. This includes punishment like 3-5 years imprisonment for medicines flagged by regulators as not of standard quality or life imprisonment in cases where they are found spurious, the official added. DTAB’s approval would allow the health ministry to amend the regulations, making them applicable to companies listed as marketers on the labels and packaging of these drugs, according to the official. “Many a times, big pharmaceutical companies get their medicines manufactured by smaller companies. Today, if something (a violation) happens (to the quality of the product), only the manufacturer can be held responsible,” said the official. “Now, legal action will be taken against both (the manufacturer and marketing company).” The amendments are expected to make these companies liable for substandard and spurious samples of medicines marketed in the country as well as violations of any labelling norms, the official said. “This will improve quality of medicines sold here because it will encourage the marketing companies to directly monitor their quality (before selling to patients),” the official added. “A company which is getting (drugs) manufactured by a third party has to be responsible for the quality of the product. Today, the law puts all the responsibility only on the manufacturer,” said DG Shah, secretary general of the Indian Pharmaceutical Alliance, a lobby group for large domestic pharma companies in the country. “If, from the outset, the legislation is clear and the responsibilities are defined, then marketing companies would take precautions to ensure facilities are as per GMP (Good Manufacturing Practices) standards and that manufacturing processes are followed as required,” he said. At the same time, some industry executives feel this development would be detrimental to pharmaceutical firms marketing products manufactured by third parties as it would make them liable for errors that they have not committed. “It would be unfair for marketing companies. They are not in a position to vouch for the manufacturer,” said an executive requesting anonymity.


Commerce Ministry in Talks with Chinese FDA for Speedy Approval of Indian Pharma Products
Hyderabad: Indian pharma companies may look forward to speedy product registrations with the Chinese Food and Drug Administration (CFDA). The Pharmaceutical Export Promotion Council (Pharmexcil) had requested the Department of Commerce to pursue the issue with CFDA officials. “The process is on, and the issue has already been discussed at the highest level,” Pharmexcil Director-General Uday Bhaskar told BusinessLine. According to data available with the council, 254 product registrations are pending with the Chinese regulator. “The delay in registration has been a problem, as the CFDA has taken 3-5 years to approve,” Uday Bhaskar said. The US FDA, on the other hand, takes not more than three years. The matter is significant in view of the growing interest of Indian drugmakers in the Chinese market, with active pharmaceutical ingredients (APIs) forming the bulk of exports. Pharma exports to China registered a 37 per cent increase, from $145 million in FY17 to $200 million in FY18, according to Pharmexcil data. North America is currently the Indian pharma industry’s largest market, accounting for over 31 per cent of total exports. In recent years, there has been increasing interest from China too, the Pharmexcil official said, adding: “Some companies prefer Indian APIs. We expect this trend to pick up further.” The Commerce Ministry has sought various details from Pharmexcil, including the number of product registration applications filed with the CFDA over the past two years, the number of applications currently pending with the Chinese regulator, and the reasons cited by the CFDA for the pendency. The council has asked its members to submit the data.


Cytecare Hospitals Secures Funding from Goldman Sachs to Build National Oncology Franchise
Bangalore: Cytecare Hospitals Private Limited (“Cytecare”), a leading provider of cancer care in India, announced the closure of its $31 million Series A round, including participation from Goldman Sachs (NYSE: GS), a leading global investment bank and active investor in India. The investment will be used towards a long-term growth strategy focused on establishing an oncology franchise across four to five cities throughout India. In November 2016, Cytecare launched its flagship 150-bed hospital in Bangalore to offer clinical excellence and patient-centric cancer care to the highest international standards. Co-founded by Dr. Ferzaan Engineer (Chairman), Suresh Ramu (CEO) and Himanshu Shah (CFO), Cytecare’s mission is to create a comprehensive organ-specific oncology platform that supports prevention, treatment and patient-centric care. “We welcome Goldman Sachs as a partner in our focus to establish India’s premier network of cancer hospitals. Cytecare will benefit from the global network of class-leading oncology companies that Goldman Sachs is helping build worldwide through the creation of significant opportunities for research, cross-training and sharing of best practices. This partnership and investment adds strategic expertise and financial strength to fuel the next stage of Cytecare’s expansion,” said Dr. Ferzaan Engineer, Co-founder and Chairman. Ankur Sahu, co-head of private equity investing in Asia at Goldman Sachs, said, “India, with its large and rapidly growing population, accounts for nearly 20 percent of cancer deaths in the developing world. Cytecare, with its experienced leadership and multi-disciplinary team of clinicians, is positioned to build a nation-wide cancer care network throughout India and address that need in the way we have already done so in Australia, Brazil and China. This investment is also consistent with our strategy to invest in critical sectors and infrastructure that assist in the continued growth and development of India.” “We are currently in the process of identifying new cities to execute our hub-and-spoke growth strategy,” said Suresh Ramu, Co-founder and CEO, adding, “Cytecare is one of India’s few organ-based cancer hospitals and offers patients a personalized experience leveraging modern clinical practices with a more than 15 member cross-functional Tumor Board. Through our partnership with Goldman Sachs and their strong global network and large portfolio in healthcare and insurance companies across the world, we will be able to fully realize our goal of creating a new benchmark for cancer treatment and care in India.” Goldman Sachs is an active investor in India, deploying more than $3.4 billion in capital since 2006.


Agendia and Angsana to Provide Breast Cancer Risk-of-Recurrence Testing with MammaPrint® and BluePrint® to Patients in Southeast Asia
Irvine, CA, USA and Amsterdam, the Netherlands (B3C newswire): Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, and Angsana Molecular & Diagnostics Laboratory Pte Ltd, a subsidiary of Parkway Pantai, announce a partnership to market the MammaPrint® Breast Cancer Risk of Recurrence test and the BluePrint® Molecular Subtyping test to physicians across Southeast Asia, including Singapore, Malaysia, Vietnam, Brunei and Myanmar. In total, almost 25,000 women in these markets will be diagnosed with breast cancer each year (1). Under the terms of the agreement, physicians in these markets can now send their patients’ samples, via Angsana, for testing at Agendia’s CLIA-certified and CAP-accredited laboratory in Irvine, California. MammaPrint analyzes 70 genes most associated with breast cancer recurrence and provides a binary result to identify women with early-stage breast cancer who are at a genomic Low or High Risk for distant metastasis within five years. BluePrint analyzes 80-genes which classify breast cancer into functional molecular subtypes, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy. These tests provide essential information to aid physicians in making informed and personalized treatment management decisions which can reduce the risk of potential overtreatment and the associated side effects to provide the best outcome for that patient. Chris Barbazette, Chief Commercial Officer at Agendia said: “South East Asia represents a significant growth opportunity for Agendia and a commercial priority for the Company. With their extensive experience in molecular diagnostics and regional insight, Angsana is an ideal partner as we continue to build our presence in this rapidly-evolving market. We are seeing increasingly more physicians and patients in these countries recognizing the clinical utility of gene expression testing in tailoring the treatment management of breast cancer. Working with Angsana we can most effectively serve these requests, improving access to the practice-changing benefits of the MammaPrint and BluePrint tests.” Dr Daniel Tan, Chief Executive Officer, Angsana Molecular & Diagnostics Laboratory said: "Breast cancer makes up almost one-third of all cancers diagnosed among women in Singapore and Malaysia. Importantly, more than two-thirds of these cases are discovered at an early stage, where survival rates are significantly higher. MammaPrint helps to empower these early stage breast cancer patients by providing extra genomic information, enabling them and their oncologists to make informed, confident decisions about their treatment, and avoiding the side-effects of unnecessary chemotherapy. The test can also help to reduce the patient’s overall treatment costs, making valuable medical resources available for other patients.”.


Lunaphore and Vitro Sign Collaboration Agreement to Develop ISH Protocols for RNA/DNA Targets
Lausanne, Switzerland and Seville, Spain, (B3C newswire): Lunaphore Technologies SA, a next generation tissue diagnostics company, and Vitro SA, a manufacturer in the field of Pathology and Biomedical Research, announced recently a collaboration agreement to develop In Situ Hybridization (ISH) protocols for RNA and DNA targets in tissue using reagents provided by Vitro on Lunaphore’s rapid autostaining platform*. ISH hybridization techniques not only require the implementation of protocols with long overnight incubation times, but also the protocol automation is challenging. The partnership is aiming to further facilitate the development of ISH applications for Lunaphore’s platform* with shorter turnaround times using one of the latest automation technologies. Lunaphore’s CEO, Ata Tuna Ciftlik, said: “Vitro and Lunaphore have a very good strategical fit to address ISH applications, which are a large portion of the tissue diagnostics market. Our partner Vitro can provide access to key know-how as well as quality ISH reagents, while Lunaphore has a unique automation technology”, and added: “While Lunaphore has so far focused on immunohistology, ISH applications have always remained strategically important. This collaboration indeed proves the potential of our technology to address this highly attractive market segment”. Vitro’s CEO, Javier Fernández, commented: “We have been in the ISH and IHC market for over 10 years and we have never seen such an advanced platform as Lunaphore’s. Its technique breaks away from all pre-existing methods and requires new conditions and protocols. We aim to facilitate the ISH tissue staining for routine lab tests by reducing the turnaround time as well as the errors associated with numerous and delicate steps, and thus providing consistent and reproducible results.”.


Aptar Pharma and Propeller Health Partner to Develop Digital Medicine Platform Across Therapeutic Areas
Crystal Lake, Illinois and Madison, Wisconsin: Aptar Pharma, a leading provider of innovative drug delivery systems, and Propeller Health, a leading digital therapeutics company, announced plans to collaborate on the launch of a comprehensive platform to develop digital medicines for multiple therapeutic areas and diseases. The digital medicine platform, spanning inhaled, injectable, nasal and dermal medicine delivery forms, will combine software and experiences with connected drug delivery devices to more effectively treat diseases and improve clinical outcomes for patients. Aptar Pharma and Propeller will work together with pharmaceutical and healthcare partners to accelerate the development, manufacturing and commercialization of digital medicines for leading marketed and pipeline brands. Digital medicines can help to personalize treatments, monitor patients in real-time, detect day-to-day changes in disease condition and increase patient adherence. Key objectives are to improve patient outcomes and help contribute to lower healthcare costs. The collaboration brings together Aptar Pharma’s decades of expertise in device development, packaging innovation and quality manufacturing with Propeller’s platform and leading experience in digital therapeutics design and implementation. The two companies initially partnered in 2016 to develop the world’s first fully-integrated connected metered dose inhaler (cMDI). Salim Haffar, President of Aptar Pharma, commented, “Aptar Pharma has been providing innovative drug delivery systems for nearly 50 years, helping billions of patients around the world. Today, we are excited to broaden our offerings as we continue this journey towards improved patient care and clinical outcomes by growing our partnership with Propeller Health, the leader in their field of digital therapeutics.” “Propeller draws on nearly a decade of experience pioneering digital respiratory medicines and putting them to work in healthcare organizations around the world,” said David Van Sickle, cofounder and CEO of Propeller. “We’re excited to expand our relationship with Aptar and apply our expertise to new diseases. Our end-to-end infrastructure enables fast, flexible and secure development and commercialization of digital medicines.” Propeller and Aptar Pharma will co-market the platform, with Propeller managing the digital services and Aptar Pharma managing the device development, manufacturing and supply chain. In addition to expanding the partnership, Aptar Pharma has made a strategic equity investment of $10 million in Propeller Health during their latest funding round.


Emergex Awarded Innovate UK Grant to Progress its Universal and Pandemic Flu Vaccine
Oxford, UK (B3C newswire): Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company pioneering a new approach to vaccine development in the field of infectious diseases, recently announced that Innovate UK, the UK’s innovation agency, has awarded the company a grant of £979,318 to progress its universal flu vaccine programme through preclinical development. This grant will cover 70% of the cost of developing Emergex’s flu vaccine programme over a period of two years. It will be used to complete preclinical toxicology and validation studies and the manufacturing of the vaccine in accordance with current Good Manufacturing Practice (cGMP). This will result in clinical batches of the vaccine which are ready for Phase I clinical testing in the first half of 2020. Emergex’s universal flu vaccine is designed to target components of the influenza virus that are common to all influenza strains. As a result this vaccine will also be suitable to target the outbreak of a new flu pandemic caused by the emergence of a novel form of influenza virus at the time it moves from an animal species into humans. The company’s vaccine is 100% synthetic and delivers highly conserved immunogenic peptide fragments from the flu virus to antigen presenting cells in the skin, eliciting a strong and long-lasting T-cell immune response. Emergex’s vaccine combines several proprietary technologies to create an immune response based on ‘reverse engineering’. This involves the identification of highly conserved internal peptide fragments from the flu virus, synthesis of these peptide fragments to create a library of 100% synthetic peptide fragments and screening these against blood from flu survivors to see which of the fragments elicit the strongest T-cell immune response. The selected peptide fragments are then combined with a gold nanotechnology carrier system to make an extremely small particle, less than 5 nanometres in diameter, which is ideal for immunization through the skin using a microneedle skin patch, which is less invasive than traditional injection.


NeuroVive and Yungjin Reports Positive KL1333 Phase I Clinical Study Results Paving the Way for Further Clinical Development
LUND, Sweden and SEOUL, South Korea, (PRNewswire): NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) and Yungjin Pharm Corporation Ltd (South Korea Stock Market, KRX 003520) today jointly announced positive topline results after data base lock in the phase I single ascending dose (SAD) clinical study of KL1333, a novel treatment in clinical development for orphan genetic mitochondrial diseases. Review of the topline phase I data shows that KL1333 has a highly favourable and very clear dose-proportional pharmacokinetic (PK) profile. There were no serious adverse events (SAEs), and only mild gastrointestinal adverse events (AEs) were recorded at higher doses. Based on the positive PK and safety results NeuroVive is moving rapidly to initiate the next study in Europe that will include repeated dosing (multiple ascending dose; MAD) in healthy volunteers and patients. Detailed analysis of the complete data set is ongoing. There is a huge unmet medical need for medicines that treat genetic mitochondrial diseases. Patients can have severe symptoms in any organ and have significantly reduced life-expectancy. These diseases are rare diseases for which there are almost no registered medicines.






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