Team JGJ

August 12,2024 New Delhi: The dengue vaccine Qdenga, pre-approved by the World Health Organization in May, has shown more than 50 per cent efficacy in reducing the number of cases, with lasting effects and a good safety profile, according to a review of 19 studies. The “first comprehensive global” review, covering more than 20,000 participants, found that upon receiving the two-dose vaccine, over 90 per cent of adults and children elicited an immune response against all four variants (serotypes) of the dengue-causing DENV virus . Of the 19 studies analysed, 13 contained data from Asian and South American locations where the disease is endemic. “Given the results in terms of safety, immunogenicity, and efficacy, the administration of two doses can undoubtedly be a key tool for dengue prevention ,” said Maria Elena Flacco from the University of Ferrara, Italy, and the lead author of the study published in the journal Vaccines. Developed by the Japan-based Takeda Pharmaceutical Industries Limited, the Qdenga vaccine — also called TAK-003 — is a live-attenuated vaccine, containing weakened versions of the four serotypes of the DENV virus. “TAK-003 showed an excellent safety profile, and the immunogenicity after two doses against the four DENV serotypes was higher than 90 per cent among both adults and children/adolescents who were either seronegative or seropositive at baseline,” the authors wrote. While seropositive indicates a prior dengue infection or exposure to DENV virus, seronegative indicates none of these. The authors also found that among those receiving a single vaccine dose, more than 70 per cent of adults and over 90 per cent of children and adolescents developed antibodies against the viral infection. “One of the included studies, with a very large sample, had a relatively long follow-up (4.5 years) and provided robust evidence of the long-term safety (and immunogenicity) of TAK-003,” the authors wrote. In February, Takeda and Biological E Limited, Hyderabad, announced a strategic partnership to accelerate access to the Qdenga vaccine. It is not yet approved for use in India. By ramping up its manufacturing capacity to up to 50 million doses a year, Biological E will help accelerate Takeda’s efforts to produce 100 million doses a year within the decade, according to the partnership. While the Qdenga vaccine has shown promising results, a comprehensive estimate of its effectiveness and safety was not available, the study’s authors said. The dengue-causing DENV virus spreads to humans from the bite of infected female Aedes aegypti mosquitoes (vector). Symptoms of dengue can include high fever, severe headache, muscle and joint pain, and rashes. In severe cases, the disease can be fatal. Tropical and sub-tropical climates are known to favour transmission of the vector-borne disease. About half the world’s population is at risk of dengue, cases of which have grown dramatically in recent decades. Yearly cases reported were over five lakh in 2000 and have increased to 52 lakh in 2019, according to the World Health Organization (WHO). Asian countries represent 70 per cent of the affected global population, even as the mosquito-borne disease is now endemic in over 100 countries from across Africa, the Americas and the western Pacific, according to the UN health agency. With climate change driving warmer temperatures and humidity around the world, the habitat of mosquitoes that carry the DENV virus is also expanding, leading to new dengue outbreaks in more countries, including those in Europe and the eastern Mediterranean. Prevention and control of dengue currently hinges on vector-control measures, and there is no specific treatment for the disease, according to WHO. Source: Pharma

Aug 13,2024 Mabwell, an innovative biopharmaceutical company with entire industry chain, announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been granted Breakthrough Therapy Designation (BTD) by Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy. The designation as a breakthrough therapy is aimed at expediting the development process of drug candidates for serious diseases, with the drug candidates included having demonstrated significant efficacy or safety advantages compared to existing therapies in early clinical trials. For drug candidates included in the breakthrough therapy list, CDE will prioritize the allocation of resources to facilitate communication and provide guidance to promote drug development, which will benefit the further advancement of the clinical development progress and the speed of market review and approval. This will help to expedite the development process of 9MW2821 and meet the unmet clinical needs of Chinese patients. 9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and also the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and breast cancer. In 2024, 9MW2821 has been granted Fast Track Designation by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has been granted Orphan Drug Designation by FDA for the treatment of EC, and also Breakthrough Therapy Designation by CDE of NMPA. 9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumour cells. Mabwell is an innovation-driven biopharmaceutical company, has the entire industry chain of R&D, manufacturing, and commercialization. The company is committed to provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Source: Pharmabiz

August 05,2024 Global pharma major Lupin Limited (Lupin) announced the successful completion of a global phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis. The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis. Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes since 2022. Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment used in the treatment of neovascular age-related macular degeneration (also called wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).  The l phase 3 study was designed as a global clinical trial, in line with recommendations from EMA and US FDA, to evaluate the efficacy, safety, and immunogenicity of LUBT010 versus Lucentis in patients with neovascular age-related macular degeneration. A total of 600 patients from India, US, EU and Russia were randomized in the study, who received either LUBT010 or Lucentis 0.5 mg, administered as an intravitreal injection once a month for 12 months. Patients were followed for efficacy, safety and immunogenicity assessment. The data from this phase 3 study will be part of Lupin’s application for marketing approval with the US FDA and the European Medicines Agency (EMA). “We are very pleased with the positive outcome of the global phase 3 study, which marks yet another significant developmental milestone for our Lucentis Biosimilar. It is a reaffirmation of our focus on developing high-quality biosimilars, to cater to patient needs,” said Dr. Cyrus Karkaria, president of Lupin Biotech. “We will be filing marketing applications for LUBT010 in all major global markets this year.” Commenting on the milestone, Nilesh Gupta, managing director, Lupin said, “This achievement of our biosimilars team demonstrates our capability to develop cutting-edge, cost-effective products. We have already commercialized four products to date and there are several more at various stages of clinical trials. We now look forward to bringing our high-quality Ranibizumab biosimilar into the global ophthalmic market, making a positive difference in the lives of our patients worldwide.” Source: Pharmabiz

Aug 13,2024 Mankind Pharma, a reputed global pharmaceutical firm, has launched a comprehensive nationwide campaign to raise awareness about organ donation. The initiative, aligning with the company’s motto of “Spreading Kindness,” aims to address the critical shortage of organ donors in India, where the donation rate stands at a mere 0.86 donors per million population. On August 4, Mankind Pharma unveiled a powerful video campaign designed to educate the public about the importance of organ donation. The campaign highlights the life-saving potential of organ donation and seeks to dispel common myths surrounding the practice. As a cornerstone of this initiative, Mankind Pharma hosted a special program at its office on August 12, in collaboration with the National Organ & Tissue Transplant Organization (NOTTO) and leading medical experts. The event, which was broadcast live on YouTube, brought together all 22,000 Mankind Pharma employees in an unprecedented show of support for organ donation. Rajeev Juneja, vice-chairman & managing director, Mankind Pharma, stated, “At Mankind Pharma, we believe in the power of collective action to drive meaningful change. Our organ donation awareness campaign is a testament to our commitment to improving healthcare outcomes in India. By engaging our Mankindians and partnering with experts, we pay tribute to the compassionate heroes who choose to give the gift of life to others, and we urge everyone to spark a wave of change by choosing to be an organ donor today.” Sheetal Arora, chief executive officer & whole-time director, Mankind Pharma, added, “This campaign represents a significant step in our ongoing efforts to contribute positively to society. With only 0.86 donors per million and an alarmingly low number of registered donors in our country, choosing to be an organ donor is not just a personal choice but an act of spreading kindness. By leveraging our reach and resources, we hope to significantly increase the number of registered organ donors in India, potentially saving countless lives in the process. “ The live event featured insightful presentations from renowned medical professionals, addressing various aspects of organ donation. Dr Arvinder Singh Soin, chairman, Liver Transplant, Medanta Gurugram, discussed the myths and facts surrounding organ donation, stating, “Organ donation is often misunderstood due to various myths. It’s crucial to understand that one organ donor can save up to eight lives. By dispelling these misconceptions, we can encourage more people to become donors and potentially save countless lives.” Dr Anil Kumar, director, NOTTO provided an overview of the current scenario of organ donation in India, emphasizing, “With a low donation rate, India faces a severe shortage of organ donors. This campaign by Mankind Pharma is a significant step towards bridging this gap. By raising awareness and facilitating easy registration, we can dramatically increase the number of potential donors and give hope to thousands awaiting life-saving transplants.” The event culminated in a collective pledge by Mankindians to support organ donation, setting a powerful example for corporations across India. By recognizing the alarmingly low number of registered donors and paying tribute to those who give the gift of life, Mankind Pharma is leading a movement for change. The company’s organ donation awareness campaign is set to continue throughout the year, with additional initiatives and partnerships planned to inspire widespread participation across nation. Mankind Pharma is one of the largest pharmaceutical company in India, which focuses on the domestic market with its Pan India presence. Mankind operates at the intersection of the Indian pharmaceutical formulations and consumer healthcare sectors with the aim of providing quality products at affordable prices. Source: Pharmabiz

Aug 14,2024 The Karnataka drugs control department, which ranks third in the country for total implementation of the Drugs and Cosmetics Act & Rules behind Maharashtra and Gujarat, aims to attain the top spot, Karnataka Drugs Controller in-charge Dr Umesh Shantharaj said. “Our state has been in the third position for a while and now my vision is to move up the ladder and take the top slot. The need of the hour is to raise the bar in enforcement of drug regulations and ensure high quality standards of medicines. There is no reason why Karnataka should lag behind in drug enforcement. We need to become No. 1,” he added. The biggest responsibility of a regulator is to ensure the safety, efficacy and high quality of the medicines reach the patients at a cost fixed by the National Pricing Control Authority (NPPA), he stated. Taking charge on August 1, Dr Umesh told Pharmabiz that he is entrusted to oversee all the functions of the state drugs control department spanning from enforcement, drug testing laboratory, Board of Control for Examination Authority. Reaching the top spot in the country for regulation adherence will indeed be challenging but a worthwhile endeavour to elevate Karnataka’s performance. Revised Schedule M on par with WHO-GMP is critical for this industry which is recognised as the Pharmacy of World. The task on hand is to inspect the large manufacturing units for which the deadline was July 5, 2024 to ensure that they are compliant and ensure total adherence by MSMEs for which the last date is December 27, 2024, he said. Then there is an impending shortfall of drug inspectors (DIs) as their recruitment decision is with the Supreme Court. DIs are the heart of the drugs control department. Yet with a handful of enforcement officers, our team is carrying out the required surprise checks for not-standard quality (NSQ) drugs and raising flags on violations to the D&C Act which is commendable. Current shortfall of DIs are 5 as against the total sanctioned posts of 112. In fact, there were 11 inspectors and six were promoted as assistant drugs controllers. We are in talks with health minister Dinesh Gundu Rao to look into this. Once the required DIs are inducted, our department will go full throttle in inspections across the 31 districts, he said. There is a visible lack of investments in pharmaceuticals and as the drugs controller in-charge, meetings will be held with the industry to ascertain reasons for not being able to attract global big ticket investments. It is of prime importance for our department as the state regulatory authority to be with the industry as only working together will enable us to help Karnataka pharma sector progress, Dr Umesh said. Every effort to interact with the government on industry issues are on. The 2022 move to form a committee for the Pharma Park will be re-ignited as this file is pending with the government and therefore the process is easier. Karnataka also needs a NIPER at Bengaluru which is justified as the state already home to 388 pharmacy colleges with an impressive line-up of the related industries. Also we will ensure that no MSMEs will shut down as the drugs control department will extend the much-needed guidance to implement the revised Schedule M, he said. On a concluding note, Dr. Umesh said that manufacturers are cooperative with the state regulatory authority. This is the only state where the adherence is total making us in top three in the country because the industry is responsible not to deviate regulations to keep their image intact. Source: Pharmabiz

August 12,2024 Mumbai: Atul Bioscience Ltd received establishment inspection report (EIR) from the United States Food and Drug Administration (US FDA) for its manufacturing facility situated in Ambernath, Maharashtra. The EIR was issued post the last inspection of the facility conducted from May 06, 2024, to May 10, 2024 which concluded with zero FDA 483 observations. The company is engaged in manufacturing and marketing of active pharmaceutical ingredients (APIs), their intermediates and contract manufacturing operations. Dr Prabhakar Chebiyyam, Managing Director, ABL, said, “The successful completion of this inspection reflects the dedication and hard work of our entire team. It strengthens our resolve to deliver high-quality pharmaceutical products consistently and further improve our processes to meet the ever-evolving needs of the global pharmaceutical industry.” Source: Pharma

August 13,2024 New Delhi: All Indian salt and sugar brands, whether big or small, packaged or unpackaged, contain microplastics, according to a study published on Tuesday. The study, titled “Microplastics in Salt and Sugar” and conducted by the environmental research organisation Toxics Link, tested 10 types of salt — including table salt, rock salt, sea salt and local raw salt — and five types of sugar purchased from both online and local markets. The study revealed the presence of microplastics in all salt and sugar samples, in various forms, including fibre, pellets, films and fragments. The size of these microplastics ranged from 0.1 mm to 5 mm. The highest levels of microplastics were found in iodised salt, in the form of multi-coloured thin fibre and films. Toxics Link founder-director Ravi Agarwal said, “The objective of our study was to contribute to the existing scientific database on microplastics so that the global plastic treaty can address this issue in a concrete and focused manner.” “We also aim to trigger policy action and attract researchers’ attention to potential technological interventions that could reduce exposure risks to microplastics.” Toxics Link associate director Satish Sinha added, “Our study’s finding of substantial amounts of microplastics in all salt and sugar samples is concerning and calls for urgent, comprehensive research into the long-term health impacts of microplastics on human health.” The concentration of microplastics in the salt samples ranged from 6.71 to 89.15 pieces per kilogramme of dry weight, the report said. Iodised salt had the highest concentration of microplastics (89.15 pieces per kilogramme) while organic rock salt had the lowest (6.70 pieces per kilogramme), according to the study. In sugar samples, the concentration of microplastics ranged from 11.85 to 68.25 pieces per kilogramme, with the highest concentration found in non-organic sugar. Microplastics are a growing global concern because they can harm both health and the environment. These tiny plastic particles can enter the human body through food, water and air. Recent research has found microplastics in human organs such as the lungs, heart, and even in breast milk and unborn babies. Previous studies found that the average Indian consumes 10.98 grams of salt and around 10 spoons of sugar every day — much higher than the World Health Organization’s recommended limits. Source: Healthworld

August 14,2024 New Delhi: Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc’s Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE. Source: Pharma

August 13,2024 Mumbai: A sperm or egg donor has no legal right on the child and cannot claim to be its biological parent , the Bombay High Court held on Tuesday while allowing a 42-year-old woman visitation rights to her five-year-old twin daughters. The woman, in her plea, said her daughters, born via surrogacy, were living with her husband and younger sister, who was the egg donor. The petitioner’s husband had claimed since his sister-in-law was the egg donor, she had a legitimate right to be called a biological parent of the twins and that his wife had no right over them. A single bench of Justice Milind Jadhav, however, refused to accept this contention, citing that though the petitioner’s younger sister was the egg donor, she has no legitimate right to claim that she is a biological parent of the twins. The court said the role of the younger sister is that of an egg donor, rather, a voluntary donor, and at the most, she may qualify to be a genetic mother and nothing more. An advocate appointed to assist the court in the matter informed it that since the estranged couple’s surrogacy agreement took place in 2018 when the Surrogacy (Regulation) Act 2021 had not come into force, the guidelines issued by the Indian Council of Medical Research (ICMR) in 2005 would regulate the agreement. As per a rule of the guidelines, the donor and the surrogate mother have to relinquish all parental rights, the court noted, adding that in the present case, the twins would be the daughters of the petitioner and her husband. “Under the guideline, it is clearly stated that the sperm/oocyte (egg) donor shall not have parental rights or duties in relation to the child and in that view of the matter, the younger sister of the petitioner can have no right whatsoever to intervene and claim to be the biological mother of the twin daughters,” the high court said. As per the plea, the couple could not conceive naturally, and the petitioner’s sister volunteered to donate her eggs. In December 2018, the babies were conceived by a surrogate woman and the twin girls were born in August 2019. In April 2019, the sister and her family met with a road accident, and her husband and daughter were killed. The petitioner lived with her husband and twin daughters from August 2019 to March 2021. Following a marital discord in March 2021, the husband moved into another flat with the children without informing his wife. The man claimed that his wife’s sister (the egg donor) had been depressed after the road accident and started living with him to take care of the twins. The petitioner filed a police complaint and an application before a local court, seeking interim visitation rights to her daughters. The local court rejected her application in September 2023, following which she approached the high court. The wife said her sister had only donated her eggs and was not the surrogate mother, and hence, she had no legal right or role in the lives of the twins. The high court, in its order, noted that the surrogacy agreement of 2018 between the intending parents, the surrogate mother and the doctor is signed by the petitioner, her husband and the doctor. “It is seen that the petitioner (wife) and Respondent No. 1 (husband) are recognised as the intending parents. At least to a naked eye, there is no ambiguity whatsoever while observing and even concluding that it is the petitioner along with Respondent No. 1 who signed the surrogacy agreement as intending parents,” it said. Justice Jadhav held that the lower court order denying visitation rights to the wife was passed without proper application of mind and is unsustainable and quashed it. The court directed the husband to give physical access and visitation rights of the twins to the petitioner for three hours every weekend. Source: Healthworld

August 14,2024 New Delhi: The division bench of the Delhi High Court has asked its single judge bench to expeditiously decide afresh a Mankind Pharma’s plea seeking to restrain Chandra Mani Tiwari and others from adopting and using the name Mercykind Pharmaceuticals. A bench led by Justice Yashwant Varma said that “although we are informed that during the pendency of the present appeal, the defendant (Tiwari) has made significant changes both in its logo and get up of products which are being marketed by it, in our considered opinion, these and other issues which arise would clearly merit consideration afresh by the learned single judge.” The HC noted that the issue which required consideration was that of “dishonest adoption” by the erstwhile employee. Mankind Pharma alleged that Tiwari, who was working with it as a marketing manager till January 2015, had incorporated a company under the name Mercykind Pharmaceuticals. Contesting the use of the suffix “Kind” by Tiwari, the pharma company submitted that it had adopted ‘Mankind’ as a trademark in 1986, and holds as many as 157 trademarks with the suffix ‘Kind’. Besides, Mankind said it has revenues over Rs 4000 crore and has a turnover of Rs 7000 crore. However, the single judge had in 2018 refused to grant any temporary injunction against Tiwari. Source: Pharma