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New Delhi: Telangana has emerged as a major hub for life sciences innovation, attracting over Rs. 36,000 crore in investments from more than 140 projects in the past year. This surge of investment has bolstered the state’s position as a global leader in pharmaceuticals, biotechnology, and biopharmaceuticals, with Genome Valley at the center of this growth. Notable investments include a Rs. 2,000 crore joint venture between European company KrKA and Laurus Labs to establish pharmaceutical finished products and biopharmaceutical manufacturing facilities in Genome Valley. In addition, Laurus Labs has inaugurated an R&D center with an investment of Rs. 250 crore. Together, these projects are expected to create over 2,800 jobs. Another significant development is the partnership between Japanese pharmaceutical giant Takeda and Biological E, aimed at manufacturing 5 crore doses of the Dengue vaccine annually from Genome Valley. This collaboration positions Hyderabad at the forefront of the global fight against dengue, further solidifying its reputation as the “vaccine capital of the world.” “We have witnessed a surge of investments from several international and domestic companies, who have chosen Telangana as their gateway to India’s rapidly growing life sciences ecosystem. From pharmaceutical manufacturing and R&D centers to GCC innovation hubs, these investments across the life sciences value chain make Telangana an undisputed leader in this space globally,” said Duddilla Sridhar Babu, Minister of Industries and Commerce, Government of Telangana. These investments are expected to create 51,000 direct jobs and an estimated 1,50,000 indirect jobs, reaffirming Telangana’s status as a powerhouse in the global life sciences industry. The state’s Genome Valley, recognized as India’s first and largest organized R&D cluster, continues to attract leading industries and innovative research institutions. In addition to pharmaceutical companies, Hyderabad has also become a strategic hub for Global Capability Centers (GCCs) in the life sciences and healthcare sectors. “The state government is particularly enthusiastic about the convergence of life sciences and advanced technologies. Hyderabad boasts a robust talent pool with specialized expertise in pharmaceuticals, biotechnology, artificial intelligence, machine learning, data analytics, and digital health solutions,” Sridhar Babu added. Vishal Goel, Managing Director of RX Propellant, emphasized the growing significance of the region in the global life sciences landscape. “Genome Valley is not just a manufacturing hub but is rapidly evolving into an epicenter of innovation in the global life sciences landscape. As we continue to invest in the Genome Valley ecosystem, we see unparalleled opportunities for growth and collaboration. There truly is no ecosystem like Genome Valley — it offers a unique blend of cutting-edge research, world-class infrastructure, and a thriving talent pool, making it the ideal destination for life sciences innovation,” said Goel. Rx Propellant has a portfolio of seven projects in the Genome Valley cluster totalling 2.5 million sq ft. These projects feature advance lab spaces and flexi-factories. Rx Propellant’s life sciences real estate portfolio comprises nine projects with over 6.5 mn sq ft under development in Hyderabad, Bengaluru and Mumbai. Other global players such as Switzerland-based Ferring Pharma, Germany’s DFE Pharma, and USA-based Vivint Pharma are also setting up or expanding operations in Genome Valley, reinforcing the region’s appeal as a global life sciences hub. In light of this momentum, the Telangana government is set to introduce a dedicated life sciences policy aimed at streamlining processes, fostering innovation, and driving sustainable growth in the sector. This policy is expected to address the evolving needs of the life sciences industry, further strengthening Telangana’s position as a key player in the global life sciences value chain. By Sobia Khan ,

At its May meeting, the European Medicines Agency's drug advisory body recommended 14 new medicines for approval, including one biosimilar and five generics, while it also backed extended labelling for seven treatments. In addition, the Committee for Medicinal Products for Human Use (CHMP) confirmed a negative opinion following a re-examination, and there were two marketing application withdrawals. All of the decisions can be found detailed below.Positive recommendations on new medicines: Takeda’s enzyme replacement therapy Adzynma (rADAMTS13) for the treatment of children and adult patients with congenital thrombotic thrombocytopenic purpura. SIFI’s Akantior (polyhexanide) for the treatment of acanthamoeba keratitis. CStone Pharmaceuticals’ anti-PD-L1 monoclonal antibody Cejemly (sugemalimab) for the treatment of adults with metastatic non-small-cell lung cancer (NSCLC). Pfizer’s gene therapy Durveqtix (fidanacogene elaparvovec) for the treatment of haemophilia B. AstraZeneca’s Fluenz (influenza vaccine [live attenuated, nasal]) for the prophylaxis of influenza in children and adolescents from 24 months to <18 years of age. Eckert & Ziegler’s GalliaPharm (germanium [68Ge] chloride / gallium [68Ga] chloride) for radiolabelling of various kits used for positron emission tomography (PET) imaging. Valneva’s Ixchiq (chikungunya vaccine [live]) to protect adults against disease caused by Chikungunya virus transmitted to humans by infected mosquitoes. Novo Nordisk’s Zegalogue (dasiglucagon) for the treatment of severe hypoglycaemia in adults, adolescents and children aged six years and over with diabetes mellitus.  Bio-Thera Solutions’ biosimilar version of Avastin (bevacizumab), named Avzivi, for the treatment of carcinoma of the colon or rectum, breast cancer, NSCLC, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Five generic medicines also received a positive opinion: Apexelsin (paclitaxel) for the treatment of metastatic breast cancer; Dasatinib Accord Healthcare (dasatinib) for the treatment of chronic myelogenous leukaemia; and generic versions of pomalidomide from Accord Healthcare, Krka and Zentiva for treatment of multiple myeloma.Positive recommendations on extensions of therapeutic indication: Sanofi/Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.  Bristol Myers Squibb/Pfizer’s Eliquis (apixaban) to include the treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to <18 years of age. Calliditas Therapeutics/Stada’s Kinpeygo (budesonide) for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).  Mirum Pharmaceuticals’ Livmarli (maralixibat) to include progressive familial intrahepatic cholestasis in patients 3 months of age and older. AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy.  AstraZeneca’s Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. BeiGene’s Tevimbra (tislelizumab) alone for the treatment of adults with locally advanced or metastatic NSCLC after prior platinum-based therapy; in combination with pemetrexed and platinum‑containing chemotherapy for the first-line treatment of certain adults with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations; and in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of certain adults with squamous NSCLC.Negative opinions on new medicines: The CHMP confirmed its initial recommendation to refuse the granting of a marketing authorisation for Neuraxpharm and Minoryx Therapeutics’ Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy.Withdrawal of applications: Cytokinetics pulled a filing seeking approval of Kinharto (omecamtiv mecarbil) for the treatment of adults with symptomatic chronic heart failure and reduced ejection fraction. The decision was based on feedback from the EMA that supporting results were not sufficient to conclude that the benefits of the cardiac myosin activator outweigh the risks. Cytokinetics recently outlined plans to conduct another study of Kinharto. Clinuvel withdrew an application to expand use of Scenesse (afamelanotide) into adolescents with erythropoietic protoporphyria. The drug has been approved in this indication in the EU since 2014 for adults. However, the company determined that it was not possible to provide the comprehensive safety and efficacy data expected by the EMA in the expanded population.

Upgrade to Calyx RIM on Microsoft Azure drives efficiencies and patient safety NOTTINGHAM, England and MORRISVILLE, N.C., Aug. 2, 2022 /PRNewswire/ -- Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced that long-term client, Krka – one of the world's leading generic pharmaceutical companies – is expanding its investment in the Calyx Regulatory Information Management (RIM) system for an additional five years. Continue Reading Krka's decision is based on Calyx's regulatory expertise, system robustness, and investment in reliable cloud technology Tweet this Calyx's Jo English values the trust that Krka continues to place in Calyx RIM after their 10+ years of successful experience with the regulatory system "We chose to continue our relationship with Calyx based on our successful experience working with their regulatory experts over the past decade, and our trust in the robustness of the Calyx RIM system," said Krka. "We're excited about the investment Calyx has made in innovating the system with reliable cloud technology, which will help us to ensure patient safety, even during system updates." Since 2011, Krka has relied on Calyx RIM to comply with increasingly complex global publishing requirements and for the management and tracking of detailed product information, registrations, and authorizations. Krka's contract extension includes an upgrade to Calyx RIM on Microsoft Azure for increased efficiencies, including simplified activities and tailored, direct delivery of system updates to minimize operational disruptions. "We value the trust that Krka continues to place in Calyx RIM and are delighted to extend our relationship as they strive to comply with evolving worldwide regulations and ensure patient access to much needed medical treatments," said Jo English, Vice President, Regulatory Information Management, Calyx More than 20 million regulatory records have been seamlessly migrated into the Calyx RIM system, representing over 1 million global submissions to date. Notably, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx RIM. Click here for more information on the benefits of Calyx RIM. About Calyx Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day. CTMS | EDC | IRT | Medical Imaging | RIM Take your trials further with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook. About Krka Krka (LJSE: KRKG) was established in 1954 and has developed into one of the leading generic pharmaceutical companies in wider Europe. Globally, it ranks among the top 20 generic companies, and is present in overseas markets and Asia. Krka has a broad portfolio of effective and innovative medicines and a strong development pipeline of 170 products. Krka's medicines are available in unique strengths and combinations, innovative dosage forms, including sustained release dosage forms, and are manufactured in advanced and patented technological processes. Our flexibility allows us to be agile and first to market. Krka has grown to become an international company with 12 thousand employees and global presence in more than 70 markets around the world. In addition to the 47 subsidiaries and representative offices abroad, the company's international presence is consolidated through its own production plants in Slovenia, Poland, the Russian Federation, Croatia, Germany, and now in China. Krka's products are marketed under our own brand names, ensuring market recognition. New products are constantly being added to the wide Krka product range, reinforcing the company's ability to enter new therapeutic areas. Krka's group business model is based on a high degree of vertical integration at all levels of its operation. SOURCE Calyx