Latest news with #EC
Time of India
2 hours ago
- Business
- Time of India
HC Junks PIL Against Lloyds' Iron Ore Expansion In Gadchiroli, Flags Petitioner's Bona Fides
1 2 3 4 Nagpur: The Nagpur bench of Bombay High Court recently dismissed two clubbed public interest litigations (PILs) challenging the expansion of iron ore mining by Lloyds Metals and Energy Limited in Gadchiroli. The court pointed out that the petition was filed by a person with no stakes in the matter, lacked locus standi and was acting without bona fides. A division bench of Justices Nitin Sambre and Abhay Mantri rejected the pleas filed by Samarjeet Chatterjee, resident of Raipur, Chhattisgarh, and co-petitioner Vishesh Bhatpalliwar from Gadchiroli. The bench stated there was no substantive connection between the petitioners and affected population. It also noted no local resident or tribal community had objected to the environmental clearance (EC) and questioned the motive and timing of the PIL. "Merely claiming to be a social servant does not give the petitioner the locus standi to filed a PIL as he has not shown any nexus with the cause of such people, who live almost 300km away from his place of residence and that too in another state (Chhattisgarh)," the bench noted. The judges added the fact that the petitioner did not question the earlier public hearing, conducted at the district headquarters in 2005-06, and is now questioning the subsequent public hearing, sufficiently demonstrates he lacks bona fides in the matter of preferring the PIL. The HC also observed that it failed to understand the petitioner's source of funds for carrying out the legal battle, especially if he has an annual income of Rs4-5 lakh. The court noted that the petitioner claimed he gave up his profession as a mine contractor and travelled all the way to Maharashtra from Raipur in Chhattisgarh, where he is based. Aheri, where the plant is located, is more than 200 km from his place, said the court. Chatterjee, a former mining contractor, challenged the environmental clearances (EC) granted to Lloyds Metals in two stages — from 3 metric tonnes per annum (MTPA) to 10 MTPA (2023) and then to 16 MTPA (2024). He alleged violations of EIA norms, improper public hearing, and non-compliance with environmental regulations. He sought to quash the terms of reference and clearances issued in 2022 and 2023 on grounds of procedural lapse under office memorandums dated April 2022 and July 2021 SOPs. However, the court noted the public hearing at the Gadchiroli district headquarters on October 27, 2022, was legally valid, widely publicised, and attended by a large number of local representatives and citizens. It also cited the Maoist threat in the mining zones for not conducting the hearing at the actual site. The bench acknowledged that Lloyds earlier operated without a fresh environment clearance post-2011, but later complied fully with the 2021 standard operating procedure, paid a ₹5.48 crore penalty, furnished a ₹26.64 crore bank guarantee. The environment clearance for 10 MTPA was then granted on February 24, 2023, followed by the terms of reference for 16 MTPA on November 26, 2024. Calling such PILs "a tool for personal vendetta" and not a genuine public interest action, the court invoked Supreme Court rulings to underscore the need to curb misuse of PILs. Lloyds, through counsel Raghav Bhandakkar, argued it created 2,000 jobs and contributed ₹2,000 crore in royalties to the District Mineral Fund, and 80% project execution was already complete. Finding no merit in the plea, the court refused to interfere with the environmental approvals and dismissed both PILs. **Key Takeaways from HC Verdict** - Petitioner had no local standing or public interest. - Lloyds Metals paid ₹5.48 crore penalty for prior EC lapse. - Environmental clearance for 10 MTPA upheld as per SOP - Public hearing held as per guidelines, no irregularity found. - 2,000 jobs and ₹2,000 crore royalty cited as development impact. - Relied on SC rulings to warn against "luxury litigation." - No locals objected to project
Time of India
2 hours ago
- Politics
- Time of India
Voting percentage in Voter Turnout App for Nilambur bypoll is approximate and not final: Chief electoral officer
T'puram: The office of the chief electoral officer stated that the voting percentage displayed in the Voter Turnout App is not final for the Nilambur bypoll. The chief electoral officer clarified that the voter turnout percentage shown in the application represents approximate voting trends in percentage terms only. These figures are indicative in nature and should not be interpreted as exact or certified data. "The voter turnout information is provided solely for facilitation and informational purposes to give the public a general sense of voting activity during the election process," a press release stated. Additionally, the displayed voter turnout information does not include data from postal ballot voting, which is compiled separately and added to the final official count, according to the statement. "Users are advised to refer to the official announcements and statutory documents issued by the respective returning officers for any legal, electoral or official purposes," the press release said. The voting process was peaceful and at the end of the polling, the electronic voting machines were transferred to the strong room and sealed in the presence of the candidates or their representatives. The strong room, where the voting machines are stored, will be under double-layer security by the Central armed police force and the state armed police force. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Beat the Rush: The $42 Serum Costco Shoppers Swear By Best Of Beauty Learn More Undo The EC successfully used new facilities at the Nilambur bypoll, including mobile phone storage facilities at the polling booth, the updated voter turnout rate (VTR) sharing process and 100% webcasting of polling stations. The updated VTR sharing process allowed the presiding officer at each polling station to directly record voting status every two hours on the new ECINET application on polling day. This helped reduce delays in updating approximate polling trends, which were automatically collected at the constituency level, a press release said. Webcasting was monitored to ensure that critical activities were conducted smoothly and that there were no violations of the polling process.
Yahoo
3 hours ago
- Health
- Yahoo
argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest study of CIDP patients to date First novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART for SC injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation. "The EC's decision has been met with hope and enthusiasm by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN). We see the introduction of a new targeted therapy for CIDP as a major step forward for the patient community," said Jean-Philippe Plançon, President of EPODIN. CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. People living with CIDP can also become wheelchair bound and unable to work as the disease progresses. Currently, 85% of patients require ongoing treatment and nearly 88% of treated patients experience residual impairment and disability. 'CIDP can severely affect quality of life by causing weakness, loss of balance and mobility, numbness and pain in a patient's arms and legs. For far too long, physicians have had limited options for helping to improve patient outcomes,' said Dr. Luis Querol, M.D., Ph.D., ADHERE Investigator, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 'The approval of VYVGART SC for the treatment of CIDP marks a turning point in clinical practice, as physicians now have access to a new, effective treatment option that, for the first time, precisely targets a key mechanism of disease and provides meaningful functional improvements to patients.' The EC approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the study, 66.5% (214/322) of patients treated with VYVGART SC demonstrated evidence of clinical improvement, including in mobility, function and strength. Clinical benefit was seen across all patient subtypes, regardless of prior treatment. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99% of trial participants elected to participate in the ADHERE open-label extension. The safety results were consistent with the known safety profile of VYVGART SC in previous clinical studies. 'VYVGART SC is the first therapy with a novel mechanism of action to be approved for this community in more than 30 years,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. 'With VYVGART SC, CIDP patients and physicians across Europe will soon have access to an effective novel therapy with a favorable safety profile that has a precise mechanism of action and a convenient self-injection option. This approval further affirms the potential of efgartigimod in IgG-mediated autoimmune diseases.' The EC approval will apply to all 27 European Union Member States, and also to Iceland, Liechtenstein, and Norway. argenx is working closely with local regulatory authorities across the region to ensure that patients who may benefit from VYVGART SC are able to access the novel treatment as soon as possible. This regulatory approval is the second for VYVGART SC in Europe, which first received approval as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. About ADHERE The ADHERE trial was a multi-center, randomised, double-blind, placebo-controlled trial evaluating efgartigimod alfa SC for the treatment of CIDP. ADHERE enrolled 322 adult patients with CIDP, 130 of whom were based in Europe. The trial consisted of an open-label Stage A followed by a randomized, placebo-controlled Stage B. In order to be eligible for the trial, the diagnosis of CIDP was confirmed by an independent panel of experts. Patients entered a run-in stage, where any ongoing CIDP treatment was stopped and, in order to be eligible for Stage A, had to demonstrate active disease with clinically meaningful worsening on at least one CIDP clinical assessment tool, including INCAT, I-RODS, or mean grip strength. Treatment-naïve patients were able to skip the run-in period with proof of recent worsening. To advance to Stage B, patients needed to demonstrate evidence of clinical improvement (ECI) with efgartigimod alfa SC. ECI was achieved through improvement of the INCAT score, or improvement on I- RODS or mean grip strength if those scales had demonstrated worsening during the run-in period. In Stage B, patients were randomized to either efgartigimod alfa SC or placebo for up to 48 weeks. The primary endpoint was measured once 88 total relapses or events were achieved in Stage B and was based on the hazard ratio for the time to first adjusted INCAT deterioration (i.e. relapse). After Stage B, all patients had the option to roll-over to an open-label extension study to receive efgartigimod alfa SC. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)CIDP is a rare and serious autoimmune disease of the peripheral nervous system. There is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can worsen over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About Efgartigimod SCEfgartigimod SC (efgartigimod alfa) is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor (FcRn) and blocking the IgG recycling process. Efgartigimod SC is the first-approved FcRn blocker globally and is marketed as VYVGART® Hytrulo in the United States and China for the treatment of generalized myasthenia gravis (gMG) and CIDP; as VYVDURA in Japan for gMG and CIDP; and as VYVGART for gMG and CIDP in other regions globally. Efgartigimod SC is currently being evaluated in more than 15 severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercialising the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Instagram, Facebook, and YouTube. Contacts Media:Kate Dion kdion@ Investors: Alexandra Royaroy@ Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements.' These forward-looking statements can be identified by the use of forward-looking terminology, including the terms 'aim,' 'is,' 'can,' 'may,' 'will,' and 'believe' and include statements argenx makes concerning argenx's aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines; its belief that the approval of VYVGART SC for the treatment of CIDP may bring meaningful functional improvements to patients; the timing of access to an effective novel therapy for CIDP patients and physicians across Europe; and the potential of efgartigimod in IgG-mediated autoimmune diseases. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx's actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx's U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx's most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 hours ago
- Business
- Yahoo
EU imposes medical device procurement restrictions on Chinese firms
The European Commission (EC) will restrict Chinese companies from EU government purchases of medical devices exceeding €5m ($5.7m). The move comes after a report found that 87% of public procurement contracts for medical devices in China were subject to 'exclusionary and discriminatory measures' and practices against EU-made medical devices and EU suppliers. In addition, Chinese entities will now be restricted from around 60% of annual spending within the medical device field, with EU contracting authorities now ordered to ensure that up to 50% of a contract's value is subcontracted to Chinese entities or includes Chinese-origin medical devices. Initiated in April 2024 with the findings published in January 2025, the report guiding the EU's decision marked the first investigation under the EU's International Procurement Instrument (IPI) regulation of 2022, a law created to promote reciprocity in access to international public procurement markets. China is the second-largest medtech market worldwide. The EU's investigation concluded that Chinese policies, including its 'Made in China 2025' economic roadmap, favoured domestic medical devices over imported ones by design. The EC also observed that China's volume-based procurement of medical devices forces bidders to offer the lowest possible price, and that the contracting authorities set a maximum reference price and maximum price margins for bid selection. The commission stated that the European procurement market is still one of the most open in the world, highlighting that Chinese medical device exports to the EU more than doubled between 2015 and 2023. The EC stated that it had made repeated efforts to engage with Chinese authorities regarding the lack of reciprocity and to seek a constructive and fair solution that would enable EU companies to access the Chinese market on terms comparable to those enjoyed by Chinese firms in the EU. However, the EC stated that China had 'so far not offered specific commitments that would address the discriminatory measures and practices identified'. The EC backed the restrictions earlier this month. Writing in state news outlet Xinhua, China's Ministry of Commerce (MoC) opposed the plans, branding the EU's move 'protectionist'. The ministry wrote: 'As responsible major economies, China and the EU should adhere to WTO [World Trade Organization] rules, uphold the principles of fairness, transparency and non-discrimination, address challenges through mutual openness, and resolve differences through cooperative dialogue to jointly safeguard the healthy development of China-EU economic and trade relations.' The EC stated that should China offer 'concrete, verifiable, and satisfactory solutions that effectively address the concerns identified', the IPI framework allows for the suspension or withdrawal of measures. Maroš Šefčovič, European Commissioner for Trade and Economic Security; Interinstitutional Relations and Transparency, commented: 'Our aim with these measures is to level the playing field for EU businesses. We remain committed to dialogue with China to resolve these issues.' "EU imposes medical device procurement restrictions on Chinese firms" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
The Sun
11 hours ago
- Business
- The Sun
New electricity tariff: over 23.6m domestic users in Peninsular Malaysia to enjoy fairer rates
KUALA LUMPUR: More than 23.6 million domestic users in Peninsular Malaysia will benefit from fairer and more progressive electricity rates due to the newly approved electricity tariff schedule approved by the government, the Energy Commission (EC) announced today. This tariff determination will take effect from July 1, 2025, to December 31, 2027, under the Incentive-Based Regulation (IBR) framework, in line with the provisions of Section 26, Electricity Supply Act 1990, it said in a statement. The electricity tariff changes for the Regulatory Period 4 (RP4) involve the restructuring of the following three components: (i) The average base tariff rate; (ii) The new tariff schedule; and (iii) The fuel cost adjustment mechanism. According to the EC, the Average Base Tariff Rate was adjusted based on the estimated cost of electricity supply for the RP4 period and is set at 45.40 sen/kWj, compared to 45.62/kWj approved in December 2024. With this adjustment, the average overall electricity tariff cost is reduced by up to 19 per cent, compared to the Third Regulatory Period (RP3).
