Madrigal gets conditional marketing authorization for Rezdiffra from EC
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Fox News
3 hours ago
- Fox News
Giving Putin the Donbas would hand Moscow powerful leverage over Kyiv's financial survival
Ukrainian President Volodymyr Zelenskyy has firmly rejected proposals to concede land to Russian President Vladimir Putin, particularly the hotly-contested Donbas region. The Donbas, which includes Donetsk and Luhansk oblasts, is Ukraine's industrial heartland where coal mining and steel production are the main drivers of economic growth. Ultimately, control of the region's mines and factories would hand Moscow powerful leverage over Kyiv's post-war economic survival. "Donbas offers both a military advantage and significant economic resources, making it a high-value target for the Kremlin," explained Elina Beketova, a fellow with the Democratic Resilience Program at the Center for European Policy Analysis. "The Donbas alone holds vast reserves of coal – especially anthracite, crucial for energy and metallurgy," Beketova said. "Of 114 mines in Donetsk region, only 15 remain functional," she pointed out, as many have been flooded, destroyed, or left inoperable by the war. Coal tells only half the story. Perhaps the crown jewel is salt: the Soledar salt mines, with an estimated 4.5 billion tons of rock salt—making it the largest reserve in Europe. These mines and the Artyomsol plant, Europe's largest salt producer, fell to Russian forces in 2022. Beketova underscored that, in the long term, natural gas could be the most strategically important resource in the region. "The region includes the Yuzivka gas field in Donetsk and Kharkiv oblasts, with potential reserves of up to 4 trillion cubic meters—a direct challenge to Russian energy dominance, and likely another reason why Moscow wants full control of the area." "Beyond coal, salt, and gas, the occupied territories of Donbas—as well as neighboring Zaporizhzhia and Kherson—are also rich in gypsum, chalk, marble, granite, sand, and clay," Beketova said. Russian forces currently occupy approximately one-fifth of Ukraine's territory, primarily in the eastern and southeastern regions, including large swaths of Luhansk, Donetsk, Zaporizhzhia and Kherson. These areas have been under partial or full Russian control at various points over the course of the Kremlin's war. For Kyiv, the Donbas is more than contested ground—it is an economic lifeline, whose coal, salt, and gas reserves could help bankroll recovery in a country already burdened with enormous post-war debts. The most recent joint assessment by the United Nations, World Bank, European Commission, and Ukrainian government estimates that Kyiv faces $524 billion in post-war reconstruction over the next decade. Of the total long-term reconstruction and recovery needs, housing accounts for the largest share at nearly $84 billion, followed by $78 billion needed for the transportation industry and $68 billion for the energy sector. Zelenskyy told reporters at the European Commission on Sunday that Putin has repeatedly tried and failed to seize the entirety of the Donbas region in eastern Ukraine for a period of 12 years. Grace Mappes, an analyst at the Institute for the Study of War, noted that conceding the region would also mean relinquishing Ukraine's "fortress belt," the fortified defensive line in Donetsk Oblast since 2014. "After trying and failing to occupy this strategically vital terrain for over a decade, Putin is now demanding that Ukraine concede this critical defensive position, which Russian forces currently have no means of rapidly enveloping or penetrating, apparently in exchange for nothing and with no guarantee that fighting will not resume." Mappes added that Ukraine's substantial investment in reinforcing its "fortress belt" with defensive structures, logistics hubs, and defense industrial facilities, underscores its central role in the country's military resilience. "Putin's proposal is not a compromise, rather a ploy to avoid the years-long, bloody campaign that would be necessary to seize the fortress belt and the rest of Donetsk militarily," she added.
Yahoo
4 hours ago
- Yahoo
China's extension of EU dairy import probe linked to September talks
China will not conclude its anti-dumping investigation into EU dairy imports until at least early next year as talks are set to continue in September. In response to China's decision this week to extend its probe to February, the European Dairy Association (EDA) said it was not surprised by the decision given Chinese officials are due to make 'technical visits' to Belgium and the Netherlands next month, as well as hold talks with the European Commission (EC). China kicked off its investigation in August last year to ascertain whether the EU was guilty of exporting dairy products to the Asian country at prices that put local producers at an unfair advantage. The probe followed similar enquiries launched by China for pork and brandy shipped from the European trading bloc that commenced in June and January of 2024, respectively. The trade spat with China was sparked by the EU threatening to impose tariffs on imports of Chinese battery electric vehicles (BEV), with the EC claiming 'unfair subsidisation' by its Chinese counterparts that risked 'causing a threat of economic injury' to local manufacturers. Xinhua, China's state-run news agency and official government mouthpiece, reported on Monday (18 August) that the Ministry of Commerce had extended its investigation into 'certain dairy products' from the EU to February The news service, citing a Ministry statement, said the extension was due to the 'complexity of the case'. Similar language emerged from the EDA. Its Secretary General Alexander Anton said in a statement: 'This highlights the increasingly complex dynamics of global dairy trade and has required coordinated responses from the industry and policymakers, and EDA will continue to work closely with the EU Commission and the 'sampled' dairies that are most involved in the process.' In October last year, China's Ministry of Commerce identified Dutch dairy giant FrieslandCampina, Elvir (France) Co. and Sterilgarda Alimenti in Italy as three EU companies that would be subject to a sampling exercise as part of its anti-dumping probe. Meanwhile, the EC took its case to the World Trade Organization (WTO) last September under a 'commitment to firmly defend the interests of the EU dairy industry and the Common Agricultural Policy against abusive proceedings'. Anton at the EDA said today (20 August) in the statement, when asked for comment and an update on those proceedings by Just Food: 'With that, for the very first time in such an early state of the procedure, the EU has given a clear political sign to step up to defend our European interest. 'WTO procedures are not known for speed and so far, we have no signs for any progress at this level.' Just Food has asked the EC for an update on the status of proceedings regarding China's probe into dairy and pork imports from the bloc, and whether there has been any progress with the WTO. When China kicked off its dairy import investigation last August, Xinhua said the probe was launched on behalf of the Dairy Association of China and the China Dairy Industry Association. The news agency suggested at the time that the review would include fresh cheese, curd and blue cheese from the EU. It was expected that the enquiry would conclude on 21 August of this year but could be extended for six months 'under special circumstances'. "China's extension of EU dairy import probe linked to September talks" was originally created and published by Just Food, 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
Yahoo
5 hours ago
- Yahoo
Madrigal wins European MASH approval as Novo rivalry looms
Madrigal Pharmaceuticals' Rezdiffra (resmetirom) has been approved in Europe for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, making it the first targeted therapy available for patients in the region with this severe form of liver disease. The conditional marketing authorisation by the European Commission (EC) follows an approval recommendation by the European Medicines Agency (EMA)'s Medicinal Products for Human Use (CHMP) in June. US pharma Madrigal expects to launch Rezdiffra in Europe on a country-by-country basis, starting with Germany in Q4 2025, as per a 19 August statement. Stock in US-listed Madrigal closed 2.2% down to $379.55 per share at market close on 19 August, with investors likely downbeat amid a tangential development. Viking's oral glucagon-like peptide-1 receptor agonist (GLP-1RA) drug posted disappointing trial results on the same day; Madrigal recently outlaid $2bn in an oral GLP-1RA licensing deal. The regulatory approval means Madrigal is the only pharmaceutical company with an approved MASH drug in Europe. Rezdiffra was also the first MASH treatment to market in the US – winning US Food and Drug Administration (FDA) approval in March 2024. MASH develops when there is a significant buildup of fat in the liver. Fibrosis, also known as scarring, is associated with MASH, and left untreated, it can lead to more serious damage, including cirrhosis. Madrigal estimates that approximately 370,000 patients have been diagnosed with MASH with moderate to advanced fibrosis in Europe. The disease is a form of non-alcoholic fatty liver disease (NAFLD) that has been billed as one of pharma's highest potential growth areas. Analysis by GlobalData forecasts sales of $25.7bn in 2032 across the seven major markets (the US, France, Germany, Italy, Spain, the UK, and Japan), meaning Madrigal's first-to-market credentials in both the US and Europe could bode well for the drug's growth. GlobalData forecasts a high ceiling for Rezdiffra. The drug is expected to reach blockbuster status by the end of 2026, and, by 2031, Rezdiffra is forecast to generate $4.8bn in global sales. GlobalData is the parent company of Pharmaceutical Technology. Administered as a daily pill, Rezdiffra works by activating a thyroid hormone receptor that reduces liver fat accumulation. While Madrigal was first to reach market in the US for a MASH treatment, it has since lost its crown of boasting the only approved therapy in the indication. Earlier this week, Novo Nordisk's blockbuster drug Wegovy (semaglutide) won FDA approval for the treatment of MASH with moderate to advanced liver fibrosis, providing direct competition to Rezdiffra. Novo Nordisk has also applied for regulatory approval in the EU, setting up a second potential rivalry with Madrigal. However, unlike Wegovy, which exerts its effect through agonism of the GLP-1 receptors, Madrigal's treatment works directly in the liver itself. GlobalData senior analyst Jay Patel says: "This approval allows Madrigal's Rezdiffra to establish an early lead in the EU MASH market. Nevertheless, Novo Nordisk's Wegovy is set to follow closely behind, with an approval expected imminently. "It remains to be seen whether Rezdiffra will be able to carve out a niche once this takes place, given greater patient and physician familiarity with Wegovy, which is already approved for common MASH comorbidities such as obesity and type 2 diabetes mellitus." The EC based its approval on results from the Phase III MAESTRO-NASH trial, in which Rezdiffra achieved both fibrosis reduction and MASH resolution primary endpoints. The pill also reduced liver stiffness, liver fat, liver enzymes, and atherogenic lipids in the MAESTRO-NASH trial, and improved health-related quality of life. Madrigal's CEO Bill Sibold said: 'MASH is the fastest-growing indication for liver transplantation in Europe, but until now, it had no approved treatment. The European labelling for Rezdiffra will set an important precedent for the entire field, with no biopsy required to qualify for treatment with Rezdiffra and a clear focus on a distinct MASH patient population with high unmet need.' Before Madrigal and Novo's approvals, MASH had become a graveyard of failed candidates. Gilead, AstraZeneca, and Intercept all fell short in getting candidates to market, all eventually pivoting pipelines away from the indication. "Madrigal wins European MASH approval as Novo rivalry looms" was originally created and published by Pharmaceutical Technology, 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. Sign in to access your portfolio
