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Dec 21 (Reuters) - Australian Competition & Consumer Commission (ACCC) on Wednesday rejected TPG Telecom's (TPG.AX) network sharing agreement with Telstra Corp (TLS.AX), saying the deal would significantly weaken competition in the country. 2 internet service provider - said it was "disappointed" with the Australian competition regulator's decision and is preparing an application for a review of the decision. In February, the companies signed a regional multi-operator core network agreement under which Telstra, the country's largest telecoms operator, would gain access to TPG's 4G and 5G spectrums. The deal was expected to deliver between A$1.6 bln ($1.07 bln) and A$1.8 billion of revenue to Telstra over the initial 10-year term. Reporting by Navya Mittal in Bengaluru; Editing by Anil D'Silva and Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.
LONDON, Dec 20 (Reuters) - A Sun newspaper column by British television presenter Jeremy Clarkson about Prince Harry's wife Meghan has become the press standards regulator's most complained about article, it said on Tuesday, with more than 17,500 complaints received. In a column published on Friday, Clarkson, who gained worldwide fame as presenter of motoring show "Top Gear", wrote of Meghan: "I hate her. The Independent Press Standards Organisation (IPSO) said it had received more than 17,500 complaints so far, the most about any article since it was established in 2014. We cannot allow this type of behaviour to go unchecked any longer," said the letter, which was posted on Twitter by Nokes. Reporting by Kylie MacLellan; additional reporting by Farouq Suleiman; editing by Jonathan OatisOur Standards: The Thomson Reuters Trust Principles.
ZURICH, Dec 18 (Reuters) - Italian businessman Silvio Berlusconi family's MediaForEurope NV vehicle has notified the Austrian competition authority about the "acquisition of de facto sole control of ProSiebenSat1 Media DE Deutschland" (PSMGn.DE), the competition watchdog said. MFE had no comment on the notification, which was first reported by German media portal DE24LIVE. The announcement, dated Dec. 13 on the Austrian regulator's website was made because ProSieben also operates in German-speaking Austria. MFE, controlled by the former Italian prime minister's family, has built, partly through derivatives, a 29.9% voting stake in its German rival, cementing its position as single biggest shareholder. "We haven't really seen ProSieben address the big challenges the industry faces: audience decline, digital transformation ... and the need for scale to compete with digital giants," MFE finance chief Marco Giordani told analysts.
Dec 16 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday it planned to hold a meeting of outside experts next month to discuss whether initial doses of COVID-19 vaccines need to be updated to combat circulating variants. While updated booster doses from Pfizer (PFE.N) and Moderna (MRNA.O) are already approved for adults as well as children as young as five years, the FDA said it was important to weigh in on the composition of both initial and booster doses as new variants spread. The independent advisers, who are scheduled to meet on Jan. 26, are also expected to weigh in on whether the timing or composition of booster doses need to be adjusted. In June, advisers to the FDA had recommended a change in the composition of COVID-19 booster shots before fall to combat more recently circulating variants of the coronavirus. Reporting by Bhanvi Satija and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Sherry Jacob-PhillipsOur Standards: The Thomson Reuters Trust Principles.
Speaking in a closed-door call hosted by Goldman Sachs, dLocal CEO Sebastian Kanovich said that a full license with the UK regulator (FCA) was pending, citing the UK's exit from the European Union. "We have been advised not to engage in a tit for tat," he responded, adding dLocal was only engaging privately with stake holders. Neither dLocal nor Goldman Sachs responded to a request for comment. Muddy Waters told Reuters that Kanovich's explanations for the multi-million deficit in merchants' accounts "were so implausible, we literally laughed out loud." The company's CEO was also asked why dLocal had nearly $6 million in funds trapped in disgraced crypto exchange FTX, which dLocal failed to withdraw before the exchange's collapse.
SEC chair Gary Gensler says the agency has "enough authority" for a crypto regulatory crackdown. Gensler's comments come a month after the demise of once-$32 billion crypto exchange FTX. The regulator has "enough authority" for a crackdown in the space, Gensler said, adding that the SEC is "already suited up." Crypto exchange Coinbase faced legal threats from the regulator for its lending offering as well, leading it to scrap the effort. Gensler's comments come after the demise of FTX, the once-$32 billion crypto exchange started by Sam Bankman-Fried.
VILNIUS, Dec 6 (Reuters) - The Latvian broadcasting regulator cancelled the license of Russian independent television station TV Rain on Tuesday, the regulator's chairman said. "In connection with the threat to the national security and public order, (the regulator) has made a decision this morning to annul the broadcast license of TV Rain", Ivars Abolins said on Twitter, adding the broadcasts will cease on Thursday. (This story has been refiled to add the dropped word 'of' in paragraph 1)Reporting by Andrius Sytas in Vilnius and Janis Laizans in Riga, editing by Stine JacobsenOur Standards: The Thomson Reuters Trust Principles.
Companies AT&T Inc FollowDec 3 (Reuters) - AT&T Inc. (T.N) has agreed to pay a $6.25 million penalty to settle a Securities and Exchange Commission lawsuit accusing the phone company of selectively leaking financial information to Wall Street analysts, the SEC said in a court filing. "We are committed to following all applicable laws and pleased to have resolution with the SEC. With this settlement, the company and its employees neither admitted nor denied the SEC’s allegations," AT&T told Reuters in an emailed statement. In a March 2021 lawsuit, the SEC accused Dallas-based AT&T and three investor relations executives of leaking details about its smartphone business to 20 firms. Reporting by Akanksha Khushi; Additional reporting by Sneha Bhowmik in Bengaluru; Editing by Toby ChopraOur Standards: The Thomson Reuters Trust Principles.
Companies AT&T Inc FollowDec 3 (Reuters) - AT&T Inc. (T.N) has agreed to pay a $6.25 million penalty to settle a Securities and Exchange Commission lawsuit accusing the phone company of selectively leaking financial information to Wall Street analysts, the SEC said in a court filing. AT&T did not immediately respond to a Reuters' request for comment outside business hours. In a March 2021 lawsuit, the SEC accused Dallas-based AT&T and three investor relations executives of leaking details about its smartphone business to 20 firms. read moreThe SEC said it violated fair disclosure which it adopted in 2000 to bar companies from disclosing material non-public information privately, helping level the playing field for investors. Reporting by Akanksha Khushi in Bengaluru; Editing by Toby ChopraOur Standards: The Thomson Reuters Trust Principles.
No spot bitcoin ETFs approved so far - U.S. SEC official
  + stars: | 2022-11-30 | by ( ) www.reuters.com   time to read: +1 min
"We've had a number of applications ... none of those have been approved to date," said Uyeda, who was in Singapore to speak at the ICI Global Asset Management Asia Forum. Earlier this month, the SEC delayed a decision on whether to allow a spot bitcoin ETF by stock-picker Cathie Wood's Ark Invest and crypto investment product firm 21Shares US to list and trade on Cboe Global Markets until Jan. 27. The regulator has rejected over a dozen spot bitcoin ETF applications, and approved several bitcoin futures-based ETFs. The rejections have focused on applicants' lack of surveillance-sharing agreements with regulated markets relating to the spot funds' underlying assets. Uyeda added that the SEC continues to consider applications filed by exchanges "as they come up".
U.S. FDA gives first-ever approval to fecal transplant therapy
  + stars: | 2022-11-30 | by ( ) www.reuters.com   time to read: +2 min
The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. While this is the first such therapy approved by the Food and Drug Administration (FDA) for recurrent C. difficile infections, fecal microbiota transplants – classified by the regulator as investigational – have long been the standard of care in the U.S. for this condition. Approval for the therapy comes on the back of a positive vote from the regulator's advisers in September, as most on the panel sought standardization of the therapy. Ferring, which gained the therapy through its 2018 purchase of U.S.-based Rebiotix Inc, was not immediately available for a comment on pricing and availability of the therapy. Besides Ferring, other companies including Seres Therapeutics (MCRB.O), which is developing an oral treatment, are working on similar therapies based on fecal microbiota transplantation.
The transfer of shares will give Adani control over a 29.18% stake in the news group. Adani is also conducting an open offer running between Nov. 22 and Dec. 5 for a 26% stake in NDTV. read moreThe open offer drew bids for 5.3 million shares as of Monday's close, or around 32% the 16.8 million shares on offer, exchange data showed. More than a decade ago, NDTV founders Radhika and Prannoy Roy took a 4 billion Indian rupee ($49.00 million) loan from a company that Adani acquired in August. NDTV said the entity backed by its founders issued shares after the market regulator's restrictions on its founders expired on Nov. 26.
TOKYO, Nov 28 (Reuters) - Japan's Kyushu Electric Power Co (9508.T) said on Monday that it has not received any notification of antitrust fines from the Fair Trade Commission and would fully cooperate with the regulator's investigation. Kyushu Electric Power said it is under the investigation and it will announce information swiftly if necessary. The Fair Trade Commission declined to comment on a report Friday in The Nikkei the commission has decided to fine three major utility firms including Kyushu Electric Power tens of billions of yen in total for breaching antitrust laws. The newspaper reported that the regulator will penalise Kyushu Electric Power, Chugoku Electric Power Co (9502.T) and Chubu Electric Power Co (9504.T) for agreeing not to expand in each other's industrial power supply markets. Reporting by Kaori Kaneko and Yuka Obayashi; Editing by David GregorioOur Standards: The Thomson Reuters Trust Principles.
Twitter meets deadline to reply to French regulator's query
  + stars: | 2022-11-24 | by ( ) www.reuters.com   time to read: 1 min
PARIS, Nov 24 (Reuters) - Twitter has met a Thursday deadline to respond to France's communications regulator about whether the company can meet its legal obligations, a spokesperson for the regulator said. Arcom sent a letter on Monday to Twitter asking if it can meet its legal obligation to guarantee transparent information in spite of steep job cuts at the firm. "Twitter responded to our letter," the spokesperson for Arcom said. "We will analyze their response. Reporting by Mathieu Rosemain Editing by Mark PotterOur Standards: The Thomson Reuters Trust Principles.
WASHINGTON, Nov 22 (Reuters) - The U.S. Securities and Exchange Commission on Tuesday charged Goldman Sachs Asset Management (GS.N) with failing to follow its policies and procedures involving environmental, socially oriented and other investments, and fined the company $4 million. The charges were specifically over "policies and procedures failures involving two mutual funds and one separately managed account strategy marketed as Environmental, Social, and Governance (ESG) investments," the regulatory agency said in a statement. Without admitting or denying the regulator's findings, Goldman Sachs Asset Management agreed to pay the $4 million penalty, the SEC added. "Goldman Sachs Asset Management, L.P. is pleased to have resolved this matter, which addressed historical policies and procedures related to three of the Goldman Sachs Asset Management Fundamental Equity group's investment portfolios," the company said in a separate statement. The SEC found that, from April 2017 until February 2020, the company had several policy and procedure failures involving the ESG research its investment teams used to select and monitor securities.
Nov 21 (Reuters) - Britain's competition regulator said on Monday it was looking into whether U.S. chipmaker Broadcom Inc's (AVGO.O) $61 billion acquisition of cloud computing company VMware Inc (VMW.N) may substantially lessen competition. The Broadcom-VMware deal, announced in May, is the second biggest globally so far this year and marks Broadcom's attempt to diversify its business into enterprise software. The companies are also seeking European Union antitrust approval. The Competition and Markets Authority (CMA) is inviting comments from interested parties by Dec. 6 to help it with an assessment on whether to formally launch an investigation into the Broadcom-VMware deal. Reporting by Radhika Anilkumar in Bengaluru; Editing by Devika SyamnathOur Standards: The Thomson Reuters Trust Principles.
Companies Petroleos Mexicanos FollowMEXICO CITY, Nov 17 (Reuters) - Under pressure to increase production, Mexico's state oil company Pemex has risked fines for violations that cause environmental damage rather than delay output to fix the underlying issues, according to two senior company sources. Mexican law stipulates that the oil regulator can only levy fines for breaches of development plans rather than for environmental damage. The world's most indebted oil company, whose profits were for years plundered to fund government spending, has struggled to reverse a decade of declining oil production. Reuters GraphicsIn Mexico, fines are decided by various factors including if it is a first or repeated offense, and damage caused. Fines are low to avoid depleting Pemex funds that could be used to resolve the underlying problems, the sources at the regulator said.
A recent multimillion-dollar transaction could show how Trump might get around that restriction. Many U.S. election law experts expect that MAGA Inc will spend money to support Trump's 2024 campaign, which he officially kicked off on Tuesday. "That's a gray area in the law that they might try to exploit," said Weiner, a former lawyer at the Federal Election Commission. If the FEC doesn't act on the Campaign Legal Center's request for a probe, the group could ask a judge to order the regulator to launch an investigation. A deadlock could lead to further court cases, potentially running out the clock before the 2024 election.
HONG KONG/SYDNEY, Nov 15 (Reuters) - The fintech arm of Chinese e-commerce firm JD.Com (9618.HK) aims to win Beijing regulators' approval to list in Hong Kong as soon as the end of the year, three people with direct knowledge of the matter said, after a first attempt failed earlier this year. Reuters reported in May that JD Tech's original plan for a Hong Kong IPO was put on ice because it could not get regulatory approval for the deal to proceed. As a domestically incorporated company, JD Tech - JD.Com's fintech, cloud and artificial intelligence unit - needs approval from the China Securities Regulatory Commission (CSRC) to list offshore, including in the Chinese-controlled territory of Hong Kong. JD Tech, which was hived off as a separate unit in mid-2017, had appointed several banks to work on the IPO, but progress had slowed as it failed to win regulatory approval first time around, sources have previously told Reuters. read moreReporting by Julie Zhu and Kane Wu in Hong Kong and Scott Murdoch in Sydney; Editing by Sumeet Chatterjee and Kenneth MaxwellOur Standards: The Thomson Reuters Trust Principles.
Opioid overdose reversal drug likely safe for OTC use, says FDA
  + stars: | 2022-11-15 | by ( ) www.reuters.com   time to read: +1 min
Nov 15 (Reuters) - Opioid overdose reversal drug naloxone may be safe and effective for over-the-counter use in some forms, the U.S. Food and Drug Administration (FDA) said on Tuesday, potentially paving the way for its use federally. The FDA would still require data on individual products from manufacturers for them to be available over the counter at a federal level. The drug regulator's preliminary assessment included up to 4 milligrams dose of naloxone nasal spray and up to 2 milligrams when given through an auto injector. The agency said the assessment does not cover higher dose naloxone products and those supplied in other forms for which more data was needed. More than 16,000 people have died from overdoses involving prescription opioids in 2020, according to government data.
Nov 14 (Reuters) - U.S. Food and Drug Administration staff reviewers on Monday raised concerns over unclear benefits of Ardelyx Inc's (ARDX.O) drug for kidney disease patients, but the company's shares rose 20% on expectations over a possible approval. The FDA's staff reviewers said, "the magnitude of treatment effect appears less than that observed with approved drugs," in briefing documents released on Monday. Ardelyx's oral drug, tenapanor, is aimed at reducing elevated blood phosphate levels in patients with chronic kidney disease (CKD). The advisers' meeting, set for Nov.16, was called by the FDA following Ardelyx's appeal against the regulator's initial rejection of the drug in July last year, after it identified deficiencies. Around 37 million people, or one in seven people, in the United States have chronic kidney disease, as per a government report last year.
SYDNEY, Nov 8 (Reuters) - Australia's corporate watchdog is investigating several companies and financial institutions for "greenwashing", or exaggerated claims regarding environment-friendly investment and products, a senior official said on Tuesday. The Australian Securities and Investment Commission (ASIC) has been increasing its oversight of climate-related reporting. Greenwashing refers to misrepresenting the extent to which an investment or a financial product is environment-friendly and sustainable. Bird said greenwashing is against the law and organisations making claims about net zero carbon emission targets should check with ASIC's information on what constitutes greenwashing. While companies have improved climate-change reporting in recent few years, a disparity in global reporting standards has left gaps, ASIC has said.
Nov 7 (Reuters) - Staff reviewers at the U.S. Food and Drug Administration on Monday identified several uncertainties around Veru Inc's (VERU.O) data for its experimental COVID-19 drug but did not raise any new concerns, sending its shares surging 52%. A panel of the health regulator's outside experts is scheduled to discuss authorization of the drug later this week, including whether additional data is required. Cantor Fitzgerald analyst Brandon Folkes said the FDA is "leading the advisory committee towards granting an EUA" provided Veru commits to an adequate post-EUA study. Veru has applied for an EUA for the drug, sabizabulin, as a treatment for hospitalized moderate-to-severe COVID-19 patients at high risk of developing an acute respiratory distress syndrome. If authorized, sabizabulin, which Veru was originally testing as a treatment for prostate cancer, would become its second drug on the market.
The broken commitment, which has not previously been reported, highlights the struggles of Mexico's oil regulator to rein in Pemex, a powerful state monopoly that is always closely connected to the government. The oil company has in recent quarterly reports stressed it was making efforts to clean up its operations and bring down flaring and other waste. Earlier this year, under increasing international criticism, Lopez Obrador said Pemex would invest $2 billion to improve infrastructure to reduce flaring and methane emissions. The regulator said in 2020 the company wasted 37.7% of the gas from Ku alone through flaring, venting or otherwise. One source said the regulator fined Pemex again for recurrence in 2021 but the oil company started legal proceedings to annul the fine, which are still pending.
Shares in UniCredit hit by report of friction with ECB
  + stars: | 2022-11-07 | by ( ) www.reuters.com   time to read: +1 min
MILAN, Nov 7 (Reuters) - Shares in UniCredit (CRDI.MI) fell on Monday after a report of tensions between Italy's only bank that regulators deem of global systemic relevance and European Central Bank supervisors. Shares in UniCredit fell 3.3% by 0835 GMT against a flattish sector (.FTITLMS3010), with a Milan-based trader saying the report by the Financial Times had triggered profit taking on the stock. Citing people familiar with the matter, the FT said UniCredit had clashed with the ECB over the bank's capital distribution plans and its failure to leave Russia. A spokesperson for UniCredit referred to comments the bank had made to the FT saying the ECB had provided ongoing "challenge and guidance" during the strategic overhaul by Chief Executive Andrea Orcel and that the regulator's "public support" was indicative of its trust in the bank. Reporting by Giancarlo Navach and Valentina Za Editing by Keith WeirOur Standards: The Thomson Reuters Trust Principles.
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