Johnson & Johnson announces new results from Phase 2 RedirecTT-1 study
Johnson & Johnson announced new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY, the first U.S. Food and Drug Administration-approved GPRC5D-directed bispecific antibody, and TECVAYLI, the first FDA-approved BCMA-directed bispecific antibody. The results show a high overall response rate with durability in patients with triple-class exposed relapsed/refractory multiple myeloma who have true extramedullary disease, EMD. EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group criteria. RedirecTT-1 is the largest study dedicated to patients with EMD to date. These data were featured in a late-breaking oral presentation at the 2025 European Hematology Association Congress.
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Hamilton Spectator
an hour ago
- Hamilton Spectator
Mark Carney to meet Donald Trump one-on-one as world leaders arrive for G7 in Kananaskis
CALGARY — Prime Minister Mark Carney has a chance to make a breakthrough in talks to lift tariffs on Canada when he sits down for a one-on-one discussion with U.S. President Donald Trump Monday before the Kananaskis G7 summit kicks off. Carney has a dual mission as he hosts this week's meeting of the world's leading democratic economies: to lead talks that end in G7 consensus, not insults, on a gamut of global challenges, from the economy, and energy security, to international security. And, in his talks with Trump, to try to achieve a breakthrough on negotiations toward a 'new economic and security agreement.' The prime minister says any deal must include the U.S. dropping so-called 'border-related' emergency tariffs, steel and aluminum tariffs, and auto tariffs that Trump wielded against Canada. Prime Minister Mark Carney touched down in Alberta, for the three-day G7 summit set in the secluded Kananaskis wilderness near Calgary. (June 15, 2025 / The Canadian Press) However, federal sources who have spoken to the Star over the past several days in advance of the summit have downplayed the prospect of a deal emerging from their bilateral meeting, while acknowledging things could change quickly. 'Obviously the condition for us participating in a new defence and security partnership is that tariffs are lifted,' Dominic LeBlanc, Carney's minister leading the Canada-U.S. file, said in an interview with the Star. 'The Prime Minister has said that to the President.' If not, LeBlanc said, Carney has prepared 'a series of options' to increase Canada's own counterpunch to the Americans. A show of maintained unity on geopolitical problems will be seen as success after President 'The government will look at all of the potential ways to increase pressure on the Americans if we conclude that we're not close to or on the verge of a discussion that would give us the deal that would see all of these tariffs lifted.' 'The Prime Minister will decide over the coming days or weeks how he wants to proceed,' LeBlanc said. But LeBlanc said their talks don't amount to a quid pro quo negotiation, in which Canada simply pays billions more for defence or to participate in the Golden Dome and tariffs are subsequently dropped. LeBlanc said that characterization makes it sound like a 'take it or leave it' discussion, whereas the minister who has been shuttling back and forth between Ottawa and Washington characterized it as a more 'nuanced' conversation, in which LeBlanc 'totally' sees as a path to zero tariffs, despite suggestions by Trump's ambassador that's not in the cards. Furthermore, Canada is ready to reopen deeper trilateral talks if the U.S. insists on turning next year's scheduled review of the Canada-U.S.-Mexico trade deal into a renegotiation, but LeBlanc said the U.S. has not demanded that. 'We're all in on a trilateral Canada-U.S.-Mexico agreement. And we're happy to work with the Americans in reviewing that,' the minister said. There is no trilateral meeting scheduled at this time between Trump, Carney and Mexican President Claudia Sheinbaum, who is also attending the G7 session that includes other world leaders. For now, Canada-U.S. talks are focused on a bilateral agreement aimed at nailing what Carney called a more comprehensive economic and security partnership, as he said repeatedly during the campaign. Carney told Radio-Canada host Patrice Roy on Wednesday that while he and Trump have made 'progress' there is no agreement yet 'ready for signing,' — which other Canadian officials who spoke to the Star on a background basis over the past two days echoed. 'We can wait,' said Carney. 'We're becoming stronger and the Americans are becoming weaker.' The prime minister noted that 'no country has free trade with the United States right now. Other countries are getting reductions in tariffs but not the elimination of tariffs.' Carney said he thinks he has a good rapport with Trump 'but he is negotiating in the interest of Americans and I am negotiating for Canada and there is a vision of the trading world that is very different than our vision, and the vision of big countries in Asia, for example. So we have to find a solution.' Meanwhile, Carney is pursuing and very publicly touting stronger alliances with other like-minded countries, downing beers Saturday with U.K. Prime Minister Keir Starmer as they watched a hockey game, and meeting Sunday on Parliament Hill in Ottawa before heading to the G7 summit. World leaders are set to gather in Kananaskis, Alberta as Canada hosts a high-stakes G7 summit focused on trade, diplomacy, and global cooperation. (June 14, 2025 / The Canadian Press) A joint statement Carney and Starmer issued highlighted their shared belief in the importance of 'fair, open and predictable global trading system; reiterated their commitment to a rules-based international order underpinned by respect for sovereignty and territorial integrity; and committed to advancing peace and trans-Atlantic security.' The prime minister said in the Radio-Canada interview it is possible to make progress at the G7 on Ukraine, noting President Volodymyr Zelenskyy, Trump, the head of NATO along with France and the U.K. as leaders of a 'coalition of the willing' will all be there, in advance of a key NATO summit later this month. Carney underscored, 'there will never be a solution without Ukraine. We are going to respect the territorial integrity of Ukraine.' How to address Ukraine and the economic fallout from his global tariff war will put Trump potentially at odds with other leaders, yet many are also seeking bilateral trade discussions with him on the sidelines. Trump told reporters Wednesday he is dealing with 'about 15 countries' and hopes to send letters out 'in about a week and a half, two weeks' on where those negotiations have landed. But on Sunday before departing Washington he suggested some new trade deals would be nailed down at the summit. Leaders from the world's richest countries will gather for a Group of Seven summit, starting Sunday, even as U.S. President Donald Trump wages a trade war against them. Later in June Trump is scheduled to attend a NATO summit in Europe. (AP Video / June 13, 2025) 'Look we have our trade deals. all we have to do is send a letter, this is what you're going to have to pay. But I think we'll have a few new trade deals' at the summit, Trump said Sunday en route to Kananaskis. When the president doubled steel and aluminum tariffs from 25 per cent to 50 per cent, Carney did not immediately retaliate heading into the G7 summit, despite calls from domestic steel companies and unions who also want the Carney government to lift counter-tariff exemptions (known as remissions) on U.S. steel. The government has, however, acted on their demand to tighten tariffs against other foreign countries who are suspected of dumping cheap steel into the Canadian market. Trump was to arrive in Calgary Sunday, along with a number of his cabinet members, Secretary of State Marco Rubio, Treasury Secretary Scott Bessent and Commerce Secretary Howard Lutnick were expected to attend. Airplane enthusiasts are setting up at the Calgary International Airport in hopes of seeing some exciting aircraft land for the start of the G7 leaders' summit in nearby Kananaskis, Alta. A group gathered at an airport viewing area in hopes of seeing Air Force 1 carrying U.S. President Donald Trump. (June 15, 2025 / The Canadian Press) Carney has scheduled a Tuesday morning bilateral meeting with India's Prime Minister Narendra Modi, an official said. The invitation to Modi drew sharp criticism in Canada. However Carney justified including Modi at the G7 outreach session, saying as leader of the world's most populous country, Modi's presence at talks on economic challenges such as harnessing critical minerals, artificial intelligence and quantum computing was important. He said Modi's government has agreed to co-operate with Canadian law enforcement agencies investigating foreign interference including the alleged assassination of a Canadian citizen at the direction of Indian government agents. Carney is expected to have about 16 bilateral meetings on the margins of the G7 sessions, said another Canadian official. Alberta Premier Danielle Smith along with Calgary Mayor Jyoti Gondek greeted Carney as he and his wife Diana Fox Carney's plane landed. They spoke for a few minutes in a brief and apparently cordial exchange, before the prime minister headed downtown for one-on-one meetings with Australian Prime Minister Anthony Albanese and South African President Cyril Ramaphosa, the G20 host who said he'd come to learn from Carney how to throw a summit. Albanese told Carney, 'We have very similar economies, historically. We share a vast continent, very vast,' Albanese said. 'You get your own continent,' Carney quipped. In the evening Carney met in Kananaskis with German Chancellor Friedrich Merz. Several G7 countries stated ahead of the summit that one of their top priorities heading into the meetings was to find a consensus on how to help Ukraine achieve a lasting ceasefire with Russia. However, with the sudden escalation of hostilities in the Middle East after Israel struck Iran's nuclear facilities and killed key military leaders, and Iran responded with missile attacks on Israel, global security is top of mind. 'Obviously, the conflict with Israel and Iran is centrepiece,' Starmer told reporters at his meeting with Carney Sunday. 'And this provides the opportunity to talk to our co-leaders about the fast-moving situation, and to make our strong case together that there must be de-escalation of this conflict in the interests of the region, and of course the world.'
New York Post
an hour ago
- New York Post
‘Gas station heroin' supplements are widely available — but experts warn of ‘underlying danger'
WASHINGTON — Health officials want you to think twice before buying one of those brightly colored little bottles often sold at gas stations, convenience stores and smoke shops. Sometimes called 'gas station heroin,' the products are usually marketed as energy shots or cognitive supplements but actually contain tianeptine, an unapproved drug that can be addictive and carries risks of serious side effects. US poison control centers have reported a steady rise in calls linked to the drug for more than a decade. And last month the Food and Drug Administration sent a warning to health professionals about 'the magnitude of the underlying danger of these products.' 5 Bottles of Neptune's Fix Elixir — an example of a tianeptine product sold in the United States. FDA Office of Regulatory Affairs, Health Fraud Branch via AP Here's what to know about gas station heroin. How are these products sold in the US? Tianeptine is approved in a number foreign countries as an antidepressant, usually as a low-dose pill taken three times a day. But it has never been approved by the FDA for any medical condition in the US Additionally, the drug cannot legally be added to foods and beverages or sold as a dietary supplement — something the FDA has repeatedly warned US companies about. Still, under-the-radar firms sell tianeptine in various formulas, often with brand names like Zaza, Tianaa, Pegasus and TD Red. Although that is technically illegal, the FDA does not preapprove ingredients added to supplements and beverages. 5 TD Red Extra Strength contains tianeptine. FDA Office of Regulatory Affairs, Health Fraud Branch via A 'It's kind of this grey area of consumer products, or supplements, where the contents are not regulated or tested the way they would be with a medication,' said Dr. Diane Calello of the New Jersey Poison Information and Education System. Last year, Calello and her colleagues published a study documenting a cluster of emergency calls in New Jersey tied to a flavored elixir called Neptune's Fix. People experienced distress, rapid heartbeat, low blood pressure and seizures after drinking it. More than a dozen of the 20 patients had to be admitted for intensive care. Why use these products? Many tianeptine products claim— without evidence or FDA approval— to help users treat medical conditions, including addiction, pain and depression. In 2018, the FDA issued a warning letter to the maker of a product called Tianna, which claimed to provide 'an unparalleled solution to cravings for opiates.' 5 The information provided on the label of TA TA, a product labeled to contain tianeptine. FDA Office of Regulatory Affairs, Health Fraud Branch via AP While tianeptine is not an opioid, the drug binds to some of the same receptors in the brain, which can temporarily produce effects akin to oxycodone and other opioids. Tianeptine also carries some of the same physiological risks of opioids, including the potential to dangerously depress breathing. 'That's what tends to get people into trouble,' said Dr. Hannah Hays of Nationwide Children's Hospital in Columbus, Ohio. 'They use it for opioid-like effects or to self-treat opioid withdrawal and that can lead to slow breathing and problems like that.' People dealing with opioid addiction, pain, depression, anxiety and other conditions should see a health professional to get a prescription for FDA-approved treatments, Hays said. 5 White Magic capsules advertise that they can cause happiness. FDA Office of Regulatory Affairs, Health Fraud Branch via A Is tianeptine use going up? Experts aren't sure but national figures show a big rise in emergency calls involving the drug. Calls to poison control centers increased 525% between 2018 and 2023, according to a data analysis published earlier this year. In about 40% of cases, the person had to seek medical care, with more than half of them needing critical care. One explanation for the rise in calls is simply that more Americans are using the products. 5 Purple Magic capsules claim to be able to increase focus and relieve stress. FDA Office of Regulatory Affairs, Health Fraud Branch via AP But experts also say that the products are triggering more emergencies as they become more potent and dangerous. And the researchers in New Jersey who analyzed Neptune's Fix found that the liquid also contained synthetic cannabis and other drugs. 'You never quite know what's in that bottle,' Calello said. 'It's important for people to know that even if they have used a product before, they could get a bottle that contains something very different from what they're looking for.' Are there policies that could reduce tianeptine use? Tianeptine is not included in the federal Controlled Substances Act, which bans or restricts drugs that have no medical use or have a high potential for abuse, such as heroin, LSD and PCP. But about a dozen states have passed laws prohibiting or restricting tianeptine, including Alabama, Georgia, Michigan, Minnesota, Ohio and Tennessee. In some cases, those laws have led to more cases of withdrawal among users of tianeptine, which can be chemically addictive. But state data also shows some success in reducing harm tied to the drug. Until recently, Alabama had the highest rate of tianeptine-related calls in the southern US, which increased more than 1,400% between 2018 to 2021. But after the state restricted tianeptine in 2021 calls began modestly decreasing while calls across other southern states continued to climb.
Associated Press
an hour ago
- Associated Press
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
Northvale, New Jersey--(Newsfile Corp. - June 16, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ('Elite' or the 'Company'), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from a pivotal bioequivalence study for an undisclosed anticoagulant generic drug product. IQVIA reported branded product sales for the twelve months ending April 2025 of $27 billion. There is no generic product on the market, and the brand has an unexpired patent listed in the Orange Book. Commercialization of a generic product depends on successful filing, FDA approval and addressing the unexpired patent. The studies conducted were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover bioequivalence studies in normal, healthy, adult, human subjects under fasting conditions. The results indicated that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration. About Elite Pharmaceuticals, Inc. Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. Contact: Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations 518-398-6222 [email protected] To view the source version of this press release, please visit
