Iovance Amtagvi receives Health Canada approval for advanced melanoma
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The Hill
27 minutes ago
- The Hill
Copycat Ozempic, Mounjaro proliferate even in postshortage era
Copycat versions of popular drugs like Ozempic and Mounjaro have continued to proliferate in a postshortage era, with some experts saying 'regulatory neglect' is allowing for potentially dangerous, unapproved drugs to reach consumers. When the Food and Drug Administration (FDA) adds a drug to its official shortage list, compounding pharmacies can sell their own versions of that drug so patients can continue to access medications. This was the case when weight loss drugs like tirzepatide and semaglutide went into shortage due to high demand. Online companies like Hims & Hers and Ro entered the GLP-1 market with compounded versions of Wegovy and Zepbound. These medications contain the same active pharmaceutical ingredient as the branded version but are formulated slightly differently, such as altering a medication for a patient who can't swallow pills. Due to the often highly individualized nature of compounded drugs, they are not FDA-approved. But although the FDA has since removed these drugs from its shortage list, stakeholders say compounded drugs continue to be sold, and lawmakers in Congress have begun raising concerns with federal regulators. There are two types of compounding pharmacies, 503A and 503B. 503A compounding pharmacies fulfill personalized, patient-specific prescriptions. 503B compounding pharmacies can do the same while also fulfilling bulk orders for clients like hospitals. Prior to the end of the shortage, telehealth companies primarily relied on 503B compounders, but according to those in the drug space, online sellers are turning to 503A compounders to keep the lucrative business going. Novo Nordisk, the manufacturer of semaglutide, partnered with Hims & Hers to sell a low-cost version of its branded product Wegovy after the shortage officially ended. But that partnership was dissolved after Novo Nordisk accused Hims & Hers of illegally continuing to sell compounded versions of its drug 'under the false guise of personalization.' Experts in the field say the maneuver falls into a regulatory 'gray area.' 'I hesitate to even call these people compounders. Because what they really are are illegal pharmaceutical companies,' said Peter Pitts, former FDA associate commissioner and president of the Center for Medicine in the Public Interest. 'You don't compound for tens of millions of people, and you don't personalize for tens of millions of people. That's just kind of a fake brand extension.' In July, a bipartisan coalition of House lawmakers sent a letter to FDA Commissioner Marty Makary asking that he direct his agency to address the flow of illicit anti-obesity medications (AOM) into the country. While not specifically focused on compounded drugs, the letter did note the possibility for ambiguity between these medications and illicitly sourced drugs. 'We understand the distinction between legitimate compounded drugs prepared in state-licensed pharmacies and counterfeit or compounded drugs made from illicit ingredients obtained from illegitimate sources,' wrote the lawmakers. 'However, unapproved AOMs continue to be widely marketed online, in print, and on television.' Sen. Marsha Blackburn (R-Tenn.) sent a letter to the Federal Trade Commission in July, calling for the agency's action on online advertising of compounded GLP-1s. She was reiterating warnings that a bipartisan group of state attorneys general had made. 'Amid the unprecedented demand for these miracle medicines, foreign criminals and con artists are defrauding and endangering Americans by selling and shipping counterfeit or deceptively-marketed GLP-1 drugs and active ingredients,' she wrote. A spokesperson for Ro said the company 'does not market or advertise compounded GLP-1s.' The Hill was able to find a half-dozen lower-profile companies still marketing compounded GLP-1s online. Hims & Hers, perhaps the most well-known of these online companies, disputed Pitt's characterization. 'Anyone claiming that we compound personalized medications for tens of millions of people is simply wrong and is mischaracterizing our business. We follow the carefully written compounding regulations and only offer access to compounded treatments when a licensed provider determines it is clinically necessary, in their independent judgment, for their individual patient,' the company said in a statement to The Hill. 'That's the future of healthcare: a system centered on the individual where providers have a way to treat the individual in front of them.' The Federal Trade Commission declined to comment as its investigations are nonpublic. The FDA did not respond to a request for comment. Pitts expressed incredulity that federal regulators hadn't stepped in already, saying, 'How long can the FDA permit kind of regulatory neglect, to allow this problem just to snowball until they get engaged?' Although the continued sale of compounded GLP-1s falls into a regulatory gray area, Pitts believes it goes against the 'spirit' of the regulations. He further cited the '5 percent rule' for compounding pharmacies, which dictates that the percentage of compounded drugs that a pharmacy distributes out of state not exceed 5 percent, saying online sellers have exceeded this rule by '10,000-fold.' According to recent polling, consumers are concerned about where compounded drugs originate from. A poll conducted by the firm Fabrizio Ward, run by President Trump's 2024 campaign pollster Tony Fabrizio, found that 64 percent of surveyed voters don't believe compounders should be able to continue to make drugs outside of the current legally permitted circumstances. Voters in the survey were split when asked how confident they were that online pharmacies sold safe, FDA-approved drugs, with 46 percent saying they were confident and 41 percent saying they were not. A majority of voters — 78 percent — said they had concerns about bulk, compounded versions of drugs like Wegovy and Zepbound coming into the U.S. from overseas sources. During the active shortage of GLP-1 products, questions were raised over where compounding pharmacies were sourcing the active pharmaceutical ingredients for their products. Telehealth companies have said their products come from FDA-regulated facilities. 'There's a difference between a product being made in an FDA-approved facility and a product being manufactured on an FDA-approved line for that product,' said Pitts. 'The FDA does not inspect production lines for illegal manufacturing, that just does not happen. So, it's an entirely fake proposition.'
Associated Press
28 minutes ago
- Associated Press
One Year Later: Ottawa's Nicotine Replacement Therapy Strategy Fuels Illicit Market, Underserves Smokers
MONTREAL, Aug. 19, 2025 /CNW/ - One year ago this week, the former federal government issued a Ministerial Order banning ZONNIC—the only nicotine pouch approved by Health Canada as a smoking cessation product—from convenience store shelves nationwide, restricting its sale to behind pharmacy counters. The policy, presented as a public health measure, has clearly backfired. Overnight, access of ZONNIC immediately dropped. While sales of ZONNIC dropped, the purchase of cigarettes jumped by 2.8% and over the last year, more than 500 million illegal and unregulated pouches have been sold on the black market. 'The government targeted the only legal, regulated nicotine pouch product in the country, and opened the door to a thriving illicit market,' said Eric Gagnon, Vice President of Corporate and Regulatory Affairs at Imperial Tobacco Canada (Imperial). 'ZONNIC wasn't the problem. It was and is the solution for many Canadian smokers.' The consequences have been swift and concerning: This policy has also dealt a blow to this country's small business economy, affecting many of Canada's 200,000 convenience retail jobs and threatening the small businesses that rely on regulated nicotine product sales to stay competitive. Health Canada approved ZONNIC as a natural health product and cessation tool. CAMH recognized its value as a fast-acting NRT. It was widely available where adult smokers were already shopping, and it was working. In stores where ZONNIC was sold, cigarette sales dropped by double digits. That progress has now been slowed down. Instead of protecting Canadians, the Order punished innovation, rewarded non-compliance, and made it more difficult and complicated for those trying to quit. ZONNIC remains the only nicotine pouch that meets national safety and quality standards — but access has been made more cumbersome for many Canadian smokers. Imperial is aligned with Health Canada's ambition of achieving less than 5% smoking incidence by 2035. Yet, to achieve that, innovative cessation tools like ZONNIC need to be widely and seamlessly accessible at the front counter of pharmacies AND in places where smokers buy their cigarettes. 'We are ready to find joint solutions with the Minister of Health so that the burden on the already over-stretched pharmacists can be reduced and especially to help as many adult smokers as possible to quit for good', said Eric Gagnon. Canadians deserve better. They deserve public health policy rooted in evidence, one that helps them quit, not one that sets them back. About Imperial Tobacco Canada Imperial Tobacco Canada is the leading tobacco and nicotine company in Canada, part of the global BAT group. Our mission at BAT is to create A Better Tomorrow™ by promoting a Smokeless World. We envision a future where smokeless products replace cigarettes, encouraging smokers to make a Switch to Better. Imperial is committed to advancing THR through transparency, innovation, and collaboration. One such initiative is Omni™, a platform developed by our parent company BAT, to support education and stakeholder engagement around THR. Omni™ serves as a dynamic resource for those working toward a smoke-free future. SOURCE Imperial Tobacco Canada
Business Insider
6 hours ago
- Business Insider
Rigetti Stock Falls 7% on Weak Earnings, While New 36-Qubit System Points to 2025 Growth
Rigetti Computing (RGTI), a pure-play quantum company, shares closed Friday's session down more than 7%, falling to $16.65. The drop came after the company's second-quarter earnings call, where results showed revenue of $1.8 million against operating expenses of $20.4 million. The net loss widened to $39.7 million, with nearly $23 million tied to non-cash losses from complex financial instruments. Investors likely saw the steep gap between costs and revenue as a cause for concern, even though Rigetti holds a cash reserve of about $571.6 million following a recent $350 million equity raise. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Rigetti Announces Cepheus-1-36Q At the same time, Rigetti pointed to significant progress on its quantum roadmap, highlighting the release of its newest system called Cepheus-1-36Q. This system marks the company's most advanced step yet, with 36 qubits connected through a multi-chip design. Importantly, Cepheus-1-36Q achieves a two-fold reduction in error rates compared to its earlier Ankaa-3 machine. In practical terms, that means more reliable results in complex quantum tasks. The new system is already available on Rigetti's Quantum Cloud Services platform and will also be hosted on Microsoft Azure (MSFT) in the future. What makes Cepheus-1-36Q stand out is its use of a chiplet-based approach. Rigetti first showed this modular design in 2021, and the current machine now integrates the largest number of chiplets in one system. The company also improved its intermodule coupler and sped up two-qubit gate operations, all of which push performance closer to fault tolerance. Median two-qubit gate fidelity now stands at 99%, a level never before reached by a multi-chip quantum system. Looking forward, Rigetti plans to scale this design further. The company expects to release a 100-plus qubit system before the end of 2025, targeting an even higher median fidelity of 99.5%. In short, while Friday's selloff reflected unease with quarterly losses, Rigetti also saw meaningful progress on the technology side. Cepheus-1-36Q demonstrates advances in performance and sets the stage for the next leap to a 100-qubit machine. For investors, the company's near-term story remains a mix of financial strain and technological progress, but its cash strength and product pipeline offer the foundation for longer-term growth. Is RGTI Stock a Buy or a Sell? average RGTI stock price target stands at $18.71, implying a 12.37% upside from the current price.
