| | | |   | Meghana here, welcoming you to your week. Today we have news on Merck's plans for a Keytruda patent, an explanation for Wegovy's shortages, and an ousted lobbyist. | | | Merck’s patent plans for a Keytruda shot Merck plans to patent a new formulation of Keytruda, allowing the blockbuster immunotherapy to be injected subcutaneously. This could protect the $20 billion drug from competition, which is expected as soon as 2028, when biosimilars could enter the picture. This new shot offers a more convenient alternative to the current infusions, which require an intravenous drip every three or six weeks. “We believe that subcutaneous formulation has the potential to be novel, non-obvious and useful, which means we would get a new patent for it,” Merck CFO Caroline Litchfield told Reuters. “The clock for that patent would start ticking from the time we would get that patent approved.” That means a Keytruda shot could have patent protection all the way through 2040. | Where’d the Wegovy go? Novo Nordisk’s popular semaglutide drug, Wegovy, is pretty darn hard to find. The company didn’t anticipate how sought-after the diabetes drug would be on social media, now that it’s been indicated for weight loss purposes as well. So it simply didn’t make enough, and then a contract manufacturer had to stop making the drug because of issues that sprung up during an inspection. “We should have forecasted better, which we did not,” Novo Nordisk CEO Lars Fruergaard Jørgensen told the Wall Street Journal. “Had we forecasted that, we would have built a different supply chain.” The company has had to ration the drug to patients who already began taking it before it went viral. It’s brought in about $700 million in sales to date, which is dramatically less than the expected $2 billion in sales that some analysts had predicted before the supply chain issues came to light. | Maintaining the momentum in cell and gene therapy development In 2022, have been at least 11 CGTs pending approval in the US and six in the EU – how can drug developers maintain the momentum? Now is the time to lay the technical, regulatory, financial and logistical foundations that will embed CGT as a pivotal element of forward-looking health provision in years to come. Download this in-depth whitepaper to gain insights on the current market state and practicalities of clinical trials through long-term commercialization. | President of generics lobby fired Dan Leonard, president of the Association for Accessible Medicines, was fired Friday, sources tell STAT's John Wilkerson. It’s still not known why he was fired, and the generic drug industry’s lobbying group did not respond to a request for comment. But sources said he will be temporarily replaced by David Gaugh, the group’s executive vice president of sciences and regulatory affairs. Notably, sources said some of the AAM’s members were frustrated that the lobby didn’t engage quickly enough with members of Congress when they were debating the Inflation Reduction Act. The law, which passed recently, gives the government the ability to negotiate branded drug prices — which can interfere with market-based generic competition. Read more. | GSK continues to demonstrate Jemperli’s efficacy GSK’s immunotherapy drug Jemperli could be used in a broader pool of patients with endometrial cancer, new data show. When the PD-1 blocking antibody is used in addition to chemotherapy, patients with advanced or recurrent forms of the disease lived longer, FiercePharma writes. Endometrial cancer is the most common gynecological cancer in the U.S., and about 15%-20% of women have an advanced form of the disease when they’re first diagnosed. Jemperli first secured FDA approval for a smaller segment of endometrial cancer patients in April. The drug is GSK’s attempt to compete with Merck’s Keytruda — which has a serious leg up in the cancer immunotherapy market. But Jemperli recently showed in a Phase 2 trial that it’s just as effective as Keytruda in some lung cancers, demonstrating that it’s a potent drug in its own right. | | | Thanks for reading! Until tomorrow,  | | | |
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