Pharma News
17 Nov 2024 to 23 Nov 2024
Nov 23, 2024
Possible connection between Singulair asthma medication and mental health issues reported - New York Post
A widely prescribed asthma drug, Singulair (montelukast), originally sold by Merck & Co., may be linked to serious mental health problems for some patients, according to government researchers. After thousands of reports of neuropsychiatric episodes, including dozens of suicides, were linked to the drug, the FDA added a "black box" warning to the prescribing label in 2020. Preliminary research shows that montelukast attaches to brain receptors critical to psychiatric functioning, but no causal link has been established between the drug and the reported side effects.
Nov 23, 2024
Embio Limited vs. Malladi Drugs & Pharmaceuticals: Madras High Court Rules in Favor of Patent Validity
The Madras High Court has dismissed a petition by Embio challenging the validity of a patent granted to Malladi Drugs & Pharmaceuticals for a method of preparing chiral beta-amino alcohols. The court upheld the patent's validity, affirming its novelty and inventive step. Malladi's patent relates to a method and a process for preparing optically pure 1-phenyl-2-(N-alkyl/arylamino) propanol hydrochlorides, which serve as crucial intermediates in pharmaceutical products. Embio claimed that the patent lacked novelty and inventive step, but the court found that Malladi's process demonstrated clear advancements over prior art.
Nov 22, 2024
New updates on Oura rings for monitoring blood sugar levels, a comparison of vaccines by RFK Jr., and the launch of Ozempic 2.0: a summary of pharmaceutical news.
Oura smart rings will partner with Dexcom to track users' blood sugar levels. The FDA's head of vaccine safety sees an opportunity to promote vaccines in light of President-elect Donald Trump's association with vaccine skeptics. Novo Nordisk is developing a stronger weight-loss drug called CagriSema.
Nov 22, 2024
Reuters reports that there may be a potential connection between mental health issues and the previous popular asthma drug, Singulair, developed by Merck.
FDA researchers have found evidence of a molecular link between Merck's former asthma drug, montelukast (marketed by Organon as Singulair), and neuropsychiatric problems. The research revealed off-target effects of montelukast on receptors and neurotransmitter transporters in the brain, which are involved in psychiatric pathways. The FDA does not plan to update the drug's label to reflect these findings. Montelukast, a blocker of leukotriene receptors, helps alleviate asthma and allergic rhinitis symptoms. The drug faced criticism for allegedly downplaying safety risks, leading to the addition of a black box warning in 2020.
Nov 22, 2024
Merck (MSD), a prominent multinational pharmaceutical corporation, has officially submitted a...
Merck has filed a patent invalidation trial against Halozyme Therapeutics in order to release the subcutaneous formulation of its blockbuster drug Keytruda. Merck previously signed a transfer contract with Korean biotech company Alteogen for the technology. The patent is for a technology that changes the formulation of subcutaneous injections. The trial must be completed within one year, and MSD claims that there is no possibility of patent infringement.
Nov 21, 2024
Algorae employs artificial intelligence to create new combinations of drugs for cancer treatment - The Sydney Morning Herald
Australian pharmaceutical company, Algorae Pharmaceuticals, is in discussions with local laboratories to start preliminary studies on new drug combinations. The company uses its cutting-edge AI system, AlgoraeOS, to predict combinations of existing drugs that could have a greater impact on diseases when used together. Algorae plans to develop an improved version of AlgoraeOS, which will include larger pharmaceutical databases, more powerful predictive AI modeling, and an expanded range of disease targets. The company previously achieved success in using AI to identify a drug combination to treat dementia.
Nov 21, 2024
Amgen Files Lawsuit Against Accord Over Proposed Biosimilar of Prolia® / Xgeva® under BPCIA
Amgen has filed a lawsuit against Accord BioPharma and Intas Pharmaceuticals, claiming that their proposed biosimilar, INTP23, for the drugs Prolia® and Xgeva® infringes on 34 of Amgen's patents. The FDA has accepted Accord's aBLA, but the acceptance date has not been disclosed. Amgen has previously filed similar lawsuits against other companies developing biosimilars for Prolia® and Xgeva®. The litigation with Accord is the first to be filed in the Eastern District of North Carolina.
Nov 21, 2024
The Impact of the Upcoming Trump Administration on Drug Patents - Life Science Leader
The Biden administration has increased government scrutiny over biopharmaceutical IP and patenting practices, leading to higher levels of uncertainty for life sciences companies. The FTC has challenged Orange Book listings and there is speculation about the Trump administration's approach to biopharmaceutical IP and patents. The new administration may bring about changes in leadership at the FTC and USPTO, potentially affecting policies in the biopharmaceutical industry. The industry remains uncertain about IP protections and collaboration between the FDA and USPTO. The IRA and drug price negotiation policies are also under scrutiny.
Nov 21, 2024
Novartis Increases Revenue Forecast Due to Strong Sales of Cancer and Inflammatory Medications - BNN Bloomberg
Novartis has raised its medium-term sales target, expecting a 6% annual growth through 2028. The company cited positive prospects for its cancer and immunological disease medicines, as well as treatments for neurological and cardiovascular conditions. Novartis also increased its peak sales estimates for several drugs, including Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio. The pharmaceutical giant plans to focus on innovative medicines and stated that mergers and acquisitions will remain an important part of its strategy. The company aims to become one of the top five pharmaceutical firms in the US.
Nov 21, 2024
Hanmi Pharma accelerates release of new anti-obesity medication - KED Global
South Korean pharmaceutical company Hanmi Pharmaceutical has rescheduled the launch of its anti-obesity drug candidate efpeglenatide to the second half of 2026, earlier than originally planned. The drug, which has completed patient recruitment for Phase 3 clinical trials, aims to offer weight-loss effects comparable to Wegovy while providing superior cardiovascular and kidney protection. Hanmi Pharmaceutical is also developing a digital combination drug that integrates efpeglenatide with a personalized obesity management component.
Nov 21, 2024
AstraZeneca and Merck introduce a new patent in their efforts to protect Lynparza from generic competition
AstraZeneca Plc and Merck & Co. have filed lawsuits against four generic-drug makers - Natco Pharma Ltd., Sandoz Group AG, Cipla Ltd. , and Zydus Lifesciences Ltd. - for infringing on a newly issued patent for the cancer drug Lynparza. The patent covers the immediate-release composition of a solid form of olaparib, the active ingredient in Lynparza. The lawsuits were filed in the US District Court for the District of New Jersey.
Nov 20, 2024
Over 50% of American adults may qualify for Ozempic, study suggests - UPI.com
The GLP-1 drug semaglutide could be used by over half of all American adults, according to a new analysis. The drug, sold as Ozempic and Wegovy, is currently used to treat diabetes and promote weight loss, but it could also be indicated for heart disease prevention. However, the high cost of the medication raises questions about who will be able to afford it. Currently, insurance companies typically only cover semaglutide for diabetes treatment. The study suggests that interventions to reduce economic barriers to access are urgently needed.
Nov 19, 2024
Invest in this Pharmaceutical Company for Potential Profit from a Promising Weight-Loss Medication - News Source
A new study published in The Lancet reveals that nearly three-quarters of US adults are overweight or obese. The study also highlights the rise in obesity rates among children, with over one in three now overweight or obese. The conditions of overweight and obesity can lead to various health issues and have a significant impact on healthcare costs. However, Novo Nordisk's upcoming weight-loss drug, CagriSema, based on the hormone amylin, shows promise in helping patients lose weight. The combination drug is expected to be more effective than existing treatments and may have fewer side effects. The trial results for CagriSema are expected in December 2021, and if successful, the drug could reach the market in 2026. NVO stock is recommended as a buy below $107.
Nov 19, 2024
Wegovy, a drug for obesity from Novo Nordisk, now available for purchase in China - Yahoo News UK
Denmark-based pharmaceutical company Novo Nordisk has confirmed that its weight-loss drug Wegovy is now available for use in China. The drug was approved for use in the country in June and is intended for adults with obesity or those who are overweight with weight-related comorbidities. China has seen a rise in weight-related disorders as a result of rapid economic development. The price of Wegovy in China is reported to be around 1,400 yuan ($193) per month. Novo Nordisk recently reported a 21% increase in net profit for the third quarter.
Nov 19, 2024
Wegovy, Novo Nordisk's weight-loss medication, now available for purchase in China
Novo Nordisk's weight-loss drug, Wegovy, has been approved for use in China as the country battles high rates of obesity. The drug is now available for the treatment of adults with obesity and those overweight with at least one weight-related comorbidity. China's rapid economic development has led to an increase in weight-related disorders, with nearly half of all adults in the country being overweight or obese. Wegovy is priced at around 1,400 yuan ($193) for a month's supply, lower than the reported US list price. Novo Nordisk expects sales to rise by 23 to 27 percent this year.
Nov 19, 2024
Over 50% of American Adults May Qualify for Ozempic
More than half of all American adults, nearly 137 million people, could be eligible for the GLP-1 drug semaglutide, according to a new analysis. Sold as Ozempic for diabetes treatment and Wegovy for weight loss, the medication could also be indicated for preventing heart disease. The analysis highlights the need for interventions to reduce economic barriers to access, as the drugs can cost nearly a thousand dollars per month and insurance typically only covers semaglutide for diabetes. Only 15 million adults are currently taking any type of GLP-1 to manage diabetes or heart disease.
Nov 19, 2024
Novo Nordisk is offering a popular weight-loss drug in China for a significantly lower price compared to the United States, reports Ars Technica.
Patients in China will be able to purchase the weight-loss drug Wegovy, made by Novo Nordisk, at a significantly lower price compared to the US. The drug will be priced at 1,400 yuan ($193) in China, while the US list price is $1,349. The Chinese price is in line with prices in other countries outside the US. The availability of Wegovy in China is expected to help tackle the rising rates of obesity in the country. Currently, the drug is not covered by China's national health insurance program.
Nov 19, 2024
Merck's Confidence Boosted by Successful Trials of SubQ Injectable Keytruda
Merck plans to seek regulatory approvals for a subcutaneous version of its blockbuster cancer drug, Keytruda, following the success of a clinical trial. The trial showed that the experimental injectable version of Keytruda, administered in minutes, was comparable to the intravenous version. An injectable formulation of Keytruda would improve patient access and help Merck maintain market share when biosimilar versions become available. Keytruda is currently the top-selling medication in the world and accounted for $21.6 billion in revenue through the first three quarters of 2020.
Nov 19, 2024
Positive Results: Eli Lilly's New Cholesterol Medication Shows Promise in Intermediate Study - NBC New York
Eli Lilly's experimental pill, muvalaplin, which is designed to lower high cholesterol, has shown promise in mid-stage trials. The daily pill is the only oral treatment being developed to treat high levels of lipoprotein(a), an inherited risk factor for heart disease, and is being seen as having "megablockbuster potential". The highest dose of the pill decreased Lp(a) levels by 70% compared to a placebo, with side effects similar to the placebo group.
Nov 18, 2024
The US Supreme Court decides not to review patent clash involving popular Bausch diarrhea medication
The U.S. Supreme Court has rejected a bid by Alvogen's subsidiary, Norwich Pharmaceuticals, to sell a generic version of Bausch Health's popular diarrhea drug, Xifaxan. The court upheld a lower court's ruling that Norwich's proposed generic infringes patents held by Bausch unit Salix Pharmaceuticals for the treatment of hepatic encephalopathy. Xifaxan had sales of more than $1.8 billion in 2023. Norwich argued that the patents did not cover the uses for which the company sought FDA approval. Bausch has settled related patent disputes with Teva Pharmaceuticals, Sun Pharmaceuticals, and Sandoz.
Nov 18, 2024
Get ready for a more potent version of Ozempic. Here's what you need to know about CagriSema, Novo Nordisk's latest weight loss medication.
Danish pharma company Novo Nordisk is developing a new weight-loss drug called CagriSema, which combines the active ingredient semaglutide with a dual amylin and calcitonin receptor agonist called cagrilintide. In early-stage clinical trials, CagriSema helped patients lose an average of 15.6% of their weight over 32 weeks, and it is anticipated that larger trials will show users can lose up to 25% of their weight. Results from the phase 3 trials are expected to be released later this year and in the first half of 2025, with a potential launch in late 2025 or early 2026.
Nov 18, 2024
Novo Nordisk Introduces Wegovy in China at Lower Prices Than in the US - BNN Bloomberg
Danish pharmaceutical company Novo Nordisk is launching its obesity drug Wegovy in China at a significantly lower price than in the US. The drug will not be covered by China's national health insurance program, meaning patients will have to pay out of pocket. Novo Nordisk is exploring ways to make the drug more affordable, such as through commercial insurance. China’s obesity rates are rising, with around 85 million adults estimated to have the condition by 2023. Novo Nordisk's rival, Eli Lilly, has also received Chinese approval for its weight-loss drug.
