Unable to scale up its manufacturing fast enough to meet the spiraling demand for its GLP-1 weight loss products, Novo Nordisk is employing a new strategy—reducing production of diabetes drug Victoza to make more Ozempic. Novo and the European Medicines Agency (EMA) divulged (PDF) the move in a letter to healthcare professionals, warning of a growing shortage of both medicines that is set to intensify during the rest of the fourth quarter. With the shortage of Victoza expected to continue into the second quarter of next year, the EMA has instructed healthcare providers not to start new patients on the drug until then. While Victoza (liraglutide) and Ozempic (semaglutide) are both GLP-1 drugs, the former—which was originally approved in 2010—is not used for weight loss. Intermittent shortages of Ozempic are expected to persist throughout 2024, though the overall supply situation should improve in the first quarter of next year, according ...
When people think of genomics, they typically don’t visualize the primary care setting — but Northshore–Edward Elmhurst Health is trying to change that. Genomics is a key part of the health system’s approach to personalized care delivery, said Kristen Murtos, its chief innovation and transformation officer, in a recent interview. NS-EEH, the third largest health system in Illinois, was created in January 2022 when NorthShore University HealthSystem and Edward-Elmhurst Health completed their merger. “Several years ago, NorthShore leaned heavily into the power of genomics and integrated that as part of primary care practice — unlocking the opportunity to more holistically understand predisposition to certain diseases, to tailor care plans and to be able to give proactive and preventative care versus waiting until disease manifests and just being treated after that,” she explained. At NS-EEH, all patients are offered genetic testing as part of their primary care visit, Murtos pointed out. ...
Long-term acute care hospitals (LTCHs) are common sites of post-acute care for patients recovering from severe respiratory failure requiring long-term mechanical ventilation. Because of longer lengths of stay compared to regular, short-stay hospitals, the Centers for Medicare and Medicaid (CMS) reimburses LTCHs at higher rates. However, since 2005, CMS implemented a series of reforms designed to restrict their growth and curb spending resulting in many LTCH closings. While it was unclear whether these closures affected patient care patterns at short-stay hospitals and overall patient outcome, a new study from researchers at Boston University Chobanian & Avedisian School of Medicine, has found that discharge patterns changed while overall spending on mechanically ventilated patients decreased following LTCH closures. According to the researchers, CMS payment reform was intended to divert less-sick, less-complex patients from higher-cost LTCHs to lower-cost skilled nursing facilities, while reserving LTCHs for complex patients like those on prolonged mechanical ventilation. ...
Nicholas Saraceno IQVIA report explores why these shortages are increasing, and how they can be mitigated. Image Credit: Adobe Stock Images/Julia Drug shortages are an issue that continue to grow in news coverage, due to their impact on patient care and public health. Data suggests that the amount of drug shortages in the US is increasing as more shortages continue to be reported than resolved. As a report by IQVIA titled Drug Shortages in the US 2023: A Closer Look at Volume and Price Dynamics1suggests, stakeholders have suggested various tactics to mitigate shortages, including prioritizing essential medicines, stockpiling, and making changes to reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them. This aforementioned report assesses shortages reported by the FDA, alongside sales and volume data of these medicines in ...
Eating disorders don’t discriminate. Equip, a virtual company that provides eating disorder support, is trying to reach different populations by having a diverse care team and working with advisors from different backgrounds, said Kristina Saffran, CEO and co-founder of the company. By MARISSA PLESCIA There is a common stereotype that eating disorders only affect thin, young White girls. But Kristina Saffran, CEO and co-founder of virtual eating disorder care company Equip, will be among the first to say that this is not true, despite fitting the stereotype. “Eating disorders affect everybody. They affect people of all different ages, races, genders, ethnicities, sexual orientations, body shapes and sizes. These do not discriminate,” Saffran said during an interview last week at the Behavioral Health Tech 2023 conference in Phoenix. “I am someone who fits the mold to a tee. … I was diagnosed with anorexia at 10, relapsed at 13, went into ...
MSD has entered a definitive agreement to acquire Caraway Therapeutics in a deal worth up to $610m. MSD will acquire the Massachusetts-based small molecule therapeutics company through one of its subsidiaries. The $610m consideration includes undisclosed upfront and milestone-based payments. MSD plans to expense the upfront payment as part of its Q4 2023 expenses, as per a 21 November press release. MSD has been a Caraway shareholder through its subsidiary, MRL Ventures Fund. As per the agreement, the company will “acquire all outstanding shares of Caraway with earnout milestones associated with the development of certain pipeline candidates”. The transaction has already been approved by Caraway’s board of directors. Caraway has a preclinical pipeline of therapies for neurogenerative diseases, especially Parkinson’s disease. Caraway’s lead preclinical candidate targets the transient receptor potential cation channel subfamily (TRPML1), which is located on lysosomes and regulates their enzymatic activity. As lysosomal dysregulation has been seen ...
Taking place from 18 to 24 November 2023, World antimicrobial resistance (AMR) Awareness Week will focus on the theme “Preventing Antimicrobial Resistance Together” to combat resistance and improve antimicrobial use in humans around the world. This AMR Awareness Week, leaders and communities across several sectors will work to preserve antimicrobials and protect the health of people, animals, plants and the environment. Designated as one of the top ten global public health threats facing humanity by WHO, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Estimated to cost the world’s economy $100trn by 2050 if left unresolved, AMR contributes to approximately five million bacterial infection-related deaths annually. Currently, the misuse and overuse of antimicrobials is one of the biggest drivers of AMR. When antibiotics and other antimicrobial treatments become ineffective, infections become more challenging or impossible to treat, increasing the risk of disease spread, severe ...
The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs. The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi. Specifically, the FTC argues “improper” listings in the FDA’s “Orange Book” can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case. In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices ...
After suffering setbacks in the clinic and in court over the last week, Bayer’s ability to overhaul its corporate structure is becoming more constricted, one group of analysts contends. Still, the German conglomerate is trying to keep its head up as it presses on with a strategic review under new CEO Bill Anderson. Bayer’s very bad week started with the failure of its potential blockbuster-in-waiting asundexian to top Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial. In light of the blood thinner’s inferior efficacy, Bayer elected to stop the study early while continuing to advance the asset in stroke. Bayer is counting on new drugs like asundexian to offset the upcoming loss of exclusivity on its Johnson & Johnson-partnered med Xarelto. Separately, a Missouri jury on Monday ordered Bayer to shell out $1.56 billion to four plaintiffs over claims the company’s Roundup weedkiller caused their cancer. Bayer ...
By Tristan Manalac Pictured: NASDAQ Stock Exchange headquarters Carmot Therapeutics on Friday filed for an initial public offering (IPO), banking on its pipeline of GLP-1 agonists and the multibillion-dollar potential of the obesity market. Carmot did not disclose how many shares of its common stock will be put up for sale or its projected earnings from the planned offering. The company expects to wrap up its IPO before the year closes, after which it will trade on Nasdaq under the proposed ticker CRMO, according to a Nov. 17 SEC filing. The California-based biotech is advancing a pipeline of “life-changing therapeutics for people living with metabolic diseases,” particularly obesity and diabetes, per the SEC filing. One of its most mature candidates is CT-868, a dual agonist of both the GLP-1 and GIP receptors, both of which play crucial roles in the regulation of insulin secretion, appetite and weight. CT-868 is being ...
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