After lackluster sales dampened the initial enthusiasm that came with a $2.1 billion acquisition, Nestlé has finally found a new owner for its peanut allergy drug Palforzia. Nestlé has divested Palforzia to U.S.-based allergy specialist Stallergenes Greer for an undisclosed sum, the food giant said Tuesday. The transaction closed when the two companies signed the agreement. Nestlé will receive milestone payments and royalties from Stallergenes Greer. The deal comes later than expected. Back in November, Nestlé announced a strategic review of Palforzia, citing slower-than-expected uptake by patients and doctors. At that time, the review was expected to be done in the first half of 2023. Palforzia became the first drug approved by the FDA for peanut allergy in children in January 2020. Back then, Evaluate Pharma projected that the drug could reach $1.28 billion in sales by 2024. Seeing Palforzia’s value in its food allergy portfolio, Nestlé in August 2020 ...
By Tristan Manalac Pictured: Novartis Institutes for BioMedical Research building in California/iStock, JHVEPhoto Novartis on Tuesday confirmed that it is pushing through with the spin-off of its generics and biosimilars division Sandoz, pending the final approval of its shareholders. To secure approval, the Swiss pharma group will hold an extraordinary general meeting set for Sept. 15. If given the go-ahead, Novartis expects to complete Sandoz’s spin-off “on or around” Oct. 4, the company said in Tuesday’s announcement. Novartis is also planning to list Sandoz on the SIX Swiss Exchange, with an American Depository Receipt (ADR) program in the U.S., for which the pharma group will likewise need to secure regulatory approvals. Novartis first launched a strategic review of its generics unit in October 2021, when it announced that it was exploring options for the business moving forward—including a potential sale. At the time, Sandoz was seeing better volume sales figures ...
By Kate Goodwin Pictured: Illumina sign in San Diego/iStock, Georgejason After months of upheaval, Illumina named Jacob Thaysen its new CEO Tuesday, replacing Francis deSouza who stepped down in June after losing a proxy fight with billionaire activist investor Carl Icahn. Thaysen, the former senior vice president of Agilent Technologies and president of its life sciences and applied markets group, will take the reins Sept. 25. He has his work cut out for him. The DNA-sequencing technology company has faced a rocky road since its acquisition agreement with cancer diagnostics maker GRAIL in September 2020. The deal faced scrutiny from both the Federal Trade Commission and the European Commission due to concerns over antitrust laws. In April, activist investor Carl Icahn went after then-CEO Francis deSouza and campaigned to replace three of Illumina’s board members. While his efforts only got him one seat on the board, deSouza did step down ...
As Medicare Advantage enrollment grows, a new study found that about half of Medicare Advantage enrollees disenroll from their plan after five years. The study was conducted by researchers at Brown University School of Public Health and was published in JAMA Health Forum. It examined nearly 82.4 million individuals “with any” Medicare Advantage enrollment between 2011 and 2020. The researchers found that after one year of enrolling in a Medicare Advantage plan, 13.2% of non-dually enrolled beneficiaries disenrolled from their plan, and 15.9% of dually enrolled beneficiaries disenrolled from their plan. Then, after five years, 48.3% of non-dually enrolled beneficiaries left their contract, as did 53.4% of dually enrolled beneficiaries. “On one hand, these levels of disenrollment may be indicative of a healthy [Medicare Advantage] marketplace, with beneficiaries freely choosing contracts and making different elections if better choices become available,” the study said. “On the other hand, this could also ...
Ready or not, value-based care (VBC) is here. For providers and medical practices, the stakes are high. Despite spending more money per person on healthcare than any country in the world, patients in the United States experience the worst outcomes overall of any high-income nation. The problem? The traditional fee-for-service model has created a misalignment between financial incentives and desired outcomes by compensating clinicians for each service delivered, encouraging greater volume rather than improved health outcomes. VBC seeks to restore that alignment, rewarding practices and providers for delivering measurable health outcomes and cost-effective care. Moreover, practices that embrace VBC can open significant opportunities to improve the health outcomes of their patients while preserving their practice’s profit margins under a stagnating fee-for-service landscape for reimbursement rates and increasing medical inflation. According to CMS.gov data, physician and clinical services expenditures sat at 5.6% in 2021, down 1% from 2020, while spending on ...
By Mariko Oi The maker of weight-loss drug, Wegovy, has become Europe’s most valuable firm dethroning the French luxury conglomerate LVMH. Shares rose after the Danish pharmaceutical giant, Novo Nordisk, launched the popular drug in the UK. At the close of trading on Monday, the firm had a stock market valuation of $428bn (£339bn). The drug is now available in the UK public healthcare system and also on the private market. Wegovy is an obesity treatment that is taken once a week which tricks people into thinking that they are already full, so they end up eating less and losing weight. Famous personalities such as Elon Musk are among the reported users of the drug, which has captivated Hollywood and the public more widely since it was approved by regulators in the US in 2021. Wegovy and Ozempic – a diabetes treatment with similar effects – have been described as ...
By Claire Jarvis Pictured: Close-up of an arm receiving a blood draw/iStock, montiannoowong Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating. With Leqembi’s full approval, the Centers for Medicare and Medicaid Services (CMS) has instituted broader coverage of the drug—with stipulations. To ensure reimbursement, physicians must participate in a qualified registry and patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid deposits. To help facilitate this, CMS proposed in July 2023 to increase its coverage of PET scans to detect these amyloid plaques—however, cheaper and faster diagnostic methods are still being developed. The past ...
Amgen and Horizon Therapeutics have reached a consent order agreement with the Federal Trade Commission (FTC) to resolve an ongoing administrative lawsuit. This sets the stage for Amgen to proceed with the last steps in finalising the acquisition of Horizon. In December last year, Amgen reached an agreement to acquire the complete issued and to-be-issued ordinary share capital of Horizon Therapeutics for $116.50 (€107.82) per share in cash or nearly $27.8bn on a fully diluted basis. As a result of the agreement, Amgen and Horizon anticipate submitting joint proposals to dismiss the preliminary injunction motion and lift the temporary restraining order (TRO) in the US District Court for the Northern District of Illinois. In May this year, the FTC took legal action in federal court to prevent the transaction, arguing that it would allow Amgen to leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy ...
Centogene has published data about the use of lyso-Gb1 (glucosylsphingosine) as a sensitive diagnostic and predictive biomarker for Gaucher disease. The study was published in the open-access MDPI journal, Diagnostics, and showed that lyso-Gb1 could be used to predict the clinical course of patients with Gaucher disease. Gaucher disease is a rare inherited metabolic disorder caused by mutations in the beta-glucocerebrosidase (GBA1) gene, responsible for producing a fat-breaking enzyme, glucocerebrosidase. Decreased activity of the enzyme causes fat accumulation in the cells causing symptoms such as liver enlargement, anaemia, bone pain, and spleen enlargement. Multiple biomarkers have been identified for the disease. However, these were present in other diseases and not exclusively in Gaucher disease. Lyso-Gb1 is a more specific biomarker for Gaucher’s, and it can be used to both diagnose the disease and monitor its progression. The confirmation of the biomarker serves as an important step forward in rare disease ...
When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
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