PharmaFocus Today – Page 276 – media

Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
- Source: drugdu
- 228
- August 30, 2023
Danaher to buy antibody supplier Abcam for $5.7B

Dive Brief Danaher plans to buy Cambridge, England-based Abcam for about $5.7 billion in cash, the companies announced on Monday. The acquisition would bring together two firms that make equipment and supplies for life sciences companies. Abcam, with a market capitalization of $5.2 billion, would operate as a standalone company under Washington, D.C.-based Danaher, which has a market cap of $191.7 billion. Danaher reportedly outbid other companies including Agilent Technologies, Reuters wrote on Friday, citing people familiar with the matter. Dive Insight Abcam, a maker of antibodies, reagents, biomarkers and assays for life science companies, began a review of strategic alternatives in June. A proxy battle waged this summer between the company’s founder and its CEO attracted “strategic inquiries from multiple parties,” Abcam said in a June statement. The company evaluated more than 20 potential acquirers, Abcam said on Monday. The agreement values Abcam at about $24 per share. The ...
- Source: drugdu
- 110
- August 30, 2023
ECLS does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock

Early extracorporeal life support (ECLS) does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock who are scheduled for early revascularization, according to late breaking research presented in a Hot Line session today at ESC Congress 2023. Cardiogenic shock is the leading cause of death in hospitalized patients with acute myocardial infarction. Evidence-based treatment is limited to immediate revascularisation of the culprit lesion. However, mortality remains high, reaching 40-50% within 30 days. Ongoing efforts to improve outcomes have led to an increase in the use of active mechanical circulatory support devices to achieve hemodynamic stabilization in severe shock. In particular, the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO), also called ECLS, has risen by more than 10 times in recent years. ECLS enables full circulatory and respiratory support, which differentiates it from other devices. However, evidence for ECLS in patients with cardiogenic shock and acute myocardial ...
- Source: drugdu
- 114
- August 30, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
- Source: drugdu
- 105
- August 30, 2023
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data

By Tristan Manalac Pictured: Ultrasound machine used to obtain images of the heart/iStock, sudok1 Detailed results from the Phase III ATTRibute-CM study showed that BridgeBio Pharma’s acoramidis met its primary endpoint, inducing significant improvements in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), the company announced Sunday. ATTRibute-CM is a randomized and double-blinded study with over 630 patients enrolled. Its primary endpoint is a combination of all-cause mortality, frequency of cardiovascular-related hospitalizations and changes from baseline in NT-proBNP levels and six-minute walk distance (6MWD) performance. Acoramidis achieved a “highly statistically significant result” compared with placebo, BridgeBio wrote in its announcement, touting a Win Ratio of 1.8 with a p-value less than 0.0001. This effect was consistent across NYHA functional classes and between wild-type and variant transthyretin amyloid cardiomyopathy (ATTR-CM) patient subgroups. BridgeBio presented the findings at the 2023 Congress of the European Society of Cardiology, held in Amsterdam over the weekend. The ...
- Source: drugdu
- 105
- August 30, 2023
MA Enrollees Use Postacute Services Less Than Traditional Medicare

Medicare Advantage enrollees report using post-acute care services less than traditional Medicare enrollees, a new study found. The study, published in JAMA Health Forum, was conducted by researchers at Vanderbilt University Medical Center in Nashville, Tennessee. It analyzed 2,357 Medicare beneficiaries and their self-reported use of post-acute care services between 2015 and 2017. Of this study sample, 815 beneficiaries were enrolled in Medicare Advantage plans and 1,542 were enrolled in traditional Medicare plans. Participants were 70 years and older and community-dwelling adults, meaning those living outside of nursing homes. The researchers found that between 16.2% and 17.7% of Medicare Advantage enrollees reported using post-acute care services, compared to 22.4% to 24.1% of traditional Medicare enrollees. Medicare Advantage beneficiaries also had a shorter duration of services than traditional Medicare beneficiaries. In addition, Medicare Advantage enrollees had “less functional improvement” during their post-acute care than traditional Medicare (TM) enrollees. Of those who ...
- Source: drugdu
- 191
- August 29, 2023
New MD Anderson Research Uncovers Drug Combo That Could Eliminate Pancreatic Cancer Tumors

Researchers at the University of Texas MD Anderson Cancer Center published two studies this week on a new approach that could improve treatment for patients with pancreatic cancer — a disease that an estimated 64,050 U.S. adults will be diagnosed with in 2023. The preclinical studies showed that combining immunotherapy with a KRAS inhibitor can lead to long-lasting tumor elimination in pancreatic cancer. The research explored the functional role of KRAS mutations in pancreatic cancer. KRAS belongs to a family of genes that encode proteins that participate in cell signaling, activating or deactivating to regulate the growth of cells. When KRAS are mutated, they cause the uncontrolled cell growth that occurs in cancer. The oncology community has known “for a while now” that KRAS mutations drive pancreatic cancer, but it has had a hard time figuring out a way to effectively drug these mutated genes, explained Dr. Raghu Kalluri, an ...
- Source: drugdu
- 120
- August 29, 2023
FDA Approves Sandoz Biosimilar to Biogen’s MS Therapy Tysabri

By Tristan Manalac Pictured: Novartis office in Switzerland/iStock, Michael Derrer Fuchs The FDA on Thursday approved Sandoz’s Tyruko (natalizumab-sztn), a biosimilar of Biogen’s blockbuster treatment Tysabri (natalizumab), a monotherapy for the treatment of adults with relapsing forms of multiple sclerosis. Tyruko is also indicated for inducing and maintaining clinical response and remission in patients with Crohn’s disease with evidence of inflammation, and who are either unable to tolerate or show an inadequate response to conventional therapies. Sandoz is the generics and biosimilars arm of Swiss pharma Novartis, which in August 2022 announced that it was spinning the division off into a standalone entity, scheduled for the fourth quarter of this year. With Thursday’s approval, Tyruko becomes “the first biosimilar product indicated to treat relapsing forms of multiple sclerosis,” Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, said in a statement. The regulator’s decision will also contribute ...
- Source: drugdu
- 109
- August 29, 2023
Merck, Eisai Drop Phase III Keytruda-Lenvima Trial for Head and Neck Cancer

By Connor Lynch Pictured: Merck logo on building/iStock, Sundry Photography Merck and Eisai have dropped another joint drug trial after disappointing Phase III results. The companies announced Friday that they would be ending their combination treatment of Keytruda and Lenvima, respectively, after a second interim analysis found no improvement in overall survival. The LEAP-010 trial was evaluating the safety and effectiveness of Merck’s anti-PD-1 therapy in combination with Eisai’s multiple receptor tyrosine kinase inhibitor for metastatic or unresectable head and neck squamous cell carcinoma (HNSCC). An independent monitoring committee conducted two interim analyses over the course of 11 months. Initial results from the first analysis were promising: the therapy combo met two of the trial’s three primary endpoints of progression-free survival and objective response (OS) rate. However, the treatment failed to show evidence of meeting the third endpoint, overall survival, in the second analysis. The companies in Friday’s announcement said ...
- Source: drugdu
- 106
- August 29, 2023
Novo Nordisk engages Thermo Fisher to produce weight-loss drug

Novo Nordisk has engaged Thermo Fisher as a contract manufacturer to produce the weight-loss drug, Wegovy (semaglutide), Reuters reported, citing a source with knowledge of the matter. ThermoFisher is carrying out the filling of the Wegovy injection pens at its plant in Greenville, North Carolina, the source added. The publication quoted Novo Nordisk chief financial officer Karsten Munk Knudsen as saying in May 2023 that the company had hired a second contract manufacturer in the US, without revealing its identity. A spokesperson from Novo Nordisk declined to comment on the latest development. The company is currently working on increasing the drug output to meet the rising demand in the US, and due to manufacturing issues at a Catalent-operated plant in Brussels, Belgium. Catalent was engaged by Novo Nordisk as the first contract manufacturer for Wegovy production. In July 2023, the Brussels factory filling self-injection pens for Wegovy violated US sterile-safety ...
- Source: drugdu
- 231
- August 28, 2023

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