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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
- 108
- 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
- 108
- 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
- 194
- 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
- 122
- 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
- 112
- 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
- 109
- 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
- 236
- August 28, 2023
Wegovy can reduce heart failure symptoms in obese patients, study shows

Data published in The New England Journal of Medicine has demonstrated that Novo Nordisk’s blockbuster weight loss drug Wegovy (2.4mg subcutaneous semaglutide) can reduce heart-failure-related symptoms in people with obesity. The results from a global Phase III trial funded by Novo Nordisk found significant symptom improvement in patients with preserved ejection fraction (HFpEF) – a condition that comprises roughly half of all heart failure cases. In the randomised, placebo-controlled trial (NCT04788511), Wegovy was administered as a 2.4mg weekly dose in 529 patients. After a year, it led to an estimated mean difference of 7.8 points in the Kansas City Cardiomyopathy Questionnaire clinical summary score – a patient-reported outcome for heart failure symptoms and limitations, compared to placebo. Along with leading to a larger reduction in body weight (13.3% versus 2.6%), Wegovy also vastly increased the distance patients were able to walk in six minutes compared to placebo – 21.5 metres ...
- Source: drugdu
- 119
- August 28, 2023
Microbiome company Enterome plans $108m raise to fund Phase II cancer trials

Enterome is planning to raise EUR100m ($108m) as part of its latest fundraising round to power its clinical studies, said CEO Pierre Belichard in an interview with Pharmaceutical Technology. The company has already started speaking to investors in Europe and plans to start contacting those in the US in early September, he said. The funding will go towards the company’s clinical trials, which include two new Phase II studies, said Belichard. Enterome’s E02463 is an off-the-shelf immunotherapy that is made of four bacterial peptides of B lymphocyte-specific lineage markers. These peptides are based on the company’s OncoMimics approach, which uses specific peptide combinations derived from bacteria in the gut microbiome. The company had previously raised EUR 46.3m as part of its Series E round, based on a June 2020 release, while Belichard added that Enterome has raised EUR 116m to date. While Enterome is not actively looking to go public ...
- Source: drugdu
- 120
- August 28, 2023
Reuters

Danish pharma company Novo Nordisk has brought in Thermo Fisher Scientific as a second manufacturer as demand for its weight-loss drug Wegovy (semaglutide) soars and amid Catalent’s production problems at a factory in Brussels, Belgium, according to reporting Wednesday by Reuters. Thermo Fisher is reportedly filling Wegovy injection pens at its factory in Greenville, NC through its CDMO subsidiary Patheon. Reuters’ source declined to be named as the information was confidential, according to the news agency, which initially reported back in May that Novo had brought on a second, then-unnamed manufacturer. The news comes after reports of difficulties with Catalent, the first manufacturer contracted by Novo to produce Wegovy. Deliveries were halted in late 2021 only months after the drug’s launch, when the FDA found issues at the Brussels syringe-filling facility. The facility was shut down again in 2022 after another inspection by the regulator found lapses. Novo ended up ...
- Source: drugdu
- 165
- August 28, 2023

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