Idorsia has decided to reacquire the global rights for the oral endothelin receptor antagonist aprocitentan almost six years after they were sold to Janssen. The news comes after Idorsia announced potential layoffs, and cost-reduction initiatives, including the sale of its Asia Pacific operations, in July due to “lower than anticipated” sales in H1 2023. The reacquisition of aprocitentan is expected to provide a much-needed boost to Idorsia’s profits. GlobalData forecasts aprocitentan to generate $241m in sales in 2029. Idorsia CEO Jean-Paul Clozel said: “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.” Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. An EU approval application was filled with the European Medicines Agency (EMA) in January. Idorsia ...
GSK has announced it is investing over £270m to build a new vaccine manufacturing facility at its Wavre campus in Belgium. The investment follows the launch of the company’s new respiratory syncytial virus (RSV) vaccine, Arexvy. Designed to increase the efficiency of manufacturing processes and reduce environmental impact, the new unit will handle freeze-dried vaccines, including Arexvy, as well as the company’s fast-growing shingles vaccine, Shingrix, and its malaria vaccine, Mosquirix. The plant will contain two wings: one for producing the UK company’s ‘non-live’ vaccines, and the other for making ‘live’ vaccines, which include Varilrix for chickenpox and Priorix for measles. A spokesperson from GSK said: “The ambition is to have tens of millions of doses lyophilized each year.” “The new centre will feature several cutting-edge technological innovations designed to increase the efficiency of manufacturing processes and reduce environmental impact,” the spokesperson added. In May, Arexvy became the first RSV ...
Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
A technical flaw has resulted in “unauthorized access” to personal information at Johnson & Johnson’s Janssen CarePath patient assistance program, IBM reported on Wednesday. After an internal investigation, IBM was unable to determine how many accounts were affected, or the exact information that may have been compromised. The company is reaching out to all Janssen CarePath customers “out of an abundance of caution,” the tech giant said in a statement. The Janssen program helped more than 1.16 million U.S. patients access medications in 2022 alone, according to the drugmaker’s website. The free initiative facilitates access by helping patients navigate health insurance, plus provides information to get patients started on and stay on treatment. The program also provides options to manage out-of-pocket costs. By IBM’s account of events, J&J first became aware of a technical loophole in the Janssen CarePath system. Once informed, IBM, which manages the service, “promptly remediated the ...
Dive Brief Guardant Health has stopped a trial of a minimum residual disease (MRD) test early after seeing the results of an interim analysis. The study, called COBRA, was evaluating the ability of Guardant’s MRD blood test to improve outcomes in patients with stage II colon cancer after surgery. Patients underwent circulating tumor deoxyribonucleic acid testing to inform further treatment. Guardant, which collaborated with NRG Oncology on the study, has yet to share data from the trial but confirmed it stopped early after the news leaked on social media. Shares in Guardant fell around 13% to below $35 on Friday. Dive Insight Guardant and NRG Oncology, a clinical trial group funded by the National Cancer Institute, began the trial in 2020 on the strength of evidence that the LUNAR-1 blood test may help identify patients who are likely to benefit from chemotherapy after surgery. The test, the product of a ...
Dive Brief A plaintiff has accused Medtronic of sharing user data for its InPen diabetes management system with companies including Google. The lawsuit alleges that Medtronic’s MiniMed business used digital platforms to acquire “a treasure trove of personal data” and shared the information with third parties to increase revenue and profits. According to the plaintiff in the proposed class action lawsuit, the disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.” Dive Insight The case centers on the app that accompanies Medtronic’s smart insulin pen. Medtronic created the app to help patients record their insulin doses, receive reminders and share data with their healthcare team. The use of the data is covered by Medtronic’s notice of privacy practices. According to the lawsuit, the company has used the data in ways that are beyond the terms covered in ...
A multidisciplinary team of investigators from the UCLA Jonsson Comprehensive Cancer Center was awarded a $2.5 million Translational Team Science Award from the Department of Defense to develop a tailored treatment for glioblastoma, a deadly brain tumor with limited treatment options. The team -; including David Nathanson, associate professor of molecular and medical pharmacology at the David Geffen School of Medicine at UCLA, Benjamin Ellingson, director of the UCLA Brain Tumor Imaging Laboratory and professor of radiological sciences, and Dr. Timothy Cloughesy, professor of neuro-oncology -; plan to target the epidermal growth factor receptor, a protein that is mutated in about 60% of people diagnosed with glioblastoma. Previous attempts have had limited success improving patient outcomes due to drugs’ inability to cross the blood-brain barrier and target genetic alterations in the protein that are unique to glioblastoma. To overcome these obstacles, the researchers have developed ERAS-801, a brain-penetrant inhibitor that ...
A new UK study led by a research team from the University of Oxford and the University of Leicester has suggested that blood clots in the brain or the lungs could potentially explain common symptoms of long COVID. The post-hospitalisation COVID-19 study (PHosp-COVID), published in Nature Medicine, found that people admitted to hospital due to COVID-19 had higher levels of the fibrinogen protein and protein fragment D-dimer, which can cause excess clotting. Excess blood clotting was found to be a possible cause for symptoms like brain fog and fatigue in long COVID. Previous research has found that blood clotting can cause a lack of blood supply to the brain or cause fatigue, which both can cause cognitive problems. People with long COVID can have a wide range of symptoms that last weeks, months, or even years after having a SARS-CoV-2 infection, and for some, it can result in disability or ...
Nestlé has unloaded its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer after previously spending billions on the treatment’s acquisition. The company will receive undisclosed milestone payments and ongoing royalties from Stallergenes Greer as part of the deal, according to the 4 September announcement. In August 2020, Nestlé acquired Palforzia through its $2.6bn takeover of Aimmune Therapeutics, the original developer of the peanut allergy treatment. Prior to this, Nestlé invested $473m in Aimmune over several years. Most recently, Aimmune received $200m from Nestlé in February 2020, only days after the US Food and Drug Administration (FDA) approved Palforzia as a peanut allergy treatment for children ages four years through 17. The European Commission approved the drug in the same patient group in December 2020. While the drug was approved for use in children, the drug can also be used in those aged 18 and older in combination with a ...
Despite scoring a number of federal contracts in recent years, it’s lights out for government-backed rescue autoinjector maker AktiVax. Late last month, AktiVax, also known as Aktiv Pharma Group, informed the state of Colorado that “the company must shut down substantially all of its operations,” citing “unexpected circumstances.” In turn, the company is mothballing three manufacturing facilities and laying off around 70 employees. The plant closures and layoffs are set to affect a facility in Broomfield, Colorado, plus two sites in Fort Collins, according to a letter sent to a state official. The “entire plants” are to be closed, and AktiVax expects the action will be “permanent.” Jobs that will be affected run the gamut from patent prosecution and purchasing agents to engineers, technicians, quality control microbiologists and human resources executives. AktiVax’s business primarily revolves around its autoinjector ARAI, which the company says is the only autoinjector with single-hand, single-step ...
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