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Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

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 ...
- Source: drugdu
- 192
- September 8, 2023
J&J’s patient assistance program suffers data breach, IBM says

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 ...
- Source: drugdu
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- September 8, 2023
Oral health worsens in morbidly obese people before and after bariatric surgery

Oral health deteriorates in morbidly obese people on a diet in preparation for bariatric surgery and patients who have undergone the procedure, with increasing caries, gingivitis and periodontitis. This is the conclusion of a study conducted by researchers at the Federal University of São Paulo (UNIFESP) in Brazil. Articles on the study are published in the Journal of Oral Rehabilitation and Clinical Oral Investigations, stressing the importance of participation by a dentist in the assessment of bariatric patients. The study was funded by FAPESP (projects 17/26400-6 and 16/10940-9), following 100 patients divided into two groups (dietary counseling and gastroplasty) at the Bariatric Clinic in Piracicaba, São Paulo state. The clinic performs some 50 such operations per month, mainly under the auspices of the SUS (“Sistema Único de Saúde”), Brazil’s national health service. Questionnaires, oral examinations, saliva samples and cheek swabs were analyzed to determine dietary changes, weight loss, inflammatory markers, ...
- Source: drugdu
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- September 8, 2023
Guardant abandons cancer blood test trial early, restates confidence in product line

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 ...
- Source: drugdu
- 127
- September 8, 2023
【Expert Q&A】How do I get started in the pharmaceutical intermediates business?

Entering the pharmaceutical intermediates business is a challenge that requires a wide range of specialized knowledge and experience, especially if you don’t have an extensive network in this field. Here are some suggestions to help you get started and succeed in your business: I. Basic Preparation Market Research: Understand industry trends, target customers, competitors, and market demand. Financing and Budget: Ensure you have enough capital to operate, including for production, sales, and marketing. Licensing and Compliance: Know and adhere to all relevant laws and regulations, including obtaining necessary permits and certifications. II. Technology and Production R&D Capability: Have or partner with reliable R&D institutions to develop and improve products. Quality Control: Establish strict quality control procedures. Supply Chain Management: Find reliable raw material suppliers and establish robust logistics and inventory management systems. III. Sales and Marketing Sales Team: Establish or hire an experienced sales team. Online Marketing: Utilize websites, social ...
- Source: drugdu
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- September 7, 2023
Licensing and Compliance market research pharmaceutical intermediates
Medtronic sued for allegedly sharing ‘treasure trove’ of diabetes patient data with Google

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 ...
- Source: drugdu
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- September 7, 2023
Researchers receive $2.5 million award to develop a tailored treatment for glioblastoma

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 ...
- Source: drugdu
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- September 7, 2023
New UK study suggests brain fog after COVID-19 is linked to blood clots

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 ...
- Source: drugdu
- 190
- September 7, 2023
Nestlé divests peanut allergy treatment Palforzia to Stallergenes Greer

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 ...
- Source: drugdu
- 233
- September 7, 2023
VGovernment-backed autoinjector specialist AktiVax shutters ‘substantially all of its operations,’ lays off 70

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 ...
- Source: drugdu
- 110
- September 7, 2023

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