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Building a Digital Stockpiling Strategy One Shelf At A Time

The Covid-19 pandemic was a teachable moment for the medical device industry. It laid bare to vulnerabilities within the U.S. healthcare system, including how quickly our supply chain can be disrupted, the impacts on medical inventory and stockpiles of personal protection equipment (PPE), and staff shortages. In a survey by Ernst & Young, 57% of companies admitted facing serious disruptions during these times. In an industry where medical supply inventory is mission-critical, and disruption is not an option, it is important to revisit your health plan and pivot in strategies so when these unforeseen events occur, you are ready for anything that comes your way. From physical to digital Right now, considerable preparation is shoring up the physical equipment supply chain for frontline workers and patients. Truth be told, the impacts of having a digital health production plan are significant. While digital stockpiling is still an undervalued strategy among medical ...
- Source: drugdu
- 105
- January 30, 2024
Biosimilar Insulins Promise Patients New Choices, But Competition Is Still Lacking

Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
- Source: drugdu
- 84
- January 30, 2024
Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products

Don Tracy, Associate Editor Atypical antidepressant linked to severe adverse effects and death as a result of misuse. This week, the FDA released a statement warning consumers to stay away from Neptune Resources’ Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets. Citing potential adverse events (AEs) such as seizures, loss of consciousness, and death, the agency stated that they have continued to receive several reports of these AEs. After releasing an initial warning statement in November, the FDA sent a letter on January 11, 2024, to multiple retailers, stressing the need to pull Neptune’s Fix and any other tianeptine-containing products from their inventory. “Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label,” the agency said in the statement “These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or ...
- Source: drugdu
- 92
- January 30, 2024
Asieris Presents for the First Time Interim Analysis Data of Oral APL-1202 in Combination with PD-1 Inhibitor Tislelizumab for Neoadjuvant Treatment of Muscle-Invasive Bladder Cancer at 2024 ASCO-GU

Shanghai, China – January 28,2024- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the first-time release of interim analysis data for the Phase II clinical trial of oral APL-1202 in combination with the PD-1 inhibitor tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer (MIBC). Release of the interim analysis data was made in the form of a rapid oral presentation abstract (Abstract No:632）at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). Patient enrollment of the trial was recently completed. Primary objective of the Phase II clinical trial is to evaluate the safety and efficacy of APL-1202 in combination with tislelizumab compared to tislelizumab monotherapy as neoadjuvant therapy for MIBC patients. The trial population includes patients with newly diagnosed MIBC for whom radical cystectomy (RC) is planned, ...
- Source: drugdu
- 95
- January 30, 2024
NHS urges more young people to take up HPV vaccine

HPV is a common group of viruses which can sometimes lead to cancer The NHS is urging both parents and young people between the ages of 12 and 13 years to take up having the human papillomavirus (HPV) vaccine to meet the NHS cervical cancer elimination goal. New figures from the UK Health Security Agency have shown that around one in six girls and one in five boys are not fully vaccinated by year 10. HPV is a very common group of over 100 viruses which affect the skin, sometimes causing genital warts or cancer. The HPV vaccine works to protect against a variety of cancers, including cervical, head and neck, anal and genital cancers. It is currently offered to all 12- to 13-year-olds within schools and community clinics and requires parental consent to receive the vaccine from NHS nurses. New statistics from the UK Health Security Agency has shown ...
- Source: drugdu
- 127
- January 30, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 97
- January 30, 2024
J&J, Merck CEOs dodge subpoenas by agreeing to testify at Senate committee’s pricing hearing

With the unusual threat of a Senate subpoena hanging over their heads, the CEOs of Johnson & Johnson and Merck & Co. have agreed to join their counterpart at Bristol Myers Squibb in testifying before the Senate Committee on Health, Education, Labor and Pensions (HELP). Friday, the HELP Committee’s chairman, Sen. Bernie Sanders (I-Vt.), said J&J’s Joaquin Duato and Merck’s Robert Davis have “reconsidered their positions” and have agreed to join BMS’ CEO Chris Boerner at a committee hearing scheduled for February 8. Duato and Davis’ cooperation comes shortly Sanders said the HELP Committee would vote to subpoena the CEOs after they declined a previous invitation to talk drug pricing. That subpoena vote has now been called off, the Committee said in a press release Friday. Sanders’ HELP Committee has already been crusading against steep drug prices over the past year. The committee has already heard testimony from chief executives ...
- Source: drugdu
- 153
- January 30, 2024
Drug shortages challenge type 2 diabetes patients in the UK

Drug shortages are continuing to persist in the UK affecting patients with different conditions, including those with type-2 diabetes who are on GLP-1 receptor agonists (GLP-1 RAs). Earlier this month, NHS England issued a National Patient Safety Alert regarding the shortage of GLP-1Ras. This was following a similar one issued in July 2023, which stated and that supplies were unlikely to stabilise sufficiently to meet market demand until at least mid-2024. In response to the January alert, the Diabetes UK issued a statement saying such shortages were being seen globally due to an increase in off-label use of semaglutide for weight loss. The alert issued actions to be taken by healthcare workers, such as only prescribing GLP-1 RAs for their licensed indications, and prescribing Rybelsus, another form of the GLP1RA semaglutide, for new treatment initiations and for those patients who can be switched from AstraZeneca’s Byetta (exenatide) and Novo Nordisk’s ...
- Source: drugdu
- 92
- January 30, 2024
Successful publication of 5-year long-term follow-up results of Phase III randomized controlled study of CD20 monoclonal antibody Hanlikang® in patients with primary diffuse large B-cell lymphoma

Hanlikang® (rituximab injection), the first CD20 monoclonal antibody independently developed by Henlius and also the first biosimilar in China, was officially approved for listing and registration by the State Administration of Pharmaceutical Affairs (SDPA) on February 22, 2019, which fills the gaps of the domestically-produced CD20 monoclonal antibody and domestic biosimilar market, and enables more Chinese patients to benefit from it! Recently, the 5-year follow-up results of patients in the Phase III study of Hanlikon® were officially published in the journal BMC Cancer (HLX01-NHL03 open-label extension study, NCT04491721). The results of the phase III HLX01-NHL03 study have demonstrated the bioequivalence of HLX01 (Hanlikon®, a rituximab biosimilar) compared to rituximab (Merovia®) in untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Here, we report 5-year follow-up results from an open-label extension study. Patients were randomly assigned to receive rituximab (Merova®) + cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or HLX01 (Hanlikon®) + ...
- Source: drugdu
- 177
- January 30, 2024
【EXPERT Q&A】What are the procedures for exporting medical devices to Japan?

Drugdu.com expert’s response: Given your company’s plans to enter the Japanese market and previous export experience, we will skip the details on export qualifications. To market their products in Japan, medical device companies must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act). However, language barriers and complex certification processes pose challenges in the registration of medical devices in Japan. Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the government-authorized local authority, including product design, production, and key process information. Foreign manufacturers must register their manufacturing information with the PMDA (Pharmaceuticals and Medical Devices Agency). Process for PMDA Registration: 1.1 Preparation Stage. Determine the product classification (Class I, Special Control Class II, Class II, Class III, Class IV) and product JMDN code, select a Japanese Marketing Authorization Holder (MAH). 1.2 The manufacturer registers the factory with PMDA. 1.3 Class II Special Control ...
- Source: drugdu
- 219
- January 29, 2024

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