PharmaFocus Today – Page 330 – media

Cipla Issues Voluntary Nationwide Recall of Six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to Container Defect

WARREN, N.J., July 6, 2023 /PRNewswire/ — Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. Sr. No Product Name Batch No Expiry Date 1 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20045 Nov.2023 2 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20055 Nov.2023 3 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20056 Nov.2023 4 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20057 Nov.2023 5 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20059 Nov.2023 6 Albuterol Sulfate Inhalation Aerosol, 90mcg (200 MI) IB20072 Nov.2023 Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and ...
- Source: drugdu
- 106
- July 10, 2023
Not eating enough of these six healthy foods is associated with higher cardiovascular disease and deaths globally

A study led by McMaster University and Hamilton Health Sciences researchers at the Population Research Health Institute (PHRI) has found that not eating enough of six key foods in combination is associated with a higher risk of cardiovascular disease (CVD) in adults. Consuming fruits, vegetables, legumes, nuts, fish and whole-fat dairy products is key to lowering the risk of CVD, including heart attacks and strokes. The study also found that a healthy diet can be achieved in various ways, such as including moderate amounts of whole grains or unprocessed meats. Previous and similar research has focused on Western countries and diets that combined harmful, ultra-processed foods with nutrient-dense foods. This research was global in scope and focused on foods commonly considered to be healthy. The World Health Organization estimates nearly 18 million people died from CVD in 2019, representing 32 percent of all global deaths. Of these deaths, 85 percent ...
- Source: drugdu
- 149
- July 9, 2023
How dietary restraint could significantly reduce effects of genetic risk of obesity

Obesity risk genes make people feel hungrier and lose control over their eating, but practicing dietary restraint could counteract this. New research by University of Exeter, Exeter Clinical Research Facility, and University of Bristol published in the International Journal of Epidemiology found that those with higher genetic risk of obesity can reduce the effects that are transmitted via hunger and uncontrolled eating by up to half through dietary restraint. Psychology Ph.D. student, Shahina Begum, from the University of Exeter is lead author and said, “At a time when high calorie foods are aggressively marketed to us, it’s more important than ever to understand how genes influence BMI. We already know that these genes impact traits and behaviors such as hunger and emotional eating, but what makes this study different is that we tested the influence of two types of dietary restraint—rigid and flexible—on the effect of these behaviors.” “What we ...
- Source: drugdu
- 131
- July 9, 2023
FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults. With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients. This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial. Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi. Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms. Eisai CEO Haruo Naito stated: “The FDA approved Leqembi under the traditional approval pathway, making Leqembi the first and only approved anti-amyloid Alzheimer’s disease treatment shown ...
- Source: drugdu
- 115
- July 9, 2023
Antidepressant prescriptions continue to steadily grow in England

The number of antidepressant drugs being prescribed on the UK’s National Health Service (NHS) rose again, according to a quarterly report by the NHS Business Services Authority (NHSBSA). The report, which covers the months from October 2022 to December 2022, lists the number of mental health medicines prescribed in England according to the five British National Formulary (BNF) drug groups. This includes drugs that could have been dispensed in England, Scotland, Wales, Isle of Man of the Channel Islands. The British National Formulary classifies mental health medications into different groups based on their use. They are antidepressants, hypnotics and anxiolytics, central nervous system (CNS) stimulants and attention-deficit/hyperactivity disorder (ADHD) drugs, dementia medication, and antipsychotics. In the Q3 2022-2023, period antidepressant drugs were the most prescribed drug class, totalling nearly 22 million items, a 2.67% increase compared to the same period in the previous year. The rise is part of an ...
- Source: drugdu
- 127
- July 9, 2023
GSK’s ViiV explores novel pathway to bring long-acting HIV med Cabenuva to tough-to-treat patients

GSK’s Cabenuva made history in 2020 as the world’s first complete, long-acting HIV regimen. But the injectable drug is approved in various countries only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach tough-to-treat patients who have difficulty controlling the virus with existing daily oral therapies, GSK’s ViiV Healthcare is getting creative. To seek an approval for Cabenuva in patients who aren’t virologically suppressed while on oral drugs, GSK’s ViiV is exploring running a clinical trial using a historical control group. This would replace the standard practice of randomizing some patients in the study to receive standard-of-care oral meds, ViiV’s R&D head Kimberly Smith, M.D., said during a recent interview. The FDA in February unveiled draft guidance laying out the considerations for the use of external control groups in clinical trials to prove a drug’s safety and efficacy. The gist is, ...
- Source: drugdu
- 111
- July 9, 2023
Horizon shares positive results for Uplizna in neuromyelitis optica spectrum disorder

Horizon Therapeutics has shared positive new MRI data from a late-stage study of Uplizna (inebilizumab-cdon) in patients with neuromyelitis optica spectrum disorder (NMOSD). Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease characterised by inflammatory lesions that primarily damage the optic nerve and spinal cord. Most patients experience unpredictable relapses that reoccur after days, months or even years and may lead to further disability. Uplizna is the first and only CD19+ B-cell-depleting therapy approved by the US Food and Drug Administration and European Commission to treat NMOSD in adults who are AQP4-IgG positive. Around 80% of all patients with NMOSD test positive for anti-AQP4 antibodies. A new analysis of MRI data from the phase 3 N-MOmentum trial, presented by Horizon at this year’s Congress of the European Academy of Neurology in Budapest, shows that Uplizna effectively reduced the formation of subclinical (asymptomatic) ...
- Source: drugdu
- 132
- July 9, 2023
Immunotherapy significantly improves overall survival for advanced NSCLC patients

A global study, led by UCL and UCLH and sponsored by Roche, has shown that the cancer immunotherapy atezolizumab significantly improved the overall survival of advanced stage non-small cell lung cancer patients who were not able to be treated with platinum-containing chemotherapy, when compared to single-agent chemotherapy. The trial results, published today in The Lancet, are good news for non-small cell lung cancer patients who are not eligible for standard of care platinum-based chemotherapy, due to concerns about their ability to withstand the treatment. Lung cancer is the leading cause of cancer death worldwide, with around 2.2 million new cases and 1.8 million deaths a year. The majority of patients present with advanced stage non-small cell lung cancer (NSCLC) . For the fittest patients with advanced stage NSCLC, first-line immunotherapy with or without platinum-based doublet chemotherapy (PDC) is now established as the standard of care treatment. This follows several randomized ...
- Source: drugdu
- 131
- July 9, 2023
New AI system could revolutionize the diagnosis of valvular heart disease

AI (artificial intelligence) may sound like a cold robotic system, but Osaka Metropolitan University scientists have shown that it can deliver heartwarming-;or, more to the point, “heart-warning”-;support. They unveiled an innovative use of AI that classifies cardiac functions and pinpoints valvular heart disease with unprecedented accuracy, demonstrating continued progress in merging the fields of medicine and technology to advance patient care. The results will be published in The Lancet Digital Health. Valvular heart disease, one cause of heart failure, is often diagnosed using echocardiography. This technique, however, requires specialized skills, so there is a corresponding shortage of qualified technicians. Meanwhile, chest radiography is one of the most common tests to identify diseases, primarily of the lungs. Even though the heart is also visible in chest radiographs, little was known heretofore about the ability of chest radiographs to detect cardiac function or disease. Chest radiographs, or chest X-Rays, are performed in ...
- Source: drugdu
- 125
- July 9, 2023
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)

SUZHOU, China, July 7, 2023 /PRNewswire/ — Transcenta Holding Limited (“Transcenta”) (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approvals from China CDE (Center for Drug Evaluation) and South Korea MFDS (Ministry of Food and Drug Safety) to initiate TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy for the first-line treatment of patients with HER2 negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. In addition, we are in the process of EU and FDA regulatory interaction. Gastric cancer (GC) is the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. The five year survival rate for gastric cancer is still around 30%. Nivolumab, an anti-PD-1 antibody, has been approved globally for the first line treatment ...
- Source: drugdu
- 182
- July 9, 2023

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