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Hyderabad: Gland Pharma Limited, a generic injectable-focused
pharmaceutical company, has received approval from the United States Food and Drug Administration
(USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose
Bags.
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava
Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma
Corporation.
The Product is used to treat amyotrophic lateral sclerosis (ALS), a condition in which the nerves that control
muscle movement slowly die, causing the muscles to shrink and weaken.
The Company expects to launch this Product through its marketing partner within FY25.
According to IQVIA,
the product had US sales of approximately USD 19 million for the twelve months ending January 2024.
Gland Pharma has also announced the receipt of approval from the USFDA for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product).
Read also: USFDA approves Gland Pharma Plerixafor Injection
Gland Pharma was established in 1978 in Hyderabad. The Company has grown over the years from a contract manufacturer of small-volume liquid parenteral products to a injectable-focused companies. Its global footprint is spread across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
Read also: Gland Pharma appoints Satnam Singh Loomba as COO, Senior Management Personnel
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Bengaluru: A fire broke out in the basement of a three-storeyed Raksha Health Care hospital in Bengaluru’s Rajanakunte on Tuesday morning. A total of 16 patients who were admitted to the hospital, including the two in ICU, were immediately shifted to the nearest hospital.
The fire department received information about the fire at 9:15 am, leading to the deployment of six fire tenders to the hospital.
Sixteen patients admitted at a private hospital in Rajanakunte near here were shifted after a minor fire broke out at the three-storey building on Tuesday, fire officials said.
No one has sustained any injury, they said.
Also Read:Fire at WINS Hospital, four sustain burn injuries
According to the department, fire broke out at a lab in the basement of the 50-bedded private hospital. Though the fire did not spread to the ground and the three upper floors of the building, the entire hospital was engulfed in thick smoke causing panic and uneasiness among patients, staff and visitors at the hospital, reports news agency PTI.
Responding promptly to the situation, all sixteen patients, including two in critical care, were transferred to the nearest medical facility. Despite some experiencing discomfort due to smoke inhalation, all patients remain stable.
During the rescue operation, two employees named Lokesh and Naveen Kumar sustained injuries and are currently receiving treatment at a nearby hospital, reports TOI.
According to a PTI report, “All patients are stable. No one sustained any injuries. Because of the thick smoke, some of them complained of uneasiness and suffocation. They were immediately shifted to the nearest hospital,” a senior fire official said.
The fire was, however, extinguished by 11 am, the fire officials said, adding that the exact cause of the fire is being ascertained.
Ramesh, a resident of Rajanukunte, told TOI, “I had come to buy medicines from the pharmacy in the hospital building. I noticed the smoke and joined the team that entered the hospital to evacuate the people stuck inside. We could hardly see anything in the building. People standing a foot away were also not visible. Somehow, we evacuated the people on the ground floor but entering the first and second floors was not easy”.
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Mumbai: The Bombay High Court has given the Navy six weeks to
reconsider its decision to revoke the disability pension of retired naval
doctor Dr Anan Jaiswal. The court warned that contempt proceedings may follow
if the Navy does not respond within the specified timeframe.
Dr Jaiswal, who served at INS Jeevanti in Goa and the
Andaman and Nicobar Islands, was discharged from service in 2012 after being
classified with a disability. The disability was due to his service. He was supposed to receive the disability pension of a retired naval doctor.
However, he has been engaged
in a legal battle to secure his pension. Although the Navy had assured the
Armed Forces Tribunal (AFT), Mumbai, that his pension would be reinstated, the
Navy unexpectedly revoked Jaiswal’s pension payment order (PPO).
According to the Times of India, the Navy began disbursing Dr Jaiswal’s disability pension in
March 2023, following the AFT’s 2019 ruling. However, the Navy has since ceased
these payments, despite the absence of a stay on the AFT’s decision. The court
has scheduled the next hearing for June 28, after its summer recess. “The Navy asked for time to reconsider, and the high court has given the Navy six weeks to respond. If they don’t respond, then our contempt petition will be accepted,” said Jaiswal’s lawyer Satendra Kumar.
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New Delhi: The vaccine most consumed in India, will soon disappear from the drug shelves of the country as AstraZeneca on Tuesday announced it had initiated the worldwide withdrawal of its COVID 19 vaccine due to a ”surplus of available updated vaccines” since the pandemic.
The UK-based pharmaceutical company in collaboration with the Serum Institute of India (SII), the world’s largest vaccine manufacturer, had made available the Covishield vaccine to the Indian population .
AstraZeneca, which partnered with the University of Oxford to develop the vaccine, is now facing a lawsuit alleging that the vaccine resulted in deaths and serious injuries to recipients.
Also Read:AstraZeneca admits ‘very rare’ side effect of COVID vaccine in UK court
However, the company has cited commercial reasons for the withdrawal as “surplus of available updated vaccines”
The company also said it would proceed to withdraw the vaccine Vaxzevria’s marketing authorizations within Europe.
“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
The Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.
The firm’s application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.
Medical Dialogues had earlier reported that the pharmaceutical giant is being sued in a class action in UK over claims that its vaccine against Covid-19, developed with the University of Oxford, caused death and serious injury, including TTS — Thrombosis with Thrombocytopenia Syndrome — which causes people to have blood clots and a low blood platelet count. In India as well, a plea was submitted to the Supreme Court last week , urging the establishment of a medical expert panel overseen by a retired apex court judge. This panel would be tasked with assessing potential side effects and risk factors associated with the Covishield vaccine.
Also Read:Plea in SC seeking expert panel to examine possible side effects, risk factors of Covishield
London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.
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China: In a significant advancement in the realm of diabetes management, a pioneering three-arm randomized controlled trial has examined the effects of two distinct 5:2 regimens—energy-restricted diet and low-volume high-intensity interval training combined with resistance exercise—on glycemic control and cardiometabolic health in adults grappling with overweight/obesity and type 2 diabetes. The findings, published in Diabetes Care, provide valuable insights into tailored interventions for this high-risk population.
The study revealed that the medically supervised 5:2 energy-restricted diet could be an alternative strategy for improving glycemic control, and the exercise regimen could improve body composition, although it inadequately improved glycemic control.
Type 2 diabetes, a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, poses a formidable public health challenge worldwide, with obesity emerging as a major predisposing factor. While lifestyle modifications, including diet and exercise, are cornerstone strategies in diabetes management, the optimal regimen for achieving glycemic control and reducing cardiovascular risk remains a subject of ongoing debate.
Mian Li, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and colleagues aimed to investigate the effects of a 5:2 regimen diet (2 days per week of energy restriction by formula diet) or an exercise (2 days per week of high-intensity interval training and resistance training) intervention versus routine lifestyle education (control) on cardiometabolic health and glycemic control among adults with overweight/obesity and type 2 diabetes.
For this purpose, the researchers conducted a two-center, open-label, three-arm, parallel-group, randomized controlled trial that recruited 326 participants with obesity/overweight and type 2 diabetes. They were randomized into 12 weeks of diet intervention (n = 109), exercise intervention (n = 108), or lifestyle education (control) (n = 109).
The study’s primary outcome was the glycemic control change measured as glycated hemoglobin (HbA1c) between the diet or exercise intervention groups and the control group after the 12-week intervention.
Based on the study, the researchers reported the following findings:
The findings showed that two days a week of a medically supervised energy-restricted diet may lower blood glucose levels in adults with overweight or obesity and type 2 diabetes.
“The diet intervention group experienced a greater energy deficit with a more pronounced metabolic benefit,” the researchers wrote. “Our study indicates that a medically supervised 5:2 energy-restricted diet could be an alternative strategy for improving glycemic control.”
Reference:
Mian Li, Jie Li, Yu Xu, Jinli Gao, Qiuyu Cao, Yi Ding, Zhuojun Xin, Ming Lu, Xiaoting Li, Haihong Song, Jue Shen, Tianzhichao Hou, Ruixin He, Ling Li, Zhiyun Zhao, Min Xu, Jieli Lu, Tiange Wang, Shuangyuan Wang, Hong Lin, Ruizhi Zheng, Jie Zheng, Callum John Baker, Shenghan Lai, Nathan Anthony Johnson, Guang Ning, Stephen Morris Twigg, Weiqing Wang, Yan Liu, Yufang Bi; Effect of 5:2 Regimens: Energy-Restricted Diet or Low-Volume High-Intensity Interval Training Combined With Resistance Exercise on Glycemic Control and Cardiometabolic Health in Adults With Overweight/Obesity and Type 2 Diabetes—A Three-Arm Randomized Controlled Trial. Diabetes Care 2024; dc240241. https://doi.org/10.2337/dc24-0241
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USA: In a groundbreaking development in breast cancer treatment, the Alliance A011502 Randomized Trial has provided compelling evidence regarding the potential benefits of aspirin as adjuvant therapy. The trial, which investigated the efficacy of aspirin compared to a placebo in preventing cancer recurrence and improving survival rates among breast cancer survivors, has garnered significant attention from the medical community worldwide.
The study, published in the Journal of the American Medical Association (JAMA), revealed that there was no benefit of aspirin at 300 mg/d on breast cancer recurrence and survival.
The randomized, placebo-controlled clinical trial comprised 3020 patients with high-risk nonmetastatic breast cancer. The trial was terminated early because of the lack of benefit from aspirin (hazard ratio for invasive disease-free survival for aspirin versus placebo, 1.27 [not statistically significant]).
Despite its wide availability and promise, aspirin should not be recommended as an adjuvant breast cancer treatment, the researchers suggested.
Breast cancer remains one of the most prevalent malignancies affecting women globally, with a pressing need for innovative therapeutic strategies to enhance outcomes and reduce the risk of disease recurrence. Adjuvant therapies, administered post-primary treatment, play an important role in achieving these objectives by targeting residual cancer cells and preventing metastatic spread.
Observational studies of breast cancer survivors and prospective trials of aspirin for cardiovascular disease suggest improved breast cancer survival among aspirin users, however, there is a lack of prospective studies of aspirin to prevent breast cancer recurrence. To fill this knowledge gap, Wendy Y. Chen, Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, and colleagues aimed to determine whether aspirin decreases the risk of invasive cancer events among breast cancer survivors.
For this purpose, the research team conducted a phase 3, randomized, placebo-controlled, double-blind trial (A011502) in Canada and the United States comprising 3020 participants with high-risk nonmetastatic breast cancer, participants were enrolled from 534 sites from 2017 through 2020, with follow-up to March 4, 2023.
Participants were randomized to receive 300 mg of aspirin (n = 1510) or placebo once daily (n = 1510) for five years (stratified for hormone receptor status [positive versus negative], body mass index [≤30 versus >30], stage II versus III, and time since diagnosis [<18 versus ≥18 months]). 3020 participants were randomized when the data and safety monitoring committee recommended study suspension at the first interim analysis because the hazard ratio had crossed the prespecified futility bound.
The primary outcome was invasive disease-free survival. The key secondary outcome was overall survival.
The following were the key findings of the study:
The findings showed that among participants with high-risk nonmetastatic breast cancer, daily aspirin therapy failed to improve the risk of breast cancer recurrence or survival in early follow-up.
“Patients with a history of early breast cancer should not be encouraged to take aspirin routinely to improve their breast cancer outcomes,” the researchers wrote.
Reference:
Chen WY, Ballman KV, Partridge AH, et al. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA. Published online April 29, 2024. doi:10.1001/jama.2024.4840
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