Vizen Life Sciences Pvt Ltd

🎉 Celebrating Our Visionary Leader: Happy Birthday, Mr. Sairam Kumar Ambati! Sir 🎉 It is with great happiness and excitement that we announce the celebration of our CEO Sir, Mr. LAxmi Sairam Kumar Ambati's birthday – a man of vision, integrity, unwavering dedication, and immense knowledge. From Admin and IT to countless other roles, he has worn many hats since the establishment of Vizen Life Sciences. This is not just a birthday celebration, but an opportunity to honor a leader who has continually inspired us with his words, actions, and commitment to excellence. Mr. Sairam Kumar Ambati's leadership has been a cornerstone of Vizen Life Sciences' success. His ability to articulate a clear vision and motivate us all to strive for greatness has been instrumental in driving our company forward. He leads by example, embodying the values of hard work, innovation, and compassion. His strategic insights and ability to navigate challenges have guided us through many milestones and set a path for a promising future. On this special occasion, we come together to celebrate not just his birthday but his countless contributions to our company. In honor of his birthday, Let us take this opportunity to express our gratitude to Mr. Sairam Sir for his remarkable leadership and the positive impact he has had on all of us. Many happy returns of the day! Once again, happy birthday to the best boss one can imagine. 🎂🎉 #Leadership #Visionary #CEO #HappyBirthday #VizenLifeSciences #Celebration #Gratitude

Check out the latest blog post from CDRH’s Digital Health Center of Excellence on the potential lifecycle management (LCM) holds for addressing the unique challenges of AI in health care. LCM considerations can help AI meet real-world needs while managing inherent risks across the software lifecycle. https://lnkd.in/dNMensDy

🚨 Medicines and Healthcare products Regulatory Agency approved semaglutide (Wegovy) to reduce risk of serious heart problems in obese or overweight adults This medicine, a GLP-1 receptor agonist, was already approved for use in the treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioural support. The approval means that semaglutide is the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. MHRA Deputy Director of Innovative Medicines, Shirley Hopper, said: "Our key priority is enabling access to high quality, safe and effective medical products. “MHRA had assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met. This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity. “As with all medicines, we will keep its safety under close review.’’ Find out more ➡️ https://bit.ly/4fiWJGP

⚠️Medicine shortage – Intravenous (IV) fluids⚠️ Therapeutic Goods Administration is aware of shortages of multiple intravenous (IV) fluid products from all three Australian suppliers (Baxter Healthcare, B.Braun, and Fresenius Kabi). The shortages are due to multiple factors including global supply limitations, unexpected increases in demand, and manufacturing issues. Managing the shortage and supply of IV fluids is a priority for TGA, as TGA understand these medicines are of critical importance. To minimise the impact of these shortages, TGA had approved multiple overseas-registered alternative saline fluids under section 19A of the Therapeutic Goods Act 1989. TGA will continue to monitor the supply and work closely with the sponsors and state and territory health departments to reduce the impact of the shortage. Visit TGA website for more information: https://lnkd.in/g8JW-kXz

French pharmaceutical giant Sanofi has announced a "temporary halt" on the sales of Allegra Suspension and Combiflam Suspension in India, due to microbiological contamination. The precautionary recall, affecting specific batches, aims to ensure safety while investigations continue. Both the drugs, which are prescribed to children, are being recalled from hospitals, distributors and retailers as a “precautionary" measure triggered by the incidents of “microbiological contamination" which is still under investigation. Allegra suspension is typically given to children for managing symptoms stemming from allergic conditions like hay fever, watery eyes, runny nose, sneezing, itching and common cold, whereas combiflam suspension is effective in reducing fever and relieving pain and swelling in both infants and children.

From 1 July 2024, Therapeutic Goods Administration is introducing temporary new arrangements for GMP inspections of domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals and blood products. These inspections will be called ‘surveillance inspections’, which are full-scope, reduced-duration re-inspections of manufacturers. The inspection will cover all aspects of the manufacturers’ Pharmaceutical Quality System (PQS) and operations, however duration can be reduced by approximately 50% of the typical inspection time. Domestic and overseas manufacturers that demonstrated a good or satisfactory compliance rating (A1 or A2) at their previous TGA inspection may be eligible for a surveillance inspection. TGA licensed sites that have not had a re-inspection in the last three years may still apply for domestic GMP or MRA certificates. The expiry of existing GMP certificates for TGA licensed sites has been extended from 3 to 4 years. Visit TGA website for more information: https://lnkd.in/g8d43EhM

Mankind Pharma is acquiring biotech company BSV Group, (formerly Bharat Serum & Vaccines) from PE firm Advent International for an enterprise value of around Rs 13,630 crore, subject to closing related adjustments. TIMES OF INDIA: The deal marks a significant leap for Mankind Pharma, positioning it as a market leader in India's women's health and fertility drug market, alongside access to other high-entry barrier products in critical care, with established complex R&D tech platforms. It will potentially establish Mankind as the number one player in the Rs 11,000 cr gynaecology market, with a 13% share. At present, Mankind is ranked third, and has a 7% market share, while BSV 6%. Source: Times of India Read more in the link below

The European Medicines Agency (EMA) has published the draft Guideline on the Development and Manufacture of Oligonucleotides”, This guideline is open for comments until 31-Jan-2025. Refer to the below document for more details

Guideline: Procedures of Scientific Advice for Biological Products (2024)  Version 1, 09-Jul-2024 The Egyptian Drug Authority (EDA) has published a comprehensive guideline detailing the procedures for obtaining scientific advice for biological products from the Central Administration of Biological and Innovative Products and Clinical Studies. This guideline highlights the benefits of seeking scientific advice, including early identification of potential issues, optimization of development plans, streamlined regulatory submissions, and an increased likelihood of regulatory approval. It's important to note that the advice is based on specific questions posed by the applicant and is not legally binding. The guidance covers the developmental, pre-authorization, and post-authorization phases, addressing issues such as laboratory testing, CTD screening, and regulatory queries. Applicants must fill out an application form, submit the necessary documents, and can request preparatory meetings. The advice report is issued within specified timeframes depending on the type of issue. #RegulatoryAffairs #CTD #Biological #DrugRegistration #EDA

FDA issued the final guidance, "Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products": https://lnkd.in/geANjjW7 The guidance includes recommendations for sponsors and other interested parties proposing to use data from electronic health records (EHRs) or medical claims to help support a new use of an FDA-approved drug or biological product or to help support or satisfy post-approval study requirements.