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ENTOD Pharma gets CDSCO approval for eye drops to treat presbyopia

ENTOD Pharmaceuticals received approval from CDSCO for PresVu, a treatment for presbyopia, by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). PresVu is a eye drop in India designed to alleviate the need for reading glasses among individuals grappling with presbyopia. Presbyopia, characterised by blurred near vision due to the decreased flexibility of the eye’s natural lens, primarily impacts individuals aged 40 and above. PresVu offers swift relief and temporary correction of vision problems associated with presbyopia. PresVu eye drops adjust rapidly to tear pH, ensuring sustained efficacy and safety for long-term use. The company completed development of these eye drops in late 2022 after which it was subjected to clinical testing in India. Reportedly, Phase 3 clinical trials carried out in India and the US have demonstrated PresVu’s efficacy in enhancing close-up vision within minutes of application, with effects lasting up to six hours. ...
- Source: drugdu
- 136
- April 22, 2024
Biocon signs licensing and supply pact with Biomm S.A for Semaglutide commercialisation in Brazil

Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima. The total addressable market opportunity of Semaglutide in Brazil is approximately $580 million as per the IQVIA MAT Q4 2023. https://www.expresspharma.in/biocon-signs-licensing-and-supply-pact-with-biomm-s-a-for-semaglutide-commercialisation-in-brazil/
- Source: drugdu
- 132
- April 22, 2024
Weekly insulin analogues approaching approval could herald change

Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London. Hodgkinson, who works at at the Lambeth Diabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April. Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added. Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three ...
- Source: drugdu
- 115
- April 22, 2024
Chiatai Tianqing Achieves Positive Results in Pivotal Registration Study of Class 1 Innovator Rovadicitinib Tablets

Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE’s consent to submit a marketing application for this product, which will be submitted in the near future. TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity. The Company announced data from a Phase I ...
- Source: drugdu
- 91
- April 22, 2024
【EXPERT Q&A】How to apply for a Class III Medical Device Operation License?

Drugdu.com expert’s response: Here are the general steps for obtaining a Class III Medical Device Operation License: 1.Qualification Review: First, ensure that your enterprise meets the conditions specified in the “Measures for the Administration of Medical Device Operation Enterprise Licenses,” such as registered capital, premises, personnel, etc. 2.Prepare Application Materials: Prepare the required application materials, including the enterprise legal person business license, medical device operation enterprise filing certificate, medical device quality management system certification certificate, etc. 3.Submit Application: Submit the prepared application materials to the local provincial-level or above drug supervision and administration department or its authorized drug supervision and administration institution. 4.Acceptance Review: The relevant department will review the submitted application to verify the completeness and accuracy of the materials. 5.On-Site Inspection: In some cases, applicants may need to undergo on-site inspections to confirm that their operating premises meet the relevant requirements. 6.Approval Decision: The relevant department will make ...
- Source: drugdu
- 107
- April 22, 2024
Urine-Based Test Detects Head and Neck Cancer

Human papillomavirus (HPV) is well-known for its role in causing cervical cancer and is also increasingly identified as being responsible for cancers in the mouth, throat, and other areas of the head and neck. Early detection of cancer is essential, as it greatly improves patient outcomes. Now, a new urine-based test that can detect DNA fragments shed by head and neck tumors could potentially enable earlier detection of these cancers, which currently lack effective screening techniques. The research team at the University of Michigan (Ann Arbor, MI, USA) utilized whole genome sequencing to show that cell-free DNA fragments found in urine, which originate from tumor cells and pass from the bloodstream through the kidneys, are predominantly ultra-short, with less than 50 base pairs. Their small size makes detection difficult using traditional urine or blood-based liquid biopsy tests for circulating tumor DNA (ctDNA). Currently in the experimental stage, this mail-in test ...
- Source: drugdu
- 143
- April 20, 2024
Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection

Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has been specifically designed to enhance the collection of high-quality blood samples from the fingertip. The hand warmer designed to improve the collection of high-quality capillary blood samples has been developed by Babson Diagnostics (Austin, TX, USA) in collaboration with experts in biomedical engineering who study the impact of heat on the human body in the design of therapeutic devices. The Babson Hand Warmer is part of its BetterWay blood testing ecosystem, which combines Babson’s proprietary sample preparation and laboratory technologies with the BD MiniDraw Capillary Collection System. This system is the result of a strategic partnership between Babson and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Slated for commercial release this year, BetterWay revolutionizes blood testing by requiring just ...
- Source: drugdu
- 124
- April 20, 2024
Cybersecurity Firm Says it Has Removed Hundreds of Sites Selling Fake Weight Loss Drugs

Mike Hollan BrandShield states that it has identified sites selling counterfeit versions of Wegovy and Ozempic, among other drugs. It’s important to always be careful whenever buying anything from a website, especially medication. In recent years, it’s become much more common for patients and other consumers to find online sources where they can directly access medications without having to visit a pharmacy. This provides clear benefits for patients, such as limiting the burden placed upon them and potentially helping to reduce the cost of some medications. As is the case with most things, however, there are also risks. A new report from Reuters details one company’s work to take down sites selling fake medications.1 Not surprisingly, a significant percentage of these sites were selling counterfeit weight-loss drugs, such as fake versions of Ozempic. The report does note, however, that the number of sites selling these counterfeit weight-loss drugs has significantly ...
- Source: drugdu
- 153
- April 20, 2024
GSK’s Five-in-One Meningococcal Vaccine Under Review by the FDA

Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
- Source: drugdu
- 145
- April 20, 2024
Glenmark recalls 6,528 bottles of BP drug in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report. The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said. “Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. https://www.business-standard.com/companies/news/glenmark-pharma-recalls-6-528-bottles-of-blood-pressure-drug-in-us-124041400116_1.html
- Source: drugdu
- 117
- April 20, 2024

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