| |SEPTEMBER 20249BHARAT BIOTECH SIGNS PACT WITH ALOPEXX FOR ANTI-MICROBIAL VACCINEAUROBINDO PHARMA ARM SECURES USFDA APPROVAL FOR ANESTHETIC DRUGBharat Biotech and Alopexx, Inc. are partnering to develop and sell AV0328, a broad-spectrum anti-microbial vaccine, in India and other low and lower middle-income nations.A statement from the vaccine manufacturer based in the city mentioned that the companies will work together to develop and sell AV0328, a synthetic vaccine that targets poly N-acetyl glucosamine (PNAG), in India and other authorized regions.It was stated that Alopexx would receive an initial payment and additional payments upon reaching specific milestones, in addition to royalties from sales of AV0328 in the specified territories.Krishna Ella, Executive Chairman of Bharat Biotech, said, "We are proud to collaborate with Alopexx to bring AV0328 to the regions where it is most needed. Our goal is to develop solutions to reduce anti-microbial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally.""This collaboration brings us one step closer to addressing the critical need for affordable, broad-spectrum antimicrobial solutions, especially in low-and middle-income countries," Daniel Vlock, CEO of Alopexx, said.Bharat Biotech International Limited, headquartered in Hyderabad, is an Indian multinational biotech firm focused on drug discovery, development, and production of vaccines, biotherapeutics, pharmaceuticals, and healthcare products. POThe pharmaceutical company announced that its subsidiary, Eugia Steriles, received approval from the USFDA for its first product, Lidocaine Hydrochloride injection. Lidocaine is a numbing medication used as a local anesthetic to reduce pain or discomfort during medical procedures like surgery, needle punctures, or insertion of catheters or breathing tubes.The new injectable facility of Eugia Steriles (a 100 percent subsidiary of Eugia Pharma Specialities and a stepdown subsidiary of the company), situated at Parawada Mandal, Anakapalli district, Andhra Pradesh, which was inspected by the US FDA from 28 March 2024 to 5 April 2024, has now received its first product approval from the US FDA for Lidocaine Hydrochloride injection, USP, 1 percent (10 mg/mL) and 2 percent (20 mg/mL), Aurobindo Pharma stated.The submission of the sANDA was for Prior Approval Supplement to include a new facility for manufacturing, labeling, packaging, and testing of a different drug product. Aurobindo Pharma's main focus is on producing and selling active pharmaceutical ingredients, generic pharmaceuticals, and related services.In Q1 FY25, the pharmaceutical firm recorded a 61.05 percent increase in total net income to Rs 919.22 crore with a 9.82 percent growth in revenue to Rs 7,457.65 crore compared to Q1 FY24. PO
<
Page 8 |
Page 10 >