Pharma News

LEO Pharma A/S, a global leader in medical dermatology announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

US-India Strategic Partnership Forum and members appreciate the efforts by leaders across the U.S. government at the highest level to identify concrete steps the United States can take to assist India through this crisis. The company looks forward to announcements soon that will support India’s efforts to fill needs like oxygen, medicines, medical supplies, and vaccines. This should include a waiver of current restrictions on the export of vaccine raw materials to ensure production of vaccine in India can continue uninterrupted.

Biocon Biologics Ltd., a subsidiary of Biocon Ltd has announced that Abevmy 100 and 400 mg, a biosimilar of Bevacizumab co-developed with Viatris Inc. has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Researchers from the University of Oxford and their partners have today reported findings from a Phase IIb trial of a candidate malaria vaccine, R21/Matrix-M, which demonstrated high-level efficacy of 77% over 12-months of follow-up. In their findings (posted on SSRN/Preprints with The Lancet) they note that they are the first to meet the World Health Organization's Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.

Biological E. Limited, a Hyderabad-based vaccine and pharmaceutical company announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).

Scientists at Sanford Burnham Prebys have identified a set of human genes that fight SARS-CoV-2 infection, the virus that causes COVID-19. Knowing which genes help control viral infection can greatly assist researchers understanding of factors that affect disease severity and also suggest possible therapeutic options. The genes in question are related to interferons, the body frontline virus fighters. The study was published in the journal Molecular Cell.

Zydus Cadila announced that the company has received Restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of  Virafin, Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults. A single dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications.

Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride Extended- Release Capsules USP, 225 mg, 325 mg, and 425 mg (US RLD: Rythmol Capsules). Propafenone is known as an anti-arrhythmic drug. It works by blocking the activity of certain electrical signals in the heart that can cause an irregular heartbeat.

Drugs Controller General of India, DCGI, is notified that all implantable devices are treated as Drugs in the country. All the rules and regulations liable on the drugs are applicable on all implantable devices and other medical devices.

Dr. VG Somani, DCGI, is informed that all implantable devices and various medical devices like CT Scan equipment, MRI equipment, Defibrillators, PET equipments, Dialysis machines, Xray machines and Bone marrow cell separator are also regulated as drugs from April 1st 2021.