Industry News

Orexo AB announces that Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc have appealed the patent litigation decision issued by the US District Court for the District of New Jersey relating to Orexo’s patents protecting ZUBSOLV  (buprenorphine and naloxone) sublingual tablets (CIII) in the US.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

European Medicines Agency (EMA) confirms acceptance of the Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab). The MAA has been submitted by Accord Healthcare, Intas’ wholly owned subsidiary on June 23rd, and the EMA accepted the MAA submission on 14th July.

The Inaugural Regulatory Program of Eminence Business Media, Pharma Regulatory Conclave 2023 set a very high benchmark for conferences based off learning and rejuvenation. The program was designed with a unique framework with one day virtual day program on 30th June and a two-day in-person conference at Hilton Resort, North Goa on July 5th - 6th.

The Pharma Computer Software Assurance 2023 conference third edition set remarkably high session originality and creativity standards, providing attendees with an engaging program full of valuable learning opportunities. This two-day in-person event occurred at Novotel Mumbai, Juhu Beach, on June 22nd and 23rd, 2023. The conference unique program design achieved a balance between CSV and CSA.

Novavax, Inc a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, has been granted full Marketing Authorization (MA) by the European Commission in the European Union (EU) for Nuvaxovid  (NVX-CoV2373). This decision follows positive opinion for a full MA from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The vaccine is now fully authorized for use as a primary series in individuals aged 12 and older and as a booster dose in adults aged 18 and older for the prevention of COVID-19.

U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

AGEPHA Pharma USA, LLC announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved LODOCO as the first anti-inflammatory atheroprotective cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.