Industry News

Tarsus Pharmaceuticals, Inc, whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that the U.S. Food and Drug Administration (FDA) approved XDEMVY (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis. XDEMVY, formerly known as TP-03, is the first and only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis.

Alexion, AstraZeneca Rare Disease, announced that it has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer). The agreement furthers Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies.

Mirum Pharmaceuticals, Inc announced that LIVMARLI® (maralixibat oral solution) has been authorized by Health Canada for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).

The European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD), Boehringer Ingelheim and Eli Lilly and Company announced today.

AstraZeneca Pharma India Limited has received Permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from the Drugs Controller General of India for Dapagliflozin Tablets 10 mg.

Dapagliflozin Tablets 10mg is indicated for the treatment of heart failure in adults. Forxiga (dapagliflozin) was developed by Bristol-Myers Squibb and AstraZeneca. It belongs to a class of drugs known as SGLT2 (sodium-glucose cotransporter 2) inhibitors.

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.