Industry News

Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with cancer and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the novel kinase inhibitor BAL0891, a potential first-in-class mitotic checkpoint inhibitor (MCI) that drives aberrant tumor cell division leading to tumor cell death.

Sun Pharma announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial. The generic product approval is based on AmBisome® Liposome for Injection, 50 mg/vial as a reference product.

Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by US FDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for the product.

Zydus, a leading discovery-based, global pharmaceutical company announced today that it has received permission to initiate the Phase II (a) clinical study of its NLRP3 inhibitor ZYIL1 in patients with Cryopyrin-Associated Periodic Syndrome (CAPS) in Australia. Phase II (a) clinical trial in Australia will study the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with Cryopyrin- Associated Periodic Syndrome (CAPS).

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), today announced the closing of the previously announced acquisition of Lyophilization Services of New England, Inc. (LSNE), a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.

The newly relaunched device is a handheld, lightweight solution that improves breathing and strengthens the lungs. With AirPhysio, chronic bronchitis sufferers can reduce mucus buildup in five minutes or less per day.

Lupin Limited (Lupin) has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

OKYO Pharma Limited a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases (DED) and ocular pain, is pleased to announce that its drug candidate OK-101 which was developed to treat DED through its anti-inflammatory mode of action also shows potent ocular pain reducing property determined using a mouse model of corneal neuropathic pain, establishing the potential to treat both pain and inflammation, the most common symptoms of dry eye, with a single drug.

Vifor Pharma announced that the first patient has been enrolled in a double-blind, randomized phase-IIa clinical trial evaluating the safety, efficacy and tolerability of vamifeport in adult patients with sickle cell disease. Vamifeport, developed by Vifor Pharma, is a novel oral ferroportin inhibitor investigated for treatment of diseases characterized by ineffective production of red blood cells and iron overload, including SCD and beta-thalassemia. It has been granted orphan drug designation from both the U.S.

Vifor Pharma and Angion Biomedica Corp announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.