Industry News

Bharat Biotech International Limited (BBIL) said that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase 2 and 3 study.

Bharat Biotech had conducted phase 2/3, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity COVAXIN in healthy children and adolescents in the 2-18 age group.

U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID (nirmatrelvir tablets and ritonavir tablets) of pfizer for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Telix Pharmaceuticals Limited a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation announces that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix®.

Syngene International, an integrated research, development and manufacturing services company, today announced the extension of its long-standing multi-discipline research collaboration with Amgen Inc, one of the world’s leading biotechnology companies. The contract is currently extended until the end of 2026 and its scope includes integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development.

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio.

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.