Industry News

Sanofi and Exscientia announced a groundbreaking research collaboration and license agreement to develop up to 15 novel small molecule candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient samples. The companies have been working together since 2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific small molecule candidate capable of targeting two distinct targets in inflammation and immunology.

Novartis announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) issued its decision upholding the validity of US Patent No. 9,187,405 covering a dosing regimen for Gilenya. In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity).

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.