Industry News

Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has approved Tavneos in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis. The approval is consistent with expectations and overall follows the U.S. Food and Drug Administration (FDA) approval of Tavneos in October 2021 for the same indication.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.

According to IQVIATM sales data for the 12 month period ending November 2021, the Lexiscan® Injection, 0.4 mg/5 mL (0.08 mg/mL) market2 achieved annual sales of approximately $659.9 million*.

Amgen announced that the European Commission has granted conditional marketing authorization for LUMYKRAS® (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Moderna Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Carisma Therapeutics Inc., a biopharmaceutical pioneer in engineered macrophage-based therapeutics, announced that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd a leading innovation-driven international healthcare group in China and Insilico Medicine an end-to-end artificial intelligence (AI)-driven drug discovery and development company, entered into a collaboration agreement to advance the discovery and development of drugs targeting a number of different targets globally through the use of AI technology.

Alembic Pharmaceuticals Limited (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine Tablets 5 mg, 10 mg, 15 mg, and 20 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trintellix Tablets 5 mg, 10 mg, 15 mg, and 20 mg, of Takeda Pharmaceuticals, USA, Inc. (Takeda). Vortioxetine Tablets are indicated for the treatment of major depressive disorder (MDD).

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.