Pharma News

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).

As countries prepare themselves to fight a possible ‘next wave’. The new variant – Omicron has been making headline and a surge in Covid 19 cases are evident. According to a study based on population-level evidence, the recently identified Omicron variant of SARS-CoV-2 is associated with a substantial ability to evade immunity from prior Covid-19 infection. Omicron is also considered to be three times more transmissible than the Delta variant.

New research suggests that the peptides short chunks of protein used to treat Type 2 diabetes may be more effective if they’re able to flexibly move back and forth between different shapes.

Infection with the virus that causes COVID-19 can trigger an immune response that lasts well beyond the initial infection and recovery—even among people who had mild symptoms or no symptoms at all, according to Cedars-Sinai investigators. The findings are published in the Journal of Translational Medicine.

Immunotherapies called chimeric antigen receptor (CAR) T cells use genetically engineered versions of a patients own immune cells to fight cancer. These treatments have energized cancer care, especially for people with certain types of blood cancers. Now, scientists at Memorial Sloan Kettering Cancer Centers Sloan Kettering Institute (SKI) have developed new CAR T cells that can do something their predecessors cannot make drugs.