Pharma News

Mount Sinai researchers have made two important discoveries about the mechanism by which bladder cancer cells foil attacks from the immune system. The research, published in Cancer Cell in September, could lead to a new therapeutic option for patients with these types of tumors.

Zika virus has a trick up its sleeve. Once inside the body, the virus likes to make a bee line for dendritic cells, the cells we rely on to launch an effective immune response.

“Dendritic cells are major cells of the innate immune system,” says LJI Professor Sujan Shresta, Ph.D., a member of the LJI Center for Infectious Disease and Vaccine Research. “How is this virus so clever that it’s able to establish infection in cells that would normally fight infections?”

Zydus Lifesciences Limited’s has received approval from the United States Food and Drug Administration (USFDA) to market Lenalidomide Capsules, USP 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. The company has received final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength. USRLD: Revlimid®.

Lupin Limited announced that Health Canada has approved Rymti, its biosimilar to Enbrel (etanercept), for use in Canada.

Rymti® is indicated in the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

University of Pittsburgh researchers describe for the first time a pathway by which cells repair damaged lysosomes, structures that contribute to longevity by recycling cellular trash. The findings are an important step towards understanding and treating age-related diseases driven by leaky lysosomes.

Bristol Myers Squibb announced new two-year results from the POETYK PSO long-term extension (LTE) trial demonstrating clinical efficacy was maintained with continuous Sotyktu™ (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis. This analysis assessed patients from the pivotal POETYK PSO-1 trial who transitioned into the LTE trial.

Targeting FGFR has recently emerged as a promising strategy in the treatment of cholangiocarcinoma (CCA), a very aggressive rare malignancy. At ESMO Congress 2022, two new agents were added to the list of FGFR inhibitors being investigated, showing some clinical benefits or potential in patients not previously treated with this anticancer drug class.

Two early studies investigate the anticancer activity of derazantinib and RLY-4008 in patients with FGFR inhibitor-naive cholangiocarcinoma.

The USFDA rejected Alvotech’s application to approve its biosimilar of AbbVie’s Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

Alvotech received communication from the U.S. Food and Drug Administration (USFDA) detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.

ICMR-National Institute of Malaria Research scientists from India published an opinion in Lancet Regional Health Southeast Asia that India requires Artificial Intelligence (AI) based approaches into the current microscopy method for detection of Malaria.

Indian Pharmacopoeia commission (IPC) to add 8 chemical monographs and 7 Veterinary Monographs and open them for Public Review and Comments.

IPC to add chemical monographs which include, Aceclofenac and paracetamol Tablets, Azacitidine for Injection, Ethamsylate, Lactulose Solution, Atropine Ophthalmic solution, Moxifloxacin Tablets, Remogliflozin Etabonate and Remogliflozin Tablets.