Humira

The FDA recently approved Amgen’s Wezlana (ustekinumab-auub) for various inflammatory conditions, marking the first biosimilar approval referencing the popular J&J drug Stelara (ustekinumab). Wezlana, mirroring its reference product, is approved for treating multiple inflammatory diseases in adults, including m...

Behcet’s syndrome is an uncommon multisystem inflammatory ailment marked by ulcers in the mouth and genitalia, different skin lesions, and eye abnormalities. It is linked to several new clinical symptoms, all caused by an underlying vasculitis that affects arteries of all diameters. The HLA-B*5101 allele of HLA-...

Psoriatic arthritis (PsA) is a type of chronic inflammatory arthritis that affects approximately 1 in every 10 people with psoriasis. According to the National Psoriasis Foundation, psoriasis is most common in adults aged 30 to 50. However, psoriatic arthritis can develop at any age, including children. Accordin...

Almost two decades ago, there were limited options for ulcerative colitis treatment. The readily available ulcerative colitis therapies were aminosalicylates and immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), with biologics (Adalimumab, Golimumab, infliximab, Ustekinumab, and Vedolizumab) rese...

Sandoz Launches generic Revlimid in 19 European Countries, Bringing a Flood of Competition to BMS' Megablockbuster Since Bristol Myers Squibb acquired Celgene and its megablockbuster Revlimid, the company has been bracing for the day when the multiple myeloma superstar would face generic competition. Sandoz, a s...

The expiration of many biologic drugs patents has sparked biosimilar development and boosted the biosimilar market growth. Biosimilars are alternative versions of innovator biologic drugs. These are biological products that are similar replicas of the biopharmaceuticals that inspired them. Biosimilars are sometimes...

Prometic bags USD 50 Million stock sale option to ease a cash crunch Prometic Life Sciences got into an agreement for selling USD 50 million in stock. This gives Prometic a way to escape its current financial pressures. Canada-based Prometic was asked by the FDA to make and validate process changes for Ryplazim, a c...

EMA to relocate to Amsterdam by March 2019 Results of the Monday's vote for the European Medicines Agency relocation led to the emergence of Amsterdam as the new headquarters, beating the other finalists Milan and Copenhagen. Nineteen European Union member states submitted proposals for the EMA headquarters, and Mil...

Idera Pharmaceuticals Present Positive Phase I Data for their Drug candidate IMO-2125 Idera Pharmaceuticals announced final results from the dose-selection phase of an ongoing Phase 1/2 trial investigating IMO-2125 in combination with ipilimumab (Yervoy). The combination dose-selection phase included 18 patients, al...

Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had a...