Dr. Graham Brearley always has had a passion for applied biology, and when he was exposed to protein biochemistry during his college years, he claims the rest was simply “a natural progression.” Brearley explained that his childhood fascination with biology attracted him to the field of biologics, specifically. “I particularly enjoyed the application of biology, as opposed to just the academic study of…

Earlier this week, an FDA advisory committee voted 21 to two against backing approval of Alkermes’ ALKS 5461 for the treatment of major depressive disorder (MDD). Ahead of the committee meeting, FDA reviewers had questioned the safety of the drug and raised a number of other concerns, particularly that in two prior late-stage studies, ALKS 5461 failed to significantly improve symptoms in certain…

Pfizer CEO Ian Read said on Tuesday that the company will likely return to “business as normal” at the start of next year in regard to drug prices, despite ongoing pressure from the Trump administration. After Trump singled out Pfizer on Twitter, the company delayed a planned price hike for nearly 100 drugs. Read and…

Earlier this week, Forward Pharma, a Danish biopharmaceutical company, announced that the U.S. Court of Appeals for the Federal Circuit upheld the decision of the Patent Trial and Appeal Board validated two patents covering Tecfidera (dimethyl fumarate), Biogen’s multiple sclerosis (MS) drug. Dr. Claus Bo Svendsen, CEO of Forward commented, “We are disappointed with the Federal Circuit’s…

DxTerity, a molecular information and diagnostics company developing at-home RNA monitoring blood tests for immune-mediated diseases, will present key findings from systemic lupus erythematosus (SLE) and multiple sclerosis (MS) studies at the 2018 ACR/ARHP Annual Meeting this week.  In the Lift and Empower studies, researchers evaluated interferon gene expression levels in participants with systemic lupus…

Novartis has entered into an agreement and plan of merger with Endocyte, a U.S.-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Under the terms of the agreement, Novartis will acquire all outstanding shares of Endocyte common stock for $24 per share, totaling around $2.1 billion. If completed, Novartis will gain rights to Endocyte’s 177Lu-PSMA-617, an investigational…

Amgen and Novartis have outrun Samsung and Mylan in the race to get their approved biosimilar versions of AbbVie’s Humira (adalimumab) to market.  Amgen will launch Amgevita in markets across Europe beginning on Oct. 16, 2018. Amgevita is the first adalimumab biosimilar to be approved by the European Commission (EC). At the same time, Novartis’ Sandoz unit announced that it will…