Dan Reynolds, the lead singer of the Grammy award-winning band Imagine Dragons, has partnered with Novartis to increase awareness of ankylosing spondylitis.
Amgen Wins U.S. Patent Battle on Arthritis Drug Enbrel
(Reuters)—A U.S. judge on Friday upheld two patents relating to Amgen Inc,’s blockbuster rheumatoid arthritis drug Enbrel (etanercept), denying a challenge by Novartis AG, which is seeking to launch a biosimilar version. The decision was a relief to investors concerned about a competitive threat to Enbrel, which had U.S. sales of $4.8 billion last year….
FDA Rejects Novartis Bid to Repurpose Inflammation Drug for Heart Attacks
ZURICH (Reuters)—The U.S. Food and Drug Administration (FDA) has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors, according to the Swiss drugmaker. The company received an FDA letter turning down its bid to make canakinumab a targeted therapy for those…
Novartis Receives EU Approval for Infliximab Biosimilar Zessly
ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
Novartis, U.S. Partner Plan Remote Trials to Boost Participation
ZURICH (Reuters)—Novartis plans up to 10 clinical trials over three years using a U.S. partner’s mobile technology to help free patients from burdensome hospital trips as the Swiss drugmaker aims to boost study participation and cut costs. Novartis said on Wednesday it would work with Science 37, a California-based company that provides technology including smart…
Novartis to Shut U.S. Generics Plant, Cut 450 Jobs
ZURICH (Reuters)—Swiss drugmaker Novartis is to cut 450 jobs in the United States over the next two years as it gradually shuts a generics manufacturing plant in Colorado and discontinues some products in the face of intense price pressures. “To remain competitive in the U.S., Novartis will discontinue or divest limited growth products in saturated…
Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…
Novartis Bid to Sell New Biosimilar Crimped by U.S. Court Battles
ZURICH (Reuters)—Novartis has won U.S. approval for a copy of Amgen’s blockbuster arthritis drug Enbrel, but the Swiss drugmaker’s bid to muscle in on the medicine’s $4.7 billion in annual U.S. revenue remains blocked by court battles. Novartis’s Sandoz unit said on Tuesday the U.S. Food and Drug Administration (FDA) approved Erelzi, its biosimilar copy…
FDA Panel Supports Novartis Biosimilar of Etanercept
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
Roche & Novartis Face Off in Biosimilar Drug Battle
ZURICH (Reuters)—Switzerland’s biggest drugmakers are clashing over cheaper copies of pricey biotech drugs—one reason why Novartis is considering selling its $14 billion stake in cross-town rival Roche. With a copycat of Roche’s blood cancer drug Rituxan (rituximab) pending European approval, Novartis aims to muscle in on a share of sales that last year hit 7…