The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
News Updates for Diclofenac Sodium, Denosumab & Sarilumab
In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
The Birth and Growth of Biotechnology, and the Impact of Biologic Drugs on Rheumatology
Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure. The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the…
Sanofi to Invest Further in Biologics
PARIS (Reuters)—Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential. In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells. They are seen as a promising answer in…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
FDA Update: Romosozumab’s Uncertain Future; Plus Tocilizumab Approved for GCA
Due to possible heart-related side effects, romosozumab is no longer expected to be approved this year for the treatment of osteoporosis…
U.K. Competition Watchdog Accuses Merck of Obstructing Biosimilars
LONDON (Reuters)—Britain’s competition watchdog has accused Merck & Co of operating an unfair discount scheme for its medicine Remicade (infliximab) that it said was designed to restrict competition from so-called biosimilar copies. The Competition and Markets Authority (CMA) says it had provisionally found the U.S. company’s European unit, Merck Sharp & Dohme (MSD), had abused…
Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis
The FDA has approved infliximab-abda, a biosimilar for treating multiple rheumatic diseases, as well as abaloparatide for treating postmenopausal women with osteoporosis…
Rheumatology Drug Updates: Sirukumab Promising for RA, Plus Efficacy Duration of Ustekinumab for Plaque Psoriasis
Sirukumab Promising for RA Sirukumab, an investigational human monoclonal antibody that selectively binds to the interleukin (IL) 6 cytokine, has completed a randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical trial (SIRROUND-T) in patients with rheumatoid arthritis (RA).1 During the trial, which took place between July 25, 2012, and Jan. 12, 2016, researchers randomized adult patients…
Pricey Arthritis Drug Effective in Small Fraction of Ulcerative Colitis Cases
NEW YORK (Reuters Health)—Pfizer’s expensive arthritis drug tofacitinib has been shown to produce a remission in nearly 1 in 5 patients with moderate to severe ulcerative colitis, but long-term remission persists in fewer than half of those cases. In a series of studies published in the May 4 New England Journal of Medicine, researchers reported…
- « Previous Page
- 1
- …
- 16
- 17
- 18
- 19
- 20
- …
- 40
- Next Page »