(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…
Pain Treatments Move Closer to U.S. Market
Two pain treatments, extended-release injectable suspension triamcinolone acetonide (Zilretta) and meloxicam, have seen movement at the U.S. Food and Drug Administration (FDA). In October, the agency approved Zilretta to treat osteoarthritis (OA) knee pain and accepted a new drug application for meloxicam to treat pain. FDA Approves Zilretta On Oct. 6, the FDA approved extended-release,…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
GlaxoSmithKline’s Shingles Vaccine Gets Approval in Canada
(Reuters)—Canadian health regulators have approved GlaxoSmithKline’s shingles vaccine, the company said on Friday.1 Shingrix, the British pharma company’s shingles vaccine for people aged 50 years or older, was unanimously recommended for approval by a U.S. Food and Drug Administration (FDA) advisory panel last week. Older people are most at risk of an outbreak of shingles,…
Flexion’s Knee Pain Drug Gets FDA Approval
(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…
Secukinumab Meets 5-Year Benchmark for Psoriasis
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
New Jersey Sues Insys as Opioid Maker Settles with Massachusetts
BOSTON (Reuters)—New Jersey on Thursday accused Insys Therapeutics Inc of engaging in a fraudulent scheme to boost sales of a fentanyl-based cancer pain drug, as Massachusetts announced a $500,000 settlement with the drugmaker to resolve similar allegations. The lawsuit by New Jersey Attorney General Christopher Porrino accused Insys of illegally directing its sales force to…
Cigna to End OxyContin Painkiller Coverage, Signs Contract for Alternative
(Reuters)—Amid a growing U.S. opioid addiction, health insurer Cigna Corp will stop covering OxyContin, the opioid painkiller sold by Purdue Pharma LP, as of January 1 and will instead cover an equivalent with a formulation less vulnerable to abuse, the company said on Wednesday. The insurer has signed a “value-based contract” with Collegium Pharmaceutical Inc…
- « Previous Page
- 1
- …
- 58
- 59
- 60
- 61
- 62
- …
- 123
- Next Page »