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…
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…
(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,…
(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…
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
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…
(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…
Shingles, also known as herpes zoster (HZ), is a common and sometimes debilitating disease that disproportionately affects elderly individuals and those who are immunocompromised. Patients with rheumatoid arthritis (RA) have a 1.5–2-fold higher risk of developing HZ compared with healthy adults. Treatment with some disease-modifying anti-rheumatic drugs (DMARDs) has been shown to increase this risk….
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
(Reuters)—Washington state on Thursday sued OxyContin maker Purdue Pharma LP, becoming the latest state or local government to file a lawsuit seeking to hold pharmaceutical companies accountable for a national opioid addiction epidemic. The city of Seattle also filed a separate lawsuit against Purdue as well as units of Teva Pharmaceutical Industries Ltd, Johnson and…