Researchers Report Positive Early Data for SB2 in Treating IBD
January 4th 2019A recent letter, published in Alimentary Pharmacology and Therapeutics, reported on early findings from an ongoing, 18-month, multicenter, observational prospective study conducted among the cohort of the Sicilian Network for Inflammatory Bowel Disease (IBD). According to the authors of the letter, these are the first data on SB2 in treating IBD.
Pharma Companies Raise Prices on More than 250 Drugs in 2019
January 3rd 2019After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.
ACR Expresses Concern About International Pricing Index in Comments to CMS
January 2nd 2019The American College of Rheumatology (ACR) is apprehensive that “without substantial changes, the demonstration program could disrupt patient access to care, worsen the rheumatology workforce shortage, and exacerbate geographic disparities in access to medical care.”
Lack of Biosimilar Awareness Persists in the US and Europe, Review Finds
January 2nd 2019Biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice. A newly published systematic review evaluated US and European healthcare provider knowledge, perceptions, and prescribing behaviors related to biosimilars, and it found that providers are still taking a cautious approach to biosimilars in part because of a lack of awareness of these medicines.
Rituximab May Treat Early-Onset Nephrotic Syndrome
January 1st 2019In children, idiopathic nephrotic syndrome (NS) generally responds well to treatment with corticosteroids, but long-term use of steroids in children can produce adverse effects (AEs) such as growth impairment and hypertension. Calcineurin inhibitors, too, are associated with AEs, including toxicity and diabetes. Rituximab has been proposed as an option for difficult-to-treat childhood-onset NS, and a recent study evaluated the efficacy and safety of a single dose of rituximab in this setting.
Rituximab Combination Has Positive Activity in Non-Hodgkin Lymphoma
January 1st 2019Hu5F9, an immune checkpoint inhibitor blocking CD47, has showed promise in working together with rituximab to eliminate non-Hodgkin lymphoma cells. A recent study looked to evaluate the drug in combination with rituximab in a clinical setting.
Key Incoming Lawmakers Have Received Major Pharma Contributions
January 1st 2019As Congress prepares to begin its new term, newly elected lawmakers will convene to tackle issues such as the high cost of drugs. As they prepare to address these policy challenges, a new analysis shows that several key congressional leaders have received major contributions from the pharmaceutical industry.
Risk of TB High in Indian Patients With IBD Who Receive Infliximab
December 31st 2018Data on the risk of tuberculosis (TB) reactivation with infliximab therapy in patients with inflammatory bowel disease (IBD) who are from countries where TB is particularly prevalent, such as India, remains limited. A recent study sought to evaluate the rate of tubercular reactivation with infliximab in a cohort of patients with IBD.
Study in Patients With IBD Finds Good Long-Term Efficacy of CT-P13
December 31st 2018Biologic drugs can effectively treat inflammatory bowel disease (IBD), but the cost of these products can be prohibitive. Biosimilars such as CT-P13 (Remsima, Inflectra), an infliximab biosimilar referencing Remicade, have the potential to drive down treatment costs and enhance access to biologics for the patients who need them.
Stakeholders Weigh In on the Key Biosimilar Developments of 2018
December 31st 20182018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.
Study: Vedolizumab In the First Line Brings Down IBD Treatment Costs
December 29th 2018Vedolizumab is approved by the FDA for the treatment of moderate to severe Crohn disease or ulcerative colitis, both forms of inflammatory bowel disease (IBD), who have had an inadequate response or loss of response to immunomodulators, tumor necrosis factor inhibitors, or corticosteroid therapy.
High Costs Drive 1 in 4 Patients With Diabetes to Use Too Little Insulin
December 27th 2018Despite the fact that the World Health Organization classifies insulin as an essential medicine that should be available at all times at a price that patients can afford, US insulin prices have continued to climb in recent years.
Study: Pegfilgrastim May Be an Option for Patients With Germ Cell Tumors
December 26th 2018Germ cell tumors are common malignancies, and chemotherapy with a regimen of bleomycin, etoposide, and cisplatin (BEP) has improved the prognosis for patients with these tumors. However, BEP involves significant myelosuppression, and the safety of pegfilgrastim for the prevention of febrile neutropenia related to myelosuppression has not been well investigated in patients with this tumor type.
Infliximab Could Help Adults With Kawasaki Disease
December 26th 2018While Kawasaki disease (KD) typically affects children, it can, in rare cases, affect adults, leading to coronary artery abnormalities and acquired heart disease. Given that the disease is rare in adults and that its etiology is not fully understood, diagnosis and treatment of KD in adults can be challenging.
Bevacizumab Plus Chemotherapy Improves PFS in Early Ovarian Cancer
December 25th 2018A recent study evaluated the impact of adding bevacizumab to chemotherapy treatment for patients who were newly diagnosed with ovarian cancer. The results, published in Gynecologic Oncology, found that while the addition of bevacizumab greatly improved progression-free survival (PFS), it did not improve overall survival.
Systematic Review Finds No Difference in Efficacy of Short-Acting and Long-Acting G-CSF Agents
December 25th 2018A recent systematic review of the literature reported on randomized controlled trials and nonrandomized studies on the use of granulocyte colony-stimulating factor therapies (G-CSFs) to reduce the incidence of febrile neutropenia, and found that short- and long-acting therapies, when dosed according to guidelines, have little difference in their efficacy.
Eye on Pharma: Chong Kun Dang's Darbepoetin Alfa Biosimilar Approved
December 24th 2018This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.
GAO Finds Trouble With Orphan Drug Designations
December 24th 2018Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.
Researchers Report on Clinical Program for Proposed Trastuzumab Biosimilar, HLX02
December 23rd 2018During the European Society for Medical Oncology’s Asia 2018 annual meeting, held in Singapore from November 23 to November 25, a research team presented an update on the clinical program for HLX02, a proposed trastuzumab biosimilar referencing Herceptin. The proposed biosimilar is being developed by the Chinese firm Shanghai Henlius Biotech.