Effective Infliximab Treatment for CD Is Associated With Improved Mental Health
June 11th 2018Crohn disease (CD) can involve physical, psychological, and social impairments that negatively impact patients’ quality of life, and high levels of anxiety and depression have been observed in patients with CD.
Rituximab Granted FDA Approval to Treat Pemphigus Vulgaris
June 8th 2018The FDA has approved Genentech’s innovator rituximab (Rituxan) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). This expanded indication makes the drug the first biologic approved for the treatment of PV, a rare autoimmune disease that affects the skin and mucous membranes with progressive blistering.
Review Finds That Switching to Biosimilar Infliximab in Patients with IBD is Acceptable
June 7th 2018The question of whether to switch patients from a reference biologic to an available biosimilar has been the subject of extensive debate, especially in patients with inflammatory bowel disease (IBD), an indication in which evidence on relevant clinical outcomes after switching is limited.
Second Patent Cliff Lies Ahead for Pharma With $251 Billion in Sales at Risk by 2024
June 7th 2018EvaluatePharma, a company that provides consensus forecasts of the pharmaceutical and biotechnology sphere, recently published its 11th edition of its World Preview. In this 2018 installment, the company provided an overview of what investors and other stakeholders can expect to see in the industry from 2018 to 2024.
Eye on Pharma: Celltrion to Develop Novel Drugs Alongside Biosimilars
June 6th 2018Republic of Korea-based biosimilar developer Celltrion, maker of Inflectra, has announced that it will launch a contract development and manufacturing business to develop novel agents alongside its biosimilar pipeline.
FDA Draft Guidance Clarifies Meeting Types for Biosimilar Applicants
June 5th 2018This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.
Celltrion Reports Positive Phase 1 Results for Subcutaneous Inflectra in CD
June 5th 2018Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).
Apobiologix's Biosimilar Pegfilgrastim Approved in Canada
June 4th 2018On June 1, drug maker Apotex announced that its Apobiologix division has received approval from Health Canada for its pegfilgrastim biosimilar, Lapelga. Lapelga is the first pegfilgrastim biosimilar to be approved in a highly regulated territory.
FDA Approves JAK Inhibitor to Treat Ulcerative Colitis, Providing an Alternative to Anti-TNF Agents
June 2nd 2018This week, the FDA approved an expanded indication of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) to include adults with moderate to severe ulcerative colitis. Tofacitinib is the first oral medicine approved for long-term use in UC, and provides an alternative to anti–tumor necrosis factor (anti-TNF) drugs that must be injected or infused.
Panel Grapples With the Role of Biosimilars in Oncology
June 1st 2018On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.
COA Sues HHS, OMB Over Medicare Sequester Cuts
June 1st 2018This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.
FDA Issues 2 Draft Guidance Documents on REMS Programs
May 31st 2018FDA Commissioner Scott Gottlieb, MD, on Thursday announced new draft guidance documents aimed at limiting the potential for drug makers to abuse Risk Evaluation and Mitigation Strategy (REMS) requirements. The announcement comes on the heels of President Donald Trump’s drug pricing plan, which called on the agency to issue guidance on how manufacturers use REMS programs to delay competition from follow-on products.
Eye on Pharma: Celltrion Resubmits BLA for Rituximab Biosimilar
May 30th 2018Biosimilar developer Celltrion has resubmitted its Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, to the FDA for regulatory consideration. The company received a Complete Response Letter for the drug in April 2018, after having received an earlier warning letter from the agency that raised concerns about the company’s manufacturing processes.
Study: Europe Is Overspending on AMD Treatment by Not Using Bevacizumab
May 29th 2018In a new paper, researchers sought to describe how much the European Union is overspending on neovascular age-related macular degeneration treatment by relying on ranibizumab and aflibercept rather than bevacizumab in ophthalmology.
Obesity Is a Predictor of Inferior Response to Anti-TNF Drugs
May 29th 2018While it is already known that obesity may contribute to an increased risk developing some immune-mediated inflammatory diseases, as well as more severe disease activity and a higher burden of hospitalization, a new review found that obesity is also a predictor of inferior response to anti–tumor necrosis factor (anti-TNF) agents.