5 Pharma Companies Cited by Industry Group For Practice Code Violations
December 15th 2017Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.
FDA Releases Draft Guidance on Refuse-to-File Action
December 15th 2017The FDA has released new draft guidance for industry on refuse-to-file (RTF) action taken by the FDA. The document seeks to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA), supplemental NDA, or a Biologics License Application (BLA), or supplemental BLA for a product regulated by CDER.
Shift in Site of Care for Oncology Has Affected the Marketplace for Oncology Drugs
December 15th 2017Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.
Federal Circuit Sides With Biosimilar Developer Sandoz in Landmark Decision
December 14th 2017The federal circuit ruled today in Amgen v Sandoz that state law cannot compel drug makers to participate in the so-called “patent dance” provided for in the Biologics Price Competition and Innovation Act because state law cannot preempt federal law.
Study: Starting Dose, Cumulative Dose Do Not Predict Rituximab Adherence in RA
December 14th 2017A recently published study explored the impact of 2 different initial doses and a cumulative 2-year dose of rituximab on drug adherence and predictors of adherence to treatment in patients with RA in an observational clinical setting.
Measuring Antibodies to Infliximab To Guide Treatment Intensification in Crohn Disease
December 14th 2017A significant proportion of patients with Crohn disease (CD) who initially respond to infliximab therapy experience secondary loss of response with symptom flares. Treatment intensification (using increases in dose, dose frequency, or a combination of both to implement intensification) is a suggested strategy for regaining response.
Congressional Testimony Calls for Action on Biosimilars
December 14th 2017On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.
Biosimilar Developers Eye Palivizumab Market
December 13th 2017Palivizumab (Synagis) is a monoclonal antibody that is used to help prevent respiratory syncytial virus (RSV). RSV is a common virus that can cause serious lung infections in infants who are at high risk, including premature infants or those who have certain heart and lung diseases.
Roche May Defend Rituximab, Bevacizumab Sales With New Drug Combinations
December 13th 2017Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.
PhRMA Sues California Over State's New Drug Pricing Law
December 12th 2017The pharmaceutical industry trade and lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA) sued California state officials in federal court on December 8, 2017, over California’s new drug pricing law, which the group states is “unprecedented and unconstitutional.”
FDA Grants Final Approval to First Short-Acting Follow-on Insulin, Admelog
December 12th 2017The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.
Eye on Pharma: Celltrion Could Receive EMA Verdict on Trastuzumab in Early 2018
December 11th 2017Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.
FDA Hosts Webinar on Biosimilar Approval Process, Looks Ahead to Interchangeability
December 9th 2017This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.
Phase 1 Data Show Sandoz's Proposed Pegfilgrastim Biosimilar Matches Neulasta's Profile
December 9th 2017Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.
Down-Titration of Biologics May Be an Option For Patients With RA
December 8th 2017A recently published systematic literature review sought to compare the effects of down-titration of biologics compared with standard dosing on clinical efficacy and health-related quality of life, and to evaluate the impact of decreased doses on the cost of RA treatment.
High Cost Sharing Associated With Lower Rates of Cancer Treatment Initiation, Study Finds
December 8th 2017Advances in research have led to increased therapeutic options for patients with cancer, but these drugs come at a substantial cost; high out-of-pocket costs pose a significant barrier to treatment initiation for patients with cancer, according to a new, retrospective claims-based study.
Study Finds Switching Patients to Biosimilar Infliximab Safe and Effective in IBD
December 7th 2017No differences in drug levels or disease activity were found when adult patients with inflammatory bowel disease (IBD) were switched from originator infliximab (Remicade) to a biosimilar infliximab (Inflectra) as part of routine care, according to the results of a Dutch study.
NAS Report: Consumer Access to Affordable Medicines Is a Public Health Imperative
December 7th 2017A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.
Novo Nordisk, Sanofi Announce Positive Data In Heated Competition for Insulin Market Share
December 6th 2017Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.
AAM Files Amicus Brief in Allergan IPR Proceeding
December 6th 2017The Association for Accessible Medicines (AAM), a trade association that represents biosimilar and generic drug makers, has filed an amicus brief in support of Mylan, Teva, and Akorn in their inter partes review (IPR) proceeding against Allergan, owner of embattled patents covering cyclosporine ophthalmic emulsion (Restasis).