House of Representatives Passes Pelosi Drug Bill 230-192
December 13th 2019The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.
Slower Price Growth, Use of Generics Balance Higher Spending on Cancer, Autoimmune Drugs
December 10th 2019Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.
Nocebo Effect Can Hamper Biosimilar Acceptance, Review Says
December 6th 2019Interestingly, nocebo effects may also be induced by exposure to information shared online, through social media, through drug advertisements, and advertised descriptions or warnings about health-related conditions. The effect can be profound; the authors said negative expectations underlying nocebo phenomena have been shown to alter activity in certain regions of the brain.
Bio-Thera Solutions Gets Clearance to Start Phase 1 Trial of Ustekinumab Biosimilar
December 5th 2019Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.
Reports Say Administration May Agree to Democrats' Demands on USMCA Biologic Patent Rules
December 3rd 2019Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.
Report Shows How Much Price of Adalimumab, Insulin Glargine, Varies Globally
November 25th 2019How much does the price of common drugs vary across the globe? A UK digital healthcare startup collected that information to display the disparities across 50 countries for 13 often-used pharmaceuticals, including adalimumab and insulin glargine.
GAO Report: Reference and Generic Sponsors Look Differently at FDA REMS Enforcement
November 20th 2019Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.
Medicare Enrollees Looking at Stand-Alone Part D Drug Plans Should Shop Around, Report Says
November 20th 2019With more choices available in 2020 for Medicare stand-alone Part D drug plans, beneficiaries should compare choices, especially if they are not low income or on specialty drugs or drugs not on the payer’s formulary, according to a new analysis.
More Data Needed on Using Biologics in Children, Review Says
November 18th 2019A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).
Bill to Stop Disingenuous Citizen Petitions Advances in House
November 15th 2019A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.
Infants Exposed to Tofacitinib In Utero Experience Very Few Serious Infections, Study Says
November 13th 2019The results will inform will inform counseling and management of pregnant women with inflammatory diseases who need tofacitinib or non-tumor necrosis factor inhibitors during pregnancy, said the author.
Rising Drug Prices Cited for Most Biologic Spending Growth
November 11th 2019Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.
Novartis' Secukinumab Narrowly Misses End Point in Trial Against Adalimumab
November 1st 2019Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.
FDA Says a "Broken Marketplace" to Blame for Drug Shortages
October 30th 2019Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.
After Public Drug Coverage for Infliximab, Adalimumab, Surgeries and ED Visits for CD Fell
October 29th 2019Between 2003 to 2014, patients in Ontario, Canada, received public drug benefits for infliximab or adalimumab at a combined rate of 2.2% in 2003, rising to 18.8% of eligible patients by 2014. During that period, the prevalence of Crohn‐related hospitalizations fell 32.4%.
Bipartisan Patent Transparency Bill Introduced in House of Representatives
October 28th 2019A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.
House GOP Lays Out Healthcare Vision in Blueprint
October 23rd 2019Republicans in the House of Representatives this week laid out their alternative to the Affordable Care Act (ACA) in an effort to position themselves against various Democratic healthcare proposals. The document contains many ideas that have been debated previously when Republicans tried to repeal the ACA, and it draws on work from the Heritage Foundation and the Cato Institute.
Have FDA Actions to Ease Generic Drug Shortages Taken Effect Yet?
October 16th 2019Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.
Oncologist Experience With Rituximab Factors Into Early Discontinuation Rate
October 15th 2019The less experience an oncologist has with administering rituximab, the more likely a Medicare beneficiary with non-Hodgkin lymphoma is to discontinue treatment, according to a new study. In addition, early rituximab discontinuation was associated with inferior lymphoma-specific and overall survival.