Aeglea BioTherapuetics announced that it had failed to secure a biologics license application (BLA) from the FDA after administrators issued a refusal to file for the company’s biologic...
FDA recently accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Pfizer’s interchangeable biosimilar to Humira, Abrilada.
Abrilada is a...
Biogen and Xbrane Biopharma recently agreed to develop, manufacture, and commercialize a preclinical monoclonal antibody and proposed biosimilar, Xcimzane, referencing Cimzia.
Cimzia is a drug...
Samsung Biologics will acquire Biogen’s stake in Samsung Bioepis for $2.3 billion to accelerate growth in biosimilars and novel therapeutic research and development.
Under the terms of the...
The estimated drug price inflation rate for this year is expected to have a moderate price increase, according to Vizient’s 2022 Pharmacy Market Outlook.
The Vizient Pharmacy Program looked at...
FDA recently approved Boehringer Ingelheim’s Cyltezo as the first interchangeable biosimilar product to treat certain inflammatory diseases.
Specifically, the agency approved the drug for...
FDA recently approved Samsung Bioepis and Biogen’s Byooviz as the first biosimilar to Lucentis to treat several eye diseases and conditions.
Byooviz is approved to treat neovascular (wet)...
FDA recently approved GSK’s Nucala, a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The new indication for...
Total net prescription drug spending is expected to reach $380 billion to $400 billion in 2025, an increase from $359 billion in 2020, according to an IQVIA analysis.
This forecast is fairly...
A Kaiser Family Foundation analysis recently found that a small number drugs accounted for a disproportionate share of Medicare prescription drug spending in 2019.
Researchers measured the share...
Thermo Fisher Scientific recently launched its Vanquish Online 2D-Liquid Chromatography (LC) system, which offers versatility for multidimensional liquid chromatography.
The system offers a robust...
Future industry-wide trends for pharmaceutical companies and manufacturers are taking root as the industry continues to respond to the COVID-19 pandemic.
Listen to the full podcast to hear...
President Joe Biden recently signed an executive order to combat COVID-19 and prepare for future biological and pandemic threats.
“The Federal Government must act swiftly and aggressively...
Thermo Fisher Scientific and the Biopharmaceutical Analysis Training Laboratory (BATL) at Northeastern University recently entered into an agreement to drive innovation across the...
FDA recently published a list of 223 essential medicines, medical countermeasures, critical inputs to have available at all times and serve patient needs in the appropriate dosage forms.
The product...
A recent Health Affairs study found that 64 percent of new biologic and drug indications deemed relevant to pediatric patients lacked pediatric prescribing information five years after FDA...
Johnson & Johnson recently announced the completion of a $6.5 billion pharmaceutical acquisition deal involving biotechnology company Momenta Pharmaceuticals, Inc.
This announcement comes a...
The FDA recently finalized a rule that would allow prescription drug importation from Canada in FDA-authorized programs.
The final rule, part of the White House’s Safe Importation Action Plan,...
Drug rebates are distorting the market for branded drugs and producing outcomes that may be harmful to both patients and the healthcare system, according to a recent study by the Pioneer Institute.
In...
Mylan and Biocon Biologics recently announced the US launch of biosimilar Semglee in vial and pre-filled pen presentations, to help control high blood pressure in pediatric patients with type 1...
