Along with the new indication, the Food and Drug Administration DA approved a next-generation sequencing-based test to identify the RAS mutation status of a patient’s tumor, which Amgen said helps identify patients who would benefit from treatment with Vectibix.
The agency has outlined its Orphan Drug Modernization plan, which it said is part of a larger effort called the Medical Innovation Development plan modernize and make efficient the FDA’s regulatory tools and policies.
Rituxan Hycela contains hyaluronidase human, an enzyme that helps with the subcutaneous delivery of Rituxan's active ingredient, rituximab, allowing for faster administration compared with intravenous Rituxan.
The Supreme Court has overturned an appeals court decision which said Sandoz had to wait 180 days under federal law after receiving Food and Drug Administration approval to launch its biosimilar of Amgen’s Neupogen (filgrastim), Zarxio (filgrastim-sndz).
The latest report on generics cost savings, compiled by the QuintilesIMS Institute on behalf of the Association for Accessible Medicines, highlights the key role generics play in healthcare cost savings.
According to the QuintilesIMS Institute’s 2017 Medicine Use and Spending report, Truvada had $3.1 billion in sales on an invoice price basis in 2016, ranking 17th among the top 20 medicines in the U.S. based on invoice spending.
Since 2011, 68 novel therapies have been approved globally across 22 cancer indications. The QunitilesIMS Institute report looks at what technological advances and development trends have made this possible, as well as their cost.
Under the acquisition, MedCart will continue to operate as it did before, but as a new business unit under Albertsons’ pharmacy team structure, with the leadership team reporting directly to Albertsons group VP pharmacy operations, Dain Rusik.
India-based Cipla announced May 25 that it would be cutting its investment in its biosimilars development arm to focus on respiratory products, Reuters reported. The company has halted plans to invest $1.3 billion in building a biotechnology plant in South Africa and is on the lookout to partner with other companies on its already existing biosimilars efforts, the report said. "We are not moving away from biosimilars. However, we are not in the aim to make them at $1 a day,” Cipla CEO Umang Vohra said. (Reuters)
Under the law, which was signed by President Barack Obama in December 2016, the payment structure for infusion drugs under Medicare Part B changed from an average wholesale price to an average sales price.
“Pharmacists need to understand what’s happening around them regarding the availability of precision medicines and their profiles,” Murray Aitken, executive director of the Quintiles IMS Institute and co-author of the report, said during the International Pharmaceutical Federation 6th Pharmaceutical Sciences World Congress.