Incoming British Prime Minister Theresa May said the government should defend Britain's pharmaceutical sector from takeovers, citing AstraZeneca's successful resistance to a 2014 takeover bid by Pfizer.
Patients in England with advanced thyroid cancer face delays in receiving Eisai's drug Lenvima, or lenvatinib, because it was left out of the revised Cancer Drugs Fund, according to the company. Eisai urged the National Health Service to find an interim solution to allow access to the drug.
A recent Swiss study found that as the cost of hepatitis C treatment rose, so did the rate of sustained viral response. In the US, each additional percentage point of SVR was associated with an incremental cost of $1063.81 for treatment.
Scientists with Scotland's University of Edinburgh Medical Research Council Centre for Regenerative Medicine studied the effects of the fusion gene MLL4-AF4 in embryonic mice to better understand the development of infant acute lymphoblastic leukemia, according to a study in the journal Cell Reports. In embryos with an inactive form of the fusion gene, the expression of enzymes that activate the gene resulted in a preleukaemic state of increased production of white blood cells.
Celyad granted Ono Pharmaceuticals an exclusive license that will expand the global presence of Celyad's allogeneic NKR-2 T-cell immunotherapy targeting solid and hematological tumors to South Korea, Japan and Taiwan. Celyad is entitled to receive an upfront payment of $12.5 million and as much as $299 million in milestone fees and double-digit sales royalties.
The US should integrate the National Evaluation System for Health Technology with EHRs, device registries developed by professional societies, claims databases and federal data collection initiatives to improve tracking and reporting of safety issues with medical devices, FDA Commissioner Robert Califf and Center for Devices and Radiological Health Director Jeffrey Shuren wrote in an article for the Journal of the American Medical Association. The system would allow for faster and cheaper generating of data to back approval decisions, reimbursement actions and payer coverage, they wrote.
A final guidance has been released by the FDA outlining the information medical device makers need to submit to support the electromagnetic compatibility of their products in applications for premarket approval, humanitarian device exemption, premarket notification, investigational device exemption and de novo requests. Companies are advised to use the guidance along with consensus standards and other device-specific FDA guidance documents.
As naloxone has been made more readily available, the cost of the overdose-intervention drug has climbed substantially. Amphastar, one of the two major manufacturers of naloxone in the US, increased prices for naloxone outpatient use by 60% in 2014, while Hospira, a major naloxone manufacturer acquired by Pfizer, raised the costs of its smaller-dose naloxone by about 50%.
Less expensive biosimilars of such drugs as AbbVie's Humira and Amgen's Enbrel may soon receive FDA approval, but patent issues and other hurdles may delay their entry into the marketplace for years. AbbVie, for example, doesn't expect a biosimilar competitor until 2022.
Sagent Pharmaceuticals will be acquired by Japanese drugmaker Nichi-Iko Pharmaceutical for $736 million. The deal, which is expected to close by March 2017, will support Nichi-Iko's biosimilar product pipeline marketing efforts in the US and boost its presence in injectable products and generic drugs.