NICE issues final green light and thus securing routine NHS funding for Roche’s Perjeta in patients with a certain type of breast cancer. The guidelines follow a confidential commercial agreement for Perjeta between NHS England and the Roche late last year, allowing for its move from the Cancer Drugs Fund to the NHS’ routine commissioning
Regulatory Professionals, part of the Clinical Professionals Group, collaborated with data analytics company, VacancySoft, to generate a monthly report that offers an in-depth analysis of EU and UK vacancies available in different sectors of the life sciences industry. The CPIA report tracks how vacancies progress over time and monitor any fluctuations that indicate areas of
US regulators are conducting a priority review of Roche/Genentech’s experimental multiple sclerosis therapy Ocrevus, which some believe has the potential to transform treatment of the disease. Ocrevus is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell, that is believed to be a key contributor to
NICE has published new guidelines endorsing NHS use of five medicines that will widen treatment options for some patients with lung cancer, high cholesterol, melanoma and the skin condition hidradentitis. Following a previous rejection for the drug, Novartis’ targeted therapy Zykadia (ceritinib) has been given approval for treating anaplastic lymphoma kinase (ALK) positive non-small-cell lung
The FDA has approved Celltrion and Pfizer’s biosmiliar of J&J’s Remicade for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Which makes it the second biosimilar approved in the US. HyoungKi Kim, CEO of Celltrion, said that the company’s biosimilar, named Inflectra, is expected to be priced 20 to 30
Roche Group announced today that the FDA has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who had disease progression during or following platinum-based chemotherapy in the metastatic setting, or whose disease worsened within 12 months of
The US Food and Drug Administration has cleared Gilead’s Odefsey for the treatment of certain patients with HIV-1 infection. Odefsey is Gilead’s second TAF-based regimen to receive approval from the US FDA, after the approval of Genvoya in November last year.
Regulatory Professionals, part of the Clinical Professionals Group, are delighted to announce that Clinical Professionals’ 2016 Life Sciences Salary Survey is complete and available for delivery. Nine months in the making, the survey was launched with the aim to analyse industry salaries, coms/benefits for core roles throughout the Life Sciences industry (pharma/biotech/CRO): • Clinical Research
Eisai has filed its cancer drug Lenvima (lenvatinib) in Europe for use against advanced or metastatic renal cell carcinoma (RCC), where its review will be fast-tracked.
The FDA has granted Priority Review status to Takeda’s New Drug Application (NDA) for ixazomib. Ixazomib is the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.