These are last month’s pharma news and developments brought to you by Congress Bookers, a reliable accommodation partner for lead pharma companies worldwide.
AstraZeneca entered agreement with TerSera Therapeutics for Zoladex
AstraZeneca entered an agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex in the US and Canada. Zoladex is used to treat prostate cancer, breast cancer and several benign gynaecological disorders.
Under the agreement, TerSera is set to pay AstraZeneca USD 250 million upfront, plus USD 70 million in sales-related milestones and a quarterly share of sales in the “mid-teen percentage” range. AstraZeneca will also develop and supply Zoladex to TerSera.
Novo Nordisk filed for regulatory approval of semaglutide for the treatment of type 2 diabetes in Japan
Novo Nordisk has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new glucagon-like peptide-1 analogue for the treatment of adults with type 2 diabetes.
This move follows the recent once-weekly semaglutide regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic.
Allergan Launched See America
Allergan launched a new initiative dubbed See America, through which it aims to make vision health a priority for all US residents. Increasing awareness of the diseases that can cause blindness and enhancing access to vision care for those who need it most are the initiative’s main focus.
The launch followed the release of a report published by the National Academies of Sciences, Engineering, and Medicine (NASEM), which stressed upon the overwhelming number of Americans affected by blindness from preventable causes.
Amgen’s Parsabiv got FDA approval
The US Food and Drug Administration (FDA) approved Amgen’s Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.
Parsabiv is the first therapy approved for this condition in 12 years. It is also the only calcimimetic that can be administered intravenously three times a week after the hemodialysis session.
Roche to start second late-stage study of Alzheimer’s disease drug
Roche’s partner AC Immune revealed that Roche is set to launch a second Phase III study of the experimental Alzheimer’s disease therapy crenezumab. The latter was discovered by AC Immune and out-licensed to Roche’s Genentech unit in 2006. The CREAD2 trial will enrol 750 patients with prodromal or mild Alzheimer’s disease.
Boehringer Ingelheim’s Giotrif got approved for lung cancer in China
Global pharmaceutical company Boehringer Ingelheim announced that their afatinib (Giotrif), an irreversible second-generation ErbB family blocker, was approved for lung cancer in China.
Afatinib has received Imported Drugs License (IDL) status by the China Food and Drug Administration (CFDA) for locally advanced or metastatic EGFR mutation-positive lung cancer patients who have not received any prior therapy with tyrosine kinase inhibitors, as well as for patients with locally advanced or metastatic squamous cell carcinoma of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.
Afatinib is the first and only second-generation ErbB family blocker approved in China.
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