Novo Nordisk decided to resubmit two rejected insulin products to the FDA for approval. In early 2013, the FDA declined to approve Tresiba, one of the drugs, over concerns about cardiovascular risks. The Danish drugmaker initiated a cardiovascular outcomes trial for Tresiba in October of that year and now plans to resubmit new drug applications for Tresiba and Ryzodeg within the next few weeks. Shares rose as much as 14% after Novo announced the news on Thursday, according to Bloomberg News. Analysts say this means Tresiba may be approved as soon as October or November of this year.
The World Health Organization urged European governments to share information about the cost-effectiveness as well as possible off-label use of medications, according to The Wall Street Journal’s Pharmalot blog. It also recommended that drugmakers make pricing for their products more transparent. Doing this will help European countries better address rising costs, the WHO report said.
The European Commission approved two weight-loss drugs—Orexigen Therapeutics’ Mysimba (which is called Contrave in the US market) and Novo Nordisk’s Saxenda. Both drugs are approved in the US. The approvals may signal a new willingness by European regulators to allow marketing of weight-loss drugs, MedPage Today reported. Regulators there have traditionally been “less welcoming” to marketing weight-loss drugs. The commission previously rejected marketing applications for Arena’s Belviq and Vivus’s Qsymia, which were both approved by the FDA.
Johnson & Johnson and Google plan to develop a robotic-assisted surgery system, Bloomberg News reported. Intuitive Surgical, which markets the da Vinci robotic surgery system, is the only company to receive FDA approval so far to sell such systems in the US.
The White House is expected to release a broad report later today that looks at antibiotic resistance and the rise of so-called superbug infections, according to Reuters. One goal in the report focuses on investing in new diagnostics and antibiotic drugs, the news service reported. In addition, hospitals will be required to put into place better infection-control programs, which reduce the use of antibiotics in patients, and physicians will have to report their antibiotic prescribing patterns.