The FDA has finally approved to market the implantable continuous glucose monitoring system named Eversense, from Senseonics, in the United States.
Keytruda is now allowed only for the patients whose tumor expression levels of the biomarker PD-L1 meet a combined positive score of 10 or higher. Tecentriq can only be used where PD-L1 immune cells can cover only 5% or more of their tumor area.
On Wednesday, a day after Keytruda got the thumbs up for cervical cancer, the drug was approved for treatment of a rare form of non-Hodgkins lymphoma patients who cancer returned after at least two previous treatment lines. Last year, Keytruda also got an indication for classical Hodgkin lymphoma.
Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
Global healthcare is being led by the US with China following close behind. Europe is simply being a spectator to the developments that are unfolding on a global level.
Pharma giant Merck & Co. revealed Keytruda had perfectly completed its final-stage research on the drug for previously untreated patients with skin cancer, who represent about 25% to 30% of the overall market.
Cincinnati-based startup Eccrine System has developed a health wearable devices called Sweatronics which tracks your health using sweat. Other bodily fluids like urine and blood contain plenty of the body information’s but are not as easy to collect. However, Sweatronics needs only sweat samples that is produces automatically while working or even sleeping.
Though the US stands first in the race in terms of sales and growth, it is highly believed that China would reach the peak in the pharma market by 2022. At present, since there has been a decrease in public health funding, there has been a slight fall in pharmerging countries like Brazil, Russia, India and China (BRIC). But it is believed that the condition of these pharmerging countries will improve in the next five years [1].
Ascletis Pharma has become the first company to seek to list (PDF) in Hong Kong under the exchange’s new, more relaxed rules on biotech IPOs. The antiviral disease specialist will use the cash to win approvals for hepatitis C drugs licensed from Roche and Presidio Pharmaceuticals.
According to reports, the biotechnology company Abpro has rescheduled its $96 million IPO, delaying a capital infusion it hoped would support the first clinical trials of its lead product candidates over the next year.
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