Tag: FDA
New technology allows control of gene therapy doses
Technique appears to solve a major safety issue and could lead to much more use of gene therapies.....................
BD Medical-Pharmaceutical Systems to hold Technovation Season 9
The event will further Becton Dickinson’s efforts to strengthen partnerships with pharmaceutical companies and bring relevant solutions to create a positive impact on the lives of patients.................
CDSCO issues alert on Medtronic’s pacemakers, company says no product recall
The CDSCO has advised patients with specific pacemakers from Medtronic to seek immediate medical assistance if they feel dizzy, light-headed, severe short breath or loss of consciousness. Meanwhile, the company has said it is in talks with the regulator............
Lupin Bioresearch Centre completes fifth successful US-FDA inspection
Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune...................
“AI has the potential to revolutionize healthcare delivery”
Mentioned Dr Geetha Manjunath, CEO & CTO of Bangalore-based healthtech startup NIRAMAI in an exclusive interaction with BioVoice where she spoke about the artificial intelligence in healthcare and an innovative early breast cancer detection technology developed by her company...….
Global home diagnostics market revenues to surpass US$ 6.3 million by...
As per a Fact.MR study, increasing preference for self-diagnosis continues to be a trigger for home diagnostics sales, whereas a combination of industry-specific and regulatory factors continue to influence the strategies of market players...………..
Indian medical device firms be given faster access to US-FDA: study
Indian medical device industry is worth over Rs 60,000 crore even as country’s import bill for this segment amounts to over Rs 23,000 crore while exports amount to about Rs 7,000 crore, as per the study by ASSOCHAM and MRSS India...………..
Regulatory support, big pharma interest will boost precision medicine for cancer
The leading market analysis firm, GlobalData has predicted that the precision medicine approaches for for tumor agnostic development will accelerate due to the enhanced regulatory support and interest from big pharmaceutical players in the market...………..
US FDA approves Mylan & Biocon’s biosimilar, Fulphila
Second FDA-approved biosimilar through the Mylan-Biocon collaboration,, Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection...............
Pricing adjustments for CAR-T therapies likely to take place in 2018,...
A fairly comprehensive study reported in February 2018 on the Health Affairs Blog claims that Novartis could lower the price of Kymriah by two-thirds and still achieve a profit..................