All Class A and Class B med device makers to switch to licensing regime within; many are dealing with slow pace of govt audits or simply not clearing them The transition of Class A and Class B medical device makers…
US drug regulator resumes surprise inspections in India
The US drug regulator has stepped up its inspection activity in India, and plans to have more surprise or ‘short notice’ inspections, ending the two-year reprieve from ‘warning letters’ and other regulatory measures that Indian drug makers have enjoyed since…
Could cancer be diagnosed from the sound of a voice?
A $14 million research project is getting underway in the US to see whether cancer and other diseases can be diagnosed by picking up subtle changes in a person’s voice patterns. The National Institutes of Health (NIH)-funded project is being…
CHMP says yes to Sanofi/AstraZeneca antibody for RSV prevention
Sanofi and AstraZeneca are closing in on EU approval of nirsevimab, their long-acting antibody for the protection of newborns and infants from respiratory syncytial virus (RSV) infections. The EMA’s human medicines committee – the CHMP – has recommended approval of…
ObvioHealth launches new decentralised clinical trial platform
ObvioGo incorporates real-world data, AI, digital instruments, and integration with clinical systems through APIs and interfaces. ObvioHealth has introduced a next-generation decentralised clinical trial (DCT) platform and mobile application called ‘ObvioGo’ to provide robust therapeutic efficacy and safety evidence. The…
New trends in the treatment of diseases
Researchers have found that an alcohol support group, such as Alcoholics Anonymous, when combined with other treatments is much more effective in getting the alcoholic to stay sober. Folks afflicted with rheumatoid arthritis normally have discomfort caused by inflammation…
Bayer bags swift OK for Nubeqa in metastatic prostate cancer
Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1…
US Democrats’ blockbuster budget bill could spell big changes for drug prices
The Inflation Reduction Act of 2022, a sweeping measure that now looks likely to be passed through budget reconciliation by Senate Democrats in the US, contains measures intended to greatly reduce US prescription drug prices — but the pharma lobby…
Government to support agri field, clinical trials for new technologies
The Technology Development Board (TDB) under the Department of Science and Technology will start extending funds for agricultural field trials and clinical trials for new technologies, according to Rajesh Kumar Pathak, Secretary of TDB. At a meeting on “Financial Assistance…
Poseida, Roche collaborate on allogeneic CAR-T Cell therapies
The collaboration will focus on advancing multiple existing and additional next-generation cell therapies against targets in multiple myeloma, B-cell lymphomas and other hematologic indications Poseida Therapeutics and Roche have entered into a strategic collaboration and license agreement to develop allogeneic…
