Bristol Myers Squibb’s (BMS) R&D budget reached almost $10bn last year. BMS strengthened its neuroscience portfolio withthe acquisition of Karuna Therapeutics, and its lead asset, KarXT (trospium chloride + xanomeline), a potential novel treatment for schizophrenia pending FDA approval. BMS also...
The FDA did not say how many companies or products it believed would be affected. The fact that its letter asks all drug companies with pending new drugs if they used Cetero suggests that the industry has not yet grasped the scale of the problem. Here's a small taste as to how m...
As at the end of December 2017, DRL's 102 generic filings were pending for approval with the US FDA (99 ANDAs and 3 NDAs).Alkem Laboratories' R&D expenditure increased to Rs.252.9 crore during first three quarter ended December 2017 from Rs.228.9 crore and worked out to 5.1 per cent of...
Its line of personal protective equipment, which includes a procedure mask, surgical mask and medical-grade mask (pending NIOSH approval), has brought in $20 million in revenue over the course of 2020, compared to the $250,000 Defender Safety made in sales one year earlier, Haggerty added. ...
The company also launchedProclaim Plus, a spinal cord stimulation system featuring the next generation of Abbott’s proprietary BurstDR therapy, which received FDA approval. This advanced device offers pain coverage across up to six areas of the trunk and/or limbs, and provides physicians with the...
Also in 2001 PRI received six first-to-file drug applications from the FDA, allowing a six-month window of exclusivity to produce and market the drugs. Moreover, the company's pipeline included 20 drugs that were pending FDA approval and another 30 in different stages of development. PRI ...
Outside of China, MiSight is performing really well, backed by its extensive seven-year clinical data and FDA approval, and we're seeing strength with key accounts and private practitioners around the world. We're also seeing a positive halo effect with customers selling MiSight accelerating their...
To date, In the United States, Stemedica has received eight IND (clinical trial) approvals from the FDA using Stemedica’s mesenchymal stem cells: Internationally, Stemedica’s Geographic Licensing Partners have advanced clinical trials with regulatory approval in their respective countries. These effort...
Even if a drug wins FDA approval and reaches store shelves, manufacturers sometimes need to voluntarily recall a defective or potentially harmful product.4When this happens, it is very difficult to bring that drug back—not because it won't be effective, but because the medical field will have...
FDA Social Media Guidance Puts Broad Responsibility On Drug Companies; Guidance On Twitter, Google Links PendingRamsey Baghdadi