The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
The latest global regulatory news, changes and updates affecting biopharma, including: SEC: electronic signatures OK; FDA releases more PSGs; HHS sees AI, NLP as regulatory clean-up service providers; MHRA gives ups and downs of reclassifying drugs; TGA: Diabetes risks greater than NDMA risks.
The latest global regulatory news, changes and updates affecting biopharma, including: Lawmakers spill Purdue documents on heels of settlement; Western states join forces to review vaccines; FDA finalizes nicotine drug guidance; CBER tackling guidance agenda; Innovation Alliance voices support for PTAB changes.
To end criminal and civil claims stemming from its marketing of Oxycontin (oxycodone hydrochloride) and other opioid products, Purdue Pharma LP agreed Oct. 21 to pay more than $8 billion and to cease operating as a for-profit private company – provided the court presiding over its bankruptcy agrees.
The latest global regulatory news, changes and updates affecting biopharma, including: Retiring lawmakers urge 340B modernization; How human are ‘human antibodies’?; ANDA suitability MAPP updated; MHRA: Drug interactions possible with COVID-19.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA advises on getting back to business as usual; ICER evidence report targets ulcerative colitis treatments.
Vaccine hesitancy could slow the development of herd immunity for COVID-19 in the U.S., but there could be other ways to help reach it. Testifying at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9, Surgeon General Jerome Adams said the numbers needed for herd immunity vary from expert to expert, but it ranges from 60% to 80% of the population.
Purdue Pharma LP filed for Chapter 11 bankruptcy Monday in a first step toward reorganizing as a new company designed to benefit plaintiffs in multidistrict litigation (MDL) and the American public in general.
With little more than a month to go before a trial begins in a multidistrict litigation (MDL) against several opioid manufacturers, privately owned Purdue Pharma LP is continuing its efforts to settle with all the plaintiffs involved.
