The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate…
An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to…
A federal judge ruled that the FDA’s denial of exclusivity of a generic version of Namenda XR was lawful, writing that the agency’s request for more information from an ANDA…
A District of Columbia court partially ruled against Amgen in a dispute with the FDA over what the company called inconsistent agency approvals of pediatric exclusivity. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb spoke about the regulatory challenges of precision medicines and the agency’s plans to focus on durability and safety issues, in a panel discussion at the World…
The drug is the first available FDA-approved Peptide Receptor Radionuclide Therapy. Source: BioSpace
Novelion will slash an unknown number of jobs as it initiates "significant cost reduction plans." Source: BioSpace
Astra has Glaxo and its COPD treatment Trelegy Ellipta squarely in its sights. Source: BioSpace
Concept will become a separate operating company within its Materials Analysis segment where it has strong synergies with the activities of Malvern Panalytical. Source: BioSpace
During an international conference in Davos, Switzerland, President Donald Trump sat down with the leaders of several European life science companies to encourage more investment in the United States. Source:…