Keyword: Food and Drug Administration (FDA)
News
02.11.2017
- Following an agreement signed in August of this year, the EU and the US Food and Drug Administration (FDA) began mutually recognizing each other’s inspections of medicines...
News
30.10.2017
- As antibiotic resistance becomes an increasingly urgent threat to public health, pharmaceutical firms Roche and Warp Drive Bio have joined forces to develop novel classes of the...
News
24.10.2017
- The US Food and Drug Administration on Oct. 20 approved Shingrix, the long awaited recombinant, adjuvant new shingles vaccine manufactured by UK drugmaker Glaxo SmithKline (GSK)...
News
18.10.2017
- As generics pricing pressure increases, Swiss drugmaker Novartis said it will close a US plant at Broomfield, Colorado, owned by its Sandoz subsidiary and employing 450 people. It...
News
03.10.2017
- Pfizer is suing Johnson & Johnson (J&J) in the US over what it terms anti-competitive practices against its biosimilar Inflectra. The lawsuit is said to be the first of its kind...
News
28.09.2017
- UK-based specialty pharmaceuticals company Indivior, formerly part of Reckitt Benckiser, has reached an-out of-court settlement with Mylan Pharmaceuticals, which was planning to...
Plant Construction & Process Technology
27.09.2017
- There is a regulatory expectation that pharmaceutical companies will verify that the excipients produced by their suppliers are to an appropriate level of GMP. This has been...
News
08.09.2017
- Danish pharmaceutical producer Novo Nordisk’s US subsidiary is paying nearly $58.7 million to resolve claims that, among other things, it misrepresented a warning by the US Food...
