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Latest From David Wallace
Teva has received FDA approval for the first US generic naloxone nasal spray after a 30-month stay linked to ongoing patent litigation expired. Launch plans have not yet been revealed. Meanwhile, the Israeli firm has also introduced the first generic version of VESIcare in the US.
Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.
Aceto has completed the divestment of its Rising Pharmaceuticals generics unit, is moving ahead with the disposal of its chemicals business and has disclosed a bonus incentive scheme for its CEO, William Kennally, aimed at securing the maximum value for its assets as part of bankruptcy proceedings.
Alvogen has gained multiple European approvals for a rival to Gedeon Richter’s Esmya through the decentralized procedure.
Amneal gets a new CSO, Acino restructures its board under a new chair, the AAM adds an assistant general counsel and the British Biosimilars Association names a vice-chair, as well as other people movements from around the generics, biosimilars and value-added medicines industries.
A waiver to allow manufacturing of generics and biosimilars during the term of supplementary protection certificates is on the verge of being realized after the European Parliament approved the Regulation by a large majority.