Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.

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.

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.

MS Pharma, a leading generics company in the Middle East, has announced an agreement to acquire Greece-based Genepharm as part of an expansion drive into Europe and farther afield.

Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.

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.

The US Food and Drug Administration has flagged more problems at Aurobindo, issuing another Form 483 to the company over one of its plants in southern India. This one, containing 11 observations, sharply faults quality controls.

In the wake of impurities being discovered in certain valsartan and other ARB drugs, the FDA has published a list of known nitrosamine-free examples of these medicines as part of ongoing efforts to address the issue.

Prior-art references render two US formulation patents protecting OxyContin unpatentable as obvious, a Court of Appeals has confirmed.

Piramal halted sales of its generic version of Amgen’s Sensipar following a US court order that also required Amgen to furnish a $39m bond. The Sensipar generic launch landscape continues to be complex with multiple legal challenges, including those from Cipla and Sun at various stages.

Several aspects of the FDA’s draft guidance on the pathway for competitive generic therapies require clarification, according to detailed feedback submitted by industry.

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.

Pfenex says it can now launch its teriparatide in the US upon FDA approval, after Lilly failed to file a lawsuit in reaction to a Paragraph IV challenge to a Forteo device patent within the statutory timeframe.