KV Pharmaceutical has begun rehiring employees to produce verification batches of certain products prior to resuming commercial manufacture, which appears to be on schedule after the FDA accepted the work plan.
KV Pharmaceutical has hired a firm specialising in restructuring and bankruptcy and said “there are significant uncertainties regarding its ability to continue as a going concern during the upcoming fiscal year”.
KV Pharmaceutical found deficiencies and instances of noncompliance during its internal investigation, which was launched in response to issues with the FDA and allegations of management misconduct.
Suspicious spikes in the trading of Schering-Plough shares prior to its merger with Merck & Co are being investigating by the SEC, according to media reports.
Acusphere has laid off two thirds off its staff, with manufacturing employees among the affected, and closed its headquarters, citing financing difficulties as the cause of the cutbacks.
As the battle for Genentech continues, the US biotech has warned its shareholders that Roche may “seek to influence our business in a manner that is contrary to our goals or strategies”.
A filing with the SEC says that Roche is not prepared to continue in a relationship with Genentech in which it owns a majority of the biotech’s equity but has limited involvement in its governance.
The strained relationship between Genentech and Roche has been revealed in a SEC filing, which details their differing valuations and accusations of misleading financial models.
Cardinal Health’s announcement that it is considering spinning off some of its divisions has provoked fevered speculation among industry analysts and media observers alike.
Recipharm has come to rescue of UK-based Ashton Pharma, which has
been nervously awaiting to discover its fate, having spent five
months in administration after its former owners Inyx Inc. suffered
major financial woes.
Cardinal health experienced a 42 per cent jump in quarterly profit,
helped by renewed growth in its drug distribution and sterile
manufacturing operations, which have both experienced problems that
dragged down earnings in previous...
US pharmaceutical giant Bristol-Myers Squibb (BMS) is to pay $150
million (€122 million) to settle an investigation in which
regulators claimed the company gave investors an inaccurate
representation of its financial performance by...
