What Obama means for pharma
Our most read story of the year came on the morning following Barack Obama’s election victory. In the article we analysed the challenges facing the new administration and how the decisions they make will impact on the industry.
At the time of writing a great deal of what we covered is still in flux, with people second guessing who will fill the FDA hot-seat and anticipating the creation of a pathway for biogenerics.
The full article can be read here.
Heparin death tally worsens; FDA issues device warning
Three months after Baxter initiated its recall of heparin in response to patients’ allergic and hypotensive symptoms we covered the latest development in a story that would run and run.
Early reports stated there had been 19 deaths as a direct result of allergic and hypotensive symptoms after heparin administration but come April the FDA’s new tally revealed a more widespread problem.
The agency said in April that 62 deaths "appear to match the type of allergic reactions that have been the main focus of safety concerns".
The full article can be read here.
Merck must axe a further 7,200 jobs “to survive”, says CEO
Our third best read story is Merck & Co’ CEO blunt assessment of the state of the industry, which he predicated could not survive unless the old business models were overhauled.
In Merck’s case this involved laying-off a further 7,200 employees as the company attempted to come to terms with a 28 per cent drop in earnings.
The full article can be read here.
Health Canada adds to Ranbaxy’s woes
Ranbaxy experienced an eventful year, with the takeover by Daiichi-Sankyo and troubles with the FDA meaning the company was never far from the headlines.
Health Canada caused a further drop in Ranbaxy’s share price when it sent a letter to the generic giant’s Canadian subsidiary requesting an action plan and a response to the FDA’s warning letter.
In the wake of the FDA blocking import of 30 Ranbaxy products other regulatory agencies began paying close attention to the company’s practices.
The complete article can be read here.
FDA suspects heparin contamination due to fraud
Closing out our top five is another article on arguably the biggest story of 2008, which brought the dangers posed by modern supply chains into sharp focus.
This particular chapter in the saga detailed the FDA’s suspicion that the contamination of heparin was a deliberate act to reduce costs.
The complete article can be read here.