Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before April.
The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
The Charles Stark Draper Laboratory Inc. has inked a three year partnership with Pfizer to create personalised versions of Draper’s Microphysiological Systems (MPS), for cheaper and more effective preclinical testing.
The US Environmental Protection Agency (EPA) has fined Pfizer $190,000 for failing to disclose that it had ammonia and methylamine at its facility in Barceloneta, Puerto Rico.
After much speculation, Pfizer has confirmed it will renew its service agreements with its largest contract research organization customers – as analysts suspected.
This month marks the renewal period for Pfizer’s contract research organizations’ Icon and Parexel, and while revenues have been declining, analysts believe the pharma giant will renew with both companies.
Using an experimental Internet of Things system that enables remote monitoring, the companies believe the multi-year project has the potential to change the way clinical trials are conducted.
Pfizer has invested $46m in separate collaborations with four R&D companies specialising in developing ADCs, immuno-oncology candidates and gene-therapies.
Pfizer says it will decide in 2018 whether to split its generics and branded businesses but M&A experts are already predicting how the giant will get rid of its established drugs programme.
Reports Pfizer is considering buying Allergan to create a company worth $330bn have once again raised fears of disruption for contract research organisations (CRO), although there are reasons to think the deal would be less troublesome than earlier megamergers.
Sanofi's inhaled insulin drug Affrezza has generated lower than expected revenue due to marketing delays rather than low demand according to MannKind CFO, Matthew Pfeffer.
Pfizer reduced costs 40% without cutting jobs at a facility in Sweden using an alternative approach to organisational and cultural behaviour, and hopes to do the same at its newly acquired Austrian plant.
In a wide-ranging interview that included his take on competition from Google and R&D spending, Pfizer CEO Ian Read offered a number of clues as to where his company is headed.
How can a pharma company invest in continuous manufacturing without bleeding money when it retreats from a local market? Pfizer’s answer is production pods it can roll out anywhere in the world via helicopter… and pack away again if a market turns.
Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a $120bn megamerger, but what would such a deal bring to the Pharma Giant? In-Pharmatechnologist investigates.
Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.
Pfizer will keep a “substantial” level of manufacturing in the UK if it takes over AstraZeneca, said the CEO in a letter to the country’s Prime Minister.
Big Pharma's split opinion on the best way to work with a CRO was in evidence in Las Vegas this week with Pfizer underlining its commitment to strategic deals and Merck KGaA backing a multi-vendor model.
A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
Pfizer says its hypothyroid drug Levoxyl will be available within a week after a musty smell coming from the oxygen-absorbing canister stopped production last February.
A longer than expected upgrade to one of its injectable plants has caused Pfizer to announce that there is a shortage of methylprednisolone sodium succinate injections.
Pfizer says its ‘off the shelf’ aseptic processing capacity is shifting the paradigm of pharma manufacturing, with emerging markets and personalised medicine driving the change.