EMEA adopts 'first-in-man' clinical trials guideline
The pan-European drug regulator, the European Medicines Agency
(EMEA), has adopted a draft guideline for first-in-man clinical
studies for potential high-risk drugs in a bid to prevent a repeat
of last year's TGN1412 drug trial...
Microtest aseptic manufacturing expansion brings new contract
Microtest Labs has bagged a new contract with UK-based Antisoma to make clinical quantities of the firm's new cancer drug - just a few months after expanding its manufacturing capacity.
New software could curb drug failures
New software has been launched that its developers say will help
companies to spot drug candidate safety failures at an earlier
PharmaNet broadens its offerings to broaden horizons
PharmaNet has entered into a partnership with Analytica in a bid to
broaden the clinical development and commercialisation services it
Cetero buys Allied Research for early-phase boost
The purchase of Canada's Allied Research International (ARI) has
given Cetero Research a boost to its early-phase clinical services
and geographic reach in Canada.
PharmaNet to suffer formal SEC scrutiny
PharmaNet has been told by the US Securities and Exchange
Commission (SEC) that it will now be the subject of a formal
investigation as it continues to be haunted by the early phase unit
it used to own in Miami.
UK start-up enters contract manufacturing arena
A small UK company has entered the contract manufacturing arena by
offering services to develop and make oral dose drugs and sterile
injectables from its new facilities in England.
New simulator touts adaptive trial savings
In anticipation of a new wave of adaptive clinical trials, UK firm
Tessella has designed a software system to help pharma firms
conduct seamless trials that could ultimately save time and money.
MDS Pharma profit dips further into the red
MDS has reported a lower first-quarter profit for its Pharma
Services unit as a result of a regulatory probe of its operations.
Encorium Group and INC Research – Clinical contract news
Outsourcing-Pharma.com compiles the news that has featured in the
clinical contract community of late, involving Encorium Group and
Lawsuit looms for Parexel over drug trial disaster
Legal action could begin today against Parexel if the firm does not
come up with "an adequate proposal" to compensate the victims of
last years drug trial disaster in Northwick Park, London.
Australia, NZ regulators propose clinical trial assessment innovation
The joint drug regulatory bodies of Australia and New Zealand are
proposing a new scheme for assessing the risk of clinical trials.
Asterand, Laureate Pharma, PPD and Kendle - People on the move
Asterand, Laureate Pharma, PPD and Kendle have all had people on
the move in the world of pharmaceutical outsourcing this past week.
Contract manufacturing news in brief
Dalton Pharma Services, Granules India and Lonza have all announced
new contract manufacturing deals this week.
PRA embarks on major restructure as profits dive
PRA has announced the closure of two facilities as part of a major
restructure as Q4 profits took a 55 per cent dive.