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Breaking News on Contract Research, Manufacturing & Clinical Trials

Top Headlines

What’s next for gene editing? After ‘knock-out’, time for ‘knock-in’

Knocking out genes: to be replaced by 'knocking-in'?

Horizon Discovery says the gene editing tool CRISPR used to engineer its human cell lines is exploding the possibilities of screening for preclinical customers.

Related news

News in brief

A researcher with the now dissolved CRO Cetero Research received a warning letter released Tuesday from the US FDA after inspectors found that he, among other things, failed to ensure that the investigation was conducted according to plan.

Elite Pharma has decided to manufacture its developmental anti-abuse pain drug in-house despite offers from several CMOs interested in the contract.

Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.

A breakdown of trials run by the top contract research organizations (CROs) reveals that the big players are leaving little room for smaller firm to compete, according to a review by Outsourcing-Pharma.com of trials in clinicaltrials.gov. 

Global Industry News

US FDA 'stamp of approval' testament to WuXi's growth in APIs from in-PharmaTechnologist.com

WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

For single-use, 2,000 litres is Fujifilm's limit as it invests in US and UK from BioPharma-Reporter.com

Single-use bioreactors do not need to be bigger than 2,000L says Fujifilm Diosynth, which is investing in such technology at plants in the UK and US

Novo Nordisk defiant despite $90,000 disclosure fine from in-PharmaTechnologist.com

Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.

Physician groups call for separate names for biosimilars, reference biologics from BioPharma-Reporter.com

The American Academies of Clinical Endocrinologists, dermatologists and neurologists, as well as eight other physician groups and a number of individual physicians are calling for unique names for biosimilars to better track adverse events and ensure physicians understand what the biosimilar was approved for.

Miltenyi Biotec acquires lentiviral vector manufacturing business of Lentigen from BioPharma-Reporter.com

Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.

US FDA approves first needle-free flu vaccine delivery system from in-PharmaTechnologist.com

For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.

US mulls Federal Trade Zone status for Neolpharma Puerto Rico plant from in-PharmaTechnologist.com

US authorities are reviewing a Neolpharma request for tax breaks for APIs imported to a former Pfizer-owned plant it operates in Puerto Rico.

G-CON launches transmissible disease containment POD from in-PharmaTechnologist.com

Access to portable and flexible technology could be one way of containing transmissible diseases says G-CON as it launches a more readily deployable version of its ‘POD’ manufacturing suite.

Spotlight

Petition calls on FDA to amend informed consent requirements

Petition calls on FDA to amend informed consent requirements

The Center for Responsible Science  has asked the US FDA to adopt informed consent rules which ensure that trial participants...

US FDA to set more specific GMP regulations for outsourcing facilities

US FDA to set more specific GMP regulations for outsourcing facilities

Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for...

Parexel taps Middle East, North Africa with Atlas acquisition

Parexel taps Middle East, North Africa with Atlas acquisition

CRO Parexel has shifted its attention overseas with the acquisition of Atlas Medical Services, a provider of...

Trial documents: only 13% of firms are fully paperless, says Veeva

Trial documents: only 13% of firms are fully paperless, says Veeva

Contract research organisations (CROs) have been slow to adopt next-generation means of recording study documents, with only...

Pfizer offers update on risk-sharing deals with Icon, Parexel
Dispatches from DIA

Pfizer offers update on risk-sharing deals with Icon, Parexel

Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still...