Breaking News on Contract Research, Manufacturing & Clinical Trials

Top Headlines

Catalent looks to cash in with $872m IPO

In the last decade, Catalent has earned revenue on nearly half of the NCE (new chemical entity) products approved by the US FDA

With its expected sale of 42.5m shares for $20.50 each, CDMO (contract development and manufacturing organization) Catalent is looking to become a public company.

Related news

News in brief

A Swiss association has recognized the European Centre for Clinical Research Training (ECCRT), a SynteractHCR company, for training investigators and sub-investigators on GCP (good clinical practice).  

Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.

Baxter BioPharma Solutions dropped four percent year-on-year for the second quarter 2014 due to a fall in demand for contract manufacturing services.

The approval of clinical trials in India is rebounding in 2014 after a year in which the country’s regulations were in constant flux.

Global Industry News

People on the Move

Role changes for AbbVie and Shire CEOs after merger from in-PharmaTechnologist.com

It has been a hectic few days for the chief executives of AbbVie and Shire since their companies agreed a £32bn ($53bn) merger on Friday.

US FDA looks to increase cooperation with Latin American counterparts from in-PharmaTechnologist.com

The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).

Glenmark to build first US manufacturing plant from in-PharmaTechnologist.com

India-based Glenmark Pharmaceuticals has announced plans to set up a new oral solid dosage manufacturing facility in North Carolina. 

UK industry groups want Drs to use biosimilar names not INNs from BioPharma-Reporter.com

UK industry groups have rejected the idea their call for doctors to use brand names rather than INNs in new biosimilars FAQ documents is about protecting member firms’ market share. 

Repligen: New CFO 'suited to growth path,' hints at acquisitions from BioPharma-Reporter.com

Protein A manufacturer Repligen has hired a CFO and says it is on the lookout for acquisition opportunities.

Biosimilars will not erode sales like generics, says J&J from BioPharma-Reporter.com

Biosimilars are not analogous to small molecule generics in terms of market share loss according to Johnson & Johnson, which is confident its biopharmaceutical portfolio can withstand competition.

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...

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