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Concerns raised over FDA’s informed consent draft guidance

Concerns raised over FDA’s informed consent draft guidance

The US FDA was flooded with comments  on its draft guidance  seeking to amend the informed consent process – with some saying the guidance will confuse patients while others took issue with what the revisions didn’t include.

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News in brief

Political instability in Ukraine has not diminished international drug industry desire to conduct clinical trials there according to a new report.

TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers in the Drug Information Association's Therapeutic Innovation & Regulatory Science journal.

The $17bn (€13.2bn) acquisition of Sigma-Aldrich is “not just a milestone but a quantum leap” for Merck KGaA, the firm says.

Following the recent IPO from Catalent, has private equity called time on the CDMO industry? Outsourcing-pharma’s Dan Stanton thinks it has for now.

Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.

Global Industry News

Pfizer and Irish port authorities working to stop API plant gathering dust from in-PharmaTechnologist.com

Pfizer is working with Irish authorities to avoid a repeat of a 2013 incident when dust produced from Cork harbour entered its nearby API facility.

Telormedix granted 'most important patent ' for TLR agonist bladder cancer drug from in-PharmaTechnologist.com

Telormedix has been granted a European patent for increasing the solubility of its lead bladder cancer toll-like receptors (TLR) treatment Vesimune.

People on the Move

Rumours at Novo Nordisk, board changes at German Merck from in-PharmaTechnologist.com

Genzyme looks to integrate up and downstream for continuous biomanufacturing from BioPharma-Reporter.com

Genzyme has filed a patent application for a technology platform that will bridge the gap between upstream and downstream processing in continuous biomanufacturing. 

update #2 - Regeneron to appeal

Of mice and mAbs: EPO revokes Regeneron patent after Kymab and Novo appeal from BioPharma-Reporter.com

European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.

Spotlight

Public CROs are sign of booming market, not PE apathy say experts
News focus

Public CROs are sign of booming market, not PE apathy say financial advisors

Experts have predicted more CROs will go public as Private Equity looks to get a return on...

Biologics trials: the ‘stretched’ global supply chain

Biologics trials: the ‘stretched’ global supply chain

The high cost and complexity of producing biopharmaceuticals for clinical trials limits supplies and makes effective logistics...

Charles River to lay off up to 30 employees following NCI contract end

Charles River to lay off up to 30 employees following NCI contract termination

Early phase CRO (contract research organization) Charles River Laboratories will lay off between 26 and 30 employees...

Pharma firms ‘saving billions’ in research – by giving away their tech

Pharma firms ‘saving billions’ in research – by giving away their tech

Pharma’s biggest players have donated more than $102m ($78m) of technology in a project to transform data...

CMO Kentucky Bioprocessing grows Ebola mAb from tobacco

CMO Kentucky Bioprocessing grows Ebola mAb from tobacco

ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being...

CRO Crown: Advancing in vitro models could benefit preclinical world

Crown Bio: New in vitro technology could revolutionise drug discovery

Increasing the predictivity of in vitro systems could cut the costs of drug development and shift preclinical...

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