Full-service CRO (contract research organization) Veristat will move its corporate headquarters from Holliston, Massachusetts, to Southborough, Massachusetts, this summer as the company has outgrown its old space.
CRO Profil Institute for Clinical Research will collaborate with Denmark-based Gubra ApS, a metabolic preclinical and drug discovery company, to discover and translate into clinical research novel drug targets, compounds and biomarkers addressing metabolic...
Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.
As Big Pharma and biotech companies continue to outsource more of their work, one of the leaders in the preclinical and discovery space – Charles River Laboratories – is seeing more strategic relationships with both large and small clients, CEO James...
The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.
Inform Genomics has selected Icon as its contract research organization (CRO) for the pivotal multicenter study of its Hematopoietic Stem Cell Transplant (HSCT)/Mucositis product candidate.
Tweets warning of Ebola were read by millions before the outbreak was acknowledged say researchers who think the network could be used as an early warning system and guide drug distribution.
Teva has been accused of "playing games" with Mylan by acquiring a 1.35% stake in the generics firm weeks after having a $40bn (EUR36bn) takeover bid snubbed.
Pluristem Therapeutics will set up manufacturing sites and find local partners to make cell therapies for the Chinese, Korean, Mexican, Russian and Israeli markets after securing various patents this week.
Albany Molecular Research Inc. (AMRI) has signed a three-year collaborative agreement with biotechnology company HarkerBIO to co-market their drug discovery services to clients.
There is still demand for alternative to injection for insulin despite the subdued launch of Sanofi’s Afrezza, Oramed says as it pushes forward with its oral candidate.
The DCGI needs to clarify expiry date labelling rules for topical drugs according to an Indian trade group, which says some members’ products are being deemed to be ‘misbranded.’
The new draft guidance from the US FDA seeks to address the lack of clarity around when new chemistry, manufacturing, and controls (CMC) information must be reported to the agency.
The former general counsel of Bio-Rad Technologies sued the research company in California federal court last week, claiming he was illegally fired in 2013 after he blew the whistle on the company’s bribery in China.
The proportion of pediatric trials of all clinical trials in the EU continues to increase since the integration of a Pediatric regulation in 2007, despite a decrease in the number of clinical trials overall since then, according to a new report from the...
The WHO has yet to decide how to investigate if barriers to competition are preventing vaccine price cuts after World Health Assembly members committed to probe the jabs industry.
Sample and assay technology provider Qiagen has launched a bioinformatics content and software platform for clinical testing labs to interpret and report on genomic variants identified in next-generation sequencing (NGS).
When translational medicine researchers recognise the need for pharma industry cash but are wary of handing over drug development to for-profit organisations, how can public-private collaborations bridge the culture gap?
Merck KGaA is confident it will close the $17bn acquisition of Sigma-Aldrich in mid-2015 despite competition concerns from the European Commission (EC).
Dutch scientists have 3D printed a protective scaffold that could make cell transplant-based diabetes treatment more successful and eliminate the need for immunosupressive drugs.
The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based...
The fourth generation of enhancements to Parexel’s Randomization and Trial Supply Management (RTSM) service aims to simplify patient randomization and clinical supply management to reduce delivery timelines.
From new service offerings to manufacturing deals to more formal strategic partnerships, the world of contract research and manufacturing organizations has been busy as of late. Here’s a roundup of some of the deals and new offerings:
Novartis has partnered with Google-backed Rani Therapeutics to assess an oral platform which delivers biologics through the intestinal wall using needles made of sugar.
US production of chemicals for the drug industry fell in April according to data released days after renewed calls for permanent tax breaks to help American manufacturers compete globally.
Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma.
Merck Millipore has entered an agreement whereby it will control and manage the Singulex Life Science Research business, which offers a technology that can provide ultra-sensitive protein detection.
With the integration of Covance moving along steadily, Dave King, chairman and CEO of LabCorp, told investors last week at the UBS Healthcare Conference that LabCorp is ramping up a series of initiatives that will lead to $300m (€276m) in new revenue...
The EMA has released draft guidelines to aid the gene therapy developers, many of which it says are small companies not familiar with the regulatory environment.
A recent spate of activity - including the acquisition of a Japanese CRO and a secondary equity offering - has boosted Quintiles’ investment appeal, an analyst says.
As the largest pharma and tech suppliers – from Novartis to GE Healthcare to Thermo Fisher – begin exploring the world of CRISPR/Cas gene editing technology, contract research organizations are also looking into the new tech to explore ways to help clients’...
Following a re-examination requested by MAHs (marketing authorisation holders) for seven of the medicines suspended, the EMA has re-confirmed its recommendation to suspend hundreds of drugs following issues with clinical studies conducted at CRO GVK Biosciences...
In a House bill that largely mirrors one reintroduced earlier this year in the Senate, CROs (contract research organizations) would be able to capture a share of the R&D tax credit, thereby making the US more competitive with other countries that...
EFPIA and EGA say European Commission GMP guidance should be more closely aligned with guidelines elsewhere to help international drugmakers understand the recently updated requirements.
