Industry group TransCelerate BioPharma has established two new global initiatives around placebo and standard of care data sharing, and electronic labels for clinical trials – both of which aim to accelerate and enhance trials.
Takeda’s development center in the US has agreed to partner with BioXcel, a cloud-based big data solution provider, to repurpose old medicines to help treat rare diseases.
Mylan has bid $29bn (€27bn) to buy Perrigo in what the firm says will create a company with “unrivalled” manufacturing and supply chain capabilities across OTCs, generics and APIs.
Fighting drug fakers relies on collaboration according to supply chain security group RX-360, which says drugmakers put rivalries on hold in the war against counterfeiters.
Artificial intelligence can aid lead optimisation according to the German firm behind a new structure-based drug oral bioavailability prediction technology.
Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information...
Central lab services provider LabConnect will be moving its operations center in Johnson City, Tenn., to a new 42,000-square-foot custom-built facility effective May 7.
A new Frost & Sullivan report predicts the Latin American clinical research market for CROs (contract research organizations) will grow at a pace of 7.1% through 2019, with larger CROs taking advantage of the market the most.
Wilmington, North Carolina-based CRO (contract research organization) PPD (Pharmaceutical Product Development) and Tokyo-based Shin Nippon Biomedical Laboratories (SNBL) have closed an agreement to form a joint venture to provide clinical development...
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.
IPEC-Americas (International Pharmaceutical Excipient Council) stopped short of recommending a specific date for implementation of a new GMP standard for excipient manufacturers, but the group is calling on manufacturers to have an implementation plan...
The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.
Connecticut-based CMO Aptuit opened a 1600L/1000L reactor stream at its API facility in Oxford, UK, and increased throughput at its 400L reactors at its site in Verona, Italy.
AMRI has confirmed it will close its Holywell, UK facility and let go 62 employees from the site following a consultation with employee representatives.
Chinese service provider WuXi PharmaTech has sold a 5.55% stake in its wholly owned CMO (contract manufacturing organization) subsidiary SynTheAll Pharmaceutical (STA) to members of STA’s and WuXi’s management for $28m.
A number of different countries offer tax incentives that generally seek to attract pharma companies conducting research, and often can help CROs (contract research organizations) as well, an Ernst & Young breakdown of R&D tax incentives found.
Computational drug designer Schrödinger has entered into a five-year early drug discovery collaboration with Sanofi in which Schrödinger will provide target analysis and validation to lead identification and lead optimization for as many as ten drug discovery...
Alkermes has been downgraded by analysts who say the success of its decision to focus on own-brand products and sell its legacy CMO site hinges on its ability to win in already competitive markets.
London-listed CRO Venn Life Sciences hopes partnering with academics will help generate drug industry interest in its recently expanded skin model tech business.
Supply of the Adenovirus Type 4 and Type 7 Vaccine to all US military personnel has been secured through a five-year contract with Teva worth $170m (€156m).
LabCorp, as well as its recent acquisition Covance, along with CRO (contract research organization) peers inVentiv and Evotec have all landed small to medium-sized pharmaceutical deals in the past week.
Piramal has agreed to sell its clinical research business based in Hyderabad, India to Indoco Remedies which will add bio-equivalence and bio-analytical services to its offerings.
The European Investment Bank (EIB) has loaned Innocoll AG €25m to support development of a post-surgical painkiller and diabetes-related infection drug delivered using its collagen-based tech.
Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.
CROs (contract research organizations) received slightly better overall ratings from investigator sites compared to two years ago, though there are still gaps between how sites view sponsors and CROs, according to the recently unveiled CenterWatch Global...
Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.
The Society for Clinical Research Sites (SCRS), which represents the interests of clinical research sites, has announced a two-year partnership with North Carolina-based CRO PRA Health Sciences, while the group’s work with INC Research has resulted in...
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
Publisher BioMed Central has withdrawn 43 papers from its scientific journals after discovering a conspiracy to rig peer review runs deeper than previously thought.
As CROs (contract research organizations) and sponsors look to shave off time from their clinical trial start-up phase, which is where delays occur most frequently, companies may want to look away from local IRBs (institutional review boards), an expert...
With an eye on central labs industry leader LabCorp, Quintiles and Quest Diagnostics are combining their clinical trials lab operations to provide clients with the world’s second-largest option.
Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally.
British MPs have signed an anti-animal cruelty pledge which scientists warn would “cripple” disease research and outlaw 89% of preclinical animal research.
In another sign that early phase research demand is picking up, North Carolina-based CRO PRA Health Sciences (PRA) is increasing its Phase I clinical footprint in the US and Russia.
Sun Pharmaceutical Industries has completed its $4bn (€3.7bn) acquisition of Ranbaxy after receiving the thumbs up from the US Federal Trade Commission (FTC).
Indiana’s new “religious freedom” law is discriminatory and will make it harder to attract the staff needed to develop drugs for cancer and Alzheimer's disease according to Eli Lilly.
Testing the toxicity of drug candidates in animals is archaic and unreliable according to PETA, which joined preclinical CROs at SOT to put forward alternatives.
