Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
GSK has stopped using an ethanol storage tank at a US R&D facility and agreed to pay a fine to settle US Environmental Protection Agency (EPA) allegations that it broke waste management laws.
As the death toll from the world’s most expansive Ebola outbreak nears 1,000, multiple companies are stepping up efforts to bring antibodies and other vaccines to human trials, though none seem likely to be ready until 2015 at the earliest.
In its third acquisition in the past 10 months, European CRO (contract research organization) Venn Life Sciences has acquired Cardinal Systems, a France-based CRO specialising in data management and randomisation systems.
Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.
Charles River Laboratories is approaching its optimal capacity utilisation but says pricing will not improve until the rest of the preclinical CRO industry follows suit.
Supply chain specialist Marken announced last week the opening of their newest clinical trials depot in Sao Paulo, Brazil to help sponsors and CROs looking to conduct trials there and elsewhere.
As small and medium sized biopharma companies continue to raise cash through IPOs and elsewhere, CROs will see an uptick in outsourced work, Parexel founder, chairman and CEO Joseph von Rickenbach predicted in the company’s earnings call last week.
For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).
Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.
US demand for biosimilar preclinical services is expected to rocket on the back of the US FDA’s acceptance of Sandoz’s biosimilar filing, according to Harlan Laboratories.
Codexis has felt the impact of Gilead’s Sovaldi with product revenues tumbling almost 60% due to the reduction in its hepatitis C biocatalyst and intermediate business.
A previously unknown signaling platform may be responsible for the success of the main psychoactive ingredient in cannabis in reducing tumour size, which also may lead to the development of a synthetic THC equivalent, scientists say.
In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
Roche subsidiary Ventana Medical Systems has agreed to partner with Quintiles to offer companion diagnostic testing services in China for pharma and biotech clients conducting early phase clinical trials.
The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell in-PharmaTechnologist.com.
Actavis says it is excited to partner with AstraZeneca over its long-acting muscarinic antagonist/beta-agonist (LAMA/LABA) fixed dose combination respiratory drug following the latter’s acquisition of Almirall.
The tightening federal budget is increasing competition between research institutes and academia when it comes to preclinical toxicology testing, according to MRIGlobal.
Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched into the top ten manufacturers in the US injectables sector following its recent acquisition.
Two Americans stricken with the Ebola virus in Liberia were flown back to the US following treatment with an unapproved treatment manufactured from tobacco plants in Kentucky. Manufacturing of the treatment is expected to ramp up as the patients improve.
Roche has renewed its interest in gene silencing drugs, paying $250m (€187m) for Santaris Pharma including its ‘antisense’ Locked Nucleic Acid (LNA) platform.
The European Medicines Agency (EMA) has issued a concept paper on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of...
Pfizer and Roche have joined a consortium of clinical trial sponsors that are looking to design and implement adaptive trial designs. The consortium was partly founded by CRO Icon’s new subsidiary Aptiv Solutions.
US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.
Icon has picked up new clients and expanded existing contracts in a robust Q2, but the CRO says it has seen no overall shift in its client concentration with strategic partners continuing to make up half its revenues.
Quintiles CEO Tom Pike told investors last week that the company is seeing “very strong demand from the larger pharmaceutical firms because their pipelines are full right now,” and at the same time, small biotech, with their plethora of funding, are starting...
Sen. Tom Carper (D-Del.) introduced a bill last week that aims to further incentivize research in the US and allows CROs (contract research organizations) to capture a share of the R&D tax credit when research is outsourced.
This summer, the National Institutes of Health (NIH) announced another funding opportunity for experimental drugs proven safe but sitting on the shelves of pharmaceutical companies. The NIH-sponsored effort is based on a crowdsourcing strategy to establish...
The Health Products Regulatory Authority (HPRA) of Ireland has published a list of 12 active substances contained in medicines that could potentially be switched from prescription-only to over the counter sale.
Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.
BioClinica, a provider of clinical trial management tools, is helping Isis Pharmaceuticals and its antisense drug development program bring on more and larger clinical trials, including 16 trials for 2014.
The season of quarterly reports is in full swing, with CRO Covance seeing its income and revenue rise in Q2 compared with the same quarter last year due to stronger-than expected early phase development and central labs work.
A group of researchers at Harvard Medical School has developed a strongly cationic nanoparticle that physically absorbs proteins to form a new type of drug-carrier complex in aqueous solution.
McKesson Corporation, a healthcare services and information technology company, today announced a three-year extension to its pharmaceutical distribution agreement with CVS Caremark.
Amgen is slashing 15% of its workforce and closing two US manufacturing facilities as part of a restructure the firm says will save $700m (€520m) a year.
The worst Ebola virus outbreak in history continues to spread in West Africa as biopharma companies are hampered by funding issues in trying to bring treatments and vaccines to human trials, a scientist says.
Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.
Increased emphasis on global clinical trials is promoting consolidation of contract research organisations (CROs), according to an industry report by M&A services firm 11T Partners.
