The Association of Clinical Research Organizations (ACRO) has joined a small business coalition as part of its effort to halt the decline of capital into biomedical research.
As CROs and pharmaceutical sponsors must begin collecting data in August to comply with the Sunshine Act, some companies are now looking to service providers for help.
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.
Supplementing prospective randomized, double-blinded clinical trial data with real-world patient data holds “an enormous amount of potential” for CROs and trial sponsors, according to an expert.
US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.
Although preclinical work for CROs has fallen flat in recent quarters, Covance is looking to take advantage of the industry’s shift to early biologic developments and lead optimization.
CRO Harlan Laboratories has more than doubled the number of isolators at its Indianapolis and Livermore, Calif., research facilities to meet client demand for immunocompromised animal models.
Cobra Biologics is confident it can win the commercial contract for Vaccibody AS’ candidate DNA vaccine, citing its production platform and recent capacity expansion as key.
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
US CRO PRA is proposing to go public again, more than six years since it was taken private, according to a confidential draft registration statement submitted to the US SEC.
Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex.
New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from pharmaceutical industry group, the ABPI.
Just days after raising more than $1B in its IPO, Quintiles announced Wednesday it signed a five-year clinical development agreement with Merck Serono.
The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
Yusen Logistics has launched a new air freight service to help UK drug major AstraZeneca ship its products to Australia in a new agreement announced today.
Extra filling capacity is to be made available in preparation for West’s Crystal Zenith (CZ) system, though approval and increased sales are still at least 18 months away.
PRA International says technology and IT innovation will help it compete with rivals that have moved their service centres to cheaper locations in the East to cut costs.
Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement.
Varicose veins could prove to be a big revenue stream for UK CMO SCM Pharma which has been named as commercial supplier for BTG’s candidate treatment, Varisolve.
Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
Evotec says it is confident underlying growth, expansion of its clinical stage pipeline and upcoming milestone payments will counter Q1’s downcast results.
Research Pharmaceutical Services' (RPS) former chief information officer (CIO) claims he was unfairly dismissed after discovering the CRO was unlawfully storing potential employees' personal data.
Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette.
Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.
Melding metals to APIs could make drugs easier to deliver according to Sweden's Recipharm which partnered to add a new chemistry to its offering last week.
Brand-to-generic conversions have been blamed for “somewhat softer than expected” financial results at McKesson, though significant FY2014 direct revenue growth has been predicted.
Tension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any time soon, but both sides seem intent on arriving at a middle ground where micromanagement stays low and the level of quality remains high.
Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
CRO PRA has expanded its clinical informatics offerings and opened a new facility in Swansea, Wales, which will create a multi-lingual help desk, as well as offer 100 graduate-level jobs in data coordination, clinical programming and safety fields.
The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline.
