In the future pharma will be reliant on technology, says physician-scientist Daniel Kraft, who warns that companies which fail to innovate risk being left behind.
By dropping 44 more employees, Novartis has completed the final phase of the planned restructuring of its once-beleaguered Lincoln, Nebraska manufacturing facility.
Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.
Quintiles reported almost 14% growth in revenue, which was largely due to increasing revenue from its Integrated Health Services (IHS), which saw almost 35% quarterly growth.
The World Health Organisation says a meeting between drugmakers and high-level government representatives last week has yielded plans to fast-track scale-up of Ebola vaccines in the face of incomplete trials and leaked production problems.
Weaker demand in Europe and Japan saw revenue from Charles River Laboratories' animal models business decline in Q3, but Argenta and BioFocus boosted discovery sales.
Struggling strategic partnerships and lower conversion rates from its backlog have caused Parexel stock to bottom out slightly, though executives remain optimistic on the second half of this year.
Hardly anybody downloads Big Pharma apps according to a new report that suggests drugmakers seeking greater mHealth engagement should ditch the product-focused model and seek expert help.
Contract research and manufacturing organization Paragon Bioservices has raised $13m in a Series A Preferred Stock financing, led by NewSpring Capital and Camden Partners, to continue to grow the company.
Although the barriers for going paperless are relatively low for CROs, the service providers have yet to fully adopt electronic TMFs (trial master files), a new survey says.
A UK writer has described how his mission to start a trial for a therapeutic virus against his friend’s cancer has led to a new model of research funding which bypasses sponsors and CROs.
A head-hunter explains why Regeneron, Novo Nordisk and Genentech top a global survey of science employers, but Pfizer is nowhere to be seen in the top 20.
India will ban PET packaging for liquid drug formulations for children, the elderly and women of reproductive age in November according to a Government statement.
The Raleigh, North Carolina-based CRO INC Research plans to raise about $150m in its initial public offering via about 8.1m shares at a price range of $17 to $20 per share.
Although a growing number of sponsors and CROs have managed strategic relationships for as many as five years, sponsors still rely on a mix of outsourcing approaches to tackle their clinical programs, according to a new report.
The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.
Jordanian drugmaker Hikma says it has received a US FDA (Food and Drug Administration) Warning Letter over environmental monitoring at its plant in Portugal.
MPI Research announced Monday it has acquired the assets of Kalamazoo, Michigan-based CRO Jasper Clinical Research & Development, which provides early-stage human clinical testing of new drugs for an undisclosed amount.
The Association of Clinical Research Organizations (ACRO) on Monday announced plans to create a CRO Forum in order to provide a formal mechanism for the CRO industry to offer insight into the work of industry group TransCelerate BioPharma.
Mid-size and large sponsors foresee increases in RFP (request for proposal) volume for outsourced clinical services across all phases through December 2014, especially for larger CROs, according to a new report.
What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance, “critically vague and legally...
A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives
The products, unveiled at BioProcess International in Boston this week, will help industry with their upstream and downstream processing and include an anti-CHO host cell protein detection kit, the first single-use fermentor, and a new mammalian expression...
A process development firm founded by ex-AstraZeneca employees says closure of the drugmaker’s Swedish R&D site gave it technical knowhow and former colleagues as customers.
Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
Horizon is already making plans for the research model company it acquired last month, announcing today it will offer patient-derived xenograft (PDX) models for breast cancer under the Sage Labs name.
Ebola vaccine developers can seek scientific guidance and approval through a rolling assessment system established by EMA to accelerate the process review.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Animal-model contract research organisation (CRO) Crown Bioscience will open a research centre in North Carolina, combining expanded oncology services with its existing cardiovascular and metabolic offerings.
Janssen-Cilag’s bedaquiline and Otsuka’s delamanid notwithstanding, the drug industry is not spending enough on the development of tuberculosis medicines according to the WHO.
The head of the US National Institutes of Health has said the organisation would have developed a finished Ebola vaccine by now if its funding had not been slashed over the last decade.
A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.
EMA tells us it looks forward to continuing close relationship with DG SANCO
DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.
As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.
Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.