Litmus Health imagines a future where all the world is “one big clinical trial,” and as the first step, it has launched its clinical data science platform into public beta.
Cempra has asked Uquifa for API manufacturing data to support its US solithromycin efforts after raising concerns that information from Wockhardt in the current dossier will delay review.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
Data integrity issues and the unexplained disappearance of drums of pharmaceutical ingredients have landed a Chinese API maker with a US FDA warning letter.
Agilent Technologies has contracted the original creators of its RapidFire 365 High-throughput Mass Spectrometry System to further develop new applications.
The global clinical trials laboratory services organization, Q2 Solutions, is expanding its genomic companion diagnostics (CDx) capabilities through a new collaboration.
Clinerion’s Patient Recruitment System (PRS) allows sponsors and clinical trial managers to identify and approach potential patients for enrollment using electronic medical records.
South Korea is a key opportunity for biopharma services firms says Thermo Fisher, reporting its third quarter which saw it up capabilities in the region.
The “double edged sword” of increased regulation is a challenge, but Envigo expects outsourcing to continue as the company looks to diversity its service portfolio.
Significant differences in large molecule clinical trials highlights the need to be more efficient, according to a recent analysis of clinical trial duration.
Envigo has collaborated with InterTek and OCSiAl to develop TUBALL™ single wall carbon nanotubes, which is the first of its kind to complete REACH registration.
Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.
The adoption of eTMF solutions is accelerating – with more than 50% of investigative sites expected to have access to a sponsor/CRO eTMF application within three years.
Daiichi Sankyo will commercialize an abuse-deterrent formulation of the opioid painkiller morphine sulphate in the US in an agreement with developer Inspirion Delivery Sciences.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
With a tax incentive program making clinical trials up to 60% more cost-effective, Australia is a “gateway” to larger studies throughout Asia, says CRO.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
The US FDA wants more information on Czech API firm Interpharm Praha AS’s efforts to prevent repetition of data manipulation uncovered during 2015 inspection.
The US Environmental Protection Agency (EPA) has fined Pfizer $190,000 for failing to disclose that it had ammonia and methylamine at its facility in Barceloneta, Puerto Rico.
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
Veeva has announced two new products and a series of new hires across its product management team after nearly doubling its customers over the past year.
EAG Laboratories has added 33,000-square-feet to its Easton, Maryland facility, with space for dedicated laboratories and equipment to support GLP-compliant ecotoxicology, environmental fate, metabolism, and other testing services.
ATCC has signed a strategic agreement with the contract research organization (CRO) BioAgilytix as part of its ongoing initiative to provide CRO services.
Biotrial has accused French newspaper Le Figaro of leading a “smear campaign” through its coverage of the Phase I trial in which one man died and five others were hospitalised in January.
Lannett is confident it can prove the extended release tech in its Concerta generic is equivalent to the original after the US FDA said it will seek withdrawal of firms ANDA.
APIs made by Laxachem Organics pvt ltd were not the source of bacteria in Pharmatech laxatives linked to a spate of Burkholderia cepacia infections according to the US Food and Drug Administration (FDA).
The Society for Clinical Research Sites recently awarded QuintilesIMS with the 2016 Eagle Award, which recognizes contract research organizations (CRO) and sponsors focusing on site relationships.
PPD has added 4,300 square feet of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices to the company’s Athlone, Ireland-based GMP facility.
Validic and Sutter Health are collaborating on a federal pilot project that seeks to determine how patient-generated health data can be best delivered to researchers.
The US Food and Drug Administration (FDA) has signed an agreement with CluePoints to "further explore" a data-driven approach to quality oversight in clinical trials.
Nucleic acid manufacturer Nitto Denko Avecia has agreed to buy Irvine Pharmaceutical Services and Avrio Biopharmaceuticals in deals designed to expand its production business.
Almac Group’s Diagnostics business will engage with pharma to validate the link between its immune response assay and checkpoint inhibitor based therapy.
