The non-clinical contract research organization (CRO) Citoxlab Group has acquired Solvo Biotechnology, a CRO specializing in drug transporters studies and the assessment of drug-drug interactions (DDI).
A lack of generic competition for Pfizer’s contraceptive Depo-Provera has influenced Amphastar’s decision to prioritise its pre-filled syringe version, says executive.
Trans-Hit Bio and Q&T Research have entered into an exclusive strategic partnership, which will provide biopharma customers with access to human biospecimens, for which there is “a great demand,” says exec.
Zelluna Immunotherapy has partnered with the CDMO MasSTherCell to develop its T-cell receptor (TCR) adoptive cell therapy platform with clinical trials expected to begin in 2019.
The industry is set up to accelerate the availability of new patient options in a “new era of medicine”– though robust intellectual property protection is critical to continued innovation.
A new method to predict the physical stability of drug candidates is attracting interest from pharmaceutical companies who could use the technology to de-risk early development.
The R&D playbook is evolving as the industry looks to break down the silos between clinical and commercial operations – bringing commercial voices to the earliest phases of asset development.
Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.
CDMOs continue to take on a larger role supporting sponsors in the pharmaceutical industry, though new technology and changing requirements could shift the models in which they operate.
Charles River has made several expansions across the globe, including a new, 73,000 square-foot facility in Wayne, PA, which doubles its laboratory footprint in the state.
World Courier has created personalized supply chain teams to support direct-to-patient, cell and gene therapy, and clinical trials execution as the company experiences double-digit growth.
Novartis hopes to eventually recruit ‘a significant portion’ of patients into a decentralized clinical trial model that has the potential to increase the company’s reach globally, says exec.
Sanofi will license more than ten R&D assets to Evotec as part of an open platform alliance designed to advance anti-infective drug discovery and development.
Theradex Oncology will support two Phase II clinical trials evaluating OncBioMune Pharmaceuticals' immunotherapy cancer vaccine and has released a clinical trial management system (CTMS).
Elligo Health Research is partnering with Saama Technologies to build a new technology platform, which it says will help sponsors achieve their objectives faster.
The European Medicines Agency (EMA) has recommended the immediate suspension and recall of AbbVie and Biogen’s multiple sclerosis drug Zinbryta (daclizumab).
The US FDA warnings sent to Chinese and Hong Kong-based firms are the latest examples of OTC makers struggling to comply with pharmaceutical standard GMP.
Novartis is expanding its strategic alliance with Science 37 and has committed to conducting up to 10 new clinical trials – blending both virtual and traditional models – over the next three years.
Altasciences Clinical Research has received iCardiac/ERT certification, which the CRO says assures clients that the critical nature of their study’s cardiac data collection is well understood.
The Czech Republic, Greece, Hungary, and Romania have joined the EU-US Mutual Recognition Agreement, a deal which aims to simplify cross-Atlantic site inspections.
Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.
Nearly one-sixth of clinical trials registered in both the US and EU have discrepancies in their completion status, errors which undermine trust in the industry and medicine, say researchers.
Grand River Aseptic Manufacturing (GRAM) has purchased a new syringe filler to help meet "the rising demand" for parenteral development and manufacturing services.
The FDA is seeking legal action against a 503B registered outsourcing facility, which is in the process of requesting an emergency hearing to file a restraining order against the agency.
Only marketing authorisation holders, and not CMOs or third-party logistic providers, will be able to report to the European Hub for serialisation compliance, says drug database coordinator EMVO.
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.
Parexel names former INC Research executive Jamie Macdonald as its new CEO – with discussion that Gregory Rush will follow after his early departure from Syneos.
BioDuro has acquired Molecular Response LLC and its translational oncology research platform, which includes a biobank of more than 100,000 viable tumor specimens.
Dutch authorities say the EMA’s permanent headquarters will be completed by November 15, 2019 – more than seven months after the agency’s relocation deadline.
LabCorp’s Covance Drug Development business has entered into a strategic technology agreement with GlaxoSmithKline plc (GSK) through which the company will use several of the CRO’s software solutions.
Uber has selected Bracket as a launch partner for its new healthcare offering which aims to expedite patient transportation – an oft-cited barrier to clinical trial participation.
A clash between Storm Emma and Arctic temperatures over Ireland has forced the closure of two Takeda sites in Dublin, and Jazz Pharmaceuticals’ Athlone facility.
With fewer global mid-sized contract research organizations (CRO) through consolidation, some stakeholders are expressing concern that the industry could become a monopoly – “we may be getting there,” one expert said.
Regulus Therapeutics has entered into an oligonucleotide synthesis collaboration with STA Pharmaceuticals for research and mid-scale non-GMP/cGMP manufacturing.
