UPS has entered into a definitive purchase agreement to acquire Marken, a global, privately-held provider of supply chain solutions to the life sciences industry. The transaction, which provides UPS with growth opportunities across the life sciences customer base, is expected to close by December 31, 2016, subject to customary conditions and regulatory approvals.
When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.
Clinical news roundup for the week of August 22, 2016 with information on the Bioclinica acquisition by Cinven, SCRS Eagle Award finalists, supporting kids with brain tumors, reducing risk in adaptive trials, Zika testing in humans, and more.
Pain management company Scintilla Pharmaceuticals has announced it will acquire SCILEX Pharmaceuticals to bolster its pain management business. SCILEX is engaged in the development and commercialization of products focused on the treatment of pain. Its lead product candidate, ZTlido, is a branded lidocaine patch formulation being developed for the treatment of postherpetic neuralgia, the chronic pain that sometimes develops with shingles.
The clinic has extensive experience with a range of trials such as bioequivalence, bioavailability, pharmacokinetic, pharmacodynamic, definitive QTc, drug-drug interaction, proof-of-concept, rising dose and Phase IIa patient studies. The center also has expertise in vaccine and delivery device study design and conduct.
For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.
The positive effect of electronic data capture (EDC) on the increase of data quality and on the decrease of time to generate clean data is well known. Today the question no longer is “Shall we use EDC instead of paper work?” but to gain insight in the advantages and pitfalls of the various solutions available.
As the world’s largest privately held provider of global communication and technology solutions to the life sciences industry, TransPerfect offers an end-to-end solution to handle all aspects of pharmacovigilance and safety management in over 170 languages.
Whether you are heading in to a meeting with the Sponsor’s management team, at lunch, dinner, stuck in traffic, at another site, or really anywhere else, you may be away from your laptop but you’re not out of range of critical notifications.
Metabolic diseases (e.g. obesity, type 2 diabetes, and hypertension) are a rapidly expanding health care concern. Although there is a high demand for novel therapies, the challenges are substantial as existing drugs typically fail due to lack of efficacy or safety, and clinical studies often extremely large and protracted.
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.
MMS Holdings Inc. recently announced that it has successfully executed disclosure management services for several clients and is poised to make strides in this area with its proprietary software, TrialAssure.
Quanticate, one of the worlds leading data-focused CROs specializing in the provision of biostatistics, programming, data management, medical writing and pharmacovigilance services has been named category winner for Innovation in the 2013 CRO Leadership Awards presented by Life Science Leader magazine.
ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has agreed, subject to certain closing conditions, to acquire the Clinical Trial Services Division of Cross Country Healthcare, Inc., for a cash consideration of $52 million, plus an earn-out of up to $3.75 million related to certain performance-based milestones.
Comprehensive, referenced and well-structured data allows users to increase the speed and accuracy of decision making in the drug development process.
WuXi PharmaTech, a leading contract research organization with operations in China and the United States, and PRA, a leading global clinical contract research organization, recently announced that they have signed a joint venture agreement to offer a broad platform of Phase I-IV clinical trial services in China, Hong Kong and Macau.
Accelovance, an award-winning clinical services company, announced recently the addition of Stephan A. Bart Sr., MD as Chief Medical Officer for the organization.
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
DATATRAK International, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced its participation at several industry events during the month of October.
Researchers have launched a clinical trial to evaluate the drug candidate DEX-M74 as a treatment for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM). National Institutes of Health scientists from the National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) will conduct the clinical trial at the NIH Clinical Center.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.
Quanticate, a leading global data-focused clinical research organization (CRO), today announced expansion of its capabilities in India with the opening of a new office in Bangalore, India.