By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
Compass Pathways has selected Worldwide Clinical Trials to conduct studies of its investigational psychoactive therapy, designed for patients with treatment-resistant depression.
DHL Global Forwarding has certified seven of its air freight stations according to the CEIV Pharma Standard of the International Air Transport Association (IATA).
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
CTI Clinical Trial and Consulting Services (CTI) and Eurotrials have consolidated to create a full-service contract research organization (CRO) with a global footprint.
Plasticell has teamed with Anthony Nolan to access the latter’s cord-blood bank and boost patient recruitment for its allogeneic haematopoietic stem cell transplantation (HSCT) therapy trials.
It is an “exciting time in drug discovery,” says Charles River CSO as the company expands its CRISPR/Cas9 service offering with a license from ERS Genomics.
Science 37 and Otsuka Pharmaceutical have announced a strategic collaboration through which the global healthcare company aims to explore patient-centric clinical trials – “with fewer physical restrictions and greater efficiencies,” says CEO.
Emergent BioSolutions says it is looking to expand auto-injector manufacturing capacity due to growing demand for its nerve agent antidote product Trobigard.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.
Ncardia is ‘moving up the value chain’ as it shifts from a product-focused company to a preclinical contract research organization (CRO) and grows in size – and clout, says VP.
Novo Nordisk’s once-weekly diabetes treatment Ozempic has been given the US FDA green light, and the firm said it expects approval in Europe and Japan early 2018.
Regulatory changes and promising starts ups are fueling demand for outsourced services in China – and as venture capital flows into the country, the pace of innovation is expected to accelerate, says STA Pharmaceutical.
The US FDA says it observed quality documents in the teeth of a staff room shredder and lenient computer access at Glenmark’s Baddi facility in India, which was issued a Form 483 last week.
Rumours fumes from Pfizer’s Viagra API facility are ‘arousing’ locals have been quashed by the drugmaker, which said emissions from manufacturing sites have no effect on human health.
The US Food and Drug Administration (FDA) has released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases.
Crucial Data Solutions, Inc. and its strategic partner Zircon Technologies have teamed up to release a “first-of-its-kind” software solution developed to accelerate the clinical trials process.
Blue Oak Pharmaceuticals, Inc. and PGI Drug Discovery LLC (PsychoGenics) have entered into a drug discovery partnership to optimize novel treatments for brain disorders and psychiatric conditions.
ERT’s purchase of iCardiac Technologies follows three months after its purchase Biomedical Systems, the additions of which further increase the company’s portfolio of cardiac safety solutions.
Australia’s consumer commission has accused GlaxoSmithKline and Novartis of marketing and pricing two of its Voltaren pain relief products – which contain the same active ingredient – differently.
Slovakian contract manufacturer Saneca says the opportunity to tap the Russian market is huge despite protectionist policies and changing GMP inspection requirements.
Seaweed extracts can reduce tumour growth and improve the effectiveness of chemotherapy says Marinova, which is developing the compounds for pharmaceutical applications.
Ncardia has entered into a non-exclusive licensing agreement with Evotec through which the drug discovery solutions company will gain access to Ncardia’s stem cell derived cellular disease modeling IP.
Apprentice has raised $2.5m in venture funding for its augmented reality solution, Affinity, which is designed to improve productivity, audit readiness quality, and safety within pharmaceutical lab and research environments, says CEO.
By Dennis Salotti, vice president of operations, The Avoca Group
Making the shift in the pharmaceutical industry from a risk-averse approach to overseeing clinical trials to a risk-based approach is – quite frankly – earthshaking.
Wasdell Group will invest €30m in a packaging, testing and distribution facility in Ireland, which it says could help UK and US customers serve European clients post-Brexit.
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Cannabinoid firm GW Pharmaceuticals says it is “inspection ready” as it prepares for potential US approval of its epilepsy candidate Epidiolex (cannabidiol or CBD).
Tjoapack has tripled its bottle packing capacity as increased legislative complexity, ageing populations and pricing pressures drive demand for outsourced packaging solutions.
Transitioning to a single strategic contract research organization (CRO) reduced Bayer’s administrative burden, but the restructuring was met with some resistance, said the firm.
Clinical research’s sordid past has “left a stain” on the medical community as it tries to gain trust among minority populations and increase clinical trial participation, which remains staggeringly low, says Northwell Health senior VP.
AMRI has more than doubled its bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity in response to an increasing need for sterile API and an evolving pharma pipeline, says CCO.
Systech International has teamed with NKP Pharma to expand track and trace services in India, saying it hopes to “wean” Indian pharmaceutical firms away from local serialisation providers.
There are several opportunities for the industry to introduce connectivity into the pharmaceutical supply chain, but a one size fits all solution will likely not be the answer, says Novartis head.
Viagra Connect will be available without prescription in the UK following a request from drugmaker Pfizer, which is preparing a manufacturing site in France for the demand.
Corning says it is planning to increase manufacturing capacity for its Valor Glass packaging technology to take advantage of a multi-billion dollar industry.
Pharmaceutical companies should share their outsourcing strategy across the company in order to ensure success, says panel discussing the benefits and challenges of working with contract organizations.
Brammer Bio has completed renovations at its gene therapy manufacturing facility in Cambridge, MA amid industrywide capacity concerns as more biologics enter late-stage clinical trials.
Almac will “eventually” move into sterile injectables says executive Brian Eastwood, adding the market has good potential for growth in the contract manufacturing space.
