CSafe Global has opened a new service center in Chicago, IL to support life science companies moving temperature-sensitive products in the Midwest US market.
JSR Corporation has acquired Crown Bioscience for more than $405m – the company’s largest investment to date as it turns its attention towards preclinical support for biopharma, says Life Sciences president.
The European Commission has publish a draft revision of its GMP guidelines on the production of sterile drugs with tweaks to recommendations on clean rooms, sealing technologies and single-use systems.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
Fresenius Kabi says drug ingredients made at an Indian plant hit with a US FDA warning letter meet quality specifications and has reiterated that tests were halted for technical reasons.
Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.
This past year, the clinical trials landscape continued to shift and adapt to promising trends—including mobile technology, real-world data, and patient engagement—that can help us build a stronger clinical trials system.
The pharmaceutical industry made significant advancements towards global regulatory harmonization in 2017 – despite a highly-charged political environment on both sides of the Atlantic.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
A piece of glass found in a vial of generic injectable product Pantoprazole Sodium has prompted AuroMedics Pharma to issue a nationwide voluntary recall.
The Good Pharma Scorecard aims to quantify what makes a “good” pharmaceutical company – as 91% of Americans think companies put money before people, says Bioethics International founder.
In 2018, the industry can expect risk-based everything, cloud-first strategies, and a focus on modernization as companies look to stand out amongst the competition, say Veeva Systems execs.
Parexel has enhanced its clinical data service offering with the addition of new features to further support data collection and analysis as well as adaptive trial design.
Merck KGaA says it will provide technology and training to a local team in Sub-Saharan Africa, to help establish a dedicated human vaccine manufacturing facility.
The National Institutes of Health (NIH) has created a new clinical trials consortium with a model focused on streamlining research and diverse recruitment.
UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.
TriNetX has announced the general availability of its natural language processing (NLP) service, which uses sophisticated algorithms to extract data from physician notes and clinical reports, says CTO.
By Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations (ACRO)
As the great Yogi Berra once said, “It’s tough to make predictions, especially about the future.” But it is safe to say that after a year of considerable consolidation and change, the CRO industry anticipates continuing and potentially rapid evolution...
Aurobindo Pharma Limited has denied rumours it is interested in Orchid Pharma after a report suggested it is vying with Dr Reddy’s to acquire the bankrupt API firm.
Harpoon Therapeutics has selected CMC Biologics to develop and manufacture three molecules for cancer treatments at the CDMO’s facilities in California and Washington State, US.
Augmented reality has unlimited potential and will address the pharmaceutical industry’s need for greater control over efficiency, safety, and reliability, says Apprentice CEO.
Three-dimensional printing technology is attracting increased attention from the US FDA say Aprecia and Cycle, which have announced a partnership to develop 3D-printed orphan drugs.
Arrowhead Pharmaceuticals says it is looking to move six candidates into the clinic within the next year thanks to its newly unveiled RNAi delivery platform.
update - CEO: ideal model is two to four API plants and six to eight drug facilities
Teva Pharmaceutical Industries will reduce its workforce by 14,000, rejig its generics portfolio and speed up optimization of its plant network as part of a $3bn (€2.5bn) cost saving plan.
Advertising, social media and individualised patient recruitment strategies can improve participation numbers according to clinical site executives, who say they favour a personalised approach.
Only eight of the top 40 CROs are Privacy Shield Framework-certified, says Science Exchange CEO as the company continues to rack up partnerships with pharma companies looking to streamline outsourcing efforts and mitigate risk.
Parexel has launched its first offering as part of its alliance with Microsoft, through which the companies are looking to redefine the life sciences industry, says CRO.
Boehringer Ingelheim is actively collaborating with a variety of partners to help increase patient diversity in clinical trials – and it will continue to identify new partners as it moves forward with its efforts, says SVP.
