Amid the constant battle with biology and new complexities in fighting disease, persistence seems to be paying off for drug developers. Major driving forces include the rise of CAR -T and other gene therapy, newly discovered cancer targets, better patient…
Cellectis gets FDA go-ahead to restart fatal CAR-T trial
The FDA has said Cellectis can restart trials of its ‘off-the-shelf’ CAR-T cancer immunotherapy, after revising protocols in a trial that killed one patient and left another with life-threatening complications. UCART123 is a CAR-T therapy produced independently of the patient,…
Speedy review for Jazz’ high-risk AML chemo
Dublin, Ireland-based Jazz Pharmaceuticals’ Vyxeos is being given a speedy review in Europe as a treatment for certain types of high-risk acute myeloid leukemia (AML). The European Medicines Agency’s Committee for Medicinal Products for Human Use is considering the chemotherapy’s…
Global Clinical Research NEWS From OCT-2017
October 31, 2017 | October was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Clinerion, Novaseek, goBalto, and more. Clinerion expands the global coverage of its services in the Americas, adding 60…
Factory CRO acquires MileStone Research Organization
Factory CRO, a leading global CRO focused on medical devices and IVDs, has announced the acquisition of MileStone Research Organization. MileStone, located in San Diego, specializes in clinical research and reimbursement solutions for the medical device and biologics industries. “The…
OCT expands presence in U.S.
OCT, an Eastern European CRO, expands its presence in North America. In October 2017, OCT’s representative office in the U.S. has been strengthened by additional employees. In particular, the U.S. team was complemented by Anna Yanaeva, Business Development Director. “We…
Dirty Rooms, Equipment Found At Dr Reddy’s Plant, Banned From Europe Exports
Hyderabad, Oct 29 (PTI) A German government’s drug regulating agency, which audited one of Dr Reddy’s Laboratories manufacturing facilities here, found “dirty rooms and equipment”, among other violations, during an inspection. According to the inspection report by Central Authority…
What Europe’s New Privacy Regulations Means For US Trials
In less than eight months, The European Union’s General Data Protection Regulation goes into effect. The GDPR applies to all types of data, but it will have a special impact on clinical trials, even ones run by US companies. The…
FDA approves first smartphone compatible heart monitor
Abbott’s first-of-a-kind smartphone compatible heart monitor has been approved by for use in the US. Now with the FDA’s blessing, the Confirm Rx Insertable Cardiac Monitor (ICM) can be used by US doctors to remotely monitor for abnormal heart rhythms.…
Microsoft, Parexel team to accelerate drug development
Microsoft is partnering with life sciences consulting firm Parexel to develop software capable of accelerating drug development. The collaboration will use Microsoft’s Azure cloud computing platform, onto which Parexel will move its Informatics software. Informatics’ core technology is Perceptive MyTrials…
