Party drug MDMA has been claimed to be effective in helping treat Post-traumatic stress disorder (PTSD) patients, with the FDA approval for a Ph III trial to go ahead in the US.
Wearable technology has been making inroads in the clinical trial industry, however several challenges and concerns surrounding lack of experience still stand in the way of increased adoption.
Vetter's new data processing center at its headquarters in Ravensburg, Germany has met all criteria required to meet the European DIN EN 50600 standard.
Dongying Tiandong Pharmaceutical Co., Ltd does not do enough to ensure the crude heparin it uses is free potentially lethal contaminant OSCS according to the US FDA.
Cellectar Biosciences has announced a partnership with the Centre for Probe Development and Commercialization (CPDC) to establish manufacturing capacity ahead of the company’s NCI-supported Ph II trial of CLR 131.
The FDA is still in “the early stages” of overseeing 503B outsourcing facilities, but efforts continue as concerns surround the oversight of drug compounders, according to a recent report by the US Government Accountability Office (GAO).
Ideal Cures has added a fourth manufacturing location at Sikkim in India to meet the demand of its local customers and to expand its global customer base.
The US FDA has cleared Lupin to restart production of drugs for the US market at its plant in Goa after the Indian firm fixed problems observed by agency inspectors.
A written quality agreement between a sponsor and a contract manufacturer can facilitate compliance with cGMP, the US FDA says in its finalised guidance.
The acquisition of a stick sachet packaging line from Merz expands Almac Group’s MHRA/FDA-approved UK commercial packaging facility to meet the growing demand for specialist packing solutions.
The full accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council is the company’s fourth as it looks to have all of its sites accredited.
While the temperature is dropping outside, keeping clinical trial therapeutics and biospecimens at the right temperature during transportation is a challenge year-round.
Clinical Ink has announced the latest release of SureSource Engage, which enables clinical trial sponsors and contract research organizations (CROs) to increase patient adherence.
Efforts by Wockhardt to fix violations at drug plant in Wrexham, Wales are inadequate according to the US FDA which detailed its concerns in a warning letter this week.
The new collaborative initiative will be led by QuintilesIMS, with founding partners including Bristol-Myers Squibb, Eli Lilly and Company, Merck KGaA, and Pfizer.
Sanofi Pasteur has confirmed the decision to stop making the bladder cancer drug TheraCys was prompted by long running problems at the Toronto manufacturing plant where it is made.
The US FDA has cleared Aduro Biotech to recruit for trials of its listeria-based immunotherapies after the firm modified protocols to reduce the risk of subjects developing listeriosis.
The new eConnect program enables integration of physician systems to clinical research and has the potential to improve data quality, decrease site visits, and expedite payment, says Medidata’s president.
Bracket has announced the strategic acquisition of CLINapps as it focuses on the “tremendous opportunities” to make the clinical supply chain more efficient.
Continuous manufacturing and sterile production innovations have dominated requests to participate in the US FDA’s Emerging Technology programme, the Agency says.
The US FDA has asked Sekisui Medical to specify how it will resolve data integrity issues uncovered during an inspection of its API plant in Hachimantai, Japan in June.
Larger CMOs are likely to be better for commercial manufacturing but small players offer niche services and agility for lower volumes, say Symbiosis and Idifarma.
Eagle Pharmaceuticals Inc. has announced its intention to buy Arsia Therapeutics citing its formulation viscosity reduction platform as the driver for the deal.
Parexel has launched an Identification of Medicinal Products (IDMP)-focused solution to help biopharmaceutical companies meet impending regulatory requirements.
Cellectar Biosciences has announced INC Research as its contract research organization (CRO) for the company’s Phase II trial of CLR 131 in hematologic malignancies.
An increase in resources dedicated to pediatric drug development is proving promising in the industry, according to a new analysis completed by the Tufts Center for the Study of Drug Development.
Envigo has launched an integrated program of in vitro technologies that help predict the likelihood of compounds causing drug induced livery injury (DILI) as part of its new De-Risking Program.
