The Association of Clinical Research Professionals (ACRP) has published a new guidance addressing the standardization of competence required for clinical trial monitors.
Antares Vision is expanding at a larger facility to help meet customer demand ahead of looming regulatory deadlines, which have driven its investment and growth.
The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.
API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.
Researchers need to design more translationally relevant animal studies to improve the potential for success in human clinical trials, according a recent report.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.
Atlas Genetics has said it will expand manufacturing capacity for cartridge-based STI tests at a UK facility owned by drug delivery technology firm Bespak Europe ltd.
Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.
BriaCell Therapeutics Corp. has submitted a chemistry, manufacturing and control (CMC) amendment to the US FDA before its planned stem-cell based vaccine trial for late stage breast cancer.
IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.
This year, DCAT Week ’17 attendees can expect several new additions to the industry event as it gathers at its new location next month in New York City.
AMRI has entered an alliance through which the global contract research and manufacturing organization will gain access to "new avenues of drug discovery."
Lannett Company, Inc. has announced it will invest $50m into its generic analgesic manufacturing subsidiary Cody Labs, creating 45 new jobs in the Wyoming facility.
Quotient Clinical has acquired SeaView Research – with another US acquisition to be announced next week, as the company looks to expand its US footprint.
DHL Global Forwarding is opening four new temperature-controlled storage chambers in San Juan this year after investing nearly $1m in the market in 2016.
If reinstated, Donald Trump’s order restricting travel to the US would hurt the cell therapy sector according to the International Society for Cellular Therapy (ISCT).
Rentschler Biotechnologie has announced a strategic alliance with Leukocare through which the CDMO hopes to emphasize drug formulation as a “key success factor” in drug development.
Unconfirmed reports suggest Laboratory Corporation of America Holdings (LabCorp) is in talks to acquire contract research organization Pharmaceutical Product Development LLC (PPD).
Thermo Fisher Scientific, Inc. saw revenue grow 8% in 2016, mostly due to acquisitions of new Chromotography and mass spectrometry tech and expanding its Bioproduction.
ChemDiv is providing Janssen Research & Development with access to its small molecule discovery platform resources as part of a hit identification collaboration.
Patheon could reap the benefits of President Donald Trump’s call for increased drug production in the US by upping capacity utilisation an analyst says.
A US-subsidiary of the Chinese CDMO Porton Fine Chemicals Ltd. has bought the New Jersey based small molecule API contract research organisation, J-STAR Research, Inc.
STA Pharmaceutical Co., Ltd. has announced it will hire approximately 100 additional R&D staff and expand its small molecule API and intermediates facility in Changzhou, China.
Outsourcing companies are expected to witness “significant investments” from private equity and venture capital, despite decreasing investment in the overall healthcare industry.
The Novo Nordisk Foundation has awarded a DKK118m ($17m) grant to fund development of a fermentation pilot plant for cell line scale up experiments at the Technical University of Denmark.
