The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.
Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.
Contract research organisation (CRO) ICON has taken a hit to its book-to-bill ratio after Pfizer dropped its anti-cholesterol candidate bococizumab in November.
Charles River Laboratories International Inc. has sold off its CDMO business QS Pharma LLC, saying the small-molecule manufacturing business was “not optimized” within the firm's portfolio.
Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.
Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.
End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.
Almac Discovery and the Royal College of Surgeons in Ireland (RCSI) and have announced a research collaboration aimed at understanding how to target therapy-resistant cancer tumors.
PRA Health Sciences and Takeda Pharmaceutical Company are expanding their partnership to Japan as Takeda accelerates the “transformation” of its R&D organization.
CMOs will struggle to compete with large in-house capacity investments, according to Results Healthcare which predicts a decline in outsourced biomanufacturing.
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.
